Drugs / Mavacamten
Mavacamten
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hypertrophic cardiomyopathy 3 milestones | |||||
| Filed | US (FDA) | CAMZYOS | hypertrophic cardiomyopathy | 2022-10-21 | “FDA has accepted its supplemental new drug application (sNDA) for CAMZYOS ® (mavacamten) for an expanded indication to reduce the need for septal reduction therapy (SRT).” bms.com ↗ |
| Filed | EU (EMA) | — | hypertrophic cardiomyopathy | 2021-10-01 | “has validated its Marketing Authorization Application (MAA) for mavacamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM).” bms.com ↗ “European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for mavacamten” bms.com ↗ |
| Filed | US (FDA) | — | hypertrophic cardiomyopathy | 2021-03-19 | “the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten” bms.com ↗ “U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten” bms.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Filed | US (FDA) | Camzyos | adolescent symptomatic obstructive hypertrophic cardiomyopathy | 2026-06-01 | “FDA accepted a supplemental New Drug Application (sNDA) for Camzyos (mavacamten) as a potential treatment for adolescents” bms.com ↗ |
| 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 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03723655 | Sep 2018 → Jan 2026 | hypertrophic cardiomyopathy | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 36 trials · 4 met primary · 1 missed | ||||||
| Phase 3 | NCT06253221 | Apr 2024 → Nov 2025 overdue | — | Bristol-Myers Squibb | Active not recruiting | Met primary |
| Phase 3 | NCT05582395 | Dec 2022 → Mar 2025 | — | Bristol-Myers Squibb | Terminated | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT04349072 | Jul 2020 → Feb 2022 | hypertrophic cardiomyopathy | Bristol-Myers Squibb | Completed | Met primary |
| Phase 3 | NCT03470545 | May 2018 → Mar 2020 | hypertrophic cardiomyopathy | MyoKardia, Inc. | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07807384 | Sep 2026 overdue | hypertrophic cardiomyopathy | Second Affiliated Hospital of Nanchang University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07103655 | Mar → Nov 2026 expected | hypertrophic cardiomyopathy | Second Affiliated Hospital, Zhejiang University, School of Medicine | Enrolling by invitation | 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 |
News releases announcing trial results or a regulatory action · 29
| Date | Issuer | Release |
|---|---|---|
| 2026-09-30 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Expanded Indication for Bristol Myers Squibb’s CAMZYOS® (mavacamten) for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) in Adults and Pediatric Patients* bms.com ↗ |
| 2026-08-29 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Data Up to Five Years Reinforcing the Long-Term Efficacy and Safety of Camzyos (mavacamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) at the European Society of Cardiology (ESC) Congress 2026 bms.com ↗
These data add to the understanding that the effects of Camzyos are sustained for up to five years with continuous, consistent treatment. |
| 2026-06-01 | Bristol-Myers Squibb | Regulatory 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 ↗
The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) date of September 30, 2026. |
| 2026-03-29 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Positive Results from Phase 3 SCOUT-HCM Trial Demonstrating Efficacy and Safety of Camzyos (mavacamten) in Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) bms.com ↗
Additionally, Camzyos showed meaningful improvement over placebo in multiple secondary endpoints at 28 weeks, and similar safety findings were observed in the Camzyos and placebo groups. |
| 2026-03-23 | Bristol-Myers Squibb | Results Bristol Myers Squibb Reinforces Leadership in oHCM with New Camzyos (mavacamten) Data at American College of Cardiology Annual Scientific Session & Expo 2026 (ACC.26) bms.com ↗
Positive Phase 3 results of SCOUT-HCM trial highlight potential of Camzyos to be the first cardiac myosin inhibitor for the treatment of adolescents with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) |
| 2026-01-12 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Positive Topline Results from Phase 3 SCOUT-HCM Trial Evaluating Camzyos (mavacamten) in Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) bms.com ↗
The trial met its primary endpoint, demonstrating a statistically significant reduction from baseline in Valsalva left ventricular outflow tract (LVOT) gradient at Week 28 versus placebo, indicating Camzyos was effective in improving LVOT obstruction. |
| 2025-11-03 | Bristol-Myers Squibb | Results Bristol Myers Squibb Showcases New Long-Term and Real-World Data From Cardiovascular Portfolio at the American Heart Association Scientific Sessions 2025 bms.com ↗
Multiple real-world analyses and an analysis of long-term extension data reinforce the well-established efficacy and safety profile of Camzyos (mavacamten) in symptomatic obstructive hypertrophic cardiomyopathy |
| 2025-08-29 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Real-World Outcomes of Camzyos (mavacamten) Across Four Continents at the European Society of Cardiology (ESC) Congress 2025 bms.com ↗
The analysis showed that Camzyos (mavacamten) was associated with reductions in left ventricular outflow tract (LVOT) obstruction and improvements in symptom burden in a racially diverse population of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) treated in an international, real-world setting. |
| 2025-04-17 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Updates CAMZYOS® (mavacamten) Label to Reduce Echocardiography Monitoring Requirements and Contraindications bms.com ↗
Label updates include simplified twice-yearly echo monitoring for eligible CAMZYOS patients in the maintenance phase and expanded patient eligibility with reduced contraindications |
| 2025-04-14 | Bristol-Myers Squibb | Results Bristol Myers Squibb Provides Update on Phase 3 ODYSSEY-HCM Trial bms.com ↗
No new safety signals were observed. |
