CAMZYOS (mavacamten)
Camzyos treats adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are classified as NYHA class II-III. This medication helps patients with this condition by improving their functional capacity and reducing their physical symptoms. It is used to manage the specific cardiac limitations caused by the disease to help patients feel and function better in their daily lives.
How CAMZYOS Works
This medication works by selectively inhibiting cardiac myosin to reduce the number of myosin heads that can form force-producing connections with actin. By shifting the myosin population into an energy-sparing, relaxed state, it reduces obstruction in the heart's outflow tract and improves cardiac filling pressures.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-04-28
- Patent Cliff
- 2036
- Revenue
- $353M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
CAMZYOS Approval History
What CAMZYOS Treats
1 indicationsCAMZYOS is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertrophic Cardiomyopathy
CAMZYOS Boxed 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....
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 )
CAMZYOS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07004972 | CV027-1146 2025/07/091820 | Ph 4 | active not recruiting | A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER) |
| NCT03723655 | CV027-003 | Ph 2, Ph 3 | completed | A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM |
| NCT05414175 HORIZON-HCM results posted | CV027-004 | Ph 3 | completed | A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy |
| NCT07103655 BRAVE-HCM | 2025-1056 | Ph 4 | not yet recruiting | The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction |
| NCT06253221 | CV027-010 2023-505650-17-00, U1111-1290-1175 | Ph 3 | active not recruiting | A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy |
| NCT05582395 ODYSSEY-HCM | CV027-031 U1111-1269-8581, 2023-506352-24 | Ph 3 | completed | A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy |
| NCT06112743 MEMENTO | CV027-1088 | Ph 4 | active not recruiting | A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy |
| NCT04349072 VALOR-HCM results posted | CV027-006 | Ph 3 | completed | A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy |
| NCT04766892 EMBARK-HFpEF results posted | CV027-005 | Ph 2 | completed | A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT |
| NCT03496168 PIONEER-OLE results posted | CV027-008 | Ph 2 | completed | Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER |
| NCT05174416 results posted | LB2001-301 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM |
| NCT05135871 results posted | LB2001-101 | Ph 1 | completed | Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects |
| NCT05719805 | CV027-1090 | Ph 1 | completed | A Study to Evaluate the Effects of Mavacamten in Healthy Participants |
| NCT05362045 | CV027-070 | Ph 1 | completed | A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants |
| NCT05320094 | CV027-043 | Ph 1 | completed | A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants |
| NCT03442764 MAVERICK-HCM results posted | MYK-461-006 | Ph 2 | completed | A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) |
| NCT03470545 EXPLORER-HCM results posted | MYK-461-005 | Ph 3 | completed | Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CAMZYOS FDA Label Details
Indications & Usage
FDA Label (PDF)CAMZYOS is indicated for the treatment of Hypertrophic Cardiomyopathy.
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 i...
CAMZYOS Patents & Exclusivity
Exclusivity
Pro Intelligence Preview
Deep insights for CAMZYOS
Revenue Insights
- • Q4-2025: $353M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 32 active patents
Trial Analysis
- • 17 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment