Drugs / Mavacamten

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) CAMZYOS 2023-06-15 – 2025-04-17 fda.gov
Approved EU (EMA) Camzyos 2023-06-26 europa.eu
Approved US (FDA) CAMZYOS 2022-04-28 fda.gov

Trials 26 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 19 trials
Phase 1 NCT06211179 Jan → Jun 2024 Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT05719805 Feb → Jul 2023 Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT05658146 Jan → Jul 2023 Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT05362045 May → Aug 2022 Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT05320094 Apr → Sep 2022 Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT05135871 Oct 2021 → Feb 2022 hypertrophic cardiomyopathy LianBio LLC Completed No outcome recorded
Phase 1 NCT02480296 Aug 2015 → Jul 2016 MyoKardia, Inc. Completed No outcome recorded
Phase 1 NCT02356289 Jan → Jul 2015 MyoKardia, Inc. Completed No outcome recorded
Phase 1 NCT02329184 Dec 2014 → Mar 2016 hypertrophic cardiomyopathy MyoKardia, Inc. Completed No outcome recorded
Phase 24 trials
Phase 2 NCT04766892 Mar 2021 → Feb 2024 diastolic heart failure Bristol-Myers Squibb Completed No outcome recorded
Phase 2 NCT03496168 Apr 2018 → Nov 2023 hypertrophic cardiomyopathy Bristol-Myers Squibb Completed No outcome recorded
Phase 2 NCT03442764 Mar 2018 → Jan 2020 hypertrophic cardiomyopathy MyoKardia, Inc. Completed No outcome recorded
Phase 2 NCT02842242 Aug 2016 → Nov 2017 hypertrophic cardiomyopathy MyoKardia, Inc. Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03723655 Sep 2018 → Jan 2026 hypertrophic cardiomyopathy Bristol-Myers Squibb Completed No outcome recorded
Phase 36 trials
Phase 3 NCT06253221 Apr 2024 → Nov 2025 overdue Bristol-Myers Squibb Active not recruiting No outcome recorded
Phase 3 NCT05582395 Dec 2022 → Mar 2025 Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT05414175 Aug 2022 → Nov 2023 hypertrophic cardiomyopathy Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT05174416 Jan 2022 → Mar 2023 hypertrophic cardiomyopathy LianBio LLC Completed No outcome recorded
Phase 3 NCT04349072 Jul 2020 → Feb 2022 hypertrophic cardiomyopathy Bristol-Myers Squibb Completed No outcome recorded
Phase 3 NCT03470545 May 2018 → Mar 2020 hypertrophic cardiomyopathy MyoKardia, Inc. Completed No outcome recorded
Phase 43 trials
Phase 4 NCT07103655 Jan → Jul 2026 overdue hypertrophic cardiomyopathy Second Affiliated Hospital, School of Medicine, Zhejiang University Not yet recruiting No outcome recorded
Phase 4 NCT07004972 Sep 2025 → Dec 2027 expected hypertrophic cardiomyopathy Bristol-Myers Squibb Active not recruiting No outcome recorded
Phase 4 NCT06112743 Jan 2024 → Jul 2026 overdue Bristol-Myers Squibb Active not recruiting No outcome recorded
Phase not applicable3 trials
NCT07120776 Mar 2026 → Oct 2028 expected hypertrophic cardiomyopathy, myocardial ischemia University of Manchester Recruiting No outcome recorded
NCT06947590 Apr 2025 → Feb 2026 overdue hypertrophic cardiomyopathy Xu Liu Active not recruiting No outcome recorded
NCT06856265 Feb → Dec 2025 overdue hypertrophic cardiomyopathy Shanghai Chest Hospital Not yet recruiting No outcome recorded

Press releases naming this drug 4 releases

DateIssuerRelease
2026-06-01 Bristol-Myers Squibb U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Supplemental New Drug Application for Camzyos (mavacamten) to Treat Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) bms.com
2022-04-28 Bristol-Myers Squibb U.S. Food and Drug Administration Approves Camzyos™ (mavacamten) for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM) to Improve Functional Capacity and Symptoms bms.com
2022-04-03 Bristol-Myers Squibb Bristol Myers Squibb Announces Data from EXPLORER-LTE Demonstrating Sustained Improvements in Clinically Meaningful Cardiovascular Outcomes at Weeks 48 and 84 in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy Receiving Mavacamten bms.com
2022-04-02 Bristol-Myers Squibb Mavacamten Demonstrated Significant Reduction in Need for Septal Reduction Therapy in Symptomatic Obstructive HCM Patients in Phase 3 VALOR Trial bms.com

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

FieldValueCited text
Known as Mavacamten ClinicalTrials.gov intervention name — accepted as the source's own label NCT05582395
21

NCT05320094

NCT03442764

NCT06253221

NCT06211179

NCT03470545

NCT06947590

NCT05719805

NCT03723655

NCT04349072

NCT05362045

NCT07103655

NCT06856265

NCT06112743

NCT07120776

NCT07004972

NCT04766892

NCT03496168

NCT05658146

NCT05135871

NCT05414175

NCT05174416

Known as CAMZYOS Camzyos (Mavacamten), a selective cardiac myosin inhibitor prescribed as part of routine care in patients with symptomatic HOCM.” NCT07120776
1

“Mavacamten (CAMZYOS) First-in-Class Small-Molecule Myosin Inhibitor for Treatment of Obstructive Hypertrophic Cardiomyopathy.” PMID 38625800 May 2024

Known as MYK-461 “mavacamten (MYK-461)” NCT04766892
4

NCT02329184

NCT02356289

NCT02480296

NCT02842242

Known as SAR-439152 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297517
Action Inhibit “a first-in-class reversible inhibitor of cardiac-specific myosin” PMID 32466879 Jun 2020
Modality Small molecule “small-molecule modulator of cardiac myosin” PMID 31035291 Apr 2019
Route Oral “single ascending (oral) dose study” NCT02329184