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Camzyos (MAVACAMTEN)
Mavacamten selectively inhibits cardiac myosin, reducing force-producing cross-bridge formation and improving cardiac function in HCM.
Camzyos (MAVACAMTEN) is a small molecule developed by Myokardia Inc and currently owned by Bristol, targeting Myosin-7 to treat obstructive hypertrophic cardiomyopathy (HCM). It was FDA-approved in 2022 and is a patented medication with no generic manufacturers available. Camzyos works by inhibiting the Myosin-7 protein, which plays a key role in the thickening of heart muscle cells. This leads to reduced obstruction of blood flow in the heart, alleviating symptoms of HCM. Key safety considerations include the need for regular monitoring of heart function and potential side effects such as headache and fatigue.
At a glance
| Generic name | MAVACAMTEN |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Cardiac Myosin Inhibitor [EPC] |
| Target | cardiac myosin |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2022 |
| Annual revenue | 600 |
Mechanism of action
Mavacamten works by selectively inhibiting cardiac myosin, which helps to reduce the number of myosin heads that can form force-producing cross-bridges with actin. This leads to a decrease in both systolic and diastolic cross-bridge formation, which is beneficial in hypertrophic cardiomyopathy (HCM) by reducing left ventricular outflow tract (LVOT) obstruction and improving cardiac filling pressures.
Approved indications
- Obstructive hypertrophic cardiomyopathy (HCM)
Boxed warnings
- WARNING: RISK OF HEART FAILURE CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction [see Warnings and Precautions (5.1) ] . Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ] . Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following [see Contraindications (4) and Warnings and Precautions (5.2) ] : • Strong CYP2C19 inhibitors • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called CAMZYOS REMS PROGRAM [see Warnings and Precautions (5.3) ]. WARNING: RISK OF HEART FAILURE See full prescribing information for complete boxed warning. • CAMZYOS can cause heart failure due to systolic dysfunction. ( 5.1 ) • Echocardiogram assessments of left ventricular ejection fraction (LVEF) required before and during CAMZYOS use. ( 2.1 ) • Initiation in patients with LVEF <55% not recommended. Interrupt if LVEF <50% or if worsening clinical status. ( 2.1 , 5.1 ) • Certain CYP450 inhibitors and inducers are contraindicated in patients taking CAMZYOS because of an increased risk of heart failure. ( 4 , 5.2 , 7 ) • CAMZYOS is available only through a restricted program called the CAMZYOS REMS Program. ( 5.3 )
Common side effects
- Atrial fibrillation
- Cardiac failure
- Echocardiogram abnormal
- Ejection fraction decreased
Key clinical trials
- A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
- ENABLE-HCM - AI-ENabled Echocardiography With Ultrasound Beyond the Echo Lab for Better HCM Imaging and Expanded Access
- A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER) (PHASE4)
- Biological Collection for the Purpose of Exploring Genetic and Clinical-biological Factors Associated With Variability in Response to Mavacamten in the Treatment of Obstructive Hypertrophic Cardiomyopathy
- A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM (PHASE2,PHASE3)
- Precision Pharmacogenetics and Genotype Class Based Prediction of Mavacamten Response in Obstructive Hypertrophic Cardiomyopathy
- Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan
- A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Camzyos CI brief — competitive landscape report
- Camzyos updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI