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Elamipretide FDA Approval Status

FDA Approved: No
Generic name: elamipretide
Company: Stealth BioTherapeutics Inc.
Treatment for: Barth Syndrome

Elamipretide is a novel mitochondrial tetrapeptide in development for the treatment of Barth syndrome.

Development timeline for elamipretide

DateArticle
Oct 11, 2024Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the Treatment of Barth Syndrome
Apr  8, 2024Stealth Biotherapeutics Announces FDA Acceptance of New Drug Application for Elamipretide for the Treatment of Barth Syndrome
Aug 24, 2021Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome
Dec 13, 2018Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Dry Age-Related Macular Degeneration with Geographic Atrophy
Dec 18, 2017Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Leber’s Hereditary Optic Neuropathy
Jul 19, 2017Stealth BioTherapeutics Initiates Phase 2/3 Study of Elamipretide in Patients with Barth Syndrome

Further information

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