DSIP has enduring appeal because sleep is universal and the idea of a sleep-linked peptide is intuitively powerful.
FDA found limited and inconsistent clinical evidence, and the committee did not give a favorable recommendation.
What a visitor should know.
Technical details: aliases, tracked claims, and data record
4 names in this peptide family.
Emideltide and delta sleep-inducing peptide (DSIP) resolve to one family; the alias does not imply a validated sleep indication.
4 evidence questions.
Human benefitLimited human evidenceDoes Emideltide / DSIP have established human clinical benefit for opioid withdrawal, chronic insomnia, and narcolepsy?
FDA approvalNo FDA approval identifiedIs Emideltide / DSIP FDA approved?
503A statusRegulatory recordIs Emideltide / DSIP on FDA's final 503A Bulks List or generally permitted because of committee activity?
Identity transferIdentity-sensitiveAre every product, alias, form, and related compound labeled Emideltide / DSIP automatically interchangeable?
See every Emideltide / DSIP evidence question →Open the machine-readable record ↗PCAC did not give a favorable recommendation
The committee did not recommend emideltide-related bulk drug substances for inclusion on the 503A Bulks List.
FDA received advice from its expert compounding committee.
The compound was not FDA-approved, and the vote alone did not add it to the final 503A Bulks List.
How the FDA record developed.
This timeline separates early nominations and scientific reviews from committee votes and final FDA decisions.
PCAC did not give a favorable recommendation
The committee did not recommend emideltide-related bulk drug substances for inclusion on the 503A Bulks List.
Read the source ↗FDA published its scientific briefing
FDA released its evaluation of Emideltide / DSIP-related bulk drug substances for the committee meeting.
Read the source ↗Emideltide entered FDA's 503A nomination record
Two organizations nominated emideltide-related substances. The nominations were later withdrawn, and FDA continued the evaluation on its own initiative.
Read the source ↗What has actually been studied?
Human studies appear on the left. Animal, cell, and laboratory studies appear on the right because they cannot establish that a treatment works in people.
FDA found limited and inconsistent clinical evidence and major safety and characterization uncertainty.
Read the FDA review ↗Sixteen people with chronic insomnia received intravenous DSIP or placebo. Some sleep measures favored DSIP, but the study was very small and does not establish a routine clinical benefit.
Read the study on PubMed ↗Preclinical findings were reviewed separately and do not establish clinical benefit in people.
Read the FDA review ↗Important unknowns.
- Human safety information is limited for the proposed routes and uses.
- FDA identified uncertainty around active-ingredient characterization, peptide-related impurities, or aggregation.
- Limited evidence of harm should not be interpreted as evidence of safety.
These are evidence and regulatory uncertainties, not an individualized assessment of whether a treatment is appropriate.
Read the original sources.
Technical change history and comparison data
3 dated changes. 2 comparison groups.
These records show what each source added and whether it changed Peplyst's public conclusion.