Review · United States
DSIP
Reviewed on
Approval and product status
No FDA-approved U.S. product; the July 2026 advisory vote did not add DSIP to the 503A list
DSIP is also called emideltide. FDA separates emideltide free base from emideltide acetate, a salt form. These forms are not automatically the same as each other or as a product sold online. A product name does not prove its identity, contents, quality, or match to study material.
What was measured in people?
- Health results · Limited
- Small older human studies gave DSIP mainly through a vein and reported mixed sleep results. The studies do not establish a treatment benefit.
- Body changes · Unclear
- Some studies measured short-term sleep or hormone changes after use through a vein. They do not define how DSIP acts in every person or product.
A change in a hormone or body signal does not by itself prove a health benefit.
Important limits
This tool is not an independent medical review. It does not recommend treatment.
FDA identified important limits in the human safety and product-quality record. Free base, acetate, and online products may differ. This guide gives no dosing, administration, sourcing, product-selection, or treatment instructions.
Still unknown: These studies do not prove that DSIP improves sleep, treats insomnia, or treats opioid or alcohol withdrawal. The studies were small and used different designs. They do not show long-term benefit or safety. FDA's 2026 review found no adequate evidence for the proposed under-the-skin route and no long-term effectiveness data. It also found no adequate safety or toxicity record for the proposed use.
This record cannot check a package, seller, batch, or personal treatment. It does not provide sport clearance.
Approval fact checks
“DSIP is FDA-approved in the United States.”
Misleading. FDA's briefing did not identify an FDA-approved U.S. drug containing emideltide. The current U.S. 503A list also does not list DSIP or emideltide. A substance record or a foreign or online product is not U.S. drug approval.
Applies to: United States approval and 503A status as reviewed August 30, 2026.
“The 2026 advisory vote added DSIP to the 503A list or approved it.”
Misleading. The July 2026 committee vote was advisory. It did not itself change the 503A list or approve a drug. The current U.S. list does not show DSIP or emideltide, and no final FDA approval was identified in this review.
Applies to: The July 2026 advisory vote and United States 503A status as reviewed August 30, 2026; an advisory recommendation is not a final FDA decision or drug approval.
Products in this review
These are selected records, not every product or form.
No product label record is included here. That is not a separate approval decision. Read the status and sources above.
What the research shows
Small sleep studies from 1981 through 1992 tested DSIP, mostly through a vein. Some reported short sleep changes. Other controlled studies found little or no useful sleep benefit. One study measured a short-term change in a blood hormone, not better sleep. A few small studies also looked at narcolepsy or withdrawal symptoms.
Read all DSIP fact checksSources used in this review
A source may support some statements, not all of them. Use the links above or this review to see what each source supports.
Show 15 sources
- FDA Global Substance Registration System record for emideltide (DSIP)
U.S. Food and Drug Administration · Reference · 2026
Source accessed
- FDA evaluation of emideltide (DSIP) and related bulk drug substances
U.S. Food and Drug Administration · FDA review · 2026
Source accessed
- July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting
U.S. Food and Drug Administration · Regulatory · 2026
Source accessed
- 21 CFR 216.23 bulk drug substances list
Electronic Code of Federal Regulations · Regulatory · 2026
Source accessed
- DSIP amino-acid sequence, synthesis, and activity
PubMed · Reference · 1978
Source accessed
- Acute and delayed effects of DSIP on human sleep behavior
PubMed · Randomized trial · 1981
Source accessed
- Synthetic DSIP and disturbed human sleep
PubMed · Human clinical study · 1981
Source accessed
- Synthetic DSIP and sleep in people with insomnia
PubMed · Human clinical study · 1981
Source accessed
- DSIP and 24-hour sleep-wake behavior in severe chronic insomnia
PubMed · Human clinical study · 1987
Source accessed
- DSIP efficacy study in chronic insomnia
PubMed · Randomized trial · 1987
Source accessed
- Double-blind DSIP study in chronic insomnia
PubMed · Randomized trial · 1992
Source accessed
- DSIP and narcolepsy
PubMed · Human pilot · 1984
Source accessed
- DSIP in withdrawal syndromes from alcohol and opiates
PubMed · Human clinical study · 1984
Source accessed
- Opioid detoxification with DSIP: open clinical trial
PubMed · Human pilot · 1998
Source accessed
- Intravenous DSIP and a blood hormone change in people
PubMed · Human pharmacology · 1989
Source accessed