DSIP (Delta Sleep-Inducing Peptide): Legal Status and Evidence

Legal status of DSIP

Not allowed in compounding

An FDA advisory committee voted against DSIP in July 2026 ^[1]. It cannot be legally compounded ^[2], and we found no new review scheduled.

FDA status

FDA removed it from Category 2 in April 2026 because the nominators withdrew their nominations ^[5]. That removal did not make it legal to compound ^[6]. FDA now lists it as "nominated but withdrawn," which is outside every category ^[7]. It is not in Category 1 and is not on the 503A bulks list, so a 503A pharmacy may not lawfully compound it today ^[2]. FDA's briefing notes only small IV studies, none by the subcutaneous route that was proposed, and says immunogenicity cannot be ruled out ^[3].

Advisory committee

On July 24, 2026, the committee voted 6 yes, 7 no and 1 abstain, so it did not recommend adding DSIP to the 503A bulks list ^[1]. The committee reviewed it for opioid withdrawal, chronic insomnia and narcolepsy ^[4]. FDA staff had recommended against listing it ^[3].

FDA-approved products

None. We found no FDA-approved drug that contains DSIP.

Sports (WADA)

DSIP is not named on the 2026 list ^[10]. The list's S0 class covers substances with no approval by any government health authority for human use ^[10]. Whether that class covers DSIP is a judgment call, so athletes should ask their anti-doping agency before use.

What happens next

We found no further FDA review scheduled for DSIP. The interim peptide access policy sent to the White House budget office has not been issued, and its text is not public ^[8]. FDA would have to act on its own for DSIP to become legal to compound. A drug safety group petitioned FDA on Oct 16, 2026 not to allow it ^[13].

Checked against FDA sources on Oct 24, 2026. We update this box when FDA acts. Report a change: [email protected].

The vote DSIP lost

Seven peptides went before FDA's Pharmacy Compounding Advisory Committee on July 23 and 24, 2026. Six won favorable votes. DSIP, listed by FDA under its official name emideltide, did not: "The vote on Emideltide (free base and acetate) failed, 6 in favor to 7 against, with 1 abstention" ^[1]. The committee reviewed it for opioid withdrawal, chronic insomnia and narcolepsy ^[4]. FDA staff had recommended against it ^[3].

Its legal position is the same as before the vote. FDA took it out of Category 2 in April 2026 after the nominators withdrew, which did not make it legal to compound ^{[5] [6]}. It now sits on FDA's nominated but withdrawn list ^[7]. We found no new review scheduled, and FDA would have to act on its own for DSIP to become legal to compound. An interim peptide access policy was under White House review in October 2026, with no public list of peptides; we found no report that it covers DSIP ^{[8] [9]}.

Delta sleep-inducing peptide explained

FDA's briefing describes emideltide as "reported to be a nonapeptide," a chain of nine amino acids, "originally found in rabbit cerebral venous blood" ^[3]. Early research reported that it promotes a type of sleep with more delta-wave activity on an EEG ^[3]. Nominators proposed an injection under the skin ^[3].

Studies from the 1980s and 1990s

Selected human DSIP studies in FDA's May 2026 briefing

Use	Study	People	Design
Chronic insomnia	Schneider-Helmert, 1987	14	Compared with an outside matched group [3]
Chronic insomnia	Bes et al., 1992	16	Small study [3]
Chronic insomnia	Monti et al., 1987	6	Severe chronic insomnia [3]
Opioid withdrawal	Dick et al., 1984	60	Uncontrolled, open-label [3]
Opioid withdrawal	Backmund et al., 1998	7	Open-label [3]
Narcolepsy	Case report	1	Single patient [3]

FDA concluded there was insufficient evidence that DSIP works for the proposed uses by the proposed route ^[3].

Injected under the skin: untested

No study FDA found used the under-the-skin injection sellers offer ^[3]. FDA also noted that DSIP free base has limited water solubility, so it is unclear how an injectable at the nominated strength would be made ^[3]. And FDA said it "cannot rule out the potential for immunogenicity," an immune reaction, tied to unknown impurities and clumping ^[3].

DSIP and drug testing

Emideltide is absent from the 2026 WADA list by both of its names ^[10]. The list still has a net for it: S0 bans active substances not approved by a government health authority for human therapy ^[10], and FDA has approved none containing DSIP. Ask your anti-doping agency before use.

No legal route yet

Vials sold as "research use only" are not a legal workaround; FDA has rejected that label in warning letters ^[11]. See our peptide status tracker for the six peptides that won July votes, including epitalon, which was also reviewed for insomnia, and Selank, another peptide sold for calm and sleep that has no review at all, plus BPC-157 and Semax. Peptides with a legal route are on the legal peptide price tracker. For research chemical sellers more broadly, see research-use-only GLP-1s.

FDA history for DSIP

• Oct 16, 2026: The Partnership for Safe Medicines filed a citizen petition asking FDA not to allow compounding of this and six other peptides, by rule, Category 1 placement or enforcement discretion ^[13].
• Jul 24, 2026: The advisory committee voted 6-7-1 against adding DSIP to the bulks list ^[1].
• May 11, 2026: FDA staff briefing documents recommended against adding it to the 503A bulks list ^[3].
• Apr 22, 2026: The removal took effect around this date. FDA now lists it as nominated but withdrawn, which does not allow compounding ^{[7] [6]}.
• Apr 15, 2026: FDA gave seven days' notice that it would remove 12 peptides, including this one, from Category 2 because the nominators withdrew ^[5].
• Sep 29, 2023: FDA placed it in Category 2, citing significant safety risks ^[12].

The other peptides FDA's committee weighed in July 2026: TB-500, KPV, MOTS-c, Semax and epitalon. For approved peptide drugs, see PT-141 and SS-31.

Our checks

Sources for this page: FDA's emideltide briefing, its 503A categories document and the July 2026 meeting page, each reopened on Oct 24, 2026 ^{[3] [2] [4]}. The failed vote count is from the FDA Law Blog, since FDA has posted no minutes ^[1]. No seller is linked or quoted. Standards: how we work.