Cortexin

Dosing from the Literature

Published for stroke and brain disorders: the Russian label’s 10 mg into the muscle once a day for 10 days, twice a day after an ischemic stroke; adult trial doses of 10–30 mg a day in 10-day courses; and 5–10 mg in children’s trials. Not published: results of GEROPHARM’s 320-patient placebo-controlled stroke trial, planned to run to December 2027, or usable functional results from the 272-patient placebo-controlled stroke trial.

The table gives doses as the Russian label and each study state them (Cortexin label; Ziganshina et al., 2023). They are label and trial doses, not recommendations.

What It Is

Cortexin is not one peptide but a mixture: a freeze-dried complex of water-soluble polypeptide fractions, each of 10,000 Da or less, extracted from the cerebral cortex of cattle, with glycine added as a stabilizer; a vial holds 5 or 10 mg of the active substance (RLS, 2022; Cortexin label). A Russian review describes it as neuropeptides, amino acids and trace elements (Gomazkov, 2015). A rat study funded by one of its producers says that 70 to 95% of it is acidic and neutral polypeptides of 1,000 to 10,000 Da, extracted from the brain cortex of cattle or pigs under 12 months old (Kurkin et al., 2021; Kurkin et al., 2025); the IV/IM form’s leaflet names cattle, while the IM form’s leaflet says livestock (скот), which Russian drug references translate as cattle (Cortexin IV/IM label; Cortexin label; Vidal, 2022).

It grew out of the organ-extract work of Vladimir Khavinson and V.G. Morozov (Belokrylov et al., 1980; Khavinson, 2020). In 1980 they and their colleague Belokrylov gave mice a low-molecular-weight polypeptide preparation from the cerebral cortex, already called cortexin, and measured their immune response (Belokrylov et al., 1980). A 2004 review in a Russian military medical journal dates the drug’s creation at the Military Medical Academy to 1986 (Tsyganov & Bogoslovskiĭ, 2004). Khavinson’s own 2020 review places it among the peptide-complex medicines the academy developed under his direction in the 1980s and 1990s, and dates the medicine to 1999: previously made by Samson-Med under registration certificate 99/136/14, now by GEROPHARM in Saint Petersburg (Khavinson, 2020). GEROPHARM says it has been in wide use since 1999 (GEROPHARM, 2026), and the first clinical study in PubMed is a 1999 trial by Khavinson and Morozov’s group (Khavinson et al., 1999). Khavinson’s St. Petersburg Institute of Bioregulation and Gerontology lists Cortexin among six medicines that the institute and the academy developed (St. Petersburg Institute of Bioregulation and Gerontology, 2024).

Cortexin is a prescription drug in Russia, registered to GEROPHARM as a 5 mg and a 10 mg product for injection into the muscle (Vidal, 2022); a 10 mg form for injection into a vein or a muscle is also listed (RLS, 2022; Cortexin IV/IM label). It is on Russia’s list of vital and essential medicines (Vidal, 2022), and Cochrane’s reviewers note that Russia’s 2021 clinical guidelines include it, with Cerebrolysin, for acute ischemic stroke (Ziganshina et al., 2023). Its label lists, as part of combined treatment, cerebrovascular disorders, brain injury and its after-effects, encephalopathies, cognitive impairment, encephalitis, epilepsy and asthenic states in adults, and reduced learning ability, cognitive impairment, epilepsy, delayed psychomotor and speech development and cerebral palsy in children (Cortexin label). It has no approval in the US and no entry in the European Medicines Agency’s list of medicines (see Legal Status).

PubMed returns 217 records for “cortexin” (searched October 4, 2026); at least 150 are about the drug, and the rest concern an unrelated brain protein and gene also named cortexin, a kidney protein called “renal cortexin”, or match the word by accident. Khavinson’s group made two of its synthetic short peptides from Cortexin: Cortagen, synthesized on the basis of an analysis of Cortexin’s amino-acid composition, and Pinealon, the three-amino-acid peptide Glu-Asp-Arg, which the group reports finding in the drug by chromatography–mass spectrometry (Khavinson, 2020).

Who Khavinson was, and what his record supports →

Mechanism of Action

Every finding below comes from cells, tissue extracts or animals, and none of the mechanisms has been confirmed in people; one of the main studies was funded by a company that produces Cortexin (Kurkin et al., 2021; Kurkin et al., 2025). The label attributes its effects to activation of brain neuropeptides and neurotrophic factors, a rebalancing of excitatory and inhibitory amino acids, dopamine and serotonin, GABA-related action, less seizure activity and fewer free radicals (RLS, 2022). Cochrane’s reviewers write that there is no clear understanding of its molecular mechanism (Ziganshina et al., 2023).

