Not Approved (US) Cognitive & Nootropic

Cortexin

also known as: Cortexinum, Cortical polypeptide complex

A Russian polypeptide bioregulator (Geropharm / Герофарм) extracted from bovine or porcine cerebral cortex, approved in Russia for a broad array of neurological indications including cerebrovascular disease, traumatic brain injury, epilepsy, and cognitive impairment. Not FDA- or EMA-approved; clinical evidence base is almost entirely Russian-language and of low-to-moderate methodological rigor by Western standards.

A complex mixture of water-soluble polypeptides with molecular weight below 10 kDa, extracted from the cerebral cortex of young cattle or pigs. Developed at the Russian Military Medical Academy in the 1980s and now produced primarily by Geropharm (Saint Petersburg). Marketed in Russia, Belarus, Ukraine, Kazakhstan, and several CIS states as a neurotropic agent for cerebrovascular disease, traumatic brain injury, post-stroke recovery, pediatric cognitive delay, and epilepsy. Mechanism is proposed as pleiotropic neurotrophic support via the mixture's aggregate small peptides and amino acids. Not approved in the US or EU.

Mechanism of action

Proposed neurotrophic and neuromodulatory effects of the low-molecular-weight peptide fraction, including putative GABAergic modulation, antioxidant effects, and support of synaptic plasticity. Mechanism is poorly characterized at the molecular level; most published mechanistic work is from Russian research institutions and has not been widely independently replicated. The heterogeneity of the preparation (a polypeptide mixture rather than a defined single molecule) complicates regulatory assessment by Western agencies accustomed to single-entity molecules.

Primary uses

  • Cerebrovascular disease (Russian approval)
  • Traumatic brain injury rehabilitation (Russian approval)
  • Post-stroke cognitive recovery (Russian approval)
  • Pediatric cerebral palsy and developmental delay (Russian approval)
  • Epilepsy as adjunct (Russian approval)

Typical dosing

10 (adults); 0.5 mg/kg (pediatrics) mg once daily for 10 days (intramuscular)

Standard Russian dosing: 10 mg IM once daily for 10 days in adults, or 0.5 mg/kg in children <20 kg, reconstituted in 1–2 mL of sterile water or saline. Repeat courses every 3–6 months as clinically indicated.

Regulatory status

Approved in Russia and in several CIS member states (Belarus, Ukraine, Kazakhstan, etc.) as a prescription medicine for a wide range of neurological indications in adults and children. Manufactured principally by Geropharm. Not approved by the FDA, EMA, MHRA, PMDA, Health Canada, or the TGA. Not available through any regulated Western pharmaceutical distribution channel.

References

  1. [other] Cortexin (Cortexinum) Russian Summary of Product Characteristics. Geropharm JSC, Saint Petersburg, Russia.
  2. [pubmed] Skoromets AA, et al. "Review of clinical studies of Cortexin in cerebrovascular disease and traumatic brain injury." Zh Nevrol Psikhiatr Im S S Korsakova, 2013;113:63-68 (Russian).
  3. [review] Granstrem O, et al. "Cortexin — a novel therapeutic agent for epilepsy, cerebrovascular and traumatic CNS disorders." Int J Biomed, 2013;3:208-213.

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Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.