SS-31
Elamipretide
In 2025 elamipretide received accelerated US approval as FORZINITY to improve muscle strength in patients with Barth syndrome weighing at least 30 kg.
Approvals
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Research areas
Evidence matrix
- Molecular identity
- Confirmed
SS-31 is elamipretide; the US authorization applies only to the defined medicine FORZINITY and does not validate other products sold as “SS-31”.
- Human research
- Limited
- Replication
- Single research group
- Clinical endpoints
- Surrogate measures
- Safety
- Characterized by prescribing information or extensive studies
- Approval
- US · Approved
The dimensions are presented separately and are not combined into an overall score.
What the source shows
The original randomized primary endpoints were not superior to placebo. Accelerated approval is based on improved knee-extensor muscle strength observed in the open-label extension as an intermediate clinical endpoint in very few patients.
- FORZINITY (elamipretide) US prescribing informationPrescribing information2025
U.S. Food and Drug Administration; Stealth BioTherapeutics Inc.
Accessed:
Research gaps
- ·Confirmatory clinical benefit is required. There is no general anti-aging authorization and no EU authorization established here.
- ·Short profile: not a complete benefit–risk assessment. Unlisted contraindications and interactions are not adequately established in this profile; missing information does not establish safety.
Mechanism
Elamipretide binds mitochondrial cardiolipin; the authorization applies only to the narrowly defined Barth syndrome setting.
- FORZINITY (elamipretide) US prescribing informationPrescribing information2025
U.S. Food and Drug Administration; Stealth BioTherapeutics Inc.
Accessed:
Study protocols
No sufficiently supported, exactly citable study protocols are available.
Calculator
Arithmetic based only on your entries. Not a dose or use recommendation.
Reported adverse effects
- ·Injection-site reactions were very common in the small development program. The label warns about serious hypersensitivity and benzyl-alcohol toxicity in neonates; this applies to FORZINITY, not other SS-31 products.
Contraindications and warnings
- ·Contraindicated in patients with serious hypersensitivity to elamipretide or any FORZINITY ingredient.
Interactions
No reviewed information on this point has been recorded here yet. This does not mean there are no risks or contraindications.
Research gaps
- ·Confirmatory clinical benefit is required. There is no general anti-aging authorization and no EU authorization established here.
- ·Short profile: not a complete benefit–risk assessment. Unlisted contraindications and interactions are not adequately established in this profile; missing information does not establish safety.
- FORZINITY (elamipretide) US prescribing informationPrescribing information2025
U.S. Food and Drug Administration; Stealth BioTherapeutics Inc.
Accessed:
- FDA grants accelerated approval to first treatment for Barth syndromeRegulatory source2025
U.S. Food and Drug Administration
Accessed:
Sources
Sources checked: · Version 3
- FORZINITY (elamipretide) US prescribing informationPrescribing information2025
U.S. Food and Drug Administration; Stealth BioTherapeutics Inc.
Accessed:
- FDA grants accelerated approval to first treatment for Barth syndromeRegulatory source2025
U.S. Food and Drug Administration
Accessed: