Mavacamten

Overview

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US	2025/08/06	NCT07107373	N/A	Active, not recruiting	Bristol-Myers Squibb
The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction	2025/08/05	NCT07103655	Not Applicable	Not yet recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University
A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)	2025/06/04	NCT07004972	Phase 4	Not yet recruiting	Bristol-Myers Squibb
Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy	2025/04/27	NCT06947590	Not Applicable	Active, not recruiting	Xu Liu
Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy	2025/03/04	NCT06856265	Not Applicable	Not yet recruiting	Shanghai Chest Hospital
Real-world Patient Reported Outcomes Among Patients Treated With Camzyos	2024/08/13	NCT06551129	N/A	Recruiting	Bristol-Myers Squibb
A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada	2024/08/12	NCT06549608	N/A	Active, not recruiting	Bristol-Myers Squibb
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)	2024/04/18	NCT06372457	N/A	Active, not recruiting	Bristol-Myers Squibb
Real-World Effectiveness of Mavacamten in Canada	2024/03/29	NCT06338202	N/A	Not yet recruiting	Bristol-Myers Squibb
A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy	2024/02/12	NCT06253221	Phase 3	Active, not recruiting	Bristol-Myers Squibb

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Camzyos	Bristol-Myers Squibb Pharma EEIG,Plaza 254,Blanchardstown Corporate Park 2,Dublin 15,D15 T867,Ireland	Authorised	6/26/2023

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
CAMZYOS CAPSULES 15MG	Patheon Inc., AndersonBrecon Inc. (Primary packager and secondary packager)	SIN16807P	CAPSULE	15.0mg	6/14/2023
CAMZYOS CAPSULES 10MG	Patheon Inc., AndersonBrecon Inc. (Primary packager and secondary packager)	SIN16806P	CAPSULE	10.0mg	6/14/2023
CAMZYOS CAPSULES 5MG	Patheon Inc., AndersonBrecon Inc. (Primary packager and secondary packager)	SIN16805P	CAPSULE	5mg	6/14/2023
CAMZYOS CAPSULES 2.5MG	Patheon Inc., AndersonBrecon Inc. (Primary packager and secondary packager)	SIN16804P	CAPSULE	2.5MG	6/14/2023

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CAMZYOS mavacamten 2.5 mg capsule blister pack	386129	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	9/19/2022
CAMZYOS mavacamten 10 mg capsule blister pack	386127	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	9/19/2022
CAMZYOS mavacamten 15 mg capsule blister pack	373115	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	9/19/2022
CAMZYOS mavacamten 5 mg capsule blister pack	386128	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	9/19/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CAMZYOS	bristol-myers squibb canada	02532565	Capsule - Oral	10 MG	6/13/2023
CAMZYOS	bristol-myers squibb canada	02532573	Capsule - Oral	15 MG	8/8/2023
CAMZYOS	bristol-myers squibb canada	02532549	Capsule - Oral	2.5 MG	1/9/2023
CAMZYOS	bristol-myers squibb canada	02532557	Capsule - Oral	5 MG	1/9/2023

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
CAMZYOS 10 MG CAPSULAS DURAS	Bristol-Myers Squibb Pharma Eeig	1231716006	CÁPSULA DURA	Diagnóstico Hospitalario	Commercialized
CAMZYOS 15 MG CAPSULAS DURAS	Bristol-Myers Squibb Pharma Eeig	1231716008	CÁPSULA DURA	Diagnóstico Hospitalario	Commercialized
CAMZYOS 5 MG CAPSULAS DURAS	Bristol-Myers Squibb Pharma Eeig	1231716004	CÁPSULA DURA	Diagnóstico Hospitalario	Commercialized
CAMZYOS 2,5 MG CAPSULAS DURAS	Bristol-Myers Squibb Pharma Eeig	1231716002	CÁPSULA DURA	Diagnóstico Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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