Mavacamten History and Updates

130 events · 2018 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

7
FDA Approvals
0
Label Revisions
123
Trial Milestones
0
Pivotal Publications
Mavacamten — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2018201920202021202220232024202520262027202820292030Trial: NCT07541833 2026-02-05 → 2026-12-31 (primary completion)Trial: NCT07557498 2026-01-15 → 2026-12-14 (primary completion)Trial: NCT07361289 2026-01-15 → 2028-08-22 (primary completion)Trial: NCT07103655 2026-01-01 → 2026-07-01 (primary completion)Trial: NCT07120776 2025-09-30 → 2028-10-31 (primary completion)Trial: NCT07150299 2025-09-05 → 2027-05-31 (primary completion)Trial: NCT07004972 2025-09-04 → 2027-12-13 (primary completion)Trial: NCT07383025 2025-05-21 → 2029-11-30 (primary completion)Trial: NCT06947590 2025-04-20 → 2026-02-01 (primary completion)Trial: NCT06856265 2025-02-26 → 2025-12-01 (primary completion)Trial: NCT06146660 2024-07-24 → 2026-11-30 (primary completion)Trial: NCT06338202 2024-06-24 → 2024-11-12 (primary completion)Trial: NCT06551129 2024-05-10 → 2026-12-31 (primary completion)Trial: NCT06549608 2024-04-20 → 2024-05-06 (primary completion)Trial: NCT06253221 2024-04-17 → 2025-11-25 (primary completion)Trial: NCT06112743 2024-01-24 → 2026-07-09 (primary completion)Trial: NCT06211179 2024-01-10 → 2024-06-13 (primary completion)Trial: NCT07529938 2024-01-01 → 2025-05-30 (primary completion)Trial: NCT07107373 2023-12-22 → 2024-07-26 (primary completion)Trial: NCT06372457 2023-12-01 → 2025-09-29 (primary completion)Trial: NCT05939700 2023-11-09 → 2027-04-30 (primary completion)Trial: NCT06023186 2023-11-03 → 2026-08-31 (primary completion)Trial: NCT07168655 2023-02-21 → 2023-03-31 (primary completion)Trial: NCT05719805 2023-02-20 → 2023-07-25 (primary completion)Trial: NCT05658146 2023-01-06 → 2023-07-05 (primary completion)Trial: NCT05582395 2022-12-14 → 2025-03-06 (primary completion)Trial: NCT05414175 2022-08-19 → 2023-11-27 (primary completion)Trial: NCT05489705 2022-08-16 → 2029-08-17 (primary completion)Trial: NCT05362045 2022-05-16 → 2022-08-19 (primary completion)Trial: NCT05320094 2022-04-15 → 2022-09-11 (primary completion)Trial: NCT05174416 2022-01-04 → 2023-03-06 (primary completion)Trial: NCT05135871 2021-10-31 → 2022-02-05 (primary completion)Trial: NCT04766892 2021-03-30 → 2024-02-26 (primary completion)Trial: NCT04349072 2020-07-06 → 2022-02-07 (primary completion)Trial: NCT03723655 2018-09-27 → 2026-01-16 (primary completion)Trial: NCT03470545 2018-05-29 → 2020-03-14 (primary completion)Trial: NCT03496168 2018-04-26 → 2023-11-09 (primary completion)Trial: NCT03442764 2018-03-30 → 2020-01-07 (primary completion)FDA approval — 2022-04-28 FDA approved Camzyos (mavacamten) (NDA 214998) Sponsor: BRISTOL. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2022-11-22 FDA approved supplemental application for Camzyos (mavacamten) — REMS (NDA 214998 S-3) Sponsor: BRISTOL. Class: REMS.FDA approval (supplemental) — 2023-01-13 FDA approved supplemental application for Camzyos (mavacamten) — REMS (NDA 214998 S-4) Sponsor: BRISTOL. Class: REMS.FDA approval (supplemental) — 2023-06-15 FDA approved supplemental application for Camzyos (mavacamten) — Efficacy (NDA 214998 S-1) Sponsor: BRISTOL. Class: Efficacy.FDA approval (supplemental) — 2023-12-19 FDA approved supplemental application for Camzyos (mavacamten) — REMS (NDA 214998 S-8) Sponsor: BRISTOL. Class: REMS.FDA approval (supplemental) — 2024-04-30 FDA approved supplemental application for Camzyos (mavacamten) — Labeling (NDA 214998 S-9) Sponsor: BRISTOL. Class: Labeling.FDA approval (supplemental) — 2025-04-17 FDA approved supplemental application for Camzyos (mavacamten) — Efficacy (NDA 214998 S-10) Sponsor: BRISTOL. Class: Efficacy.Results posted — 2021-10-04 Trial results posted: NCT03470545 Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic CardiomyopathyResults posted — 2022-08-09 Trial results posted: NCT03442764 A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)Results posted — 2023-03-07 Trial results posted: NCT04349072 A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction TherapyResults posted — 2024-07-25 Trial results posted: NCT05135871 Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese SubjectsResults posted — 2024-09-19 Trial results posted: NCT05174416 A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCMResults posted — 2024-12-04 Trial results posted: NCT05414175 A Study of Mavacamten in Obstructive Hypertrophic CardiomyopathyResults posted — 2025-01-09 Trial results posted: NCT03496168 Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEERResults posted — 2025-03-20 Trial results posted: NCT04766892 A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnTtoday (2026-06-15)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-15Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Mavacamten since 2018, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (4)

