Cortexin

Cortexin®, cortex polypeptide complex, "brain bioregulator"

Cognitive & neuro

Awaiting medical reviewEN ES DE FR PT ZH+ Follow for updates

Note on this profile. Cortexin is an approved prescription medicine in Russia and several CIS countries, given by intramuscular injection for stroke, brain injury and a range of cognitive and neurological conditions. It is not approved in the EU, UK, US, Australia or South Africa. It is a tissue extract containing many peptides, not a single defined peptide; this page explains what is and is not known about it.

Summary

Class: Polypeptide extract from the cerebral cortex of calves or pigs: a mixture of low-molecular-weight peptides (under ~10 kDa) with amino acids, vitamins and minerals; exact composition is not fully defined
Mechanism: Claimed to be neuroprotective and "nootropic" — reducing glutamate toxicity, oxidative stress and inflammation and supporting neuron survival — but the active components are not identified
Routes studied: Intramuscular injection (clinical); intraperitoneal (rodent); intranasal (some rodent and small clinical reports)
Dose range reported: Russian label: adults 10 mg IM once daily for 10 days; children under 20 kg 0.5 mg/kg daily; repeat courses after 3–6 months †. Community use follows the label
Half-life: Not meaningful for an undefined mixture; individual peptides would be cleared in minutes to hours
Storage: Lyophilised vials: 2–20 °C per label, protect from light; reconstitute immediately before use and do not store the solution †
Regulatory status: Approved in Russia and some CIS states; not approved elsewhere

Doses are as reported in studies or by the community — never recommendations.

1What it is

Cortexin is a extract of brain cortex, originally from cattle and now largely from pigs, produced by Geropharm in St Petersburg. It came out of the same Soviet-era bioregulation programme as Thymalin and Epithalamin and has been registered in Russia since 1999. Each vial contains 10 mg of "polypeptide complex" plus glycine as a stabiliser. Because it is an extract, no two batches are chemically identical in the way a synthetic peptide would be, and the manufacturer has not published a full molecular inventory.

It is closest in concept to Cerebrolysin (set 2 if included; otherwise see Austrian porcine-brain hydrolysate literature), which has far more published international trial data. Cortexin is widely used in Russian neurology and paediatrics, and appears in the peptide community mostly through people who have encountered it in those countries or through Russian-language forums.

The Tier 2 caveat applies: the evidence base is almost entirely Russian-language, from a limited circle of institutions, with no independent replication in Western journals.

2How it's thought to work

Proposed, from rodent and cell studies by Russian groups:

Reduces excitotoxic damage from glutamate and lowers calcium overload in neurons.

Antioxidant effects, lower lipid peroxidation in brain tissue.

Shifts the balance toward GABAergic inhibition.

Raises brain-derived neurotrophic factor and other neurotrophins; supports dendrite growth in culture.

Anti-inflammatory effects on microglia.

Proposed: a peptide fraction from calf or pig cortex, used in Russia for stroke and brain injury. The clinical evidence is almost entirely Russian and not independently replicated.Schematic — not to scale

Which molecules in the extract do what is not established. Whether peptides of this size injected into muscle cross the blood–brain barrier in meaningful amounts is unresolved.

3What the research shows

Graded B (Russian RCT data of limited quality)

Acute ischaemic stroke

A multicentre Russian randomised study reported better neurological recovery scores at 3 weeks in patients given two 10-day courses of Cortexin added to standard care, compared with standard care alone (Stakhovskaya 2012, Zh Nevrol Psikhiatr Im S S Korsakova). Blinding and allocation concealment are unclear in the English abstract; no independent replication. We grade B rather than A because methodology cannot be verified to standard. [1]

Traumatic brain injury and post-concussion

Open-label and comparative Russian series report improved cognitive and headache outcomes.

Graded B/—

Childhood neurological conditions (cerebral palsy, developmental delay, epilepsy adjunct)

A large body of Russian paediatric practice and small open-label studies; no placebo-controlled trials we can verify.

Graded B/—

Cognitive impairment, encephalopathy, neuropathy

Open-label series only.

Neuroprotection in rodents

Reduced infarct volume, improved learning after hypoxia, and anti-seizure effects reported in rats and mice (various Bulletin of Experimental Biology and Medicine papers).

