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Crx2.0
Cortexin Research
Mostly mechanism / observational
17 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Cortexin studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from medium-quality meta-analyses and randomised trials published 1999–2026 with a typical study size of 110 participants.
Based on 17 studies · 1 meta-analysis · 11 RCTs · 110 total participants
Confidence
Moderate confidence
By outcome
Cognitive functionMarketed for faster neurological/cognitive recovery after stroke, but supporting human data are unblinded and it often underperforms comparator drugs. · Not established
Mostly mechanism / observational15 studies
Neuroprotection & brain agingA brain-derived polypeptide studied for post-stroke neuroprotection; plausible receptor-level/antioxidant effects in animals but no better than saline in a rigorous animal comparison, and human trials are unblinded. · Not established
Mostly mechanism / observational9 studies
Steady research
4 studies in the last 5 years · Latest meta-analysis: 2021
199920122026
1RCT2006
Skorokhodov AP, Dudina AA, Kolesnikova EA, Koron AE, Kobantsev IuA, Sedova AA · Zh Nevrol Psikhiatr Im S S Korsakova (2006)
2RCT2018
Fedin AI, Belskaya GN, Kurushina OV, Kovalchuk VV, Starych EV, Chichanovskaya LV · Zh Nevrol Psikhiatr Im S S Korsakova (2018)
In plain English: The domestic drug Cortexin is one of the most promising drugs for further clinical trials.
Putilina MV. · Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova (2025)
Traditionally applied treatment standards, strict glycemic control does not allow us to talk about complete correction of manifestations and/or reducing the risk of developing DPN without CI or mild CI.
In recent years, the possibilities of peptide drugs to reduce CI and chronic neuropathic pain have been actively studied.
Neuropeptides of animal origin combine the functions of hormones, growth factors, neurotransmitters, ion channel ligands, and anti-inflammatory agents.
In plain English: Conclusion The comprehensive therapy with Cortexin proved to be highly effective, safe, and well-tolerated in patients with neurological complications of T2DM, and it is recommended for use in general clinical practice.
· Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova (2026)
Of the participants, 70.6% were females and 29.4% were males, aged 45 to 70 years (mean age: 60.8±0.71 years).
Results The regression of cognitive symptoms in group 1 patients was superior to that in group 2 (6.0 times vs. 1.7 times), as confirmed by a 1.2-fold increase in the average MoCA score after 3 months of follow-up ( p <0.001).
In the Cortexin group, the mean HADS anxiety score decreased by 1.6 times, and the mean depression score decreased by 1.7 times, with minimal changes noted in the control group ( p <0.001).
In plain English: The limited number of eligible studies for Actovegin (n = 2 trials,563 participants) and Cortexin, (n = 1 trial,80 participants) precluded meta-analyses but data suggested potential efficacy and no safety concerns.
Alsulaimani RA, Quinn TJ. · Cereb Circ Cogn Behav (2021)
Independent systematic review and meta-analysis of animal-derived nootropics (Cerebrolysin, Actovegin, Cortexin) in cognitive disorders, using Cochrane risk-of-bias and GRADE
For cortexin, only ONE eligible trial (80 participants) was found — too few to meta-analyse, so no pooled cortexin estimate could be generated
Across the drug class, risk of bias was moderate to high and certainty of evidence was low to very low; only cerebrolysin had enough trials to show a (modest) cognition benefit
In plain English: Similar functional outcome was observed for saline control, Cognistar®, Cerebrolysat® and Cortexin®; in contrast, a significantly improved neurological outcome was observed with Cerebrolysin® treatment.
Zhang L, Chopp M, Wang C, Zhang Y, Lu M, Zhang T, Zhang ZG. · J Neurol Sci (2019)
Independent, prospective, randomized, double-blind, placebo-controlled rodent embolic-stroke comparison of four brain-hydrolysate drugs vs saline
Cortexin produced functional outcomes and lesion volumes NO DIFFERENT from saline
Only cerebrolysin significantly improved neurological outcome vs saline and vs the comparator drugs
In plain English: Cortexin® (10 μg/ml) demonstrated high or moderate binding to AMPA-receptors (80.1%), kainate receptors (73.5%), mGluR1 (49.0%), GABAA1 (44.0%) and mGluR5 (39.7%).
Kurkin DV, Bakulin DA, Morkovin EI, Kalatanova AV, Makarenko IE, Dorotenko AR, Kovalev NS, Dubrovina MA, Verkholyak DV, Abrosimova EE, Smirnov AV, Shmidt MV, Tyurenkov IN. · PLoS One (2021)
Best mechanistic study: rat acute (MCAO) and chronic (carotid stenosis) ischemia models plus in-vitro receptor binding and BBB-permeability assays
Radiolabeled cortexin crossed the blood-brain barrier (6-8% of whole-blood concentration) and bound AMPA/kainate/mGluR/GABA-A receptors in vitro
Cortexin reduced necrosis size in acute ischemia, supported the antioxidant system and limited neurodegeneration in chronic ischemia — comparable to cerebrolysin, better than actovegin
In plain English: It was noted more rapid and complete regression of cognitive disorders in patients of the 1st and 2nd groups, in comparison with patients of the 3rd group.
Belova LA, Mashin VV, Abramova VV, Proshin AN, Ovsjannikova AN. · Zh Nevrol Psikhiatr Im S S Korsakova (2016)
Controlled (non-blinded) trial in 90 hemispheric ischemic-stroke patients comparing single vs double cortexin courses (20 mg/day) vs basic therapy
Cortexin groups showed faster and more complete regression of cognitive deficits than basic therapy alone
The double-course regimen gave the best cognitive outcome (MMSE, FAB, clock-drawing, MoCA)
In plain English: The most complete regression of neurological deficits and manifestations of cardiac autonomic neuropathy during the acute period of ischemic stroke was observed in the group of patients treated with cortexin.
Mashin VV, Belova LA, Aizatullin IF, Pavlova VA, Slasten EV, Abramova VV, Belov DV. · Zh Nevrol Psikhiatr Im S S Korsakova (2019)
Three-arm controlled (non-blinded) trial in 90 acute ischemic-stroke patients: cortexin 20 mg/day + early verticalization vs verticalization alone vs basic therapy
The cortexin arm showed the most complete regression of neurological deficits and cardiac autonomic neuropathy
Assessed with NIHSS, modified Rankin, Barthel, Rivermead, MMSE and MoCA
In plain English: A decrease in NR2-peptide concentration (from 8.5 to 5.9 ng/ml, p<0.0001) was noted in patients treated with cortexin after 10-day treatment course.
Dambinova SA, Aliev KT, Bondarenko EV, Ponomarev GV, Skoromets AA, Skoromets AP, Skoromets TA, Smolko DG, Shumilina MV. · Zh Nevrol Psikhiatr Im S S Korsakova (2017)
Observational biomarker study in 120 patients with TIA or ischemic stroke evaluating the NR2-peptide blood marker of brain ischemia
NR2-peptide correlated with ischemic-lesion size and fell after a 10-day cortexin course
Authors interpret the biomarker decline as evidence of cortexin's therapeutic efficacy