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FDA Medication Tracker

← All approvals · Rare & genetic · 2025

Forzinity (elamipretide)

The FDA approved Forzinity (elamipretide) on September 19, 2025 to improve muscle strength in patients with Barth syndrome weighing at least 30 kg.
Brand name
Forzinity
Generic name
elamipretide
FDA approval date
September 19, 2025
Approved use (FDA wording)
To improve muscle strength in patients with Barth syndrome weighing at least 30 kg
Company
Stealth Biotheraps
Application
NDA215244
Dosage form / route
SOLUTION · SUBCUTANEOUS
Boxed warning on label
Not listed
Category on this site
Rare & genetic

Indications and usage, from the FDA label

FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. FORZINITY™ is a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. ( 1 ) This indication is approved under accelerated approval based on an improvement in knee ext…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.