A mitochondria-targeted tetrapeptide that received accelerated approval for Barth syndrome in 2025.
Key takeaway
Elamipretide binds cardiolipin in the inner mitochondrial membrane and is designed to support mitochondrial structure and function.
At a glance
| FDA status | In an FDA-approved drug |
|---|---|
| 503A compounding | Eligible for 503A compounding (component of an approved drug) |
| Body areas | Cellular energy & aging, Muscle, joints & recovery |
| Through ScriptMates | Prescribable by licensed providers |
| Open questions | 1 noted below |
What is Elamipretide (SS-31)?
Elamipretide binds cardiolipin in the inner mitochondrial membrane and is designed to support mitochondrial structure and function.
FDA granted it accelerated approval as Forzinity on September 19, 2025, to improve muscle strength in people with Barth syndrome who weigh at least 30 kg. Continued approval depends on a confirmatory trial.
Dosage forms
FDA-approved Forzinity is a solution for subcutaneous injection, supplied in single-patient-use vials. Compounded preparations are not FDA-approved.
Is Elamipretide (SS-31) FDA-approved?
Active ingredient of Forzinity, approved under accelerated approval (NDA 215244). Compounded elamipretide is not itself FDA-approved.
Can it be prescribed through ScriptMates?
Eligible for 503A compounding (component of an approved drug). A 503A partner pharmacy lists this peptide, and it has a lawful 503A compounding pathway.
What we could not confirm
- Forzinity’s approval is accelerated and could be withdrawn if the confirmatory trial fails. 503A limits on compounding essentially copies of an approved drug also apply.
Sources
- Drugs@FDA: Forzinity (elamipretide)
- FDA: Accelerated approval of the first treatment for Barth syndrome
Checked October 27, 2026. FDA updates these pages, so confirm before relying on them.