Quick answers
- What is Elamipretide hydrochloride used for?
- The FDA-approved label (Forzinity, Stealth Biotherapeutics Inc., December 10, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Elamipretide hydrochloride have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Elamipretide hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Elamipretide hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Elamipretide hydrochloride?
- 1 company lists prescription products of Elamipretide hydrochloride in the FDA NDC Directory, including Stealth Biotherapeutics Inc..
What Elamipretide hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved 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 […]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. …
— FDA label: Forzinity, Stealth Biotherapeutics Inc., effective December 10, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Forzinity |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Stealth Biotherapeutics Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA215244 FORZINITY | Stealth Biotheraps | September 19, 2025 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2725604, 2725610 |
|---|---|
| SPL set ID of the quoted label | 146bf34c-76f2-48db-ac07-fb29cce2cd75 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA215244 |
| Active ingredients (FDA) | ELAMIPRETIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Forzinity, Stealth Biotherapeutics Inc., effective December 10, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →