Published in FDA’s meeting briefing packet.
Emideltide / DSIP: committee recommended against inclusion. FDA final is still pending.
The advisory committee recommended against inclusion for Emideltide free base / emideltide acetate. The two form-specific votes are advisory and non-binding; FDA's final determination remains pending.
- Staff · against inclusion
- Committee · Recommend against
- Final FDA action · pending
Three stages. The first two are complete.
This tracker separates the stages that headlines often collapse together.
Emideltide (free base): Yes 6, No 7, Abstain 1. Emideltide acetate: Yes 6, No 7, Abstain 1. Advisory and non-binding.
FDA says it will consider committee input and complete its review.
FDA staff says the evaluation criteria weigh against placing emideltide free base or emideltide acetate on the 503A Bulks List.
FDA says neither form is a component of an FDA-approved drug. The briefing identifies inconsistent naming and uncertainty about which substance a reference standard describes as characterization concerns.
- Opioid withdrawal
- Chronic insomnia
- Narcolepsy
The agenda uses the formal name emideltide and notes that it is also referred to as delta sleep-inducing peptide, or DSIP.
What this committee recommendation does not change
The committee recommended against inclusion for both forms.
The forms were separate questions and received separate tallies. This is advisory committee input, not FDA approval, final list placement, or FDA's final determination.
Should Emideltide (free base) be placed on the list?
Should Emideltide acetate be placed on the list?
Primary verification: July 25, 2026. Independent verification: Claude, July 25, 2026. FDA final action remains pending.
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