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Synthetic nonapeptide (delta sleep-inducing peptide)

Emideltide

A nonapeptide also known as DSIP. FDA uses the INN emideltide. No United States approved product. Discussed at PCAC on 24 July 2026 for nominated uses of opioid withdrawal, chronic insomnia and narcolepsy.

Also listed as: DSIP, Delta sleep-inducing peptide

Chemical identity

Compound class
Synthetic nonapeptide (delta sleep-inducing peptide)
Sequence
WAGGDASGE
Molecular formula
C35H48N10O15
Molecular weight
848.8 g/mol
CAS number
62568-57-4
PubChem CID
68816
Research categories
Peptide fragments, Preclinical research compounds

United States regulatory status

No FDA-approved product

  • No approved drug product exists in Drugs@FDA.
  • Listed on FDA's table of bulk substances nominated for compounding and subsequently withdrawn, as emideltide (DSIP). Published concerns include immunogenicity risk and absence of identified safety information for the proposed route.
  • On 24 July 2026 PCAC discussed emideltide (free base) and emideltide acetate (uses evaluated: opioid withdrawal, chronic insomnia and narcolepsy). FDA briefing materials proposed that they NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed. Committee recommendations are non-binding; FDA has not published a listing decision as of this review.

Regulatory status describes how a substance is classified. It is not a safety assessment, and it says nothing about the quality of any particular material.

Evidence overview

3 records in this file

  • ANIMAL1
  • REGULATORY2

Research areas. Sleep EEG models; United States compounding.

Publication span. 1977–2026.

Open the evidence file

What we know

  • Schoenenberger and Monnier 1977 characterised a rabbit-derived nonapeptide WAGGDASGE as delta-sleep-inducing peptide.
  • FDA uses the INN emideltide. No United States approved product. Withdrawn compounding nomination.
  • PCAC discussed emideltide-related bulk substances on 24 July 2026. FDA briefing materials proposed against inclusion. That is not a listing decision.

Editorial reading of the records below, labelled as Therapept analysis. How records are built

What remains uncertain

  • Whether an endogenous human DSIP of this sequence is established — later literature has debated that point.
  • Controlled human interventional data for the nominated uses (opioid withdrawal, insomnia, narcolepsy).

Sources

  1. PubChem CID 68816
  2. FDA — Pharmacy Compounding Advisory Committee, 23–24 July 2026
  3. FDA — Certain bulk drug substances for use in compounding may present significant safety risks

Last reviewed 12 September 2026 · Compiled by Therapept Editorial · How these records are built