U.S. regulatory status
Emideltide (DSIP)
Also known as Delta sleep-inducing peptide · DSIP · Emideltide acetate
Is Emideltide (DSIP) legal right now?
Emideltide, better known as delta sleep-inducing peptide or DSIP, is not FDA-approved and is not on the FDA's Section 503A Bulk Drug Substances List, so it is not eligible for pharmacy compounding. On July 24, 2026 the FDA's Pharmacy Compounding Advisory Committee voted 6-7, with 1 abstention, against recommending it - the only one of the seven peptides reviewed at this meeting that the committee declined to recommend, and a result consistent with the FDA review staff's own position on all seven. Emideltide therefore stays off the 503A list, with no further FDA action scheduled. Its removal from the interim Category 2 list in April 2026 did not authorize compounding either: it was never in Category 1, the category that does.
In limbo: Nominated or removed from a restricted list but NOT approved - the headline implies a change, but the legal reality did not move.
Verified Aug 11, 2026 (ET) · status held since Jul 24, 2026
The committee vote
July 24, 2026 ETQuestion put to the FDA Pharmacy Compounding Advisory Committee (PCAC)“Should Emideltide (free base) be placed on the list? - and, as a separate vote, Emideltide acetate?”
Not recommended by the committee
- 6 in favour
- 7 against
- 1 abstained
14 votes recorded. Tally reported by Healio and the FDA Law Blog (Hyman, Phelps & McNamara). The panel was not the same size for every substance - the meeting roster seats temporary voting members for single topics - so the totals legitimately differ between votes - the FDA has not yet published the meeting minutes, so treat the counts as reported rather than official.
What this does not do: an advisory committee recommendation is not an FDA decision and does not bind the agency. Emideltide (DSIP) is not on the 503A Bulk Drug Substances List, and a pharmacy compounding it today has no more federal authorisation than it did the day before the vote. Only a completed FDA rulemaking can change that.
Where it sits in the process
- Nominated (passed)
- Under review (stalled here - not advancing)
- Rulemaking (not reached)
- Compounding-legal (not reached)
Not on a path to the 503A list right now. The process stalled or reversed at this stage - read the status above. Sitting at an earlier step is not a sign it will advance.
What changed last
FDA advisory committee (PCAC) voted 6-7, with 1 abstention, AGAINST recommending Emideltide (DSIP) for the 503A list - the only one of the seven peptides reviewed that it declined to recommend. It stays off the list, with no further FDA action scheduled.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | In limbo | Not on the 503A Bulks List. PCAC voted against adding it on Jul 24, 2026 (6-7, 1 abstention). No further FDA action is scheduled. |
| Australia (TGA) | Unscheduled | Not individually named in the Poisons Standard; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides. |
| Sport / anti-doping (WADA) | Restricted | Not individually named, but prohibited at all times under the S0 catch-all for non-approved substances. |
Sources & transparency
Sources for this entry
- Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895) Federal Register · primaryEmideltide (also referred to as DSIP), free base and acetate, on the July 24, 2026 agenda.
- FDA - 503A bulk drug substances: Category 1 & Category 2 lists FDA · primaryEmideltide/DSIP is not on the 503A (Category 1) list; the FDA 503A categories govern compounding eligibility.
- FDA - PCAC meeting page, July 23-24, 2026 FDA · primaryOfficial meeting record. FDA has not yet published the minutes or vote tallies.
- FDA - PCAC July 23-24, 2026: questions put to the committee FDA · primaryFDA's own vote questions. Confirms each substance was voted on twice - free base and acetate separately - and gives the session order.
- FDA - PCAC July 23-24, 2026: meeting roster FDA · primaryVoting members plus temporary voting members seated for single topics, which is why the vote totals differ between substances.
- Frier Levitt - FDA to remove peptides from the Category 2 list (2026) analysisEmideltide/DSIP among the peptides removed from Category 2 in April 2026; removal does not authorize compounding.
- FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara) analysisConfirms Emideltide/DSIP on the July 2026 PCAC agenda; the vote is advisory and any listing requires rulemaking.
- Healio - FDA committee recommends looser restrictions for several peptides analysisReported per-substance vote tallies; also records that FDA review staff recommended against all seven.
- Mintz - FDA's Advisory Committee Votes on Peptides: What It Does and Doesn't Do analysisLegal analysis: the vote is not an agency action and nothing has legally changed.
- Last verified by a human
- Aug 11, 2026 (ET) · how we verify
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