Is Emideltide (DSIP) legal in the US?
The short answer
Emideltide (DSIP) is not an FDA-approved drug and is not on the 503A Bulks List as of 2026-07-28. On 2026-07-24, FDA's Pharmacy Compounding Advisory Committee voted against recommending it.
The July 23-24, 2026 vote
Full regulatory status
| FDA-approved drug? | No FDA-approved drug product contains Emideltide free base or acetate. |
|---|---|
| Indication FDA reviewed | Opioid withdrawal, chronic insomnia and narcolepsy |
| PCAC recommendation | Not recommended |
| FDA reviewers' position | Do not add to the 503A Bulks List. |
| Category 2 status | Previously in FDA's interim Category 2 (significant safety risk). Moved to the “nominated but withdrawn” table after the nomination was withdrawn in April 2026. Removal from Category 2 did not authorize compounding and did not move it to Category 1. |
| 503A Bulks List today | Not on the 503A Bulks List. The negative vote did not impose a new prohibition — the substance already lacked final-list status. |
| 503B status | Not on the final 503B Bulks List, and not in FDA's published interim 503B categories. |
| Prescription status | No FDA-approved US status. Not an approved prescription or OTC drug. “Research use only” is a seller label, not authorization to administer to patients. |
| Next federal event | No substance-specific federal event announced. An unfavorable recommendation makes favorable rulemaking less likely but does not legally bind FDA's final decision. |
If you compete in sport
No substance-specific WADA or USADA determination was found.
We could not find a substance-specific ruling. Treat this as unknown, not as permission, and check with your governing body before use.
Why FDA's own reviewers recommended against it
- Inadequate characterization and inconsistent naming
- Insufficient impurity, aggregate and endotoxin testing
- Inadequate solubility and formulation information
- Immunogenicity concerns
- No adequate toxicology program
- Small, preliminary, inconsistent or inadequately controlled efficacy studies
- No persuasive evidence for subcutaneous administration
- Reported headache, nausea, vertigo and progressive hypotension
- Theoretical concern involving opioid-system stimulation
What you can actually do today
You can seek licensed care for opioid withdrawal, insomnia or narcolepsy and discuss approved options. Emideltide is not FDA-approved for any of them.
What would have to happen for this to change
- 1FDA completes its own evaluation. The advisory vote is non-binding — FDA can accept or reject it.
- 2FDA publishes a proposed rule in the Federal Register identifying substances proposed for inclusion or exclusion, with its reasoning.
- 3A public comment period opens. Anyone may submit evidence and scientific or legal objections.
- 4FDA reviews the comments and the administrative record.
- 5FDA publishes a final rule, or withdraws or modifies the proposal.
- 6The final rule takes effect and amends the list at 21 CFR 216.23.
Sources
See the status of all seven peptides side by side in the FDA 503A compounding tracker.
Medical Disclaimer: This content is for informational purposes only and should not be considered medical advice. Always consult with a qualified healthcare provider before beginning any peptide therapy treatment.