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction
Primary completion· ClinicalTrials.gov
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Primary completion· ClinicalTrials.gov
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Primary completion· ClinicalTrials.gov
Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US
Primary completion· ClinicalTrials.gov
Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)
Primary completion· ClinicalTrials.gov
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Primary completion· ClinicalTrials.gov
Myocardial Perfusion Changes Following Optimal Medical Treatment in Symptomatic Hypertrophic Cardiomyopathy
Primary completion· ClinicalTrials.gov
A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
Primary completion· ClinicalTrials.gov
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Primary completion· ClinicalTrials.gov
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receivi
Primary completion· ClinicalTrials.gov
Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan

Past events

2026
Trial started· ClinicalTrials.gov
Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)
Primary completion· ClinicalTrials.gov
Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy
Trial started· ClinicalTrials.gov
Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US
Trial started· ClinicalTrials.gov
A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
Trial started· ClinicalTrials.gov
The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction
2025
Primary completion· ClinicalTrials.gov
Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Trial started· ClinicalTrials.gov
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Primary completion· ClinicalTrials.gov
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive H
Trial started· ClinicalTrials.gov
Myocardial Perfusion Changes Following Optimal Medical Treatment in Symptomatic Hypertrophic Cardiomyopathy
Trial started· ClinicalTrials.gov
A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)
Primary completion· ClinicalTrials.gov
Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy
Trial started· ClinicalTrials.gov
Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan
Trial started· ClinicalTrials.gov
Efficacy of Mavacamten in Patients With Symptomatic Latent Obstructive Hypertrophic Cardiomyopathy
Results posted· ClinicalTrials.gov
A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
Trial started· ClinicalTrials.gov
Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Results posted· ClinicalTrials.gov
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
2024
Results posted· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM
Primary completion· ClinicalTrials.gov
A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US
Results posted· ClinicalTrials.gov
Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects
Trial started· ClinicalTrials.gov
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Primary completion· ClinicalTrials.gov
A Study to Assess the Relative Bioavailability of 5 mg Mavacamten Opened Capsule Administered Via Nasogastric Tube Compared to Intact Oral 5
Trial started· ClinicalTrials.gov
Real-world Patient Reported Outcomes Among Patients Treated With Camzyos
Primary completion· ClinicalTrials.gov
A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada
Trial started· ClinicalTrials.gov
A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada
Trial started· ClinicalTrials.gov
A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Primary completion· ClinicalTrials.gov
A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
Trial started· ClinicalTrials.gov
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Trial started· ClinicalTrials.gov
A Study to Assess the Relative Bioavailability of 5 mg Mavacamten Opened Capsule Administered Via Nasogastric Tube Compared to Intact Oral 5
Trial started· ClinicalTrials.gov
Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy
2023
Trial started· ClinicalTrials.gov
A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US
Trial started· ClinicalTrials.gov
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive H
Primary completion· ClinicalTrials.gov
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
Trial started· ClinicalTrials.gov
Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM
Results posted· ClinicalTrials.gov
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM
Trial started· ClinicalTrials.gov
A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
2022
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
Trial started· ClinicalTrials.gov
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receivi
Results posted· ClinicalTrials.gov
A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)
Trial started· ClinicalTrials.gov
A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
Trial started· ClinicalTrials.gov
A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
Primary completion· ClinicalTrials.gov
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
Trial started· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM
2021
Results posted· ClinicalTrials.gov
Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Trial started· ClinicalTrials.gov
A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
2020
Trial started· ClinicalTrials.gov
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
Primary completion· ClinicalTrials.gov
Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Primary completion· ClinicalTrials.gov
A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)
2018
Trial started· ClinicalTrials.gov
Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Trial started· ClinicalTrials.gov
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
Trial started· ClinicalTrials.gov
A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.