Where the claims come from
The name is doing most of the marketing. A peptide isolated from the blood of sleeping animals suggests a natural sleep switch, and that story survives even though the molecule’s own biology was never pinned down. European and Soviet work in the 1980s and 1990s explored it for insomnia, opioid withdrawal and stress, and modern sellers cite that literature.
What evidence exists outside the registry
Human studies were published before trial registration was standard, so the registry count of zero understates what exists. A 1992 double-blind study in chronic insomniacs and a 1998 open-label opioid-detoxification study are the most-cited. Open-label means everyone knew who received the compound, so it cannot separate an effect from expectation. Two further studies measured hormone responses rather than sleep outcomes, and one of those reported no effect.
- DSIP in chronic insomnia (Neuropsychobiology, 1992) — Double-blind study; among the few controlled human trials of DSIP.
- DSIP in opioid detoxification (J Clin Psychopharmacol, 1998) — Open-label, no control group.
- FDA — bulk drug substances nominated but withdrawn — Emideltide (DSIP) appears in the withdrawn table, not the active Category 2 list.
Approved for, studied for, sold for
Three separate lists, kept by three separate processes: a regulator decides the first, researchers the second, and whoever is selling it the third. They are often not the same list, and the differences are the most useful thing on this page.
Not approved by the FDA for any use. Nothing has been reviewed for safety, effectiveness or manufacturing quality.
No registered trial in ClinicalTrials.gov lists a studied condition for this compound. That is a gap in the registry, not a finding that it was tested and failed. See what evidence exists outside the registry below.
- Sleep quality
- Stress & cortisol
- Withdrawal support
- Pain
Every trial on record
Every registered human study we can find for DSIP. Click any ID to read the original record — we would rather you checked us than trusted us.
What regulators have said
Compounded drugs containing emideltide may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has not identified safety-related information regarding emideltide for the proposed route of administration.
A withdrawn nomination means the substance was proposed for use in pharmacy compounding and the proposal was later pulled, so it is not on FDA's active list. FDA had published the concern above while it was under review. Neither the concern nor the withdrawal is a finding about whether DSIP works.
Why you may see a different number
Published papers and registered trials are different things. A study can be written up without ever appearing on a trial registry — particularly older work, work done outside the US and EU, and animal research. We count registered human trials because they can be independently verified. A count of zero here means nobody has registered a human trial, not that no paper exists.
Common questions about DSIP
How many human trials does DSIP have?
None on ClinicalTrials.gov. We found no registered interventional study of DSIP in humans. Published human research may still exist — registration only became standard in the mid-2000s — but it is not in the registry this count comes from.
Is DSIP FDA approved?
No. DSIP is not approved by the FDA for any indication. Compounded or "research use only" preparations are not FDA-approved and receive no premarket review for safety, effectiveness, or manufacturing quality.
Where does this data come from?
ClinicalTrials.gov, the US public registry of clinical studies. We count interventional human studies only — observational studies are not evidence of effect. Every trial on this page links to its original record so you can check us rather than trust us.
More on DSIP: how many human trials it has · is it FDA approved · has it been studied for safety
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