Selank

Not FDA-approved Category 2 nomination withdrawn

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 2 of 68 publications on PubMed
Registered clinical trials 2 0 active
Adverse event reports 0 0 classified as serious
  • Selank is not an FDA-approved drug: Drugs@FDA has no record of it.
  • It was on FDA's Category 2 safety-risk list until the nomination was withdrawn. A withdrawal is not an approval.
  • PubMed lists 68 publications mentioning it, including 2 randomized controlled trials and 49 animal-only studies.
  • ClinicalTrials.gov lists 2 registered studies testing it (0 active).
  • FDA’s adverse event system (FAERS) has no reports mentioning it.

Research topics

  • Anti-Anxiety Agents 23
  • Nootropic Agents 10
  • Behavior, Animal 9
  • Brain 9
  • Tuftsin 9
  • Adrenocorticotropic Hormone 8
  • Anxiety 6
  • Cytokines 6
  • Memory 6
  • Stress, Psychological 6

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

Category 2 nomination withdrawn
FDA's stated risk · Original FDA text (English) Compounded drugs containing selank acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA lacks important information regarding any safety issues raised by selank acetate administered to humans.

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 68
  • Human (MeSH) 15
  • Animal only 49
  • Clinical trials 3
  • Randomized controlled trials 2
  • Systematic reviews & meta-analyses 0
  • Case reports 0
  • Retracted 0

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

Registered
2
Active
0
With posted results
0

Conditions studied

  • Developmental Dyslexia 1
  • Repetitive TMS (rTMS) 1
  • Sham rTMS 1
  • Bilateral rTMS 1
  • Unilateral rTMS 1
Study Status Phase Start
Comparing the Efficacy of tDCS and tRNS to Improve Reading Skills in Children and Adolescents With Dyslexia
NCT05832060 Bambino Gesù Hospital and Research Institute
Unknown status N/A May 1, 2023
Effects of Transcranial Magnetic Stimulation on Object Recognition
NCT01747200 National Institute of Neurological Disorders and Stroke (NINDS)
Completed N/A November 16, 2012

All 2 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

No FAERS reports mention this peptide.

Source: FDA FAERS · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.