CortexinКортексин
What the studies found
Comparison in people · 2014
Cortexin and childhood autism: Larkina and Khaletskaya’s preschool comparison
- Overall speech development
- No statistically significant changep = 0.119
- Social communication
- No statistically significant changep = 0.058
- Verb selection and use
- Improvement reported on an individual taskp < 0.001 (printed as 0.000)
At three months, the Cortexin autism arm showed changes on selected word-association tasks. Overall speech development (p = 0.119) and social communication (p = 0.058) did not reach statistical significance.
More reported outcomes
- Noun selection and use
- Improvement reported on an individual taskp = 0.001
- Word association
- Improvement reported on an individual taskp = 0.019
- Overall speech development in the risperidone arm
- A statistically significant within-arm change was reportedp = 0.039
- Social communication in the risperidone arm
- No statistically significant within-arm changep = 0.765
Study notes · methods, sources and limitations
Participants or model 130 children aged 4–6 with language delay: 45 with residual organic brain disorders, 45 with ADHD, and 40 reported with early childhood autism. The printed autism treatment-arm counts are inconsistent with 40.
Design Active-comparator study with reassessment three months after rehabilitation began. Both autism arms received speech-language and psychoeducational support.
Important limitations
- The article reports 40 autistic children, but lists 23 receiving Cortexin and 22 receiving risperidone. The autism arm denominators cannot be reconciled. All children received speech-language and psychoeducational rehabilitation. The reported p-values compare each arm with its own baseline. Allocation concealment and masking were not established. Multiple task comparisons, limited follow-up and missing autism-arm adverse-event counts limit interpretation.
- Separate within-arm p-values do not test superiority. The reported arm counts sum to 45 despite a stated autism cohort of 40. The 2015 dissertation describes the same research program.
Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(12):94–98. PMID 25726787. · Publication record
Comparison in people · 2010
Endonasal Cortexin for chronic fatigue syndrome: Melnikova dissertation and companion reports
- Author-rated improvement in the 100-person comparison
- 88% with Cortexin electrophoresis, 60% with galvanization alone and 44% with sham, as summarized in 2013.
- Additional results in the dissertation excerpts
- Reduced asthenic and neurotic symptoms in 88% and pain in 90%, with improved neurological status in 92%. The excerpts do not identify the denominator for each measure.
- Duration of reported benefit
- The 2010 excerpt and 2017 paper describe benefit at one year in all observed treated patients. The 2010 excerpt reports 25% beyond one year. The 2020 abstract says most still benefited at one year. The publications reviewed give no follow-up denominator for this comparison.
88% with Cortexin electrophoresis, 60% with galvanization alone and 44% with sham, as summarized in 2013.
Study notes · methods, sources and limitations
Participants or model The 2017 paper reports 100 adults aged 28–45 with historical CFS, mean age 31.5 ± 4.8 years. The arms were Cortexin electrophoresis (50), endonasal galvanization alone (25), and sham (25).
Design Melnikova’s dissertation excerpts identify endonasal electrophoresis using a Potok-1 device and describe bench tests of Cortexin stability under direct current. The accessible CFS sources do not establish the Cortexin amount, solution concentration or session schedule. A later glaucoma paper citing her method used 10 sessions at 1–2 mA, with 10 minutes for the first three sessions and 15 minutes thereafter. Those settings are documented for glaucoma.
Important limitations
- The available dissertation material consists of excerpts. Allocation, masking, adverse-event counts, follow-up denominators, and a required post-exertional malaise criterion could not be verified. The comparative percentages reflect the authors’ combined clinical and instrumental assessment. The 2017 paper coauthored by Melnikova cites her 2010 dissertation and reports the same 50/25/25 allocation as the 2020 abstract. Their EEG and cognitive results use nearly identical wording. The reports likely reuse the same cohort and contribute a single 100-person comparison to the evidence summary. Participant-level confirmation is unavailable.
Candidate of Medical Sciences dissertation, Moscow, 126 pp., RSL 01004662270 · Dissertation excerpts and companion publications
Comparison in people · 2026
90-day combination study reported cognitive and mood improvements
- Depression response, ASIA A
- 90% versus 20% achieved at least 50% HDRS-17 reductionCortexin plus citicoline and rehabilitation versus standard care; subgroup denominators not suppliedDay 90No between-group p-value or confidence interval supplied in the abstract
- Cognitive change, ASIA A
- MoCA +2 [1.75; 3.25] versus +1.5 [1; 2] pointsCombination versus standard care; median changes with source-reported bracketed intervalsDay 90
- Depression change, ASIA A
- HDRS-17 −10 [−12.25; −9] versus −5 [−5.75; −2] pointsCombination versus standard careDay 90
At day 90, the combination groups had larger reported improvements in cognition, depression and fatigue than standard care. In the ASIA A stratum, at least 50% depression-score reduction occurred in 90% versus 20%.
More reported outcomes
- Fatigue change, ASIA A
- Asthenic State Scale −33 [−34.25; −31.75] versus −26 [−26; −25] pointsCombination versus standard careDay 90
- Cognitive change, ASIA C
- MoCA +2 [2; 3] versus +1.5 [1; 2] pointsCombination versus standard careDay 90
- Depression change, ASIA C
- HDRS-17 −12.5 [−14; −9] versus −8 [−8.75; −6.25] pointsCombination versus standard careDay 90
- Fatigue change, ASIA C
- Asthenic State Scale −31 [−32; −30] versus −22 [−23.75; −22] pointsCombination versus standard careDay 90
- Serious adverse events
- None reportedOther adverse-event counts and subgroup denominators absent from abstract; not evidence of long-term safety
Study notes · methods, sources and limitations
Participants or model 60 adults aged 18–55 after gunshot-related spinal-cord injury; four groups defined by ASIA A/C severity and treatment
Design 60 adults aged 18–55 after gunshot-related spinal-cord injury; four groups defined by ASIA A/C severity and treatment; open prospective longitudinal comparison against standard care; assessment to day 90.
- Assessment schedule
- Days 1, 15±2, 30±2 and 90±7
Important limitations
- Cortexin was combined with citicoline and rehabilitation. Open assignment and missing subgroup uncertainty prevent a Cortexin-specific effect estimate.
- Prospective open comparison; randomization and allocation concealment are not established by the abstract. Citicoline and rehabilitation were co-interventions; effects cannot be attributed to Cortexin alone. Subgroup denominators, confidence intervals and between-group p-values are not supplied in the abstract. Mood and cognitive outcomes do not demonstrate spinal-cord repair, restored walking or reduced disability.
- Results concern the combined treatment program. Open assignment, concurrent rehabilitation and missing subgroup uncertainty prevent a reliable Cortexin-specific effect estimate. No claim of spinal-cord regeneration is supported.
Zh Nevrol Psikhiatr Im S S Korsakova. 2026;126(10):63–70. PMID 42973255 · Original clinical journal publication
About Cortexin
A tissue-derived mixture of small peptides from animal cerebral cortex, studied as a neuroprotective preparation. It is a mixture rather than one defined peptide.
Identity / background source ↗
Research background
A tissue-derived preparation with Russian stroke, cognitive, pediatric and other clinical reports. Study designs vary; the independent stroke review is shown alongside favorable original reports. None validates the personal WHOOP diary.
Autoimmune research: disease-specific findings, immune effects and open questions ↗
Russian ME/CFS and fatigue research ↗
Pregnancy and offspring research
The 2014 abstract reports lower offspring mortality with Cortexin, without an exact percentage or group size. Learning performance was ranked below Pinealon and Deltaran. This is maternal animal exposure, distinct from neonatal Cortexin treatment.
Conference-level evidence; missing untreated-hypoxia comparator and internally contradictory caspase-3 statements limit interpretation.
Reported findings and methods ↗ · Pregnancy research: full evidence review and archive ↗
Archival sources and remaining questions ↗ · Conference sources and research collaborators ↗ · Pyatibrat tables: recovery values and conflicting counts ↗ · Shustov papers, coauthors and archival leads ↗
More study findings
Comparison in people · 2014
Cortexin, shooting and race performance in biathletes
- Shooting misses and time
- 26% fewer misses and 2.5 s less total shooting timeReported in the Cortexin arm after ten days. The 26% result also appears in the related patent trail.
- Speed across the 10 km race
- +5.6% in the Cortexin armThe authors describe the increase as 2.6% better than the comparator’s result.
- Integrated work-capacity score
- +5.5% Cortexin versus +2.9% placeboThe paper cites RU2469730C2 alongside the result.
