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Synthetic nonapeptide (delta sleep-inducing peptide)

Emideltide — evidence

What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.

Evidence overview

3 records in this file

  • ANIMAL1
  • REGULATORY2

Research areas. Sleep EEG models; United States compounding.

Publication span. 1977–2026.

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 Withdrawn compounding nomination.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).

Regulatory notes

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  • Listed on FDA's table of bulk substances nominated for compounding and subsequently withdrawn, as emideltide (DSIP).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 Nominations had been withdrawn; FDA elected to proceed.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 of any particular material.

Studies and documents

  1. REGULATORY2026FDA compounding classification

    FDA — bulk substances nominated for compounding and withdrawn: emideltide (DSIP)

    U.S. Food and Drug AdministrationFDA compounding communications

    Objective
    To record FDA's published compounding position on emideltide.
    Endpoint investigated
    Compounding classification

    Emideltide (DSIP) appears on FDA's withdrawn-nominations table. Published concerns include immunogenicity risk, peptide-related impurities and API characterisation, and absence of identified safety information for the proposed route.

    Limitations. Withdrawn nomination; not a clinical trial review.

    FDA — Certain bulk drug substances for use in compounding may present significant safety risksReviewed 12 September 2026

  2. REGULATORY2026FDA advisory-committee briefing

    FDA PCAC briefing — emideltide-related bulk drug substances (24 July 2026)

    U.S. Food and Drug AdministrationFDA PCAC briefing

    Objective
    To record FDA staff's published proposal on 503A Bulks List inclusion for emideltide.
    Endpoint investigated
    Proposed compounding-list classification

    PCAC discussed emideltide (free base) and emideltide acetate on 24 July 2026 (uses evaluated: opioid withdrawal, chronic insomnia and narcolepsy). The briefing-document introduction states that FDA is proposing that both NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed.

    Limitations. Staff proposal and committee advice are non-binding. FDA has not published a listing decision as of this review. Secondary press about committee votes is not used as an identity or listing fact.

    FDA — PCAC briefing for emideltide-related bulk drug substancesReviewed 12 September 2026

  3. ANIMAL1977Isolation, synthesis and in-vivo rabbit EEG assay

    Characterization of a delta-electroencephalogram (-sleep)-inducing peptide

    Schoenenberger GA, Monnier MProceedings of the National Academy of Sciences

    Population
    Rabbits, intraventricular infusion, neocortical and archicortical EEG
    Sample
    58 rabbits including controls
    Objective
    To isolate, sequence, synthesise and test a nonapeptide reported to enhance delta and spindle EEG after intraventricular infusion.
    Endpoint investigated
    Delta and spindle EEG patterns in rabbits

    Reports isolation from rabbits of a nonapeptide Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu, named delta-sleep-inducing peptide, and that among nine synthetic peptides tested under double-blind conditions only the synthetic nonapeptide showed significant enhancement of delta and spindle EEG. This is the originating characterisation paper, not a human sleep trial.

    Limitations. Rabbit intraventricular EEG model. Later literature has debated whether an endogenous human DSIP of this sequence is established. The experiment does not speak to United States compounding policy.

    DOI 10.1073/pnas.74.3.1282Schoenenberger and Monnier, Proc Natl Acad Sci USA (1977)Reviewed 12 September 2026

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