For Barth syndrome weighing at least 30 kg. NDA 215244, held by Stealth Biotheraps. Elamipretide Hydrochloride.
As of Nov 13, 2026, NDA 215244 (Forzinity), held by Stealth Biotheraps, was first approved by FDA on Sep 19, 2025, with 0 approved supplements and 1 published complete response letter.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 19, 2025 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| May 15, 2025 | ElamipretideDeficiencies, Path Forward, Facility Inspections | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ForzinityEQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) · solution;subcutaneous | Elamipretide Hydrochloride | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