The paper reports 26% fewer shooting misses in the Cortexin arm after ten days, 5.6% faster course speed and a 5.5% versus 2.9% increase in an integrated work-capacity score.
More reported outcomes
- Moving-target reaction accuracy
- 1.6-fold versus placeboReported p<0.05. The paper cites RU2469730C2 alongside the result.
- Physiology and safety reporting
- Systolic blood pressure rose and heart rate rose slightly in the Cortexin groupNo numerical blood pressure or heart-rate values or systematic adverse-event table were supplied in the checked article.
Study notes · methods, sources and limitations
Participants or model 20 biathletes, 10 Cortexin and 10 placebo.
Design Author-described double-blind comparison of 10 Cortexin and 10 placebo athletes during a 10 km biathlon race with four shooting stages.
Important limitations
- The article cites RU2469730C2 and repeats its 26% shooting result. Its relationship to the 2011 paper and 2012 congress cohort remains unresolved.
- The article cites RU2469730C2 and repeats its 26% shooting result. Its relationship to the 2011 paper and 2012 congress cohort remains unresolved. The 127 vs 53 s race-time result attributed to the 2011 paper in a later review is a separate source claim.
- The 20 reported participants are held out of the archive tally pending cohort matching.
Scientific Notes of Lesgaft University. 12(118):210–213 · Scientific Notes of Lesgaft University. 12(118):210–213
Animal research · 2018
Original hypoxia, heat and cold results
Study of multiple preparations
- Cortexin · course hypoxia and heat
- 5.2±3.2 min at 1 mg/kg in hypoxia; 88.6±2.4 vs 96.5±5.2 min at 5 mg/kg in heatSeparate stress experiments and different doses. The heat endpoint shortened.Both selected contrasts p<0.05 as marked
- Publication overlap
- 2014 Table 11 and 2018 Table 1 repeat the same valuesCounts as one reported experiment. Both publications also describe a distinct acute mouse screen.
The 2014 and 2018 course-hypoxia tables repeat the same experiment.
Study notes · methods, sources and limitations
Participants or model Outbred male mice in the single-dose hypoxia screen; male rats (180–210 g) in the repeated-dose hypoxia table. Separate temperature experiments.
Design The single-dose mouse screen used 10,000 m, 8–10 per dose in the 2018 report (6–10 in the 2014 book). Table 1 instead reports a three-day rat series tested at 11,500 m the next day. Arm sizes for the repeated-dose table are not stated in the audited passage.
Important limitations
- Separate mouse and rat protocols. Human performance was not assessed.
- The 2018 rat course results and 2014 book table belong to one evidence family. The book omits an explicit course-series species and altitude in the adjacent paragraph. Short survival in an extreme animal model is separate from human endurance or safety.
- The papers distinguish the single-dose mouse screen from the three-day rat protocol. The matching table adds no independent animals or human participants.
Biomeditsina 2018(2):4–14, Tables 1–3; paired with 2014 Volume III Table 11 · Biomeditsina 2018(2):4–14, Tables 1–3; paired with 2014 Volume III Table 11
Comparison in people · 2014
Single intranasal exposure at simulated altitude
Study of multiple preparations
- Cortexin · complex visuomotor reaction latency
- 423±12 vs 381±9 msSlower response, even with some favorable markers.p<0.01 versus saline
Table 12 compares four small peptide arms with saline at 4,500 m.
Study notes · methods, sources and limitations
Participants or model Men aged 20–25 with asthenic or immune-status features. Four active arms of 6–8 each and 11 saline controls.
Design Author-described random assignment. Exposure for 60–80 min at simulated 4,500 m with postural testing, a three-minute 100 W cycling load, motor tasks and blood measurements.
Important limitations
- Participant overlap with the broader aerospace archive remains unresolved.
- Small arms, numerous endpoints and several comparisons reported at p<0.1. Exact allocation counts and overlap with the Medilab lineage remain unresolved.
- The 4,500 m protocol differs from Cheprasov’s 5,000 m comparison. Participant independence has not been established and this series adds no people to the historical tally.
Essays on Sports Pharmacology, Vol. III, Vectors of Pharmacoregulation, Chapter 7, pp. 177–180, Table 12 · Essays on Sports Pharmacology, Vol. III, Vectors of Pharmacoregulation, Chapter 7, pp. 177–180, Table 12
Animal research · 2014
Twenty-one-day loaded swimming comparison
Study of multiple preparations
- Cortexin · first swim
- 84.3±3.9 → 227.25±4.5 sDay 0 to 21. Second and third day-21 swims: 159.0±4.28 and 204.6±10.9 s.
- Control · first swim
- 63.8 → 71.9±3.9 sDay 0 to 21. Control rose to 91.4±3.3 s on day 28.
- Cortexin · recovery index
- Transient deterioration at day 14Recovery and first-swim duration are separate outcomes.
Cortexin and Dalargin were given to separate rat arms.
Study notes · methods, sources and limitations
Participants or model Rats in separate Cortexin, Dalargin and control arms. Per-arm n remains unconfirmed.
Design Repeated forced swimming with a 7%-body-mass load. Three swims per test session measured persistence and recovery. Tests before treatment, on days 7, 14 and 21, and one week after dosing.
Important limitations
- Baseline swimming means differed.
- Unequal baseline results, non-equivalent doses and repeated training exposure limit between-group interpretation.
- The arms compare the peptides individually. They do not test a Cortexin–Dalargin combination.
Essays on Sports Pharmacology, Vol. III, Vectors of Pharmacoregulation, Chapter 5, pp. 148–151, Table 9 · Essays on Sports Pharmacology, Vol. III, Vectors of Pharmacoregulation, Chapter 5, pp. 148–151, Table 9
Comparison in people · 1997
Cheprasov’s Medilab peptide comparisons in aerospace stress
Study of multiple preparations
- Hypobaric comparison
- Thymalin: 15–20% higher work measures; Cortexin: 10–15% improvement in selected operator measuresAbstract narrative; full arm-level estimates unavailable.
- Coriolis motion tolerance
- Cortexin +89%, Thymogen +73%, Epithalamin +68%Reported tolerance-time improvement relative to control, ten per arm.
- Sustained work
- Author reported recovery of selected Thymogen-group measures to baseline by three hoursFour per arm. Cortexin and oral Bemitil plus sydnocarb were separate comparators.
The three test series covered hypoxia, motion tolerance and 24 hours of work. The abstract reports favorable task results for selected peptides and gives a tiny separate postflight Thymogen comparison.
More reported outcomes
- Postflight respiratory infections
- 1 of 4 in Thymogen arm versus 4 of 4 salineReported during the following year, a descriptive count from four pairs.
- Program headcount
- 328 stated; stage rows add to 338The 116 and 8 are subseries, with no additional headcount contributed to the historical tally.
Study notes · methods, sources and limitations
Participants or model 116 men across three stress comparisons (30, 70 and 16), plus an eight-cosmonaut comparison within the reported dissertation program of 328.
Design Hypobaric test: three arms of 10 at 5,000 m for 60 min. Motion: seven arms of 10 in a Coriolis test. Work: four arms of four at 50% of individually tolerated load. Postflight: four mission pairs, one participant per pair given Thymogen.
- Reported study exposure
- Hypoxia: intranasal Cortexin or Thymalin, 20 mg per course over two days, or placebo. Motion: single intranasal 5 mg Thymalin, Cortexin, Prostatilen or Epithalamin, or 50 µg Thymogen, with oral scopolamine 0.1 mg and placebo controls. Work: nasal Thymogen 100 µg or Cortexin 10 mg before work and after 6 and 12 h, or oral sydnocarb plus Bemitil, or saline. Postflight: intranasal Thymogen 100 µg/day for seven days.
Important limitations
- Small comparisons, incomplete outcome reporting and unclear separation from related Medilab publications.
- Small comparisons, incomplete outcome reporting and unclear separation from related Medilab publications. The 47 modeling experts were outside the participant table.
- The aerospace findings concern separate stress and recovery tasks, with no reliable pooled treatment effect.
Kirov Military Medical Academy doctoral dissertation author abstract, Table 1 and methods · Kirov Military Medical Academy doctoral dissertation author abstract, Table 1 and methods
Randomized study in people · 2008
Cortexin and other adjuncts in military combined-injury rehabilitation
Study of multiple preparations
- Cortexin · work-capacity score
- 516.0±21.4 → 569.3±5.2Day 1 to day 14. Standard care 526.1±10.2 → 509.8±12.2.Reported p<0.05 versus standard care
- Vinpotropil · work-capacity score
- 524.1±23.7 → 613.2±19.5Day 1 to day 14. Separate treatment arm.Reported p<0.05 versus standard care
- Cortexin · clinician-rated anxiety
- 13.4±2.1 → 4.5±0.6Day 14. All arms showed some improvement.
