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Mavacamten FDA Approval Status

FDA Approved: No
Generic name: mavacamten
Company: Bristol-Myers Squibb Company
Treatment for: Hypertrophic Cardiomyopathy

Mavacamten is a first-in-class, oral, allosteric modulator of cardiac myosin in development for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Development Timeline for mavacamten

DateArticle
Mar 19, 2021U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Aug 29, 2020MyoKardia Presents Results from Phase 3 EXPLORER-HCM Clinical Trial of Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Jul 23, 2020MyoKardia Announces Receipt of Breakthrough Therapy Designation from FDA for Mavacamten for the Treatment of Symptomatic, Obstructive Hypertrophic Cardiomyopathy
Nov 11, 2019MyoKardia Announces 48-week Data from PIONEER-OLE Study of Mavacamten
Nov 11, 2019MyoKardia Announces Positive Topline Data from its Phase 2 MAVERICK-HCM Clinical Trial of Mavacamten

Further information

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