Peptide dossier, updated Oct 31, 2026

Emideltide (DSIP)

A nine-amino-acid peptide, also called delta sleep-inducing peptide (DSIP). FDA says it was first reported in rabbit blood in 1963 and gives the sequence Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu. It is the only one of the seven peptides FDA took to its July advisory committee that the committee did not recommend, and, per two law-firm summaries, it is not covered by HHS’s Oct 30 enforcement pause. This page lays out what each source actually says.

See all 13 verified records for Emideltide (DSIP) on the Records page

FDA safety-risk page

Listed

FDA says compounded drugs containing it may pose immunogenicity risk for certain routes. It has found no safety information for the proposed route.

HHS enforcement, Oct 30

Not covered

Two law-firm summaries list the six peptides the draft policy covers. Emideltide is not one of them. We could not open the policy attachment itself.

FDA advisory panel, July

Not recommended

Nonbinding. The only one of seven peptides the committee did not recommend. FDA’s own staff also proposed not adding it.

WADA prohibited list

Not named

The 2022 and 2026 lists do not name emideltide or DSIP. Section S0 covers substances with no approval from any government health authority.

Human evidence

Small studies, intravenous

FDA found only intravenous studies and called the effectiveness evidence insufficient. No registered trial.

Human studies

ClinicalTrials.gov returns no study listing emideltide or delta sleep-inducing peptide as an intervention, as of Oct 31, 2026. The human studies we found are published papers from 1984 to 1998, listed under Published research below.

A broader text search returns unrelated studies that mention sleep. Registry entries are written by sponsors and are not reviewed for scientific merit. The absence of a registered study is not evidence about safety or effect.

FDA review

Two FDA documents address emideltide: the safety-risk page (content current Apr 22, 2026) and a briefing document for the July advisory committee, in a memo dated May 11, 2026. The committee then declined to recommend it.

What the briefing document found

FDA evaluated emideltide (free base) and emideltide acetate for the 503A bulks list. Two nominations, from Wells Pharmacy Network and LDT Health Solutions, were withdrawn, so FDA reviewed both forms on its own initiative.
The uses evaluated were opioid withdrawal, chronic insomnia and narcolepsy. The proposed product was a 1 mg/mL subcutaneous injection. FDA did not evaluate “paradoxical sleep disorder” for lack of information.
FDA says no USP or National Formulary monograph exists and neither form is part of an FDA-approved drug. “Emideltide” is a common name, not a United States Adopted Name.
The nominators gave inconsistent information. For one, the certificate of analysis tested acetic acid content, which points to the acetate, while the chemical data matched the free base. FDA says it was unclear which form was intended.
FDA notes limited water solubility and says it is unclear how the proposed 1 mg/mL injection could be formulated.
The nominators submitted 33 articles. FDA says none explicitly discussed a compounded emideltide product in humans. It cites a press release from the U.S. Attorney’s office for the Eastern District of Kentucky saying a pharmacy compounded and distributed emideltide products from Oct 25, 2018 to Apr 1, 2020, with the form unclear. We have not read that release.
Human studies date from 1981. FDA found studies giving it intravenously at 25–150 nmol/kg, and no clinical safety data for the proposed subcutaneous route.
A search of FDA’s adverse event database (FAERS) through Mar 3, 2024 retrieved zero reports. FDA found no relevant case reports.

What FDA concluded

The balance of criteria weighs against placing either form on the list.
FDA called both forms not well characterized: names that do not follow standard nomenclature, and no impurity, aggregate or endotoxin data in the literature or the nominations. It cited immunogenicity concern for an injectable form.
It found insufficient information on effectiveness for chronic insomnia, narcolepsy and opioid withdrawal by the intravenous route, and no data for the subcutaneous route. It called the insomnia studies inconclusive and at best preliminary, with poor controls and small samples.
It said clinical practice guidelines do not discuss emideltide, and that FDA-approved treatments exist for all three conditions.
Nonclinical: its sleep-inducing effect is reported to work through opioid-dependent mechanisms. It does not appear to bind opioid receptors directly but can stimulate release of endorphins. FDA says that could lead to addiction and found no nonclinical studies of addictive potential, and no nonclinical toxicity studies.
Clinical safety: intravenous studies in insomnia reported no significant adverse effects. Studies in withdrawal reported transient headache, nausea and vertigo, and cases of hypotension that was “progressive” after a second intravenous injection.
FDA says injection and intranasal products are sold in the US through clinics, medical spas and online retailers, and that it is unclear whether they are compounded.

Sources: FDA briefing document (PDF)FDA: bulk substances that may present significant safety risks Federal Register notice of the meeting

Published research

PubMed returns 407 results for “delta sleep-inducing peptide” and 1 for “emideltide.” The human studies we read are intravenous and decades old. The recent papers we saw are animal and manufacturing studies.