Reported work-capacity scores rose from 516.0 to 569.3 with Cortexin and from 524.1 to 613.2 with Vinpotropil. Standard care fell from 526.1 to 509.8.
More reported outcomes
- Attrition
- 16 early discharges; zero attributed to adverse effectsThe abstract does not provide a comprehensive adverse-event table.
Study notes · methods, sources and limitations
Participants or model 317 screened, 76 selected (61 men and 15 women), 60 analyzed in four groups of 15. Sixteen early discharges.
Design Author-described double-blind randomized adjunctive study. Outcomes at days 7 and 14 included asthenia, anxiety, memory and tapping-based performance. Control included B-vitamin injections.
- Reported study exposure
- Cortexin 10 mg intramuscularly once daily, Mexidol 100 mg intramuscularly once daily, or Vinpotropil one oral capsule three times daily as separate adjuncts. Standard-care comparator included B1 and B6 injections.
Important limitations
- Blinding implementation across different routes is unclear. Complete arm flow, attrition by arm and outcome units need the full dissertation.
- This is short-term treatment research in hospitalized patients after trauma. The 60 analyzed are included within the 76 selected.
Kirov Military Medical Academy candidate dissertation author abstract · Kirov Military Medical Academy candidate dissertation author abstract
Comparison in people · 2006
Savchenko’s naval rehabilitation Cortexin comparison
- Physical work-capacity normalization
- 50% vs 50%Cortexin versus control.
- Recovery index and post-treatment severity
- 80.5 vs 71.6; severity 12.62 vs 20.13Author-reported metrics and scale units.
- Psychophysiological normalization
- Emotional state 46% vs 27.3%; intellectual function 100% vs 20%; neurophysiology 83% vs 41.7%Original arm denominators and uncertainty not supplied in the conclusion.
The author reported a recovery index of 80.5 versus 71.6 in the control group. Physical work capacity normalized in 50% in both groups.
Study notes · methods, sources and limitations
Participants or model Military officers and retired personnel in a rehabilitation program. Cortexin-comparison arm denominators unresolved.
Design Military officers and retired personnel in a rehabilitation program. Cortexin-comparison arm denominators unresolved.
Important limitations
- Unresolved assignment, group sizes, concomitant care and measurement definitions. These data do not establish improved physical work capacity.
- The neutral physical outcome qualifies the broader reported pattern. The combined psychotherapy and laser groups are separate.
Doctoral dissertation, Psychophysiological correction of psychosomatic disorders in military personnel, conclusion 10 · Doctoral dissertation, Psychophysiological correction of psychosomatic disorders in military personnel, conclusion 10
Comparison in people · 2021
Cortexin and blood chemistry in elite swimmers
- Blood urea
- −42% Cortexin versus −50% salineBoth within-group changes reported p<0.001.
- Outcome scope
- Training blood chemistryThe comparison does not report timed swimming performance.
Blood urea fell in both groups and fell more with saline in the reported comparison. Race-time benefit was not measured.
Study notes · methods, sources and limitations
Participants or model 14 national-team swimmers aged 20–23, seven in each arm.
Design 21-day training camp with matched described training loads. Blood measures before and after the intervention.
Important limitations
- Small conference report, incomplete allocation and dose details, and no verified between-arm effect.
Lesgaft University proceedings, printed pp. 8–11 · Lesgaft University proceedings, printed pp. 8–11
Animal research · 2011
Intranasal carrier and injected Cortexin in rat seizure models
- Intranasal arm
- No significant protection on the reported key chronic endpointCarrier-bound formulation tested at 0.15 mg/kg.
- Injected arm
- Less severe provoked seizures after a ten-day rest1.0 mg/kg intraperitoneally in the applicable kindling schedule.
- Acute provocation
- Protocol-specific effectsRoute and dose were not matched for estimating bioavailability.
The intranasal carrier arm did not reproduce the significant delayed effect seen at 1.0 mg/kg intraperitoneally.
Study notes · methods, sources and limitations
Participants or model 180 male Wistar rats across three experiment designs, six groups of 10 per design.
Design Acute pentylenetetrazole convulsions and chronic kindling. Saline and diazepam controls.
- Reported study exposure
- Intraperitoneal Cortexin at 0.015, 0.15 or 1.0 mg/kg. Separate intranasal calcium-carbonate formulation at 0.15 mg/kg.
Important limitations
- These results concern seizure assays. Neither route establishes a pharmacokinetic estimate or a human outcome.
Original journal article, methods and Figures 1–4 · Original journal article, methods and Figures 1–4
Comparison in people · 2014
Intranasal Cortexin and statokinetic tolerance in volunteers
- Coriolis motion tolerance
- 96.2±3.8 → 151.6±7.4 sSaline: 90.0±4.5 → 86.5±6.8 s. The paper marks the within-arm change with Cortexin.
- Static balance
- 21.3 → 27.5 sCortexin arm in the Bondarevsky test.
- Selected stabilography measures
- 1.40–1.44-fold reported changesThe authors also reported 1.22–1.24-fold reductions in center-of-gravity amplitude and asymmetry.
The authors reported 1.40–1.44-fold changes on selected stabilography measures and longer motion tolerance. The findings do not measure brain uptake.
More reported outcomes
- Follow-up
- Effect described through 30 daysOther measures showed no clear difference in change.
Study notes · methods, sources and limitations
Participants or model 86 healthy men aged 18–20 screened. Thirty-two with baseline tolerance below two minutes entered the Cortexin or saline comparison.
Design Modified Coriolis acceleration test, Bondarevsky balance test and computer stabilography after a ten-day course and during follow-up.
- Reported study exposure
- Intranasal Cortexin 0.25 mg per nostril twice daily, eight hours apart, for ten days, 10 mg total. The paper does not specify the final reconstitution volume.
Important limitations
- Small selected volunteer population. Exact allocation, protocol differences from related vestibular reports and independent replication require additional verification.
Reviews on Clinical Pharmacology and Drug Therapy 12(4):67–71 · Reviews on Clinical Pharmacology and Drug Therapy 12(4):67–71
Observational study · 2004
Cortexin in 187 patients with prior brain injury
- Good or satisfactory
- 157 of 187 (84.0% from the reported counts)Good: 95; satisfactory: 62; unsatisfactory: 30.
- Unsatisfactory by severity
- 8/117 (6.8%) versus 22/70 (31.4%)Less severe versus severe injury.
- Cohort scope
- 107 combat injuries within 187 overallThe parallel publication and later dissertation are related sources, with no confirmed independent cohort.
The authors classified 95 outcomes as good and 62 as satisfactory. Thirty were unsatisfactory. Less-severe injuries had more favorable results.
Study notes · methods, sources and limitations
Participants or model 187 patients aged 19–56, 107 injured during combat. Severity analysis included 117 less severe and 70 severe injuries.
Design Clinical neurological and psychological testing, EEG and Doppler examinations. No randomized untreated comparison.
- Reported study exposure
- In the parallel text, 10 mg Cortexin intramuscularly daily for 10–20 days.
Important limitations
- Case-series outcome grading and concurrent rehabilitation do not isolate the effect of Cortexin.
Bulletin of the Russian Military Medical Academy, 2004(2):74–76; parallel report with outcome table · Bulletin of the Russian Military Medical Academy, 2004(2):74–76; parallel report with outcome table
Animal research · 2019
Blinded rat stroke comparison of four peptide preparations
Study of multiple preparations
- Serial functional testing
- Cerebrolysin improved outcomes; Cortexin, Cerebrolysat and Cognistar did not show a comparable significant benefitFigure 1. Neurological severity, adhesive removal and foot-fault testing.
- Lesion volume
- No significant improvement versus saline in any treatment groupFunctional and histological outcomes are separate.
Only Cerebrolysin improved measured functional outcomes versus saline. The other hydrolysates had no significant functional effect and no treatment reduced lesion volume significantly.
Study notes · methods, sources and limitations
Participants or model Male Wistar rats with embolic middle cerebral artery occlusion, 23 initially randomized per arm; early deaths excluded from analysis.
Design Prospective, randomized and blinded comparisons of saline, Cognistar, Cerebrolysat, Cortexin and Cerebrolysin. Serial neurological testing through day 28.