Not gradednone

Western or independent controlled trials

No English-language, independently conducted, placebo-controlled trial of Cortexin is known to us.

4Reported side effects and interactions

Literature-reported

Russian label and clinical reports describe it as well tolerated; listed adverse effects are allergic reactions (rare) and injection-site pain. As a bovine/porcine brain product, prion (BSE) risk is a theoretical concern that the manufacturer addresses through sourcing controls; independent verification is not available.

Community-reported

injection-site pain (the 10 mg dose in a small volume of local anaesthetic is standard in Russia for this reason), occasional headache, transient agitation or insomnia in children, rarely allergic rash.

Theoretical. immune reactions to foreign animal proteins with repeated courses; unknown effects of an undefined mixture; the usual caution in epilepsy (both pro- and anti-seizure effects are described in the literature).

Interactions. none formally studied. Russian practice combines it freely with standard stroke and epilepsy medicines.

Markers researchers commonly monitor

No compound-specific laboratory markers exist. The Russian trials used clinical scales, which remain the only validated read-outs:

Marker	Why it's watched
Standardised cognitive and neurological scales (e.g. MoCA, NIHSS, Barthel index)	the actual trial endpoints; a repeatable baseline matters more than any blood test here.
CBC and CMP	general baseline for a repeated injected animal-derived product.
Allergy history and skin reaction at injection site	the main documented risk is hypersensitivity.
Seizure diary where relevant	both directions of effect are reported.
BDNF (serum)	appears in some Russian mechanistic reports; research interest only, assays poorly standardised.

Free for everyone. Safety information is never behind a paywall.

5Reconstitution and handling

Supplied as 10 mg (adult) and 5 mg (paediatric) vials. The Russian label directs with 1–2 ml of 0.5% procaine, water for injection or saline immediately before injection; the solution should not be stored or combined in the same syringe with other drugs. or intravenous use is off-label. Because the content is a mixture, the calculator cannot express a concentration in meaningful molar terms; it can only track mg per ml.

Open in calculator, pre-loaded →

6Commonly studied alongside

Cerebrolysin (the closest comparator; some Russian comparative studies), Semax and Selank (set 2; Russian nootropic peptides), Pinealon and Epitalon (set 2), Retinalamin (profile 79, same manufacturer and programme).

Informational cross-links. Not stack recommendations.

7Regulatory status by region

Region	Status (checked —)
United States	Not FDA-approved; import of animal-derived brain products is additionally restricted †
European Union	Not authorised; animal-derived brain tissue products face TSE/BSE import controls
United Kingdom	Not licensed
Australia	Not approved; bovine-derived products subject to biosecurity import restrictions
South Africa	Not registered
Sport	Not named by WADA; non-approved substances fall under S0 †
Russia / CIS	Approved prescription medicine (Geropharm) †

8Open questions

What, chemically, is in a vial, and does it vary between batches?
Do any of its peptides cross the blood–brain barrier after injection?
Would the stroke and TBI findings survive a properly blinded, independently run trial?

9References

1Stakhovskaya LV et al. (2012). Results of a randomized double-blind multicenter placebo-controlled study of the efficacy and safety of Cortexin in acute and early recovery periods of hemispheric ischemic stroke. Zh Nevrol Psikhiatr Im S S Korsakova [verify title and whether placebo was used]. PubMed
2Khavinson VKh, Morozov VG (2003). Peptides of pineal gland and thymus prolong human life. Neuro Endocrinol Lett. (Background on the bioregulator programme) PubMed
3Skoromets AA et al. (2008). Cortexin: neuroprotection and neuroplasticity in stroke and brain injury [verify; Russian-language monograph or review]. PubMed
4Pinelis VG et al. (2008). Neuroprotective effect of Cortexin in experimental hypoxia and glutamate toxicity. Bull Exp Biol Med [verify]. PubMed
5Cortexin — Russian State Register of Medicines entry / prescribing information (Geropharm) [verify current text]. PubMed

References are being resolved to PubMed/DOI identifiers; links search PubMed for the citation until then.

† Being confirmed by our reviewers against current sources.

10Community

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community protocols include this →

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Self-reported side effects Phase 2

Not enough data yet. 0 of the 50 members needed have logged this compound for 4+ weeks. We don't show anything below 50, so no one can be identified.

11Page history

26 Oct 2026Profile published — awaiting medical review

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