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FDA-approved product exists

Elamipretide

Also called SS-31, MTP-131, Forzinity.

Elamipretide has FDA-approved products for specific uses. This page cites 2 sources, and the strongest evidence comes from human trials.

Status
FDA-approved product exists
Form
Injection
Half-life
Not modeled
Strongest evidence
Human trials
Cited claims
1
Last updated
November 6, 2026

What the evidence says

Each claim names the kind of study behind it, what it can't tell you, and where it comes from.

  1. Human trials

    In the 12-person TAZPOWER crossover trial, elamipretide did not outperform placebo on six-minute walk distance or Barth syndrome fatigue scores during 12-week treatment periods.

    Limits: Later knee-extensor-strength improvements occurred during the uncontrolled extension. These findings in the same small group cannot establish causality or prove benefit in healthy people. FDA granted accelerated approval while requiring confirmation of clinical benefit.

Regulatory status

United States

Forzinity received FDA accelerated approval on September 19, 2025, to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg. It is a subcutaneous injection. Approval relies on knee-extensor strength as an intermediate clinical endpoint; confirmatory clinical benefit remains required.