What happened to DSIP at the FDA peptide meeting?

Emideltide, commonly called DSIP, was the only one of the seven reviewed peptides the committee did not recommend. The vote was 6 in favor, 7 against, and 1 abstention for both the free-base and acetate forms.

What FDA reviewed

Emideltide — delta sleep-inducing peptide — was reviewed in the context of opioid withdrawal, chronic insomnia, and narcolepsy. FDA described the insomnia research as inconclusive and preliminary, with weaknesses in study design.

What the negative vote means

A negative vote does not prove the peptide has no biological effect. It means the current case was not strong enough to earn a positive recommendation for the 503A list, and the meeting created no new compounding pathway for it.

Medically reviewed by Dr. Michael Mimlitz, MD (NPI 1508891870), Chief Physician of GOAL.MD. Physician-supervised telehealth. More at goal.md/answers.