For clinicians
SS-31 (elamipretide) for prescribers: status, evidence and what FDA has said
A neutral reference. It reports SS-31 (elamipretide)'s regulatory status, the quality of its human evidence and what FDA has said about it. It does not suggest a dose, a protocol or a source.
Status reviewed 2026-07-17 · By the Grey Peptides Editorial Board · Regulatory fields generated from our tracker
| Also known as | — |
| FDA approval | Approved (Forzinity) |
| Compounding (503A) | Rx (FDA-approved as Forzinity) |
| Outsourcing (503B) | No 503B status recorded |
| WADA 2026 List | Not on the 2026 List |
| WADA 2027 List | Not on the 2027 List |
| Evidence grade | High |
| Status reviewed | 2026-07-17 |
What FDA has said
SS-31 (elamipretide) is FDA-approved. The prescribing information is the authority on its dosing, monitoring and contraindications; below is what each label carries in its boxed warning and how its Warnings and Precautions section is organised, read from DailyMed on 2026-10-01.
Forzinity label version 10, effective 2025-12-10
No boxed warning.
Its Warnings and Precautions section is organised under these headings:
- 5.1 Risk of Benzyl Alcohol Toxicity in Neonates
- 5.2 Hypersensitivity
Read the full Forzinity prescribing information on DailyMed
Monitoring: what the literature does and does not say
For an approved drug, the prescribing information is where monitoring is set out — in its Warnings and Precautions section, whose headings are listed above for each label, and in its dosing and specific-populations sections. This page lists those headings so a prescriber can see what the label covers; it does not restate the label, and the label, not this page, is the authority.
Compounding: where it stands
Today's position for SS-31 (elamipretide): Rx (FDA-approved as Forzinity). An FDA advisory committee's vote is a non-binding recommendation; until FDA acts, a vote does not change what may be compounded. Our explainer on the 503A and 503B categories sets out what each status means, and the regulatory tracker is updated as FDA acts.
The evidence
A 4-amino-acid aromatic-cationic peptide (D-Arg-Dmt-Lys-Phe-NH2) that concentrates in the inner mitochondrial membrane (1000-fold over cytosol) by binding cardiolipin, stabilizing mitochondrial cristae architecture and restoring ATP production — FDA-approved in 2025 for Barth syndrome.
The encyclopedia entry lists the human and animal studies we hold, each with its PMID.
What this page leaves out
Doses, regimens and titration. For an approved drug those belong to the prescribing information, linked above; restating them here would create a second, unmaintained copy.
Sources
- Forzinity prescribing information, DailyMed SPL version 10; read 2026-10-01. DailyMed
- Grey Peptides regulatory tracker, row for SS-31 (elamipretide), reviewed 2026-07-17. Tracker · dataset
- World Anti-Doping Agency. Prohibited List 2027, dated August 26, 2026, in force January 1, 2027. WADA
This page is a reference for qualified professionals. It is not medical advice, it does not recommend any treatment, and it is not a substitute for the prescriber's own judgement and their state and federal obligations.
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