• Caspase-8, an enzyme that starts cell death — In the test tube, Cortexin inhibited caspase-8 from brain tissue, with much weaker or no effects on caspases 1, 3 and 9, cathepsin B and calpain; a peptide fraction isolated from it kept all of the inhibition, and both the drug and the fraction protected cultured neurons from glutamate-induced death (Yakovlev et al., 2017).
• Glutamate (AMPA, kainate, mGluR1, mGluR5) and GABA-A receptors — At 10 µg/mL in a receptor-binding panel, Cortexin displaced test ligands from AMPA receptors by 80.1%, kainate receptors by 73.5%, mGluR1 by 49.0%, GABA-A receptors by 44.0% and mGluR5 by 39.7%; the authors suggest its effects in rats may run through glutamate and GABA signalling (Kurkin et al., 2021). Pharm-Holding funded the study and employed three of its authors (Kurkin et al., 2021).
• Entry into the brain (mice) — Thirty minutes after an injection of radio-labelled Cortexin into a vein or muscle, radioactivity in mouse brain was 6–8% of that in whole blood, against about 5% for Cerebrolysin (Kurkin et al., 2021); in a later mouse study, with Cortexin given into a vein or rectally, urine was the main route of excretion, within the first 2 hours (Kurkin et al., 2025). No such measurement in people turned up in PubMed (searched October 4, 2026), and the label says the mixture’s makeup does not allow a conventional pharmacokinetic analysis of its components (RLS, 2022).
• Oxidative stress and inflammation (rats) — In rats with narrowed carotid arteries, 3 mg/kg a day raised superoxide dismutase and glutathione and lowered malondialdehyde in the brain (Kurkin et al., 2021). In a Turkish rat model of stroke and reperfusion, 1 and 2 mg/kg lowered blood oxidant levels and brain staining for OPG, RANK, RANKL and TRPC1 (Guven et al., 2026). A review reports anti-inflammatory effects in rats with accelerated aging and names β5-tubulin, creatine kinase B and 14-3-3 proteins as binding partners of its peptides in the brain (Gulyaeva, 2018).
• Nerve-fibre growth in culture — In chick-embryo tissue cultures, in a study by the developers’ own group (Khavinson and Morozov), 20 and 100 ng/mL increased nerve-fibre outgrowth from sensory ganglia, and 100 ng/mL was active in cortex cultures but inhibited nerve-fibre growth in cultures of deeper (subcortical) brain structures (Khavinson et al., 1997). In cultured adult rat sensory neurons exposed to high glucose, 40 µg/mL partly preserved the cell index, a measure of viability and attachment (area under the curve 0.66 against 0.18 with glucose alone; Yazar & Ayar, 2023).

What the Research Shows

Everything below is animal work; the next section covers work in humans.

• Stroke in rats — In rats with a blocked middle cerebral artery, 1 or 3 mg/kg a day for 10 days improved neurological scores and coordination, and in a separate 3-day experiment at 3 mg/kg the dead-tissue volume was 45% smaller than on placebo, in 9 rats per group; Pharm-Holding funded the study (Kurkin et al., 2021). In a randomized, blinded study at Henry Ford Hospital in Detroit, whose listed funder is EVER Pharma, the maker of Cerebrolysin, 1.7 mg/kg into the abdomen daily for 10 days, from 4 hours after an embolic stroke, gave functional recovery similar to saline’s, and lesion volume, 33.5% against 30.8% on saline, did not differ significantly; only Cerebrolysin improved recovery (Zhang et al., 2019). A single 1 mg/kg dose at reperfusion did not significantly shrink the infarct (32.75% against 38.16% on saline, p = 0.198) but lowered TNF-α, Fas and bax; Mexidol had the largest effect in that study (Shchulkin et al., 2026). In a rat study of hemorrhagic stroke published in Ukrainian, degenerating neurons in the cortex numbered 18.0 per mm² after Cortexin and 17.6 after Cerebrolysin, against 25.5 after the stroke alone, in the abstract’s “secondary” stroke model; the authors rated Cortexin and a third preparation, Cerebral, the most effective, and the abstract gives no doses or group sizes (Savos’ko et al., 2012).
• Long-term brain ischemia (rats) — In rats with carotid arteries narrowed by half, 1 or 3 mg/kg improved learning in the Morris water maze and reduced damage to cortex and hippocampus, about as much as Cerebrolysin (Kurkin et al., 2021).
• The developing brain (rats) — In young rats harmed by alcohol given to their mothers late in pregnancy, or by hypoxia–ischemia after birth, 0.5 mg/kg into the muscle, or rectal suppositories of 1.6–16 mg/kg, for 20 days reduced neurological deficits and nerve-cell damage (Kurkin et al., 2025). Pharm-Holding, which produced the drug tested, funded the study and employed three of its authors (Kurkin et al., 2025); suppositories are not among the forms the RLS drug reference lists (RLS, 2022), and the product search of Russia’s state register, behind a CAPTCHA, could not be read for this page.
• Seizures (rats) — Given in advance at 0.015–1.0 mg/kg into the abdomen, or into the nose bound to nanoparticles, Cortexin did not change pentylenetetrazole-induced status epilepticus but had a dose-dependent anticonvulsant effect in a chronic (kindling) model (Aniol et al., 2011).
• Hearing and the facial nerve (Turkish studies) — In rats given cisplatin, 10 per group, 2 mg a day into the abdomen for 7 days lessened the loss of inner-ear (otoacoustic) emissions (Eroğlu et al., 2018). In 21 rabbits with crushed facial nerves, 7 per group, 3 mg a day into the muscle for 10 days improved nerve histology against saline about as much as methylprednisolone did, with no difference in electromyography (Tunçcan et al., 2016).

Human Data

PubMed tags 18 “cortexin” records as randomized controlled trials (October 4, 2026); one is an unrelated exercise study, and in two of them every patient received Cortexin. Two published trials in acute ischemic stroke compared Cortexin with placebo, both described by their authors as double-blind (Skoromets et al., 2008; Ziganshina et al., 2023). One other group reports placebo-controlled trials in newborns with acute brain failure and in severe head injury or infectious encephalitis, with no numbers in its abstract (Shmakov et al., 2011). Most other studies compared it with no added drug, with another drug or with a second form of Cortexin, or were observational programs without a control group (Fedin et al., 2018; Khabirov et al., 2020; Fedin et al., 2025; Mashin et al., 2014). No Cortexin trial is registered on ClinicalTrials.gov (searched October 4, 2026).

