Forzinity FDA Approval History

FDA Approved: Yes (First approved September 19, 2025)
Brand name: Forzinity
Generic name: elamipretide hydrochloride
Dosage form: Injection
Company: Stealth BioTherapeutics Inc.
Treatment for: Barth Syndrome

Forzinity (elamipretide hydrochloride) is a mitochondrial cardiolipin binder for the treatment of Barth syndrome.

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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Development timeline for Forzinity

Date	Article
Sep 19, 2025	Approval FDA Grants Accelerated Approval to Forzinity (elamipretide hydrochloride) for the Treatment of Barth Syndrome
Aug 21, 2025	Stealth Biotherapeutics Announces FDA Acceptance of Elamipretide NDA Resubmission
Aug 18, 2025	Stealth Biotherapeutics Resubmits New Drug Application for Elamipretide for the Treatment of Barth Syndrome
May 29, 2025	Stealth BioTherapeutics Announces “Path Forward” Despite Disappointing Delay for Ultra-Rare Barth Syndrome
Apr 29, 2025	Stealth BioTherapeutics Announces Delay in FDA Action Date for Barth Syndrome Application for Elamipretide
Jan 23, 2025	Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome
Oct 11, 2024	Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the Treatment of Barth Syndrome
Apr 8, 2024	Stealth Biotherapeutics Announces FDA Acceptance of New Drug Application for Elamipretide for the Treatment of Barth Syndrome
Aug 24, 2021	Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome
Dec 13, 2018	Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Dry Age-Related Macular Degeneration with Geographic Atrophy
Dec 18, 2017	Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Leber’s Hereditary Optic Neuropathy
Jul 19, 2017	Stealth BioTherapeutics Initiates Phase 2/3 Study of Elamipretide in Patients with Barth Syndrome

Further information

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