FDA-approved product exists

Elamipretide

Also known as: SS-31, MTP-131

FDA-approved

Elamipretide has FDA-approved prescription products (FORZINITY (NDA215244)). Elamipretide is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 21 registered ClinicalTrials.gov studies cite Elamipretide (14 completed, 3 terminated, 2 recruiting, 1 active not recruiting, 1 available); registration is not evidence of approval, efficacy, or safety. CompoundedGuide is verifying compounding status, safety signals, and current evidence. This is not medical advice.

What we've verified

Product status: FDA-approved: FORZINITY (NDA215244)
Still checking: Compounding status, shortage status, safety signals

Verified sources

openFDA Drugs@FDA P0 · retrieved 2026-07-25
503B Bulks List and Interim Categories P0 · retrieved 2026-07-25
ClinicalTrials.gov API v2 P0 · retrieved 2026-07-25

Research and evidence

FDA-approved product exists cite Elamipretide. Registration is not evidence of approval, efficacy, or safety.

Browse every trial and publication for Elamipretide →

For developers

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