Is Cerebrolysin FDA-approved?

Not in the US. Drugs@FDA lists no application with Cerebrolysin as an active ingredient. Austria authorizes it as a prescription medicine, but that doesn't apply in the US.

Checked 25 Oct 2026. The sources are below, with the non-US regulator in More sources.

Cerebrolysin

Also: FPF-1070, FPE 1070, Cerebrolysin Ebewe, porcine brain peptide preparation

Status label in the Peptimes Library
Approved outside the US
Routes in Peptimes
IntramuscularOther
Updated
25 Oct 2026

US regulatory status

  • FDA status

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

    Source: Drugs@FDA, checked 25 Oct 2026

How to track it in Peptimes

Add Cerebrolysin 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 Austria, the medicines agency BASG publishes the product information for Cerebrolysin as an authorized prescription medicine (marketing authorization 1-21380). That authorization doesn’t apply in the US, and other brain peptide products don’t share it.

  • Routes: intramuscular or Other. Choose the one that matches each dose.
  • Logging: the amount you took, the route and how you feel.
  • Injection sites: intramuscular doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Doses logged as Other skip this step.
  • 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 Cerebrolysin or any other compound.

More sources

  • BASG (Austrian Federal Office for Safety in Health Care), Cerebrolysin product information (in German, dated March 2021), checked 25 Oct 2026: marketing authorization 1-21380, first authorized in 1996, prescription only, for intramuscular or intravenous use, and its description as a peptide fraction of pig brain protein made of short peptides.
  • FDA, Global Substance Registration System, Cerebrolysin, checked 25 Oct 2026: a protein fraction from mammal brain, and the names FPE 1070, FPF 1070 and Cerebrolysin Ebewe.

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