• Placebo-controlled stroke trial, 62 patients (Skoromets et al., 2008) — A multicenter, double-blind trial in hemispheric ischemic stroke: 32 patients got 20 mg into the muscle daily for 10 days, starting within 6 hours of the first symptoms, and 30 got basic treatment with placebo injections; stroke severity (NIHSS), disability (modified Rankin scale) and daily function (Barthel index) were scored up to day 28. The authors write that the data suggest efficacy compared with placebo and confirm safety; the abstract gives no figures, and the trial is not among those Cochrane’s 2023 review analysed (Ziganshina et al., 2023).
• Placebo-controlled stroke trial, 272 patients (Ziganshina et al., 2023) — Published in 2012 and 2014, this multicenter trial, described as double-blind, randomized patients 2:1:1 within 24 hours of an ischemic stroke: 136 got two 10-day courses of 10 mg twice a day into the muscle, 10 days apart; 72 got one course and then placebo; 64 got placebo (mean age 62, median NIHSS 6). The 2014 report calls Cortexin effective and safe, with the largest effect after two courses (Aliferova et al., 2014). Cochrane could not extract its functional results, which were shown only as graphs without baseline data, so it used the trial only for deaths, adverse events and dropouts. The corresponding author did not reply; Cochrane found no protocol and no conflict-of-interest statement, and rated the trial at unclear risk of bias in every domain except missing data, blinding included. Four of 136, 3 of 72 and none of 64 patients died (two repeated strokes, a pulmonary embolism and a pneumonia in the two-course group; a bowel obstruction and two sudden deaths in the one-course group; the trial’s authors did not report when the deaths occurred), and the investigators judged none drug-related (Ziganshina et al., 2023). Adverse events: 20 of 136, 11 of 72 and 7 of 64 (Ziganshina et al., 2023).
• Vein against muscle, 490 patients (Fedin et al., 2025) — A double-blind trial in acute ischemic stroke gave 246 patients Cortexin into a vein and 244 into the muscle, each with a placebo injection by the other route, 10 mg twice a day for 10 days, then a second 10-day course into the muscle for all. At day 90, 93.64% and 86.50% had little or no disability (modified Rankin 0–2), and memory-test (MMSE) gains did not differ (4.11 against 3.88 points, p = 0.249); 74 adverse events occurred in 60 patients and 51 in 41 (Fedin et al., 2025). With no group off Cortexin, the trial compares the two forms; it cannot show that Cortexin works. Cochrane lists a GEROPHARM trial comparing the same two forms, recorded in Russia’s register of trial permissions from December 2, 2021 (GP20011-P4-36), that planned 974 patients (Ziganshina et al., 2023); the 2025 paper’s abstract reports 490 patients and names neither GEROPHARM nor a registration (Fedin et al., 2025).
• Long-term brain ischemia, 189 patients (Fedin et al., 2018) — Patients with chronic cerebral ischemia (mean age 64.3; 147 women) were randomized to 20 mg or 10 mg into the muscle or to basic treatment only, for 10 days, repeated after 6 months. The authors report dose-dependent effects on neurological symptoms, fatigue and sleep, insignificant effects on anxiety and depression, and an antioxidant effect at both doses; the abstract gives no figures and does not mention blinding.
• Against other drugs — In acute ischemic stroke, Cortexin gave effects similar to piracetam (Nootropil) in 35 patients and to Cerebrolysin in 45 (Skorokhodov et al., 2006). In 40 patients in the early recovery period, randomized to 10 days of Cortexin 10 mg into the muscle or of Cellex, a peptide drug given under the skin, the authors report more improvement with Cellex on the stroke scale (NIHSS, p = 0.03) and the memory test (MMSE, p = 0.04) (Khabirov et al., 2020).
• Children with speech delay (Zavadenko et al., 2019; Zavadenko et al., 2020) — In 54 children aged 3–4 with developmental dysphasia, randomized to one 10-day course into the muscle or to no drug, with speech-stimulation advice for all parents, the treated group’s active vocabulary rose 2.3-fold and its phrase count 3.6-fold over two months (Zavadenko et al., 2019). A 2020 paper by the same group adds 40 children given two courses a month apart to a one-course group and a no-drug group of 27 each, the 2019 trial’s group sizes, with the same 2.3- and 3.6-fold gains after one course; active vocabulary at least doubled in 80.0% after two courses, 44.4% after one and 22.2% with no drug (Zavadenko et al., 2020). Neither abstract mentions a placebo or blinding, and the 2020 abstract does not say its groups were randomized (Zavadenko et al., 2019; Zavadenko et al., 2020).
• Children with cerebral palsy, epilepsy or brain injury — In 60 children aged 2–7 with hemiparetic cerebral palsy, all given microcurrent reflexology, the half randomized to two courses of 10 mg Cortexin improved in complex arm and hand movements more often (37% against 17%; Ukhanova & Gorbunov, 2012). In 84 children aged 1–11 with cerebral palsy and epilepsy given 5–10 mg alongside antiepileptic drugs, without a control group, seizures fell by more than half with better movement in 36.9%, 27.4% did not respond, and seizures worsened in one girl with West syndrome (Kholin et al., 2017). In 74 children aged 6–13 with a moderate brain contusion, adding Cortexin to standard treatment was followed by fewer symptoms at 30 days than standard treatment alone (Skripnik et al., 2020). One group reports prospective placebo-controlled trials in newborns with acute brain failure, and in severe head injury or infectious encephalitis, but its abstract gives no numbers (Shmakov et al., 2011).
• Large programs without controls — A multicenter study gave 635 children aged 3–7 with ADHD, speech delay, after-effects of perinatal brain injury or asthenia a course of 10 injections and reports an effect on cognition; its abstract describes no control group (Zykov et al., 2018). An “all-Russian screening” in 2013 enrolled 50,000 patients with brain ischemia in 70 cities, all given 10 mg a day for 10 days, and analysed 500 of them (Mashin et al., 2014). A post-COVID program enrolled 979 patients through 674 neurologists in Russia, Azerbaijan, Kyrgyzstan and Kazakhstan, all given 10 or 20 mg a day for 10 days (Putilina et al., 2022). Without control groups, these programs show how widely it is prescribed, not whether it works.
• Other conditions — In 110 patients with neurological complications of type 2 diabetes, randomized to ten 10 mg injections plus basic treatment or basic treatment alone, the Cortexin group’s average cognitive score (MoCA) rose 1.2-fold at 3 months, and its HbA1c was 7.3% against 7.8% in the control group; 5 adverse events occurred, 3 against 2, none judged treatment-related (Putilina et al., 2026). The first published trial, in 1999, came from the developers’ own group (Khavinson and Morozov): it gave Cortexin by nasal electrophoresis to 45 of 76 patients with chronic circulatory encephalopathy and reported 22.7% better rehabilitation results (Khavinson et al., 1999). In 98 patients with depressive disorder, 48 given 10 mg into the muscle once a day for 10 days on top of antidepressants and 50 given antidepressants alone, the author reports a larger fall in depression scores (MADRS) by day 28 with Cortexin (p = 0.001); the abstract mentions no randomization, placebo or blinding (Schastnyy, 2026). In 40 patients aged 34–72 with alcoholic encephalopathy, given 10 or 20 mg for 10 days alongside other hospital treatment and with no control group, memory-test (MMSE) scores rose from 27.3 to 28.9 points (Masaleva & Ivenkov, 2026).
• What independent reviewers found — Cochrane’s 2023 review pooled the 272-patient trial with Cerebrolysin trials for deaths: 53 among 922 patients on the peptide mixtures and 47 among 767 on placebo (risk ratio 0.96, 95% CI 0.65–1.41; moderate certainty), no effect on deaths, and wrote that there is “concern from one trial” on Cortexin that peptide mixtures in acute ischaemic stroke “may contribute to deaths” (Ziganshina et al., 2023). A 2021 systematic review of animal-derived nootropics for cognitive disorders found one eligible Cortexin trial, 80 patients with post-stroke cognitive impairment followed for 12 months, at high risk of bias in three of five domains, and noted that Cortexin has more reviews than original randomized trials (Alsulaimani & Quinn, 2021).