- Reported study exposure
- Daily intraperitoneal doses for ten days starting four hours after occlusion: Cognistar, Cerebrolysat and Cerebrolysin 2.5 mL/kg each, Cortexin 1.7 mg/kg or saline 1 mL per rat. One methods line repeats Cerebrolysin where the abstract and other sections identify Cerebrolysat.
Important limitations
- Animal ischemia results do not transfer between differently manufactured formulations.
Journal of the Neurological Sciences 398:22–26 · Journal of the Neurological Sciences 398:22–26
Comparison in people · 2009
Epitalon and Cortexin after acute systemic cold injury
Study of multiple preparations
- Severe cold injury · day-five neuron-specific enolase
- 23.2 ng/mL combined vs 58.9 standard careCortexin alone 35.3; Epitalon alone 45.0 ng/mL. The source marks p<0.05 for Cortexin and the pair versus standard care.
- Moderate cold injury · day-five neuron-specific enolase
- 11.3 ng/mL combined vs 15.1 standard careEpitalon 14.8 and Cortexin 14.4 ng/mL. Selected small subgroups.
- Consciousness and immune markers
- Faster recovery and altered immune measures describedOriginal allocation and longer-term functional outcomes remain unresolved.
In the severe-injury table, day-five neuron-specific enolase was 23.2 ng/mL with both agents and 58.9 ng/mL with standard care. No formal interaction analysis was reported.
Study notes · methods, sources and limitations
Participants or model Hospitalized cold-injury patients. Three adjunct arms had 25 patients each. The severity-specific outcome tables use smaller subgroups.
Design Standard care alone or with Epitalon, Cortexin or both. Serial neuron-specific enolase, immune measures and clinical observations.
- Reported study exposure
- The author abstract reports intramuscular Epitalon 10 µg and Cortexin 10 mg daily for ten days, separately or together depending on arm.
Important limitations
- A historical treatment comparison with substantial concurrent care, small subgroup sizes and an imperfect source transcription.
- This is a patient rehabilitation study. The biomarker changes do not establish cold tolerance in healthy people.
Candidate dissertation author abstract, Tables 1–3 · Candidate dissertation author abstract, Tables 1–3
Animal research · 2022
Cortexin and Semax in a prolonged rat cold-stress model
Study of multiple preparations
- Semax · day-14 limiting swim
- 3.2±0.1 vs 1.3±0.1 min salineTable 5, p<0.05 versus saline as marked.
- Cortexin · day-14 limiting swim
- 1.3±0.1 vs 1.3±0.1 min salineEarlier differences did not persist at day 14.
- Temperature plateau near 35°C
- 10 days saline; 12 Cortexin; 14 SemaxReported thermoregulation endpoint, separate from the swim outcome.
Day-14 swim time was 3.2±0.1 min with Semax and 1.3±0.1 min with either saline or Cortexin. The 35°C plateau lasted 10, 12 and 14 days across the three groups.
More reported outcomes
- Publication overlap
- Identical weighted-swim means and uncertainties at all six time pointsThe 2023 Russian Biomedical Research paper (DOI 10.56871/RBR.2023.20.34.002) repeats Table 5. Count one animal experiment.
Study notes · methods, sources and limitations
Participants or model 90 outbred male rats (180–220 g), with 30 each in the placebo, Cortexin and Semax groups.
Design Ninety outbred male rats, 30 per group. Prolonged cold exposure combined with altered lighting, noise and dietary restriction. Serial thermoregulation and weighted-swim measurements.
Important limitations
- The report conflicts on administration route and frequency. Cortexin and Semax were given to separate groups.
- The report conflicts on administration route and frequency. Cortexin and Semax were given to separate groups. The 2023 report repeats the weighted-swim table. It supplies no independent animal count or human performance evidence.
- Cortexin and saline had the same mean swim time at day 14. The paper reports a 14-day temperature plateau for Semax.
Pediatrician 13(6):85–96 · Pediatrician 13(6):85–96
Comparison in people · 2007
Cortexin: work-capacity indices under simulated altitude
Study of multiple preparations
- Cortexin · simulated altitude
- Higher work-capacity indices describedThe conference abstract does not provide magnitudes or uncertainty. Psychological effects were described as smaller than with Dilept or Noopept.
Original proceedings: 86 men total across the Tabai chamber experiments.
Study notes · methods, sources and limitations
Participants or model 86 healthy men aged 18–22, considered fit for military service; Tabai climate chamber with cold, heat and simulated altitude
Design 86 healthy men aged 18–22, considered fit for military service; Tabai climate chamber with cold, heat and simulated altitude
Important limitations
- Per-arm counts, doses and reliable between-arm comparisons are unavailable. Possible overlap with related journal reports.
- Treatment allocation, masking, arm denominators and complete comparator data unavailable. The text says placebo and control measurements did not differ while printing p<0.05; this inconsistency cannot be resolved from the abstract. This report may overlap the 2007 journal reports or 2008 dissertation. The 86 participants are listed separately and excluded from the combined total.
- The outcomes are condition-specific and largely qualitative. Use the journal record for its separate tables and route details, with possible cohort overlap kept visible.
Visceral Systems and Their Regulation, conference proceedings, p. 79 · Original conference abstract
Animal research · 2024
Kim’s five-peptide animal comparison: tables missing
Study of multiple preparations
- Comparative preparations
- Cortexin, Pineamin, Prostatilen, Thymalin and ThymogenChapter 6.4 title. Thymogen is a defined dipeptide; the five entries are not all tissue extracts.
- Five-agent effect estimates
- Original comparative tables not recoveredNo verified head-to-head result for Pineamin versus Cortexin, Thymalin, Thymogen or Prostatilen.
Named comparator in Chapter 6.4; original per-preparation outcomes are unavailable.
Study notes · methods, sources and limitations
Participants or model Separate animal pharmacology experiments; participant-level and group-level counts for the five preparations unavailable
Design Separate animal pharmacology experiments; participant-level and group-level counts for the five preparations unavailable
Important limitations
- No established human environmental-performance result.
- The 1990s Biorhythmology and Rang-97 records were reanalyzed; they are not new human recruits. The 2022–2024 physiology studies were separate. The conclusions do not provide numerical comparisons between the five preparations. The accessible account associates HIF-1α and TSPO measurements with stress physiology and discusses the nonpeptide DMAE derivative separately; a Pineamin-mediated biomarker mechanism is not established.
- This is a documented animal comparison with inaccessible efficacy tables. Existing Pineamin reproductive studies establish a separate clinical setting, not evidence for physical performance or environmental resilience.
Kirov Military Medical Academy doctoral dissertation, 359 pp.; 2024 bibliography, related catalog entry dated 2025 · Dissertation
Animal research · 2015
Central peptide dosing: rat self-stimulation assay
Study of multiple preparations
- Cortexin · central self-stimulation
- 209.3±22.9 → 295.1±26.2 presses/5 min (+41%)100 µg into the ventricle; 1 and 10 µg lacked significance marks.p<0.05 before vs after
Selected row from author abstract Table 4; 496 rats across the program, not one assay.
Study notes · methods, sources and limitations
Participants or model 496 Wistar rats (200–220 g) across several behavioral experiments; not the denominator for a single comparison
Design 496 Wistar rats (200–220 g) across several behavioral experiments; not the denominator for a single comparison
- Reported study exposure
- Central series 1, 10 and 100 µg. Systemic comparison 1 mg/kg intraperitoneally.
Important limitations
- Within-condition results. Central administration does not prove brain access after systemic dosing.
- Table 4 marks within-condition changes from before administration; no verified between-preparation superiority test. Central and systemic behavioral similarities do not directly measure brain penetration or tissue pharmacokinetics. The assays concern behavior and electrical reinforcement, not athlete endurance.
- Behavioral effects differed by route, dose and test. The low central dose had an effect in this assay; it does not establish systemic exposure, human dosing or superiority in other outcomes.
Kirov Military Medical Academy dissertation author abstract · Dissertation
Animal research · 2009
Rat behavioral assays: cortexin
Study of multiple preparations
- Cortexin · self-stimulation
- +23% in lateral-hypothalamic pedal pressesReported relative increase; no direct statistical test versus Oleyl-Cortagen supplied in narrative.
- Open-field behavior
- Oleyl-Cortagen increased horizontal and vertical movement but halved hole explorationCortexin and Cerebrolysin increased horizontal movement; Dilept reduced horizontal and vertical movement.
