Mitochondria-targeted tetrapeptide, described in FDA labelling as a mitochondrial cardiolipin binder
Elamipretide — evidence
What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.
Evidence overview
No evidence records in this file yet.
What we know
Editorial reading of the records below, labelled as Therapept analysis. How records are built
What remains uncertain
Regulatory notes
FDA-approved drug substance
- FORZINITY (elamipretide hydrochloride), NDA 215244, approved 19 September 2025 as a new molecular entity under priority review.
- The indication is approved under accelerated approval based on improvement in knee extensor muscle strength, an intermediate clinical endpoint.
- Not named on the WADA 2026 Prohibited List.
Regulatory status describes how a substance is classified. It is not a safety assessment of any particular material.
No records in this file match the current filter. That is an empty result, not a finding about the compound.
Last reviewed 15 September 2026 · Compiled by Therapept Editorial · How these records are built