Medicine and research reference
SS-31 (Elamipretide)
Elamipretide’s specific U.S. Barth syndrome approval, the evidence supporting it, and limits on broader claims.
Source and review status
Published sources checked
Sources checked on: 6 September 2026
Qualified clinical review: Pending. This page has not been clinically reviewed.
About this source check
AI-assisted editorial source checking covers the cited material and its stated limits. It is not a systematic review, verification of a supplied product, or clinical sign-off.
Editorial role: InfoAddict. Last material change: 6 September 2026. Next source review: 6 December 2026.
Identity and approved product
SS-31 is a development name for elamipretide. FDA approved Forzinity, an elamipretide medicine, on 19 September 2025 to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg.
Sources: Thompson and colleagues, Genetics in Medicine; PubMed Central, U.S. Food and Drug Administration
Why the evidence needs context
The supporting programme began with 12 participants at one U.S. site. The randomised phase did not show superiority on the primary walking and fatigue outcomes. Muscle-strength improvement was observed during the longer open-label extension. FDA used accelerated approval, with further confirmation of clinical benefit required. This small, specific disease population does not establish healthy-ageing or athletic benefits.
Sources: U.S. Food and Drug Administration
Safety and identity limits
FDA describes local reactions and potentially serious allergic reactions. The authorised product and indication are the relevant clinical context. A vial sold simply as SS-31 does not inherit Forzinity’s identity, manufacturing assurance or approval.
Sources: U.S. Food and Drug Administration
Published sources
- A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism
Thompson and colleagues, Genetics in Medicine; PubMed Central. Published 2021; accessed 6 September 2026.
Supports: SS-31/elamipretide identity and Barth syndrome research context.
- Drug Trials Snapshots: Forzinity
U.S. Food and Drug Administration. Original approval 19 September 2025; accessed 6 September 2026.
Supports: U.S. accelerated approval for Barth syndrome, restricted population, trial limitations and adverse reactions.
Change history
| Date | Change | Clinical-review status |
|---|---|---|
| 6 September 2026 | Source-linked reference published | Pending |
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