Cortexin

Bioregulator

Also known as: Cortexin (cortex polypeptide complex)

Tier 2, Investigational, human data

Studied in registered human trials with published pharmacokinetic data, but not approved. Dosing outside a trial protocol has no established safety margin.

Half-life

Not established · animal data · intramuscular, intravenous, rectal (animal study)

In rodents, peak brain/blood concentration observed ~30 min post-administration (IV, IM, rectal); primary urinary excretion within first 2 hours (Kurkin et al. 2025, PMC12024793). No terminal half-life value reported. No human PK data located.

Dosing

10000 - 30000 mcg

Physician-administered injectable dosing in published Russian clinical trials: 10 mg (10,000 mcg) IM once daily up to 10 mg IM three times daily in ischemic-stroke/brain-ischemia protocols. This is supervised medical dosing of a heterogeneous injectable extract, NOT a self-administered microdose, do not extrapolate to unsupervised subcutaneous use.

Frequency

10 mg IM once to three times daily in 10-day courses per Russian clinical trials (supervised clinical use only)

Regulatory status

Described in the Russian literature as a clinically used neuroprotective drug preparation (hospital-based RCTs/screening studies). Not evaluated or listed by FDA (no accessdata.fda.gov/dailymed record found) or EMA. Some sibling tissue peptides in this class are sold in Russia as registered 'food supplements'/'parapharmaceuticals', which is NOT drug approval.

Evidence base

human clinical · confidence: medium

Most extensively studied compound in this set: a multicenter double-blind placebo-controlled RCT (n=272) plus a large open all-Russian screening study exist. However all identified trials are Russian-language, from a single research lineage, with no independent Western replication found and abstract-level detail only (randomization/blinding quality and conflicts of interest unverifiable from abstracts).

Safety

Trials report 'high efficacy and safety' at 10-30 mg/day IM under medical supervision, but abstracts do not enumerate adverse-event rates. Cortexin is a heterogeneous bovine/porcine-derived polypeptide extract (batch-to-batch variation), carrying a theoretical immunogenicity/allergy risk not systematically quantified. No FDA/EMA safety review exists. Absence of reported harm in these trials is not proof of safety in unsupervised or self-injected use.

Sources