Noopept (omberacetam)

Also known as: GVS-111

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 0 of 107 publications on PubMed
Registered clinical trials 0 0 active
Adverse event reports 15 15 classified as serious
  • Noopept (omberacetam) is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 107 publications mentioning it, including 0 randomized controlled trials and 71 animal-only studies.
  • No study registered on ClinicalTrials.gov tests it as an intervention.
  • FDA's adverse event system (FAERS) holds 15 reports mentioning it; 15 classified as serious. Reports do not prove causation.

Research topics

  • Dipeptides 83
  • Nootropic Agents 62
  • Neuroprotective Agents 28
  • Piracetam 17
  • Brain 16
  • Avoidance Learning 10
  • Behavior, Animal 10
  • Neurons 9
  • Diabetes Mellitus, Experimental 8
  • Maze Learning 8

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 107
  • Human (MeSH) 28
  • Animal only 71
  • Clinical trials 3
  • Randomized controlled trials 0
  • Systematic reviews & meta-analyses 0
  • Case reports 0
  • Retracted 1

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

No registered study on ClinicalTrials.gov lists this peptide as an intervention.

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
15
Serious
15
With death outcome
1

Most reported reactions

  • Dystonia 13
  • Sinus tachycardia 13
  • Somnolence 13
  • Hypotension 12
  • Extrasystoles 10
  • Palpitations 10
  • Toxicity to various agents 10
  • Drug abuse 9
  • Facial spasm 8
  • Muscle twitching 8
  • Overdose 6
  • Substance use 6

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.