- Porsolt immobility
- Lower with Oleyl-Cortagen, Dilept and Cortexin; higher with Cerebrolysin, Semax, Cortagen and SelankThis unweighted behavior assay is distinct from loaded endurance swimming. Piracetam was inactive in the report.
Separate comparisons in an assay battery.
Study notes · methods, sources and limitations
Participants or model 192 Wistar rats, 200–220 g; methods describe at least 10–12 per group across a behavioral test battery
Design 192 Wistar rats, 200–220 g; methods describe at least 10–12 per group across a behavioral test battery
- Reported study exposure
- 1 mg/kg intraperitoneally in the rat study.
Important limitations
- Electrical self-stimulation and immobility do not measure athletic endurance.
- Multiple behavioral comparisons, endpoint-specific group sizes and precise uncertainties need table recovery. Deltaran is the tested DSIP-containing formulation; no result for isolated DSIP can be inferred. The 2015 dissertation used separate doses/routes; it is not confirmed as independent replication of every experiment.
- Opposing effects across assays are informative. Electrical self-stimulation and immobility are behavior readouts, and neither establishes improved human motivation or endurance.
Medical Academic Journal, 2009; publisher article 9357 · Original journal article
Laboratory analysis · 2017
Measured amino acids in organ peptide preparations
Study of multiple preparations
- Cortexin versus Cerebrolysin · composition
- Higher Cortexin amounts of several amino acids per mg of preparationThe authors report roughly 6.5–7-fold for Asp, Glu and Tyr, ninefold for serine and twelvefold for arginine. This is a chemical comparison.
This is analytical chemistry, with hydrolysis-released amino acids.
Study notes · methods, sources and limitations
Participants or model Laboratory composition comparison of Cortexin, Cerebrolysin, Retinalamin and Pineamin; three Pineamin manufacturing batches
Design Laboratory composition comparison of Cortexin, Cerebrolysin, Retinalamin and Pineamin; three Pineamin manufacturing batches
Important limitations
- The comparison does not identify intact peptide sequences or predict effects.
- Amino-acid totals are not the molecular-mass distribution or an inventory of intact peptides. The mass denominator and formulation excipients matter when comparing liquid and lyophilized organ preparations. Table discrepancies are left visible; they are not silently corrected.
- Chemical characterization helps distinguish the preparations. It cannot establish that amino-acid contents explain stress resistance, and it does not identify which peptides were present.
Bulletin of the Russian Military Medical Academy. 19(1):129–136 · Original journal article
Comparison in people · 2009
Cortexin in radiation-accident responders: Bioregulation follow-up
- Memory complaint prevalence
- 93.3% → 33.3% with two 20-day courses; 93.3% → 91.7% with usual careAt 12 months; n=30 and n=60 in the displayed groups.
- Headache prevalence
- 93.3% → 43.3% with two 20-day courses; 95.0% → 90.0% with usual careTable 3; reported symptom prevalence, not headache intensity.
- Schulte task time
- Reported decrease 15.6±1.6 s with two 20-day coursesOther groups: decreases 4.5±1.7 s, 8.1±1.6 s and 10.2±1.4 s; comparison-group relative change 2.3%, nonsignificant.
At 12 months, reported memory complaints in the two 20-day-course group fell from 93.3% to 33.3%, versus 93.3% to 91.7% in the comparison group. Repeat-course selection limits attribution.
More reported outcomes
- Safety reporting
- No complete adverse-event table recoveredThe author describes monitoring, but the available follow-up does not establish safety.
Study notes · methods, sources and limitations
Participants or model 165 Chernobyl response workers in the reported three initial groups (55, 50 and 60); five follow-up subgroups after repeat-course selection
Design 165 Chernobyl response workers in the reported three initial groups (55, 50 and 60); five follow-up subgroups after repeat-course selection
- Reported study exposure
- Cortexin 10 mg intramuscularly daily in reported 10- or 20-day courses. Selected subgroups received a second course at six months. The comparison group received usual care without Cortexin.
Important limitations
- Repeat-course subgroups formed during follow-up, not clearly randomized groups. Baseline symptoms differed.
- Repeat-course subgroups formed during follow-up, not clearly randomized groups. Baseline symptoms differed. Self-reported symptoms and cognitive-test results in radiation-accident responders do not establish operational performance in healthy people. No systematic longer-term adverse-event table was recovered.
- The author-abstract table supplies a rehabilitation lead, with nonrandom follow-up and subjective endpoints. This is not a worker enhancement or radiation-protection trial.
Kirov Military Medical Academy dissertation; VMA.03.12.08.0910/0226 · Dissertation
Animal research · 2011
Cortexin in rat seizure models: nanoparticle nasal delivery and a neutral acute result
- Acute status model
- No effect on convulsions after long-term pretreatment described
- Chronic model
- Dose-dependent antiepileptic effect described; no numerical magnitude supplied
Long-term pretreatment did not affect convulsions in the acute status model, while a dose-dependent antiepileptic effect was described in the chronic model. The abstract does not quantify outcomes separately by route.
Study notes · methods, sources and limitations
Participants or model Rats with acute and chronic chemically induced seizure models; sample sizes unavailable in the abstract
Design Acute and chronic rat seizure models; intraperitoneal solution or intranasal nanoparticle Cortexin. Group sizes and route-specific outcomes not supplied.
- Dose and formulation
- 0.015, 0.15 and 1.0 mg/kg; intraperitoneal solution or intranasal nanoparticle complexNo fully resolved route-specific schedule or dose–outcome table in the abstract
Important limitations
- Group sizes, route-specific effect sizes, dosing frequency, pretreatment duration and adverse-event counts unavailable in the abstract. The abstract pools discussion of intraperitoneal solution and intranasal nanoparticle preparations; it does not establish which dose produced which route-specific outcome. A seizure model does not establish improved athletic performance, human nasal bioavailability or PPK-V efficacy.
- Positive and neutral model results coexist. The nanoparticle nasal formulation cannot be equated with an ordinary nasal solution or with PPK-V. No human absorption or safety conclusion follows.
Zh Nevrol Psikhiatr Im S S Korsakova. 2011;111(12):68–73. PMID 22433813 · Original animal journal research
Comparison in people · 2002
Application of Cortexin to enhance human statokinetic resistance
- Statokinetic resistance
- Improvement compared with control indexes described; no numerical change or uncertainty supplied
- Attribution and safety gaps
- Training contribution, drug-specific effect, adverse-event counts and human nasal pharmacokinetics not established
The publisher abstract reports improved statokinetic resistance after ten days of nasal Cortexin plus active sensory/vestibular training. It supplies no numerical treatment effect or denominator.
Study notes · methods, sources and limitations
Participants or model Human statokinetic-resistance experiment; participant and group counts not supplied by the abstract
Design Human statokinetic-resistance comparison; nasal Cortexin plus active sensory/vestibular training. Group counts and allocation safeguards unavailable.
- Reported treatment program
- Ten-day intranasal Cortexin course with active sensory/vestibular trainingDose and frequency unavailable in the abstract
Important limitations
- Participant counts, allocation, blinding, dose, exact numerical changes, uncertainty and adverse events absent from the abstract. Concurrent training prevents attribution to Cortexin alone. This is not a PPK-V trial, an exercise-endurance trial or a pharmacokinetic demonstration of nose-to-brain transport.
- A combined training program, not an isolated Cortexin effect. It does not validate PPK-V, exercise-endurance claims or direct nose-to-brain delivery.
Medical Academic Journal. 2002;2(3):91–98. · Original human journal publication
Animal research · 2014
Maternal Cortexin: conference comparison with missing denominators
Study of multiple preparations
- Cortexin survival
- Qualitative improvement; exact percentage and n not supplied
- Learning comparison
- Authors rank Cortexin < Pinealon < DeltaranNo numerical maze means, uncertainty or between-drug p-values in abstract
The 2014 abstract reports lower offspring mortality with Cortexin, without an exact percentage or group size. Learning performance was ranked below Pinealon and Deltaran. This is maternal animal exposure, distinct from neonatal Cortexin treatment.
Study notes · methods, sources and limitations
Participants or model 21-day-old outbred rat offspring; seven listed treatment groups; no group sizes supplied
Design Maternal intraperitoneal exposure throughout pregnancy. Daily hypobaric hypoxia on gestation days 13–20, 66.41 kPa for three hours. Offspring Morris maze and cortical/brainstem caspase-3 at day 21.
Important limitations
- Conference-level evidence; missing untreated-hypoxia comparator and internally contradictory caspase-3 statements limit interpretation.
