Published in FDA’s meeting briefing packet.
MOTS-c: committee recommended inclusion. FDA final is still pending.
The advisory committee recommended inclusion for MOTS-c free base / MOTS-c acetate. The two form-specific votes are advisory and non-binding; FDA's final determination remains pending.
- Staff · against inclusion
- Committee · Recommend inclusion
- Final FDA action · pending
Three stages. The first two are complete.
This tracker separates the stages that headlines often collapse together.
MOTS-c (free base): Yes 7, No 5, Abstain 2. MOTS-c acetate: Yes 7, No 5, Abstain 2. Advisory and non-binding.
FDA says it will consider committee input and complete its review.
FDA staff says the evaluation criteria weigh against placing MOTS-c free base or MOTS-c acetate on the 503A Bulks List.
FDA says neither form is a component of an FDA-approved drug. The briefing also flags inconsistent naming and uncertainty about substance identity.
- Obesity
- Osteoporosis
The meeting agenda lists obesity and osteoporosis. FDA’s briefing says the nomination did not contain enough information for the agency to evaluate proposed uses and that FDA did not identify clinical studies evaluating them.
What this committee recommendation does not change
The committee recommended 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 MOTS-c (free base) be placed on the list?
Should MOTS-c 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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