For clinicians
Emideltide (DSIP) for prescribers: status, evidence and what FDA has said
A neutral reference. It reports Emideltide (DSIP)'s regulatory status, the quality of its human evidence and what FDA has said about it. It does not suggest a dose, a protocol or a source.
Status reviewed 2026-10-01 · By the Grey Peptides Editorial Board · Regulatory fields generated from our tracker
| Also known as | Delta sleep-inducing peptide, DSIP |
| Substances FDA reviewed | Emideltide (free base) and emideltide acetate |
| FDA approval | Not FDA-approved |
| Compounding (503A) | Not compoundable; PCAC voted against it 6–7 (Jul 2026) |
| Outsourcing (503B) | No 503B status recorded |
| FDA advisory committee | Reviewed July 23–24, 2026 (docket FDA-2025-N-6895): not recommended, 6–7, 1 abstention |
| WADA 2026 List | Prohibited (S0 catch-all) |
| WADA 2027 List | Prohibited (S0 catch-all) |
| Evidence grade | Low |
| Status reviewed | 2026-10-01 |
What FDA has said
FDA staff's position, in its briefing for the July 23–24, 2026 committee meeting: FDA proposes not adding either emideltide substance to the 503A Bulks List. This is the one case of the seven where FDA accepts that the substance has a genuine history of compounding use — and still concludes the balance weighs against it, on characterisation, effectiveness and safety.
The use FDA evaluated. FDA evaluated all three nominated uses: opioid withdrawal, chronic insomnia, and narcolepsy.
FDA's objections
FDA says neither form is well characterised, and specifically notes that endotoxin testing for the injectable route is lacking.
The sharpest technical objection of the seven. Emideltide has limited water solubility, and FDA says it is unclear how the proposed injectable at 1,000 µg/mL could be formulated at all without a co-solvent. The nomination did not explain how.
FDA found no study evaluating effectiveness that would support the use of emideltide, and insufficient evidence to conclude on intravenous emideltide. Where studies did report positive responses, FDA describes the results as difficult to interpret — small numbers, externally controlled designs, imbalanced baseline characteristics and outcomes.
Nonclinical and clinical safety data were lacking, and FDA did not identify information addressing aggregation or immunogenicity risk.
Specific to Emideltide (DSIP)
FDA states that available data suggests emideltide has been used historically in compounding. On the four-criteria balance, that counts in its favour — and FDA still proposes against it, because the other three criteria weigh the other way. This matters for reading the meeting: historical use alone does not carry a substance onto the list.
FDA notes that the American Academy of Sleep Medicine and American College of Physicians guidelines on chronic insomnia do not discuss emideltide, and neither do the AASM and European narcolepsy guidelines. ACP guidance recommends cognitive behavioural therapy for insomnia as first-line treatment for all adults.
FDA notes approved drugs exist for insomnia, narcolepsy and opioid withdrawal in adults — all three of the nominated uses, all serious conditions.
FDA lists Emideltide (DSIP) among substances it has identified as potentially presenting significant safety risks outside Category 2 (page current as of 2026-04-22). In FDA's words:
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.
Monitoring: what the literature does and does not say
- No label. Emideltide (DSIP) has no FDA-approved label, and therefore no labelled guidance on monitoring.
- What FDA has said about its risks is quoted above, from its list of bulk substances that may present significant safety risks.
- Immunogenicity. FDA's July 2026 review found no adequate information to assess the risk that emideltide (DSIP) provokes an immune response.
- What is in the vial. FDA judged the substance not well characterised physically and chemically — the property FDA relies on to know what a compounded product actually contains.
- Findings specific to emideltide (DSIP). FDA's review also describes points particular to this compound, some of them safety signals; they are set out above in FDA's own terms.
These are gaps, not a monitoring schedule. This page does not supply one, and for a compound in this position the human evidence would not support one.
Compounding: where it stands
Today's position for Emideltide (DSIP): Not compoundable; PCAC voted against it 6–7 (Jul 2026). An FDA advisory committee's vote is a non-binding recommendation; until FDA acts, a vote does not change what may be compounded. Our explainer on the 503A and 503B categories sets out what each status means, and the regulatory tracker is updated as FDA acts.
The evidence
Grey Peptides grades DSIP's evidence base as low. Most of the human literature is Eastern European work from the 1980s and 1990s, and the compound was never commercially developed. FDA's characterisation of the effectiveness evidence as small, externally controlled and difficult to interpret is a fair description of that record.
The encyclopedia entry lists the human and animal studies we hold, each with its PMID and FDA's full briefing is summarised on our page for the July 2026 review.
What this page leaves out
Doses, regimens, cycle lengths and sources. That is deliberate. A reference that reports status and evidence is useful only if it is not also a protocol, and for a compound in this position there is no approved one to report.
Sources
- US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026: briefing documents, docket FDA-2025-N-6895. FDA
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of 2026-04-22; read 2026-10-01. FDA
- Grey Peptides regulatory tracker, row for Emideltide (DSIP), reviewed 2026-10-01. Tracker · dataset
- World Anti-Doping Agency. Prohibited List 2027, dated August 26, 2026, in force January 1, 2027. WADA
This page is a reference for qualified professionals. It is not medical advice, it does not recommend any treatment, and it is not a substitute for the prescriber's own judgement and their state and federal obligations.
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