For Barth syndrome weighing at least 30 kg. Sold as Forzinity. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Elamipretide Hydrochloride (sold as Forzinity), first approved Sep 19, 2025, with 0 new uses approved and 1 published complete response letter.
| Clinical Trial in Patients With Barth Syndrome- 4TAZPowerBarth Syndrome · Stealth BioTherapeutics Inc. | Phase 4 | Recruiting | Apr 15, 2026 |
| ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)Age Related Macular Degeneration (ARMD) · Stealth BioTherapeutics Inc. | Phase 3 | Active, not recruiting | Apr 18, 2024 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Sep 19, 2025 | ForzinityNDA 215244 · New molecular entity | Stealth Biotheraps | 0 | Marketed |
| Letter | Product | Now |
|---|---|---|
| May 15, 2025 | ElamipretideDeficiencies, Path Forward, Facility Inspections | Unapproved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
