U.S. regulatory status

Emideltide (DSIP)

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

Under reviewRemoved from Category 2 (Apr 2026); not on the 503A list; before the FDA committee Jul 24, 2026

Is Emideltide (DSIP) legal right now?

Emideltide, more commonly known as delta sleep-inducing peptide or DSIP, is a short neuropeptide studied for sleep and explored in older literature for opioid-withdrawal symptoms and narcolepsy, mostly in small and dated studies. In the United States it is not FDA-approved, no approved product exists, and it is not on the FDA's Section 503A list of bulk substances eligible for compounding. It was removed from the interim Category 2 list in April 2026, but that removal follows a withdrawn nomination and does not authorize compounding, and DSIP was never on the permitted Category 1 list. It is scheduled for FDA advisory committee (PCAC) evaluation, under the name Emideltide, on July 24, 2026 (Docket FDA-2025-N-6895). The committee's recommendation is advisory only, and any addition to the 503A list would require a separate formal FDA rulemaking process.

Under review: Actively before the FDA advisory committee; a decision is pending and the status can move.

Verified Jul 16, 2026 (ET) · status held since Apr 16, 2026

Primary source: Federal Register All 4 sources

Where it sits in the process

Nominated(completed)
Under review(current stage)
Rulemaking(upcoming)
Compounding-legal(upcoming)

Next milestoneFDA advisory committee (PCAC) evaluates Emideltide (DSIP) for the 503A list - Jul 24, 2026 (in 8 days)

What changed last

No recorded changes yet - this entry has held one status since it was added.

Status elsewhere

Emideltide (DSIP): regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	Under review	Not on the 503A list; removed from Category 2 in April 2026 (never in Category 1); under active PCAC review, meeting July 23-24, 2026 (Docket FDA-2025-N-6895).
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.
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.

Last verified by a human: Jul 16, 2026 (ET) · how we verify
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