Mavacamten
- Generic Name
- Mavacamten
- Brand Names
- Camzyos
- Drug Type
- Small Molecule
- Chemical Formula
- C15H19N3O2
- CAS Number
- 1642288-47-8
- Unique Ingredient Identifier
- QX45B99R3J
- Background
Mavacamten is a myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM). It received initial US FDA approval in 2022, and it is one of the first myosin inhibitors to be used in humans. Mavacamten was also approved by Health Canada in October 2022 and by EMA in July 2023 for the same indication.
- Indication
Mavacamten is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms by the FDA, Health Canada, and the EMA.
- Associated Conditions
- Symptomatic Obstructive Hypertrophic Cardiomyopathy
A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Interventions
- First Posted Date
- 2021-02-23
- Last Posted Date
- 2025-03-20
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 30
- Registration Number
- NCT04766892
- Locations
- 🇺🇸
Local Institution - 0014, Miami, Florida, United States
🇺🇸Local Institution - 0011, Tucson, Arizona, United States
🇺🇸Local Institution - 0005, Los Angeles, California, United States
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
- Conditions
- HOCM, Hypertrophic Obstructive Cardiomyopathy
- Interventions
- Drug: Placebo
- First Posted Date
- 2020-04-16
- Last Posted Date
- 2024-07-11
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 112
- Registration Number
- NCT04349072
- Locations
- 🇺🇸
Local Institution, Houston, Texas, United States
🇺🇸Local Institution - 0015, Rochester, Minnesota, United States
🇺🇸Local Institution - 0002, Portland, Oregon, United States
A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
- Conditions
- Obstructive Hypertrophic CardiomyopathyNon-obstructive Hypertrophic CardiomyopathyHypertrophic Cardiomyopathy
- Interventions
- First Posted Date
- 2018-10-29
- Last Posted Date
- 2024-03-06
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 282
- Registration Number
- NCT03723655
- Locations
- 🇮🇱
Local Institution - 0023, Safed, Israel
🇵🇹Local Institution - 0036, Almada, Portugal
🇮🇱Local Institution - 0022, Ramat-gan, Israel
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
- First Posted Date
- 2018-04-12
- Last Posted Date
- 2025-01-09
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 13
- Registration Number
- NCT03496168
- Locations
- 🇺🇸
Local Institution - 0003, Scottsdale, Arizona, United States
🇺🇸Local Institution - 0001, New Haven, Connecticut, United States
🇺🇸Local Institution - 0004, Durham, North Carolina, United States
Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Interventions
- Drug: Placebo
- First Posted Date
- 2018-03-20
- Last Posted Date
- 2021-10-04
- Lead Sponsor
- MyoKardia, Inc.
- Target Recruit Count
- 251
- Registration Number
- NCT03470545
- Locations
- 🇺🇸
Cedars-Sinai Medical Center (Smidt Heart Institute), Los Angeles, California, United States
🇺🇸Northwestern University, Chicago, Illinois, United States
🇺🇸Houston Methodist Hospital, Houston, Texas, United States
A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)
- Conditions
- Non-obstructive Hypertrophic Cardiomyopathy
- Interventions
- Drug: Placebo
- First Posted Date
- 2018-02-22
- Last Posted Date
- 2022-08-09
- Lead Sponsor
- MyoKardia, Inc.
- Target Recruit Count
- 59
- Registration Number
- NCT03442764
- Locations
- 🇺🇸
The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States
🇺🇸UPMC Presbyterian, Pittsburgh, Pennsylvania, United States
🇺🇸University of Washington Medical Center, Seattle, Washington, United States
A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
- Conditions
- Left Ventricular Outflow Tract ObstructionCardiomyopathy, Hypertrophic Obstructive
- Interventions
- First Posted Date
- 2016-07-22
- Last Posted Date
- 2021-06-08
- Lead Sponsor
- MyoKardia, Inc.
- Target Recruit Count
- 21
- Registration Number
- NCT02842242
- Locations
- 🇺🇸
Mayo Clinic Arizona, Scottsdale, Arizona, United States
🇺🇸Yale New Haven Hospital, New Haven, Connecticut, United States
🇺🇸Oregon Health and Science University, Portland, Oregon, United States
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy Volunteers
- First Posted Date
- 2015-06-24
- Last Posted Date
- 2017-03-22
- Lead Sponsor
- MyoKardia, Inc.
- Target Recruit Count
- 60
- Registration Number
- NCT02480296
- Locations
- 🇦🇺
Nucleus Network, Melbourne, Victoria, Australia
Single Ascending Dose Study of MYK-461 in Healthy Volunteers
- First Posted Date
- 2015-02-05
- Last Posted Date
- 2015-09-23
- Lead Sponsor
- MyoKardia, Inc.
- Target Recruit Count
- 48
- Registration Number
- NCT02356289
- Locations
- 🇬🇧
Quintles LTD, London, United Kingdom
Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461
- First Posted Date
- 2014-12-31
- Last Posted Date
- 2016-09-14
- Lead Sponsor
- MyoKardia, Inc.
- Target Recruit Count
- 15
- Registration Number
- NCT02329184
Drug Development Updates
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