The evidence meter on the Cortexin card reads “Controlled trials”: it counts published human data on Cortexin itself, for stroke and brain disorders, and two stroke trials comparing it with placebo, both described as double-blind, are published (Skoromets et al., 2008; Ziganshina et al., 2023). Controlled is not the same as convincing: the smaller trial’s abstract gives no figures, the larger one’s functional results could not be extracted, and in the larger one deaths occurred only among patients given Cortexin (Skoromets et al., 2008; Ziganshina et al., 2023).

Reconstitution & Storage

Cortexin comes as a white or yellowish freeze-dried powder: 5 mg of active substance with 6 mg of glycine in a 3 mL glass vial, or 10 mg with 12 mg of glycine in a 5 mL vial, ten vials to a pack (RLS, 2022; Cortexin label).

• Diluents — The label’s diluents are 1–2 mL of 0.5% procaine (novocaine), water for injection or 0.9% saline, for an injection into the muscle; the solution is clear and colourless or slightly yellowish (Cortexin label).
• Lidocaine and mixing — The label excludes lidocaine as a diluent, because in children it was associated with more severe adverse reactions, and it does not mix the solution with other solutions (RLS, 2022; Cortexin label).
• After dissolving — A dissolved vial is not kept, and what is left after the dose is not reused (Cortexin label).
• Route limits — Neither form is for injection under the skin; the IM-only form is not for a vein, and the IV/IM form goes into a vein only in adults with stroke, given by medical staff (Cortexin label; Cortexin IV/IM label).
• Storage — Unopened vials: protected from light at no more than 25 °C, not frozen, shelf life 3 years (Cortexin label); a Russian drug reference lists 2–25 °C (Vidal, 2022).
• Products sold online — The exported packs read for this page are GEROPHARM’s; no independent analysis of an exported vial turned up in PubMed (searched October 4, 2026).

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Side Effects & Risks

• On the label — Listed as very rare, in no more than 1 in 10,000 people: anaphylactic shock and swelling of the larynx, both life-threatening; drug allergy, skin redness, hives, rash, itching and allergic dermatitis; redness and warmth at the injection site; fast or irregular heartbeat; raised blood pressure; fatigue; chills; agitation; poor coordination; headache; dizziness; drowsiness; anxiety; and insomnia (Cortexin label). The leaflet of the IV/IM form adds pain and hardening at muscle injection sites and reduced skin sensation (Cortexin IV/IM label).
• In the stroke trials — Adverse events occurred in 20 of 136 and 11 of 72 patients on Cortexin against 7 of 64 on placebo, among them recurrent stroke, epilepsy, heart-rhythm problems, raised liver enzymes and pneumonia, none judged treatment-related by the investigators (Ziganshina et al., 2023). In the vein-against-muscle trial, 74 events occurred in 60 patients and 51 in 41 (Fedin et al., 2025).
• In children — Seizures worsened in one of 84 children with cerebral palsy and epilepsy (Kholin et al., 2017).
• Who the label excludes — People allergic to Cortexin or glycine, and pregnant or breastfeeding women, the latter for lack of clinical data (RLS, 2022; Cortexin label).
• Driving — The label lists agitation and dizziness as possible effects on driving and, for children under treatment, advises against bicycles and scooters (Cortexin label).
• Animal origin — Cortexin is made from animal brain. A 2003 paper by Khavinson’s group on its organ-extract drugs, which PubMed indexes under Cortexin, reports that tests by World Health Organization methods show that the production of these drugs from the organs of young animals “guarantees the absence of infectious agents, protooncogenes, nucleic acids, and prion proteins” (Ryzhak et al., 2003). The sources disagree on nucleic acids: a 2015 review of Cortexin counts among its components the cortex’s nucleoprotein complexes, which “can also retain elements of chromatin with DNA fragments” (Gomazkov, 2015). No independent test turned up in PubMed (searched October 4, 2026).
• What has not been tested — The label says the mixture’s makeup does not allow a conventional pharmacokinetic analysis of its components (RLS, 2022); no measurement of how long they stay in people’s blood, and no study in pregnancy, turned up in PubMed (searched October 4, 2026).
• WADA — Not prohibited. Cortexin is not named on the 2026 Prohibited List, and none of its sections names brain extracts. It is approved in Russia, so S0, which covers substances “with no current approval by any governmental regulatory health authority for human therapeutic use”, does not apply (World Anti-Doping Agency, 2026).

