Elamipretide

Drug profile

Key facts

Elamipretide is an onp drug catalogued in DrugCentral. It was first approved by the FDA in 2025. Recorded indications include Improvement of muscle strength for Barth syndrome.

• Approval status: onp (first approved 2025 by the FDA).
• Indications: Improvement of muscle strength for Barth syndrome.
• Molecular formula: C32H49N9O5; molecular weight 639.80 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (1)

• Improvement of muscle strength for Barth syndrome

Regulatory approvals (1)

Date	Agency	Marketed as	Applicant	Orphan
2025-09-19	FDA	—	Stealth BioTherapeutics	Yes

Chemical structure

Full physicochemical, ADMET and 3D-structure analysis of Elamipretide is on its molecule page.

• Molecular formula: C₃₂H₄₉N₉O₅
• Molecular weight: 639.80 g/mol
• CAS number: —
• InChIKey: SFVLTCAESLKEHH-WKAQUBQDSA-N
• PubChem CID: 11764719

CC1=CC(=CC(=C1C[C@@H](C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC2=CC=CC=C2)C(=O)N)NC(=O)[C@@H](CCCN=C(N)N)N)C)O

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Elamipretide used for?

DrugCentral lists the following indications for Elamipretide: Improvement of muscle strength for Barth syndrome.

When was Elamipretide first approved?

Elamipretide was first approved by the FDA in 2025.

What is the chemical formula of Elamipretide?

Elamipretide has the molecular formula C32H49N9O5 and a molecular weight of 639.80 g/mol.

Sources

• DrugCentral drug card 5806 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL3833370 — compound record and bioactivity
• PubChem CID 11764719 — chemical identifiers
• DrugBank DB11981 — drug record
• FDA UNII 87GWG91S09 — substance identity
• DailyMed: FDA labels for Elamipretide — current prescribing information (label search)

How this page is built: methodology · editorial policy & corrections.