- Conference abstract with missing denominators and an internally inconsistent biochemical result; not a clinical trial. Deltaran is a DSIP-containing formulation with glycine; results are not proof for isolated DSIP. Formulation mass versus active-peptide mass is not resolved by this abstract. Shared Rostov authors and models may overlap the 2012 papers and dissertations; no pooled sample or independent-replication count is calculated.
X International Congress “Neuroscience for Medicine and Psychology”, Sudak, 2–12 June 2014, pp.233–234 · Conference abstract
Animal research · 2013
Pinealon versus Cortexin after prenatal hypoxia
Study of multiple preparations
- Third-day maze latency, late prenatal hypoxia
- Pinealon 34.5 ± 3.9 s; Cortexin 58.37 ± 3.22 s; saline 121.8 ± 19.01 sIntact 18.72 ± 1.73 s; table n=15/(60), n=15/(60), n=7/(28), intact n=18/(72)Third testing dayTable # denotes within-group day 3 versus day 1, not a treatment-versus-control test
- Cortexin without hypoxia
- 38.55 ± 2.34 s versus intact 18.72 ± 1.73 sAuthor reports 106% longer latency; no benefit in this healthy comparisonThird testing dayp<0.01 in narrative
- Survival
- Pinealon reduced stillbirths in some models; residual loss remained in the longest hypoxia windowExact independent dam denominators and complete cohort flow unresolved
For gestation-day-13–20 hypoxia, third-day maze latency was 34.5±3.9 seconds with Pinealon, 58.37±3.22 with Cortexin and 121.8±19.01 with saline. Cortexin-only offspring also performed worse than intact controls. Source is an author-abstract transcription, not an authenticated full thesis.
Study notes · methods, sources and limitations
Participants or model Young-rat prenatal arm and a separate 120-old-male ischemia arm; prenatal Table 2 contains two n values per group with unclear hierarchy
Design Maternal treatment throughout gestation; hemic and hypoxic injury windows compared. Offspring killed at days 21–23; Morris maze, brain HPLC monoamines and fluorimetric caspase-3. Older-rat carotid occlusion is a separate experiment.
Important limitations
- Third-party transcription of the author’s abstract, not the complete original thesis; verify the scan before relying on uncertain table formatting.
- Third-party transcription of the author’s abstract, not the complete original thesis; verify the scan before relying on uncertain table formatting. Two n values per prenatal group are not adequately explained; animal, dam, litter and repeated-trial denominators cannot be reconciled. Related journal/conference publications may share these cohorts. Within-group learning p-values do not demonstrate between-drug superiority. The prose and table indicate incomplete protection, including impaired Cortexin-only learning; neither compound has demonstrated human pregnancy safety here.
Candidate dissertation author’s abstract. St. Petersburg, 2013; “Peptide regulation of neurodegenerative processes in young and old rats” · Dissertation author-abstract transcription
Animal research · 2016
USING CORTEXIN TO MANAGE THE CONSEQUENCES OF PERINATAL HYPOXIC BRAIN INJURY IN INFANT RATS
- EMG
- Transient spectral improvement at day 10; no amplitude benefit; earlier EMG benefit absent at day 30
- Autonomic outcomes
- Day-30 autonomic balance favored treated injured animals, but intact treated pups showed disturbancesDirection differed by injury status
- Respiration
- Rate remained higher than intact controls in both injured groups
Cortexin transiently improved EMG spectral structure at day 10, but not amplitude; the EMG benefit was absent at day 30. Intact treated pups developed autonomic and heart-rhythm disturbances. This experiment began after birth.
Study notes · methods, sources and limitations
Participants or model Infant rats with injury induced at postnatal day 7, plus intact treated controls; n absent from abstract
Design Day-7 carotid ligation plus hypoxia; Cortexin 1 mg/kg intraperitoneally starting one hour later for ten days. EMG, ECG, respiration and heart-rate variability assessed 10 and 30 days after injury.
Important limitations
- Neonatal treatment is not maternal or fetal exposure. Do not summarize this as a pregnancy-safety trial.
- Neonatal treatment is not maternal or fetal exposure. Do not summarize this as a pregnancy-safety trial. Mixed benefits, transient effects and adverse physiological changes in intact pups must accompany positive findings. Sample sizes, numerical traces and effect estimates are not available in the abstract.
- Treatment began after birth. Results included benefits, transient effects and adverse physiological changes in intact pups. Sample sizes, numerical traces and effect estimates are not available in the abstract.
Zhurnal evoliutsionnoi biokhimii i fiziologii. 2016;52(2):195. PMID 30695499 · Original journal publication
Observational study · 2025
Dizziness symptoms improved in all groups; numerical treatment effects unavailable
- Dizziness, anxiety and insomnia
- Improvement described in all three groups; strongest reported changes in the Cortexin/citicoline combination armNo verified numerical post-treatment group contrast providedEnd of treatment and two-month follow-up
- Baseline symptom scores, not treatment effects
- Vestibular balance 27.15±2.83; autonomic anxiety 16.05±2.35; insomnia 18.3±1.76 pointsThe repeated baseline value in the English follow-up sentence is not used as an endpointBefore treatment
- Adverse events
- No event counts given in the abstract
All groups reported less dizziness, anxiety and insomnia; the authors described the strongest changes with the combined adjuncts. The abstract does not provide numerical post-treatment group differences.
Study notes · methods, sources and limitations
Participants or model 60 patients; 20 escitalopram plus Cortexin, 20 escitalopram plus Cortexin/citicoline, 20 escitalopram alone
Design 60 patients; 20 escitalopram plus Cortexin, 20 escitalopram plus Cortexin/citicoline, 20 escitalopram alone
- Cohort and groups
- 60 patients; three groups of 20; all received escitalopram
Important limitations
- Observational allocation; no blinded placebo comparison established. All patients received escitalopram; the combination arm does not isolate Cortexin. The English abstract repeats a baseline vestibular score in its follow-up sentence. It is not treated as a verified post-treatment outcome. No numerical between-group effect, confidence interval or adverse-event count was available in the abstract.
- Baseline severity scores are not improvement estimates. The observational, multidrug comparison does not establish an isolated Cortexin benefit.
Zh Nevrol Psikhiatr Im S S Korsakova. 2025;125(5):89–94. PMID 40457673 · Original clinical journal publication
Animal research · 2026
Potapov–Shustov: pharmacological correction of delayed neuropathy in rats
Study of multiple preparations
- Aminoethanol derivative and citicoline
- Favorable responses depended on the experimental model.
- Unfavorable response
- An inositol derivative worsened selected neuromuscular findings in some animals.
Responses at approximately one month varied by model; an inositol derivative worsened selected neuromuscular findings in some animals.
Study notes · methods, sources and limitations
Participants or model Rat study; group denominators not verified
Design Rat experiment with day-30 neuromuscular measurements; compound identities and group denominators need full-paper confirmation.
Important limitations
- Animal findings do not establish human protection or clinical neuropathy benefit. The exact aminoethanol preparation is not sufficiently identified to equate it with ADK-17 or FDES. Group flow and agent-specific numerical outcomes require full text.
- Not every tested agent showed benefit. No human efficacy estimate or equivalence with ADK-17/FDES established.
Bulletin of the Russian Military Medical Academy. 2026;28(1):33–44 · Original preclinical journal publication
Animal research · 2020
Cortexin in the 2020 peptide-profile study
Findings for Cortexin within a multi-preparation animal study
- Cortexin: hypoxia time
- 201±11 s versus displayed control 95±3 sTable 2, M±m; male rats; ten per group
- Cortexin: loaded swimming
- 172±44 s versus displayed control 135±6 sTable 2, M±m; female rats; ten per group; 10% body-weight load
Hypoxia and swimming results came from separate animal cohorts. The original raw times and dose statements are retained below.
Study notes · methods, sources and limitations
Participants or model Outbred rats; ten per treatment group and separate control groups for each endpoint. Hypoxia: three-month-old males, 250±20 g. Loaded swimming: pretrained females, 200±20 g. A pooled analysis of separate experiments, not a verified single contemporaneous head-to-head cohort.
Design Ten rats per group; males for chamber hypoxia (time to agonal signs) and females for loaded swimming (time to exhaustion). Single rectal exposure one hour before testing; saline vehicle controls. Separately performed experiments were standardized and pooled.