Bloodwork & Monitoring

Cortexin’s label sets no laboratory monitoring (Cortexin label). The trials measured these:

• Stroke scales — Stroke severity (NIHSS), disability (modified Rankin scale) and daily function (Barthel index) (Skoromets et al., 2008); NIHSS and modified Rankin scale in the vein-against-muscle trial (Fedin et al., 2025); mobility (Rivermead index) (Belova et al., 2018).
• Memory and thinking tests — MMSE and MoCA (Fedin et al., 2025; Putilina et al., 2026) and the Schulte attention tables (Putilina et al., 2022).
• Blood tests — Glycated hemoglobin (HbA1c) in the diabetes trial (Putilina et al., 2026); reduced SH-groups and superoxide dismutase as markers of oxidative stress (Fedin et al., 2018).
• Brain electrical activity — EEG in children with cerebral palsy or brain contusion (Ukhanova & Gorbunov, 2012; Skripnik et al., 2020).
• Which tests fit a given person — A question for a licensed healthcare provider. This page can’t answer it.

Commonly Stacked With

Cortexin has been studied as an add-on to standard treatment, and in observational programs alongside citicoline, memantine or Neuromexol (Belova et al., 2019; Fedin, 2018; Mashin et al., 2023); the authors of one program name GEROPHARM as the maker of both drugs it paired (Belova et al., 2019). None of those drugs has a page on this site. In rats it has been compared side by side with Cerebrolysin, Pinealon and Cortagen, not combined with them (Kurkin et al., 2021; Mendzheritsky et al., 2015; Zarubina & Shabanov, 2011). Apart from a 2002 study of Thymalin, Epithalamin and Cortexin in patients with heart and brain circulation disorders, whose abstract does not say whether any patient received more than one of them (Cherkashin et al., 2002), no study of Cortexin combined with a compound on this site turned up (PubMed, searched October 4, 2026).

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Legal Status

Related Compounds

People researching Cortexin often also look at these:

