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Drug

Mavacamten

Approved medicine
ClassCardiac myosin inhibitorResearchActive indication expansion

Also known as Camzyos, 6-(((1S)-1-Phenylethyl)amino)-3-(propan-2-yl)-1,2,3,4 tetrahydropyrimidine-2,4-dione.

RxNorm2600867ChEMBLCHEMBL4297517ATCC01EB24UNIIQX45B99R3J
7
Active clinical trials
7
Protein targets
9
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Camzyos gets OK to treat pediatric patients with obstructive HCM

Industry2026-10-01Healio Cardiology

United Therapeutics' legal victory; BMS' Camzyos approved for kids

Regulatory2026-10-01Regulatory news · Endpoints News

Bristol Myers Squibb secures expanded US approval for Camzyos

Regulatory2026-10-01Regulatory news · Pharmaceutical Technology

Indication expansion: MAVACAMTEN (NDA214998)

Regulatory2026-09-30FDA

MEMENTO - A Phase 4, Single-arm, Open-label Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy to Assess the Impact on Myocardial Structure With Cardiac Magnetic Resonance Imaging (CMR)

Clinical trial2026-07-16Primary completion · ClinicalTrials.gov

The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction: A Prospective, Interventional, Real-World Clinical Study.

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in Hypertrophic Obstructive Cardiomyopathy: The PEACH Trial

Clinical trial2026-05-22Results expected Q4 2028 · ClinicalTrials.gov

A Phase 4, Single-Arm, Open-Label Study to Evaluate Safety, Tolerability, and Efficacy of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy in India

Clinical trial2026-04-28Results expected Q4 2027 · ClinicalTrials.gov

Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy: A Randomized Controlled Trial

Clinical trial2026-02-01Primary completion · ClinicalTrials.gov

Indication expansion: MAVACAMTEN (NDA214998)

Regulatory2025-04-17FDA

Label change: MAVACAMTEN (NDA214998)

Regulatory2024-04-30FDA

Supplemental approval: MAVACAMTEN (NDA214998)

Regulatory2023-12-19FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Mavacamten
Aliases & brands
Camzyos6-(((1S)-1-Phenylethyl)amino)-3-(propan-2-yl)-1,2,3,4 tetrahydropyrimidine-2,4-dione
RxNorm CUI
2600867
ChEMBL ID
CHEMBL4297517
ATC codes
C01EB24
UNII
QX45B99R3J
Primary mechanism
Cardiac myosin inhibitor
Regulatory jurisdictions
fdaema

Pharmacology & targets

7 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Myosin-7
MYH7 · P12883
INHIBITORCardiac myosin inhibitor
Myosin-6
MYH6 · P13533
INHIBITORCardiac myosin inhibitor
Myosin-7B
MYH7B · A7E2Y1
INHIBITORCardiac myosin inhibitor
Myosin light chain 3
MYL3 · P08590
INHIBITORCardiac myosin inhibitor
Myosin regulatory light chain 2, ventricular/cardiac muscle isoform
MYL2 · P10916
INHIBITORCardiac myosin inhibitor
Myosin regulatory light chain 2, atrial isoform
MYL7 · Q01449
INHIBITORCardiac myosin inhibitor
Myosin light chain 4
MYL4 · P12829
INHIBITORCardiac myosin inhibitor

Regulatory timeline

9 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2022-04-28 → 2023-12-19)
Earliest approval
2022-04-28
Latest approval
2026-09-30
Authorities
FDA · EMA
Total events
9
fdaU.S. Food and Drug Administration· 8 events
2026-09-30Indication expansion
Indication expansion: MAVACAMTEN (NDA214998)
Evidence ↗
2025-04-17Indication expansion
Indication expansion: MAVACAMTEN (NDA214998)
Evidence ↗
2024-04-30Label change
Label change: MAVACAMTEN (NDA214998)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2023-06-26Original application approvalMulti-authority
Marketing authorisation: Camzyos (EMA)

Indication: Treatment of symptomatic obstructive hypertrophic cardiomyopathy.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

20 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
20
registered trials across all phases
LATEST COMPLETION 2026
7
Active studies
3
Recruiting
13
Late-stage (III+)
13
Completed
PHASE DISTRIBUTIONn = 20
Phase 14Phase 23Phase 2 / 31Phase 36Phase 43Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 4, Single-Arm, Open-Label Study to Evaluate Safety, Tolerability, and Efficacy of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy in India

Active, not recruitingPH IVBristol-Myers Squibbn=502027

MEMENTO - A Phase 4, Single-arm, Open-label Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy to Assess the Impact on Myocardial Structure With Cardiac Magnetic Resonance Imaging (CMR)

Active, not recruitingPH IVBristol-Myers Squibbn=632027

The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction: A Prospective, Interventional, Real-World Clinical Study.

Not yet recruitingPH IVSecond Affiliated Hospital, School of Medicine, Zhejiang Universityn=1322027

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adolescents (Age 12 Years to < 18 Years) With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Active, not recruitingPH IIIBristol-Myers Squibbn=442031

A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)

CompletedPH II/IIIBristol-Myers Squibbn=3142026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)

CompletedPH II/IIIBristol-Myers Squibbn=3142026

A Phase 3, Open-label, Single Arm, Clinical Study to Evaluate Efficacy, Safety and Tolerability of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

CompletedPH IIIBristol-Myers Squibbn=382025

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy

CompletedPH IIIBristol-Myers Squibbn=5802025

A Phase III, Randomized, Double-blinded, Placebo-controlled Clinical Study With A Long-term Extension to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

CompletedPH IIILianBio LLCn=812024

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction Therapy

CompletedPH IIIBristol-Myers Squibbn=1122024

An Exploratory, Open-label, Proof-of-concept, Phase 2a Study of Mavacamten (MYK-461) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Chronic Elevation of Cardiac Biomarkers

CompletedPH IIBristol-Myers Squibbn=302024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.