Mitochondria-targeted tetrapeptide, described in FDA labelling as a mitochondrial cardiolipin binder
Elamipretide
An approved mitochondria-targeted tetrapeptide, marketed as FORZINITY for Barth syndrome under FDA's accelerated approval pathway.
Why people are interested in Elamipretide
An approved mitochondria-targeted tetrapeptide, marketed as FORZINITY for Barth syndrome under FDA's accelerated approval pathway.
- Mitochondria-targeted peptides— a research-category classification, not a claimed use
- Approved drug substances— a research-category classification, not a claimed use
Where the interest comes from differs by compound: published research, an approved use, clinical discussion, community discussion and vendor claims are different things. This page keeps them apart — the sections below say which kind of source supports each statement.
Quick facts
- Molecular weight
- 639.8 g/mol as the free base (PubChem); 749.2 as the trihydrochloride (FDA label)
- Sequence length
- 34 chars
- CAS number
- 736992-21-5
- PubChem CID
- 11764719
0 evidence records indexed · 0 clinical trials · last reviewed 15 September 2026
Research at a glance
No evidence records in this file yet.
What has actually been studied
What is still unknown
What we know
Editorial reading of the records below, labelled as Therapept analysis. How records are built
What remains uncertain
Preparation and handling
Lyophilized peptides ship as powders; whatever happens next involves diluents, concentrations and storage conditions that are compound- and product-specific. Therapept’s preparation guides explain the vocabulary and the arithmetic; the product’s own documentation states its requirements.
United States regulatory status
FDA-approved drug substance
NDA 215244 (FORZINITY)
Marketed in the United States as FORZINITY, approved under accelerated approval to improve muscle strength in adult and paediatric patients with Barth syndrome above a label-specified body weight. Continued approval may be contingent on verification of clinical benefit in a confirmatory trial.
- 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, and it says nothing about the quality of any particular material.
Technical identity
- Compound class
- Mitochondria-targeted tetrapeptide, described in FDA labelling as a mitochondrial cardiolipin binder
- Sequence
- D-Arg-2,6-dimethyl-Tyr-Lys-Phe-NH2
- Molecular formula
- C32H49N9O5
- Molecular weight
- 639.8 g/mol as the free base (PubChem); 749.2 as the trihydrochloride (FDA label)
- CAS number
- 736992-21-5
- PubChem CID
- 11764719
- Research categories
- Mitochondria-targeted peptides, Approved drug substances
Sources
Last reviewed 15 September 2026 · Compiled by Therapept Editorial · How these records are built