Next Steps

References

1. RLS (Register of Medicines of Russia, an online drug-reference publication). Cortexin® (polypeptides of the cerebral cortex of cattle), lyophilizate for solution for intramuscular injection, 5 mg and 10 mg: description based on the official instruction (agreed February 10, 2022), with dosage forms, makers and pharmacy price listings. rlsnet.ru/drugs/korteksin-11698. Page updated September 21, 2026. Read October 4, 2026. In Russian.
2. GEROPHARM. Cortexin® 10 mg, lyophilizate for solution for intramuscular injection: package leaflet (patient information, Eurasian Economic Union format). korteksin.ru/assets/files/instruction/korteksin-instrukciya-dlya-vzroslyh.pdf. Read October 4, 2026. In Russian.
3. GEROPHARM. Cortexin® 10 mg, lyophilizate for solution for intravenous and intramuscular injection: package leaflet (patient information, Eurasian Economic Union format). korteksin.ru/assets/files/instruction/korteksin-instrukciya-dlya-detej.pdf. Read October 4, 2026. In Russian.
4. GEROPHARM. Cortexin: official product website, korteksin.ru (home page and “Кортексин” page: in wide use since 1999; “Cortexin for children” holds half the amount per vial; packaging redesigned from January 1, 2026). Read October 4, 2026. In Russian.
5. Vidal (Russian drug reference). Cortexin® 5 mg, registration ЛП-№(000620)-(РГ-RU) of March 9, 2022 (previously ЛСР-003190/09), and Cortexin® 10 mg, registration ЛП-№(000636)-(РГ-RU) of March 24, 2022 (previously Р N003862/02), lyophilizate for intramuscular injection; holder GEROPHARM; prescription only; on the list of vital and essential medicines. vidal.ru/drugs/cortexin__21252 and vidal.ru/drugs/cortexin__2477. Read October 4, 2026. In Russian.
6. GRLS (State Register of Medicines, Ministry of Health of the Russian Federation). Permission for a clinical trial No. 473 of August 29, 2019: aim, assessment of the efficacy of Cortexin® in patients in the acute period of ischemic stroke; Cortexin® lyophilizate for solution for intramuscular injection, 10 mg; list of medical organizations; no status or results shown. grls.rosminzdrav.ru/CIPermissionMini.aspx?CIStatementGUID=71c142c1-fcc2-45da-8dba-b48971284d39. Read October 5, 2026. In Russian.
7. St. Petersburg Institute of Bioregulation and Gerontology. Medicines (Лекарственные препараты): six medicines developed by the institute and the S.M. Kirov Military Medical Academy, among them Cortexin® (registration Р N003862/02). gerontology.ru/medications, 2024 (the page’s copyright year). Read October 4, 2026. In Russian.
8. Khavinson VKh. Peptide medicines: past, present, future. Clinical Medicine (Russian Journal). 2020;98(3):165-177. DOI: 10.30629/0023-2149-2020-98-3-165-177. (Full text read on cyberleninka.ru, October 4, 2026: Cortexin created in 1999, previously made by Samson-Med under registration certificate 99/136/14 and now by GEROPHARM under ЛСР-003190/09; peptides of up to 10 kDa from the cerebral cortex of cattle; Glu-Asp-Arg found in it by chromatography–mass spectrometry; Cortagen synthesized from an analysis of its amino-acid composition.)
9. Tsyganov VN, Bogoslovskiĭ MM. [Influence of cortexin on memory and attention]. Voen Med Zh. 2004;325(9):31-35, 80. Russian. PMID: 15537099.
10. Belokrylov GA, Khavinson VKh, Morozov VG. [Effect of substances of a polypeptide nature isolated from the thymus and cerebral cortex on the primary immune response of mice to thymus-dependent and thymus-independent antigen]. Zh Mikrobiol Epidemiol Immunobiol. 1980;(3):97-100. Russian. PMID: 7191185.
11. Khavinson VKh, Morozov VG, Rybnikov VIu, Zakutskiĭ NG. [Cortexin effectiveness in circulatory encephalopathy]. Klin Med (Mosk). 1999;77(4):42-45. Russian. PMID: 10356917.
12. Gomazkov OA. [Cortexin. Molecular mechanisms and targets of neuroprotective activity]. Zh Nevrol Psikhiatr Im S S Korsakova. 2015;115(8):99-104. Russian. PMID: 26356623. DOI: 10.17116/jnevro20151158199-104.
13. Gulyaeva NV. [Molecular mechanisms of brain peptide-containing drugs: cortexin]. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(10):93-96. Russian. PMID: 30499504. DOI: 10.17116/jnevro201811810193.
14. Yakovlev AA, Lyzhin AA, Khaspekov LG, Guekht AB, Gulyaeva NV. [Peptide drug cortexin inhibits brain caspase-8]. Biomed Khim. 2017;63(1):27-31. Russian. PMID: 28251948. DOI: 10.18097/PBMC20176301027 (as registered with Crossref; the form in PubMed’s record does not resolve).
15. Kurkin DV, Bakulin DA, Morkovin EI, Kalatanova AV, et al. Neuroprotective action of Cortexin, Cerebrolysin and Actovegin in acute or chronic brain ischemia in rats. PLoS One. 2021;16(7):e0254493. PMID: 34260655. DOI: 10.1371/journal.pone.0254493. (Funding: Pharm-Holding CJSC, which employed three of the authors.)
16. Kurkin DV, Bakulin DA, Morkovin EI, Petrov VI, et al. Neurotropic Effects of Cortexin on Models of Mental and Physical Developmental Delay. Biomedicines. 2025;13(4):860. PMID: 40299434. DOI: 10.3390/biomedicines13040860. (Full text at PMC12024793: the cortexin tested was produced by CJSC Pharm-Holding, which funded the study and employed three of the authors.)
17. Zhang L, Chopp M, Wang C, Zhang Y, et al. Prospective, double blinded, comparative assessment of the pharmacological activity of Cerebrolysin and distinct peptide preparations for the treatment of embolic stroke. J Neurol Sci. 2019;398:22-26. PMID: 30665068. DOI: 10.1016/j.jns.2019.01.017. (Henry Ford Hospital, Detroit; grant listed by Europe PMC: EVER Pharma.)
18. Shchulkin AV, Chernykh IV, Abalenikhina YV, Gatsanoga MV, et al. [The effect of neuroprotectors on the level of BDNF, tumor necrosis factor alpha and apoptosis markers, and in acute cerebrovascular accidents]. Zh Nevrol Psikhiatr Im S S Korsakova. 2026;126(2):123-129. Russian. PMID: 41782540. DOI: 10.17116/jnevro2026126021123.
19. Savos’ko SI, Chaĭkovs’kyĭ IuB, Pogoriela NKh, Makarenko OM. [Histostructural changes of rat cerebral cortex during hemorrhagic stroke modeling]. Fiziol Zh (1994). 2012;58(5):28-35. Ukrainian. PMID: 23233944.
20. Aniol VA, Novitskaia Iu, Borodina TN, Bukreeva TV, et al. [Evaluation of antiepileptic effects of cortexin in a model of convulsions]. Zh Nevrol Psikhiatr Im S S Korsakova. 2011;111(12):68-73. Russian. PMID: 22433813.
