DSIP (emideltide)

Also known as: delta sleep-inducing peptide

Not FDA-approved Category 2 nomination withdrawn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 6 of 463 publications on PubMed
Registered clinical trials 0 0 active
Adverse event reports 0 0 classified as serious
  • DSIP (emideltide) 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  • It was on FDA's Category 2 safety-risk list until the nomination was withdrawn.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 463 publications mentioning it, including 6 randomized controlled trials and 322 animal-only studies.
  • No study registered on ClinicalTrials.gov tests it as an intervention.
  • FDA’s adverse event system (FAERS) has no reports mentioning it.

Research topics

  • Brain 35
  • Stress, Psychological 29
  • Neurotransmitter Agents 19
  • Electroencephalography 18
  • Anticonvulsants 16
  • Neuropeptides 15
  • Antioxidants 14
  • Behavior, Animal 14
  • Neurons 14
  • Aging 12

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Category 2 nomination withdrawn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 emideltide may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has not identified safety-related information regarding emideltide for the proposed route of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if 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 463
  • Human (MeSH) 111
  • Animal only 322
  • Clinical trials 18
  • Randomized controlled trials 6
  • Systematic reviews & meta-analyses 0
  • Case reports 4
  • 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

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

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.