U.S. regulatory status

Emideltide (DSIP)

Also known as Delta sleep-inducing peptide, DSIP, Emideltide acetate

In limboPCAC voted against listing (6-7, Jul 24, 2026); not on the 503A list

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: Moved on paper - nominated, removed from a restricted list, or recommended by an FDA committee - but not added to the 503A list. The headline implies a change; the legal status has not moved.

Verified Sep 22, 2026 (ET) · status held since Jul 24, 2026

Primary source: Federal Register All 12 sources

The committee vote

July 24, 2026

The question 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 minutes, so treat the counts as reported, not 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

Jul 24, 2026
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.
Not legalizedView on healio.com

Status elsewhere

Emideltide (DSIP): regulatory status by jurisdiction
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.
United Kingdom (MHRA)	Restricted	No UK marketing authorisation; supply for human use treated as an unlicensed medicine.
European Union (EMA)	Restricted	No EU marketing authorisation for emideltide (DSIP); sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level.
Canada (Health Canada)	Restricted	Not authorized in Canada; Health Canada’s April 2026 advisory names DSIP among unauthorized injectable peptide drugs that are illegal to sell.
Sport / anti-doping (WADA)	Restricted	Not individually named, but prohibited at all times under the S0 catch-all for non-approved substances.

The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it

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.
MHRA Products database - search: emideltide UK gov · primaryBasis for the United Kingdom (MHRA) status row.
Health Canada public advisory (Apr 9, 2026) - unauthorized injectable peptides Health Canada · primaryBasis for the Canada (Health Canada) status row.
EMA medicines search - emideltide (no results) EU · primaryBasis for the European Union (EMA) status row.
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: Sep 22, 2026 (ET) · how we verify
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