21. Khavinson VKh, Morozov VG, Chalisova NI, Okulov VB. [The effect of brain peptides on nerve tissue cells in vitro]. Tsitologiia. 1997;39(7):571-576. Russian. PMID: 9490497.
22. Yazar U, Ayar A. Cortexin® Ameliorates High Glucose-Induced Neuropathy in Cultured Rat Sensory Neurons. Neuroendocrinology. 2023;113(9):924-929. PMID: 37080184. DOI: 10.1159/000530766.
23. Guven C, Türk A, Koçak S, Zencirci B, et al. Cortexin modulates OPG/RANK/RANKL and TRPC1 expression in cerebral ischemia-reperfusion injury. Neurol Res. 2026;48(4):510-521. PMID: 40783844. DOI: 10.1080/01616412.2025.2536075.
24. Eroğlu O, Karlıdağ T, Kuloğlu T, Keleş E, et al. The Protective Effect of Cortexin on Cisplatin-Induced Ototoxicity. J Int Adv Otol. 2018;14(1):27-33. PMID: 29092803. DOI: 10.5152/iao.2017.3825.
25. Tunçcan T, Yalçın Ş, Demir CF, Akın MM, et al. Efficacy of Cortexin and Methylprednisolone on Traumatic Facial Nerve Paralysis. J Int Adv Otol. 2016;12(3):303-309. PMID: 27819650. DOI: 10.5152/iao.2016.1166.
26. Mendzheritsky AM, Karantysh GV, Ryzhak GA, Prokofiev VN. [Pinealon and Cortexin influence on behavior and neurochemical processes in 18-month aged rats within hypoxia and hypothermia]. Adv Gerontol. 2015;28(3):532-539. Russian. PMID: 28509493.
27. Zarubina IV, Shabanov PD. [Cortexin and cortagen as correcting agents in functional and metabolic disorders in the brain in chronic ischemia]. Eksp Klin Farmakol. 2011;74(2):8-15. Russian. PMID: 21476278.
28. Ryzhak GA, Nekrasov PA, Kiselev OI, Khavinson VKh. Study of protein components of natural peptide regulators. Bull Exp Biol Med. 2003;135(1):52-54. PMID: 12717513. DOI: 10.1023/a:1023445912682. (Indexed by PubMed under the substance cortexin.)
29. Skoromets AA, Stakhovskaia LV, Belkin AA, Shekhovtsova KV, et al. [New possibilities of neuroprotection in the treatment of ischemic stroke]. Zh Nevrol Psikhiatr Im S S Korsakova. 2008;(Suppl 22):32-38. Russian. PMID: 19431244.
30. Aliferova VM, Dadasheva MN, Doronin BM, Kovalenko AV, et al. [Clinical efficacy and pharmacoeconomic characteristics of the neuroprotection with low doses of cortexin in the treatment of acute ischemic stroke]. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(4):41-46. Russian. PMID: 24874316.
31. Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2023;10(10):CD007026. PMID: 37818733. DOI: 10.1002/14651858.CD007026.pub7. (Full text at PMC10565895, read October 4, 2026: the Cortexin trial’s groups, deaths and adverse events, and its two publications, Stakhovskaya et al. 2012 and Aliferova et al. 2014; GEROPHARM’s trial permissions GP20011-P4-32 and GP20011-P4-36 in Russia’s register; Russia’s essential-medicines list and 2021 stroke guidelines.)
32. Fedin AI, Khairova EN, Artyukov OP, Timchenko LV, et al. [Therapeutic equivalence of intravenous and intramuscular dosage forms of Cortexin in ischemic strokes]. Zh Nevrol Psikhiatr Im S S Korsakova. 2025;125(12):60-67. Russian. PMID: 41524350. DOI: 10.17116/jnevro202512512160.
33. Fedin AI, Belskaya GN, Kurushina OV, Kovalchuk VV, et al. [Dose-dependent effects of cortexin in chronic cerebral ischemia (results of a multicenter randomized controlled study)]. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(9):35-42. Russian. PMID: 30335070. DOI: 10.17116/jnevro201811809135.
34. Belova LA, Mashin VV, Abramova VV, Slastyon EY, Belov DV. [Efficacy of Korteksin in acute period of hemispheric ischemic stroke]. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(7):30-34. Russian. PMID: 30132453. DOI: 10.17116/jnevro20181187130.
35. Skorokhodov AP, Dudina AA, Kolesnikova EA, Koron AE, et al. [Comparative analysis of efficacy of certain neuroprotectors in ischemic stroke]. Zh Nevrol Psikhiatr Im S S Korsakova. 2006;(Suppl 17):52-56. Russian. PMID: 18193579.
36. Khabirov FA, Khaibullin TI, Granatov EV, Akhmetova GI, Akhmetzyanov NM. [Comparison of the efficacy of Cellex and Cortexin in patients in the early recovery period of ischemic stroke]. Zh Nevrol Psikhiatr Im S S Korsakova. 2020;120(12 Vyp 2):11-15. Russian. PMID: 33449527. DOI: 10.17116/jnevro202012012211.
37. Zavadenko NN, Davydova LA, Suvorinova NY, Khondkaryan GS. [Potential of peptidergic nootropic therapy in developmental dysphasia in children]. Zh Nevrol Psikhiatr Im S S Korsakova. 2019;119(11):47-53. Russian. PMID: 31851172. DOI: 10.17116/jnevro201911911147.
38. Zavadenko NN, Davydova LA, Suvorinova NY. [Developmental dysphasia in children: a comparison of the effectiveness of two modes of peptidergic nootropic therapy]. Zh Nevrol Psikhiatr Im S S Korsakova. 2020;120(10):38-44. Russian. PMID: 33244956. DOI: 10.17116/jnevro202012010138.
39. Ukhanova TA, Gorbunov FE. [Efficacy of reflexology in the combination with neuroprotective treatment in hemiparetic form of children cerebral palsy]. Zh Nevrol Psikhiatr Im S S Korsakova. 2012;112(7):28-31. Russian. PMID: 23011423.
40. Kholin AA, Zavadenko NN, Il’ina ES, Kolpakchi LM, et al. [Peptidergic nootropic therapy in cerebral palsy associated with epilepsy]. Zh Nevrol Psikhiatr Im S S Korsakova. 2017;117(9):37-42. Russian. PMID: 29053119. DOI: 10.17116/jnevro20171179137-42.
41. Skripnik OY, Sumenko VV, Trusova OY, Danilova EI, et al. [Treatment of contusion of moderate severity in children in outpatient clinics]. Zh Nevrol Psikhiatr Im S S Korsakova. 2020;120(3):29-33. Russian. PMID: 32323940. DOI: 10.17116/jnevro202012003129.
42. Shmakov AN, Kasymov VA, Kokhno VN. [Adjuvants to the treatment of acute cerebral insufficiency in newborns]. Zh Nevrol Psikhiatr Im S S Korsakova. 2011;111(2):60-63. Russian. PMID: 21350426.
43. Zykov VP, Serebrennikova EB, Panchenko TN, Sycheva YB, et al. [Results of a multicenter study on the efficacy of cortexin in treatment of cognitive dysfunction in children]. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(3):27-31. Russian. PMID: 29652302. DOI: 10.17116/jnevro20181183127-31.
44. Mashin VV, Belova LA, Chaplanova OI, Khusnullina AF, Manasian AM. [An open clinical trial of cortexin in treatment of brain ischemia]. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(9):49-52. Russian. PMID: 25403301.