- Reported animal exposure
- Cortexin 1 mg/kg rectally, once, one hour before testingExperimental route; not a human regimen
Important limitations
- Different experiments and unequal doses limit comparisons. The 2019 book reproduces these results; it is not independent confirmation. The paper gives no pairwise p-value showing superiority for this preparation.
- Different-sex cohorts and separate experiments contributed to the two endpoints; randomization is stated, but masking, allocation concealment and complete animal flow are not established. Doses were unequal, and the nominal experimental-preparation dose in methods conflicts with the discussion maximum. Table 2 does not resolve each complex’s actual exposure. Table 2 reports M±m; its uncertainty notation is retained without relabeling it as a verified SD. No preparation-specific pairwise p-values or confidence intervals establish PPK-V superiority over Cortexin. T-scores standardize results against experiment-specific controls. Their percentages and ratios cannot be interpreted as proportional increases in raw swim time or clinical performance. Table 1’s final bin is printed >1 kDa, while the narrative describes <1 kDa. Some fractions do not sum to 100%; blank cells are not assumed zero and values are not renormalized. The 5–10 kDa association is observational within the pooled analysis, not isolation of an active sequence or proof of brain penetration. Rectal results do not establish intranasal delivery. Matching 2019 and 2020 numerical tables are treated as one research program. No human PPK-V efficacy or long-term safety follows from these results.
- This is a composition–activity hypothesis from pooled animal experiments. PPK-V is a distinct experimental cortex hydrolysate, not Cortexin or the brainstem PPK-B. Unequal exposures, source inconsistencies and matching earlier tables limit comparisons. No clinical superiority, formal combination synergy or intranasal PPK-V delivery has been established.
Search for the optimal mass profile of neuropeptides for the implementation of antihypoxic and activating actions. Pharmacy Formulas. 2020;2(4):72–81. · Original animal and analytical journal research
Observational study · 2026
Attention, fatigue and reading improvements reported in a pediatric cohort
- Reported improvement
- 82% of casesThe study assessed attention, working memory, fatigue and reading after treatment. The rounded percentage leaves the exact responder count uncertain.
- Reference groups
- 30 children with combined ADHD; 30 healthy childrenThese are diagnostic comparisons, not a placebo-controlled treatment comparison
After Cortexin treatment, the authors reported improvement in attention, working memory, fatigue symptoms and reading skills in 82% of cases in the sluggish-cognitive-tempo group. EEG changes accompanied the clinical observations. ADHD and healthy children were diagnostic reference groups, not randomized untreated children with the same condition.
Study notes · methods, sources and limitations
Participants or model 40 children ages 12–14 with sluggish cognitive tempo; comparison groups of 30 with combined ADHD and 30 healthy children.
- Treated clinical group
- 40 children ages 12–14
Important limitations
- Before-and-after treatment observation without a randomized placebo comparison in the affected group. The abstract does not give endpoint-specific effect sizes, a response definition sufficient to reconstruct individual counts, or an adverse-event rate.
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova 126(9) · Journal publication
Randomized study in people · 2026
DIACORT: day-90 findings and a neutral earlier mood comparison
- MoCA, day 90
- 27.28±0.26 versus 24.78±0.35.
- NTSS-9, baseline → day 90
- 10.19±0.70 → 3.74±0.32 versus 9.93±0.66 → 7.67±0.52.
- CSI, baseline → day 90
- 33.59±1.45 → 18.37±1.43 versus 33.80±1.47 → 28.07±1.27.
Of 110 randomized participants, 109 completed DIACORT. Selected day-90 cognition and neuropathy measures favored adjunctive Cortexin; the day-30 depression-category comparison was nonsignificant.
More reported outcomes
- HADS depression categories, day 30
- p=0.114; nonsignificant between-arm comparison.
- Adverse events
- Five: three active, two comparison; judged unrelated by authors.
Study notes · methods, sources and limitations
Participants or model 110 randomized; 109 completed: 54 adjunctive Cortexin, 55 comparison
Design 110 randomized by envelopes; 109 completers (54 Cortexin, 55 comparison). One active participant lost after visit 2. Background care in both arms; Holm adjustment described.
Important limitations
- Background care in both arms; masking, completer analysis and conflicting dose text limit interpretation.
- Masking and envelope concealment not established. Dose text conflicts between abstract and methods; confirmation from page images is pending. Uncertainty notation and CGI percentages need reconciliation; authors declare no conflicts.
- Reported uncertainty notation retained. Completer outcomes are not labeled intention-to-treat. Resolve conflicting dose text before interpreting the regimen.
S. S. Korsakov Journal of Neurology and Psychiatry. 2026;126(4):101–112. DOI 10.17116/jnevro2026126041101 · Original clinical journal publication
Animal research · 2026
Inflammatory markers changed, but tissue injury did not significantly shrink
- Cortexin: necrosis volume
- 32.75±4.91% versus 38.16±5.98% in saline controlsOriginal report does not establish a reduction in brain injury24 hours after reperfusionp=0.198; nonsignificant
- Cerebrolysin: necrosis volume
- 32.57±3.31% versus 38.16±5.98% in saline controls24 hoursp=0.176; nonsignificant
- Mexidol: necrosis volume
- 20.48±2.33% versus 38.16±5.98% in saline controls24 hoursp<0.001
In a rat ischemia–reperfusion model, Cortexin did not significantly reduce lesion volume (32.75±4.91% versus 38.16±5.98%; p=0.198). Selected inflammatory/apoptosis markers changed, but BDNF did not.
More reported outcomes
- Cortexin: BDNF and cell-death markers
- BDNF unchanged; TNF-α, Fas and bax reducedNumerical marker values not provided in the abstract; Cortexin-related caspase-3 reduction not reported
Study notes · methods, sources and limitations
Participants or model Male Wistar rats after cerebral ischemia–reperfusion
Design Male Wistar rats after 60-minute middle-cerebral-artery occlusion; saline, Mexidol, Cerebrolysin and Cortexin comparisons. Five rats per biochemical group; this is not a verified lesion-volume denominator.
- Biochemical group sizes
- Five animals per group; not assumed to be the lesion-volume analysis denominator
Important limitations
- The stronger result was reported for Mexidol. Biochemical analyses used five animals per group; assessment was at 24 hours. A neutral tissue-injury result alongside biomarker changes does not establish clinical stroke benefit.
- Marker changes do not establish smaller infarcts, functional recovery or human benefit. The Cortexin and Cerebrolysin lesion-volume comparisons were neutral.
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova; 2026 · Indexed abstract
Review of earlier studies · 2023
No clear reduction in deaths in the pooled stroke trials
Study of multiple preparations
- All-cause mortality
- RR 0.96; 95% CI 0.65–1.41Cerebrolysin/Cortexin pooled; moderate-certainty evidence
- Non-death attrition
- RR 0.72; 95% CI 0.38–1.39Six trials, 1,689; very low certainty
- Any serious adverse event
- RR 1.16; 95% CI 0.81–1.66Cerebrolysin: three trials, 1,335
The pooled mortality analysis of Cerebrolysin or Cortexin found probably little or no difference (RR 0.96, 95% CI 0.65–1.41; 6 trials, 1,689 participants).
More reported outcomes
- Fatal serious adverse event
- RR 0.90; 95% CI 0.59–1.38Cerebrolysin: three trials, 1,335
- Nonfatal serious adverse event
- RR 2.39; 95% CI 1.10–5.23Cerebrolysin: three trials, 1,335
- Nonfatal SAE: 30 mL/day for ten days subgroup
- RR 2.87; 95% CI 1.24–6.69Two trials, 1,189; cumulative dose 300 mL
- Any adverse event
- RR 1.03; 95% CI 0.92–1.14Four trials, 1,607
Study notes · methods, sources and limitations
Participants or model Cochrane review: 7 RCTs, including one Cortexin trial with 272 participants
Design 2023 Cochrane review: seven randomized trials, 1,773 participants; includes a 272-person Cortexin trial. Mortality analysis: six trials, 1,689 participants.
Important limitations
- The mortality estimate combines Cerebrolysin and Cortexin. The serious-adverse-event concern applies to Cerebrolysin.
- The mortality estimate pools Cerebrolysin and Cortexin, not either preparation alone. The review also raises concern about nonfatal serious adverse events with Cerebrolysin; a neutral mortality result does not establish safety.
- Mortality mixes two preparations; the serious-event estimates concern Cerebrolysin. A risk ratio whose interval crosses 1 is not a proven reduction or increase. Underlying trials overlap other pages.
