Is Cortexin FDA-approved?

Not in the US. Cortexin isn't FDA-approved in the US: Drugs@FDA lists no application with it as an active ingredient.

Checked 1 Nov 2026. The sources are below.

Cortexin

Also: Кортексин

Status label in the Peptimes Library
Approved outside the US
Routes in Peptimes
Intramuscular
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-approved in the US. Drugs@FDA lists no application with Cortexin as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

What studies have looked at

Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.

  • In animals or the lab

    In a randomised, blinded, placebo-controlled study in rats with embolic stroke, functional recovery with Cortexin was similar to saline, and the size of the brain damage didn't differ from saline.

    Source: PMID 30665068, checked 1 Nov 2026

  • In animals or the lab

    In rats with acute or chronic brain ischaemia, Cortexin improved neurological recovery and reduced brain-tissue death in acute ischaemia. Three of the authors worked for Pharm-Holding CJSC.

    Source: PMID 34260655, checked 1 Nov 2026

How to track it in Peptimes

Add Cortexin in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “Approved outside the US”. In the US it is not FDA-approved.

  • Logging: the amount you took and how you feel.
  • Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell Cortexin or any other compound.

More sources

  • US National Library of Medicine, MeSH, cortexin, checked 1 Nov 2026: a supplementary substance record describing it as a polypeptide complex from cattle.
  • FDA, Drugs@FDA, checked 1 Nov 2026: no application lists Cortexin as an active ingredient.

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