Human studies

Chronic insomnia, 1987. 14 middle-aged chronic insomniacs got DSIP or placebo for 7 nights under double-blind conditions. The authors report improved night sleep and daytime performance and call the study a demonstration of efficacy. Eur Neurol PubMed
Chronic insomnia, 1992. 16 patients got 25 nmol/kg intravenously or glucose placebo before three nights. Sleep efficiency was higher and latency shorter with DSIP, but the authors say the effects were weak and partly due to a change in the placebo group, and conclude short-term treatment is not likely to be of major benefit. Neuropsychobiology PubMed
Opioid detoxification, 1998. An open clinical trial, reported as a letter. We read the title only. J Clin Psychopharmacol PubMed
Alcohol and opiate withdrawal, 1984. A clinical report, title only. Eur Neurol PubMed

Read with care

The two controlled insomnia studies we read reach different conclusions, and FDA judged the evidence inconclusive.
The studies give it intravenously. The proposed compounded product is a subcutaneous injection, and FDA found no data for that route.
We read abstracts only, not full text, funding or author disclosures. For the 1998 and 1984 papers, not even an abstract.
A 2021 rat study reports DSIP improved motor function after focal stroke, per its title. Animal findings are not evidence of an effect in people. Molecules PubMed

FDA warning letters

We found one FDA warning letter that names DSIP. It is addressed to a compounding pharmacy and is not a finding about DSIP’s safety. This rests on web searches, not a full pull of FDA’s database.

Recipient	Date	Letter	What it says
Tailor Made Compounding LLC, a compounding pharmacy	Apr 1, 2020	Warning letter 594743	FDA says an inspection found the firm compounding with a list of 22 bulk substances that includes DSIP, and that drugs made from them were not eligible for the section 503A exemptions. The letter says none of them is covered by a USP or NF monograph or is a component of an FDA-approved drug, and that the listed substances “have not been nominated” for the bulks list. We read the letter text. The letter lists it as “DSIP,” which FDA’s briefing gives as another name for emideltide. FDA’s 2026 briefing says two nominations, in dockets FDA-2015-N-3534 and FDA-2018-N-2973, were later withdrawn. We do not know how to reconcile that with the letter’s wording.

A warning letter is FDA’s statement about one firm’s conduct on one date. It is not a finding about the substance. FDA’s list of letters cannot be searched by peptide, so other letters could exist that we did not find.

SEC filings

We found one SEC filing that names emideltide. EDGAR’s full-text search was not available to us, so this rests on web searches of sec.gov.

Filer	Filing	What it says
BioScience Health Innovations Inc.	Form 10-Q Filed May 11, 2026	In a section on why a federal peptide reclassification matters to the company, the filing lists “DSIP (Emideltide)” among peptides it expects to return to Category 1. It ties this to a Feb 27, 2026 statement by the HHS Secretary on a podcast. It adds that reclassification would not be FDA approval and that formal rulemaking had not been published as of April 2026.

What a company says in a filing is its own claim about its business. It is not a finding about emideltide. This one reads differently from what followed: FDA’s staff proposed against listing it and the advisory committee did not recommend it. We read the passages naming emideltide, not the whole document.

Timeline

Newest first. Every entry links to the document it comes from.

Government or registry record
Journal

Oct 30, 2026Regulatory
HHS publishes draft policy pausing enforcement on six peptides; Emideltide is not one of them
Per two law-firm summaries the six are BPC-157, TB-500, epitalon, Semax, KPV and MOTS-c. The policy is a draft and not FDA approval. We could not open the policy attachment, so this rests on the summaries.
Federal Register Docket BakerHostetler summary
July 23–24, 2026Regulatory
FDA advisory committee does not recommend emideltide for the compounding list
It was the only one of seven peptides the committee did not recommend. The vote is nonbinding. Holland & Knight gives no vote count and no reason specific to emideltide. Vote counts differ between trade-press reports, and no official tally was in the FDA documents we could read.
Holland & Knight summary
May 11, 2026Regulatory
FDA staff brief the committee: the balance of criteria weighs against listing emideltide
Details above.
FDA briefing document (PDF)
Apr 22, 2026Regulatory
FDA’s safety-risk page lists emideltide
The page showed content current as of Apr 22, 2026. It says FDA lacks sufficient information to know whether the drug would cause harm if administered to humans.
FDA page
Apr 16, 2026Regulatory
FDA announces the advisory committee meeting and names emideltide
The Federal Register notice lists emideltide, with opioid withdrawal, chronic insomnia and narcolepsy as the evaluated uses.
Federal Register notice
Apr 1, 2020Enforcement
FDA warning letter to a compounding pharmacy names DSIP among 22 substances
The letter says drugs the firm compounded from these bulk substances were not eligible for the 503A exemptions.
Warning letter 594743
1998Literature
Open clinical trial of DSIP in opioid detoxification
Reported in J Clin Psychopharmacol. We read the title only.
PubMed
1992Literature
Double-blind study in 16 chronic insomniacs finds weak effects
The authors conclude short-term treatment is not likely to be of major therapeutic benefit.
PubMed
1987Literature
Placebo-controlled study in 14 chronic insomniacs reports improved sleep
Published in Eur Neurol. The authors report improved night sleep and daytime performance.
PubMed

Still not covered

Left off rather than guessed:

Policy coverage: HHS’s list of covered peptides sits in a policy attachment we could not open. That emideltide is outside it comes from two law-firm summaries, not from the document itself.
Panel vote counts and reasons: not in the FDA documents we could read, and trade-press tallies differ. We found no source stating the committee’s reasons for declining to recommend it.
Name of the form: FDA evaluated the free base and the acetate. We do not know which form the committee’s vote addressed.
U.S. Attorney press release: cited by FDA, not read by us.
Patents: not researched for this dossier.
Seller claims and independent lab reports: how it is marketed versus what testing finds. FDA says it is sold in the US but we have not collected testing data.
Unread items: full text of every paper, including the 1984 and 1998 clinical reports; WADA lists for years other than 2022 and 2026; EU and other non-US trial registries.
Warning letter and SEC completeness: web searches only.