Is Noopept FDA-approved?

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

Checked 1 Nov 2026. The sources are below.

Noopept

Also: omberacetam, GVS-111, N-phenylacetyl-L-prolylglycine ethyl ester

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

US regulatory status

  • FDA status

    Not FDA-approved in the US. Drugs@FDA lists no application with omberacetam (Noopept) 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 rats, Noopept itself wasn't found in the brain an hour after it was given, but cyclo-prolylglycine rose 2.5-fold, and enzymes formed it from Noopept in the lab. The authors propose that Noopept is a prodrug of this cyclic dipeptide.

    Source: PMID 9358206, checked 1 Nov 2026

  • In animals or the lab

    In rats trained on avoidance tasks, Noopept kept the anti-amnesic activity seen in earlier studies and stimulated learning in a one-session model, which the authors say sets it apart from cyclo-prolylglycine and piracetam.

    Source: PMID 11782792, checked 1 Nov 2026

  • In humans

    An EEG study in people with cognitive and asthenic problems after brain injury or vascular brain disease: Noopept increased alpha and beta power and reduced delta power, most clearly in vascular disease. The Russian-language abstract gives no patient numbers.

    Source: PMID 19008801, checked 1 Nov 2026

How to track it in Peptimes

Add Noopept 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. It’s logged as oral, so there’s no injection site to record.
  • 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 Noopept or any other compound.

More sources

  • FDA, Global Substance Registration System, Omberacetam, checked 1 Nov 2026: its chemical name and formula, and the names Noopept and GVS-111.
  • FDA, Drugs@FDA, checked 1 Nov 2026: no application lists omberacetam or Noopept as an active ingredient.

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