45. Putilina MV, Mutovina ZY, Kurushina OV, Khalilova DM, et al. [Determination of the prevalence of postcovid syndrome and assessment of the effectiveness of the drug Cortexin in the treatment of neurological disorders in patients with postcovid syndrome. Results of the multicenter clinical and epidemiological observational program CORTEX]. Zh Nevrol Psikhiatr Im S S Korsakova. 2022;122(1):84-90. Russian. PMID: 35175707. DOI: 10.17116/jnevro202212201184.
46. Putilina MV, Khairova EN, Zakharov AV, Chernikova IV, et al. [Cortexin in the comprehensive treatment of neurological complications of type 2 diabetes mellitus. (Results of the DIACORT multicenter randomized clinical trial)]. Zh Nevrol Psikhiatr Im S S Korsakova. 2026;126(4):101-112. Russian. PMID: 42133422. DOI: 10.17116/jnevro2026126041101. (PubMed lists no authors; the names are from the journal’s page and Crossref.)
47. Schastnyy ED. [Efficacy and safety of Cortexin as additional therapy in patients with depressive disorder]. Zh Nevrol Psikhiatr Im S S Korsakova. 2026;126(2):92-96. Russian. PMID: 41782536. DOI: 10.17116/jnevro202612602192.
48. Masaleva IO, Ivenkov MP. [Cortexin in the comprehensive therapy of alcoholic encephalopathy]. Zh Nevrol Psikhiatr Im S S Korsakova. 2026;126(6):52-58. Russian. PMID: 42360215. DOI: 10.17116/jnevro202612606152.
49. Alsulaimani RA, Quinn TJ. The efficacy and safety of animal-derived nootropics in cognitive disorders: Systematic review and meta-analysis. Cereb Circ Cogn Behav. 2021;2:100012. PMID: 36324709. DOI: 10.1016/j.cccb.2021.100012. (Full text at PMC9616232.)
50. Belova LA, Mashin VV, Dudikov EM, Belov DV, Krupennikov AA. [A multicenter observation study of the efficacy of cortexin and recognan (citicoline) in the treatment of cognitive impairments in chronic cerebrovascular pathology]. Zh Nevrol Psikhiatr Im S S Korsakova. 2019;119(2):35-38. Russian. PMID: 30874524. DOI: 10.17116/jnevro201911902135.
51. Fedin AI. [The efficacy of cortexin and memantinol (memantine) in the treatment of cognitive impairment in patients with chronic cerebral ischemia]. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(1):30-36. Russian. PMID: 29460902. DOI: 10.17116/jnevro20181181130-36.
52. Mashin VV, Belova LA, Kotova EY, Dolgova DR, et al. [Results of a multicenter observational program to evaluate the effectiveness of complex therapy of patients with chronic cerebrovascular pathology with cognitive impairment with Cortexin and Neuromexol (CORNELia study)]. Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(12):34-41. Russian. PMID: 38147380. DOI: 10.17116/jnevro202312312134.
53. Cherkashin VA, Semin GF, Veretenko AA. [Optimization of cardiovascular function by peptide bio-regulators]. Klin Med (Mosk). 2002;80(5):30-34. Russian. PMID: 12087883. (Abstract only: no full text turned up through PubMed, Europe PMC or a web search, October 5, 2026.)
54. FDA. Drugs@FDA through openFDA (api.fda.gov/drug/drugsfda.json): searches for cortexin and korteksin, October 4, 2026 (no records). European Medicines Agency. Medicines data table (ema.europa.eu, medicines-output-medicines_json-report), searched for Cortexin, October 4, 2026 (no entry).
55. U.S. Code of Federal Regulations. 21 CFR 216.23, Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act; and 21 CFR 216.24, Drug products withdrawn or removed from the market for reasons of safety or effectiveness. ecfr.gov. Read October 4, 2026.
56. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated May 14, 2026. fda.gov/media/94155/download.
57. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated March 21, 2025. fda.gov/media/94164/download.
58. World Anti-Doping Agency. Prohibited List 2026 (in effect January 1, 2026). S0, Non-approved substances. wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf. Read October 4, 2026.
59. Searches of October 4, 2026: PubMed, “cortexin” (217 records; at least 150 about the drug, the rest about an unrelated brain protein and gene named cortexin, a kidney protein called “renal cortexin”, or chance matches), “korteksin” (13, all also under “cortexin”), “kortexin” (1), “cortexin AND randomized controlled trial[pt]” (18), “cortexin AND placebo” (9); PubMed, cortexin with semax (1, a review), selank (0), cerebrolysin (18, comparisons and reviews), pinealon or Glu-Asp-Arg (5, rat comparisons and a review), cortagen (4), epithalamin or epitalon (11), thymalin or thymogen (7, among them a 2002 study of Thymalin, Epithalamin and Cortexin whose abstract does not say whether any patient received more than one of them; Cherkashin et al., 2002), noopept, dihexa or P21 (4) and BPC-157 or thymosin (2): no other study of Cortexin combined with a compound that has a page on this site; with case reports (0), prion terms (1), pregnancy terms (4, none in pregnant women) and toxicology terms (7, none a toxicology study of Cortexin); ClinicalTrials.gov, “Cortexin” (0), “Korteksin” (0) and “Geropharm” (23, none of Cortexin); openFDA Drugs@FDA, “cortexin” and “korteksin” (0); European Medicines Agency medicines list (no entry); fda.gov, Cortexin warning letter or import alert (none); Russia’s state register, grls.rosminzdrav.ru (no response, HTTP 503); an online shop’s listing of exported Cortexin vials (not named). Searches of October 5, 2026: PubMed, “cortexin AND 2025:2026[dp]” (20 records; among them the depression and alcoholic-encephalopathy studies cited above, and three more clinical reports whose comparison groups had no added drug, none placebo-controlled) and “cortexin AND placebo” (9, as on October 4); PubMed’s record of a Ukrainian-language rat study of hemorrhagic stroke comparing Cortexin with Cerebrolysin (Savos’ko et al., 2012); the full text of the 2002 study of Thymalin, Epithalamin and Cortexin (Cherkashin et al., 2002): no full-text link in PubMed, the abstract only in Europe PMC, and none found by a web search; Russia’s state register, grls.rosminzdrav.ru (the trial permission No. 473 answered, with no status or results; the product search asks for a CAPTCHA and was not read); and FDA Import Alerts 66-40, 66-41 and 66-80 (no mention of Cortexin, its Russian name or its makers).

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