Read This First
This page is not built on clinical evidence. It is built on the FDA's July 2026 evaluation, the regulatory record and peptide chemistry. What DSIP does, or does not do, in people is covered on the library entry; this page is about what is in the vial, and about one certificate the FDA examined that got the molecule wrong.
DSIP is a nine-residue peptide with a half-life under ten minutes, no approved product anywhere, no human study by any route in use today, and a July 2026 advisory vote against compounding it.1 It is sold as an injectable and a nasal spray for sleep. The sourcing question here is not only whether the powder is DSIP but whether a molecule that blood destroys in minutes can be meaningfully delivered by either.
Legal Status
Where Does DSIP Stand?
Approved nowhere. The FDA found emideltide "not registered drugs in any country searched" and absent from the European, Japanese and international pharmacopoeias.1
In the United States it was placed in Category 2 of the FDA's interim compounding policy in September 2023 and is now listed among substances nominated but withdrawn.2 On 24 July 2026 the Pharmacy Compounding Advisory Committee voted 7 to 6, with one abstention, against placing it on the 503A bulks list, agreeing with the FDA's recommendation. It was the only rejection among seven peptides that week.3 No pharmacy in the United States has a lawful basis on which to compound it.
Has It Been Compounded Anyway?
Yes, and the record includes a conviction. The FDA's review states that compounding with forms of emideltide "can be traced back to at least 2018," when "a compounding pharmacy and its owner pled guilty and were sentenced for unlawful distribution of compounded prescription drugs, including emideltide." An online search found no pharmacy currently offering it, but found integrative neurology clinics, medical concierge services, medical spas, wellness clinics and online retailers offering injectable and intranasal products for sleep disorders, stress, pain, cancer, Alzheimer's, Parkinson's, and alcohol and drug detoxification.1
Product Identity
The Certificate That Got the Molecule Wrong
This is the most instructive item in the FDA's DSIP review, and it is worth describing exactly.
The nomination came with certificates of analysis for both forms. The certificate for the acetate gave a molecular formula, C35H48N10O15, that matches emideltide, and a molecular weight of 848.814, which also matches. The certificate for the free base gave the same molecular weight and a molecular formula containing sulphur atoms that, in the FDA's words, "does not correspond to any emideltide structure."1 DSIP contains no sulphur; none of its nine residues is cysteine or methionine.
So a certificate submitted to a federal regulator in support of a nomination described, in its formula line, a molecule that cannot be DSIP, alongside a weight that is. Whether that reflects a template error, a copied field, or something else, the FDA does not say. What it shows is that a certificate can carry an internal contradiction that a buyer who reads only the purity line would never see.
What Else Did the FDA Find?
That neither form was well characterised. The certificates gave "no information on impurity limits/testing results," nothing on aggregation, and no microbial bioburden or endotoxin testing. Naming conventions were inconsistent. The free base is soluble in water at only 0.5 mg/mL, which the FDA flagged as a concern; the acetate reaches 10 mg/mL in buffered saline.1 A free-base product labelled at a higher aqueous concentration is not fully dissolved.
Purity Testing Versus Identity Testing
| Test | Question it answers | Question it cannot answer |
|---|---|---|
| HPLC purity | What proportion of the sample is one substance | Whether it is Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu or a truncated or deletion sequence |
| Mass spectrometry identity | Whether the mass matches, about 849 daltons | How much of the sample it represents |
| Molecular formula on the certificate | Whether the laboratory knows what it was testing | Anything, if it is wrong; see above |
| Endotoxin and sterility | Whether the vial is safe to inject | Identity; missing from the certificates the FDA reviewed |
Certificates of Analysis
What a Certificate Is
A laboratory report on one batch. Read it for the laboratory's independence from the seller, the lot number and whether it matches the vial, the date, the substance named including free base or acetate, and which tests were run. For DSIP, read the formula and weight lines too, because the FDA has seen one that contradicted itself.1
What It Cannot Establish
That the vial in hand came from the batch tested. Its value rests on a chain of custody the buyer cannot inspect. A certificate is a PDF, and nothing about the format prevents reuse or fabrication; the FDA has documented fabricated labels on gray-market peptide products.4
The Route Problem
Why Does It Matter That the Studies Were Intravenous?