Cochrane Database Syst Rev 10:CD007026. PMID 37818733 · Indexed abstract
Randomized study in people · 2019
Potential of peptidergic nootropic therapy in developmental dysphasia in children
- Active vocabulary
- 2.3-fold increase with Cortexin versus 1.4-fold without medication
- Spoken phrases
- 3.6-fold increase with Cortexin versus 1.5-fold without medication
- Adverse events
- The authors reported none during treatment in this small study
Randomized comparison with no drug treatment reported speech and parent-questionnaire changes over two months.
Study notes · methods, sources and limitations
Participants or model 54 children aged 3–4 with developmental dysphasia
Design Open randomized comparison of 54 children aged 3–4 with developmental dysphasia: 27 received one 10-day intramuscular course, and 27 received no drug. All parents received speech-stimulation guidance. Outcomes were assessed at day 60.
Important limitations
- No masking described; parental ratings and speech-development advice are relevant co-interventions. Pediatric clinical findings do not establish enhancement or safety in healthy adults.
- The fold changes compare each arm with its own baseline. The open design, lack of placebo, and caregiver-reported measures limit causal inference. Matching arm sizes and selected outcomes suggest overlap with the 2020 report.
Zh Nevrol Psikhiatr Im S S Korsakova 119(11):47-53. PMID 31851172 · Publication record
Comparison in people · 2020
Developmental dysphasia in children: a comparison of the effectiveness of two modes of peptidergic nootropic therapy
- Active vocabulary at two months
- 2.3-fold after one course, 2.8-fold after two courses, and 1.4-fold with no medicationOne versus two courses at two months: p = 0.01
- Spoken phrases at two months
- 3.6-fold after one course, 4.2-fold after two courses, and 1.5-fold with no medication
- Active vocabulary at least doubled
- 12/27 (44.4%) after one course, 32/40 (80.0%) after two courses, and 6/27 (22.2%) with no medication
Compares one course, two courses and no medication over two months; reports vocabulary and phrase-use changes.
More reported outcomes
- Spoken phrases after one versus two courses
- 7.1 ± 1.1 versus 8.4 ± 1.4 at day 60p = 0.795 between the two treated groups
Study notes · methods, sources and limitations
Participants or model 94 children aged 3–4 with developmental dysphasia
Design Open controlled comparison of 94 children aged 3–4 with developmental dysphasia: one Cortexin course 27, two courses 40, untreated 27. Each course ten days; repeated courses a month apart; follow-up two months. All parents received speech-stimulation advice.
Important limitations
- Allocation and masking unclear; overlap with earlier reports needs checking. Pediatric clinical findings do not establish enhancement or safety in healthy adults.
- Fold changes compare each group with its own baseline. The later article reports the same 94-child cohort. The open design and caregiver-reported measures limit causal inference. The one-course and control arms match the 2019 report in size and selected baseline and follow-up results. Treat the two reports as likely overlapping and avoid adding their participant counts.
Zh Nevrol Psikhiatr Im S S Korsakova 120(10):38-44. PMID 33244956 · Publication record
Review of earlier studies · 2026
ADHD council assessment places these preparations in its limited-evidence group
Study of multiple preparations
- Cortexin, Cerebrolysin and Semax
- Group B: limited evidence base for ADHD
- Document type
- Expert-council resolutionCouncil meeting 16 July 2026; publication 22 October 2026
The expert council places Cortexin, Cerebrolysin and Semax in Group B, its category for preparations with a limited evidence base in ADHD. It discusses adjunctive use within psychoeducation and behavioral care, rather than replacement of established first-line treatment.
Study notes · methods, sources and limitations
Participants or model Expert-council assessment of adjunctive ADHD pharmacotherapy in children and adolescents; no new patient trial.
Important limitations
- Expert consensus and evidence appraisal, not a new efficacy trial. The assessment concerns childhood ADHD, not every clinical use of these preparations.
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova 126(9. Vyp. 2) · Expert-council resolution
Performance research in context
Military & occupational evidence map ↗ Sports performance evidence map ↗
- Compound class
- Peptide preparation
- Research collection
- Neuropeptide research · editorial grouping
- Research institutions
- No institutional affiliation recorded
- Source review
- Review dates and the material assessed are listed with each publication below.
Understanding the evidence
Human research
Condition-specific trials, comparisons and observational reports
Study methods
Clinical reports plus independent Cochrane review
Independent replication
New citations are not automatically independent replication; shared programs and translated reports require cohort checks
Source access
New indexed primary abstracts and/or report reproductions linked; review depth shown per source
Safety evidence
Reported tolerability is not proof of safety; uncommon harms and long-term outcomes remain unresolved
Open a topic for the evidence assessment.
Cortexin in childhood autism and speech development
A Russian preschool study found changes on selected word-association tasks after Cortexin. At three months, the autism subgroup did not show a statistically significant improvement in overall speech or social communication. Russia’s 2024 autism guideline found insufficient evidence that peptide or nootropic preparations improve cognitive and language development in autistic children.
Larkina and Khaletskaya, 2014
The study enrolled 130 children aged 4–6, including 40 reported with early childhood autism. Autistic participants received Cortexin or risperidone alongside speech-language and psychoeducational rehabilitation. The reported arm counts of 23 and 22 add up to 45, so the autism-arm denominators remain uncertain.
| Measure | Finding | Reported significance |
|---|---|---|
| Overall speech development | No statistically significant change | p = 0.119 |
| Social communication | No statistically significant change | p = 0.058 |
| Verb selection and use | Improvement reported on an individual task | p < 0.001 (printed as 0.000) |
| Noun selection and use | Improvement reported on an individual task | p = 0.001 |
| Word association | Improvement reported on an individual task | p = 0.019 |
The analyses compare the Cortexin arm with its own baseline. They cannot tell us whether Cortexin outperformed risperidone or whether rehabilitation contributed to the changes.
Study methods, reported dose and results ↗
The 2015 Larkina dissertation extended the same research program with neuropsychological and memory assessments. It contributes no independent cohort. The full autism-arm memory tables remain to be verified.
Earlier sources document historical use. Shaposhnikova’s 2008 review describes clinical impressions without numerical Cortexin outcomes. Simashkova and Yakupova followed 80 selected cases for 7–10 years from an initial sample of 370. The authors used several interventions and did not isolate Cortexin’s effects. A 2006 dissertation documents the related program.
Randomized trials and comparisons for speech-development disorders
Zavadenko et al., 2019 randomized 54 children with developmental dysphasia to a 10-day intramuscular course or no drug treatment. At two months active vocabulary increased 2.3-fold with Cortexin versus 1.4-fold without medication. Spoken phrases increased 3.6-fold versus 1.5-fold. Both groups received speech-stimulation guidance. The trial was open, and the fold changes compare each group with its own baseline.
Zavadenko et al., 2020 compared one course (27 children), two courses (40), and no drug treatment (27) in an open study. Active vocabulary rose 2.3-, 2.8-, and 1.4-fold, respectively. Spoken phrases rose 3.6-, 4.2-, and 1.5-fold. The two-course group had higher vocabulary at day 60 (p = 0.01), while the phrase count difference between the two treated groups was nonsignificant (p = 0.795). The one-course and control arms match the 2019 report in size and selected results, so those samples should not be added together. The 2023 account describes the same 94-child study.
| Protocol | Formulation | Registry count | Status |
|---|---|---|---|
| GP20021-P4-21 | 10 mg intramuscular lyophilisate | Phase II · 150 participants listed | Listed end December 2023. No public results located. |
| GP20061-P4-02-01 | 10 mg and 20 mg rectal suppositories | Phase II · 132 participants listed | Listed end April 2025. No public results located. |
| GP20061-P4-03-01 | 20 mg rectal suppository | Phase III · 180 participants listed | Scheduled to end January 29, 2027. No public results located. |
The dysphasia studies and the registered trials concern speech-development disorders. They do not establish efficacy in autism. Registry counts are excluded from counts of verified treated participants.
Patents and claimed inventions
These 5 grouped records distinguish claimed molecules, uses, formulations and related chemistry. Patent disclosure does not establish clinical benefit or approval.
Status is an indexed snapshot, not an official legal assessment. Search the patent collection and read the method →
Linked sources
Separate personal WHOOP observation ↗ — uncontrolled n=1 data; not included as clinical evidence.
Explore the research map and unresolved leads ↗
Explore related historical combinations ↗
Related compound research
Follow shared publications or research classes. These links do not establish equivalent effects between compounds.
Research collection curated by @PepMariner · editorial standards. Send a source correction ↗
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