Because every human study of DSIP gave it as an intravenous infusion in a laboratory, and the peptide's half-life is under ten minutes.1 That is a pharmacology in which the drug is present for a short window at a known concentration. A subcutaneous injection delivers the same peptide slowly into tissue full of the peptidases that destroy it; a nasal spray delivers it to a mucosa with its own enzymes and variable absorption. Neither has been studied, and the FDA's conclusion was that there is "no data to support use of emideltide via the nominated SC route" for any purpose.1
The nasal route is worth a specific note, because it is marketed as the gentler option. It is also the least characterised: no study has measured how much intranasal DSIP reaches the blood, let alone the brain.
"Research Use Only"
Does the Label Change Anything?
No. It is a liability position adopted by the seller, not a regulatory category. The FDA has held in warning letters that the disclaimer does not survive product copy establishing human use.5 A product sold with a bedtime dosing schedule for sleep is not a research reagent whatever the label says.
Storage and Handling
What Is Known
The FDA reproduced the manufacturers' recommendations from the certificates: the free base at 0 to 4°C for two years or -20°C for three, the acetate at 2 to 8°C in a fridge or freezer, both dry and sealed, both "sensitive to product formulation, process, and environmental conditions which may lead to aggregation and degradation."1 Those are raw-material conditions. No reconstituted stability or in-use period exists for any consumer product.
Multi-Dose Vials and Nasal Sprays
The FDA's guidance for compounded injectables is to discard a multi-dose vial within 28 days of first use regardless of what remains, and to use a new sterile needle and syringe for every dose.4 A nasal spray bottle is a multi-dose aqueous preparation opened nightly for weeks; without a preservative system and a validated in-use period, it is a culture vessel.
Signs to Stop Rather Than Proceed
A certificate whose molecular formula or weight does not correspond to DSIP
A free-base product labelled at an aqueous concentration above about 0.5 mg/mL with no explanation
Injectable product with no sterility or endotoxin result
Powder that does not dissolve, or a solution that turns cloudy or develops particles
Any drowsiness, dizziness or low blood pressure after a dose, which were the events recorded with intravenous use, and any sense of needing more of it, given the opioid-system mechanism the FDA flagged1
Community Language
DSIP
Delta sleep-inducing peptide. The subject of this page; named for a hypothesis.
Emideltide
The international nonproprietary name for the same nonapeptide, and the name the FDA uses.
Nasal DSIP, DSIP spray
An intranasal formulation with no human data by that route.
Category 2
The FDA's interim classification for nominated compounding substances that may present significant safety risks. Emideltide was placed there in 2023 and is now listed as nominated but withdrawn.2
Certificate of analysis
A laboratory report on one batch. It describes the batch tested, not necessarily the vial received, and for this compound the FDA has seen one that did not describe DSIP at all.
Related ONPEPS Coverage
DSIP library entry: the riddle, the 1980s trials and the July 2026 rejection
DSIP cost and access: the one peptide the committee said no to
FDA peptide news July 2026: the votes, the dissent and what happens next
Sources
US Food and Drug Administration. Emideltide-related bulk drug substances (emideltide (free base) and emideltide acetate): FDA presentation to the Pharmacy Compounding Advisory Committee, 24 July 2026. Docket FDA-2025-N-6895. fda.gov
US Food and Drug Administration. Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act. Entry for emideltide (DSIP). Content current as of 22 April 2026. fda.gov
ONPEPS. FDA peptide news July 2026: the only source you need. Records the 7 to 6 vote with one abstention against emideltide. onpeps.com
US Food and Drug Administration. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Drug Alerts and Statements. Cited for the agency's general guidance on multi-dose vials and fabricated labels. fda.gov
US Food and Drug Administration. Warning Letter: Gram Peptides. MARCS-CMS 721806, 31 March 2026. fda.gov
Not Medical Advice
DSIP holds no marketing authorisation for human use in any jurisdiction. If you are already using a product obtained outside a pharmacy, the route back to oversight is a clinician who knows what you have taken.
Regulatory sources verified 16 September 2026. The compounding record changes frequently. Re-verify before relying on any statement here.