| 2025-02-06 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2024 bms.com ↗
In addition, the company is today announcing the receipt of an April Prescription Drug User Fee Act (PDUFA) goal date from the FDA in the same setting. |
| 2024-09-01 | Bristol-Myers Squibb | Results Long-Term Follow-Up Data from Phase 3 Study of CAMZYOS® (mavacamten) Underscores Established Efficacy and Safety Profile in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) bms.com ↗
They also experienced an improvement in symptoms and functional capacity as measured by NYHA class and patient-reported outcomes, including most patients achieving NYHA class I. |
| 2024-03-25 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Present Data at the American College of Cardiology Annual Scientific Session 2024 Reinforcing Extensive Body of Evidence in Clinical and Real-World Settings Across Cardiovascular Portfolio bms.com ↗
Analysis from a 10-month post-launch evaluation of the REMS Program finds 2.8% incidence of LVEF <50% in over 1500 patients, strengthening the safety profile of CAMZYOS ® (mavacamten) for NYHA class II-III obstructive hypertrophic cardiomyopathy |
| 2023-08-28 | Bristol-Myers Squibb | Results Long-Term Follow-Up Data from Two Phase 3 Studies of CAMZYOS® (mavacamten) Demonstrate Consistent and Durable Response in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM) bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced new long-term follow-up results from two Phase 3 studies evaluating CAMZYOS ® (mavacamten), a first-in-class cardiac myosin inhibitor, in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). |
| 2023-06-26 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives European Commission Approval of CAMZYOS® (mavacamten), for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM) bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved CAMZYOS ® (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients. |
| 2023-06-15 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Addition of Positive Data from Phase 3 VALOR-HCM Study to CAMZYOS® (mavacamten) Label bms.com ↗ |
| 2023-04-26 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for CAMZYOS® (mavacamten) for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM) bms.com ↗
We are encouraged by the CHMP’s positive recommendation, which puts us one step closer to offering patients in the EU a first-in-class treatment for obstructive HCM, and reinforces our commitment to delivering transformative cardiovascular therapies to patients worldwide. |
| 2022-10-25 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Reports Third Quarter Financial Results for 2022 bms.com ↗
The U.S. Food and Drug Administration (FDA) has accepted our supplemental new drug application for Camzyos for an expanded indication for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity, improve symptoms and reduce the need for septal reduction therapy. |
| 2022-10-21 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for CAMZYOS® (mavacamten) in Symptomatic Obstructive Hypertrophic Cardiomyopathy to Reduce the Need for Septal Reduction Therapy bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for CAMZYOS ® (mavacamten) for an expanded indication to reduce the need for septal reduction therapy (SRT). |
| 2022-04-28 | Bristol-Myers Squibb | Regulatory 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 ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Camzyos™ (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. |
| 2022-04-03 | Bristol-Myers Squibb | Results 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 ↗
These data, which showed sustained improvements in cardiovascular outcomes at 48 and 84 weeks, were presented today as a late-breaking clinical trial at the American College of Cardiology’s 71 st Annual Scientific Session. |
| 2022-04-02 | Bristol-Myers Squibb | Results Mavacamten Demonstrated Significant Reduction in Need for Septal Reduction Therapy in Symptomatic Obstructive HCM Patients in Phase 3 VALOR Trial bms.com ↗
Of patients treated with mavacamten, 82% had not proceeded with SRT and no longer met the criteria for SRT according to the 2011 ACC/AHA Guidelines compared to 23% of patients receiving placebo. |
| 2022-02-16 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Positive Topline Results from Phase 3 VALOR-HCM Trial, Evaluating Mavacamten in Patients with Obstructive Hypertrophic Cardiomyopathy Who are Eligible for Septal Reduction Therapy bms.com ↗ |
| 2021-11-19 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Announces New PDUFA Date for Mavacamten bms.com ↗
The FDA notified Bristol Myers Squibb on November 18, 2021 of the extension of the PDUFA date to allow sufficient time to review information pertaining to updates to the proposed Risk Evaluation Mitigation Strategy (REMS). |
| 2021-11-08 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Present Data Across Robust Cardiovascular Portfolio at American Heart Association Scientific Sessions 2021 bms.com ↗
Data demonstrates mavacamten benefit for symptomatic obstructive HCM patients with or without Beta-blocker therapy. |
| 2021-10-01 | Bristol-Myers Squibb | Regulatory European Medicines Agency Validates Bristol Myers Squibb’s Application for Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for mavacamten, an investigational, first-in-class cardiac myosin inhibitor, for the treatment of patients with obstructive hypertrophic cardiomyopathy (obstructive HCM). |
| 2021-05-15 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Late-Breaking Phase 3 Data Demonstrating Health Status Benefits of Mavacamten in Patients with Obstructive Hypertrophic Cardiomyopathy at American College of Cardiology’s 70th Annual Scientific Session bms.com ↗
At 30 weeks, the change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ OSS) was greater in mavacamten patients than placebo, with similar benefits across all KCCQ subscales. |
| 2021-05-03 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents New Clinical and Real-World Data on Mavacamten and Obstructive Hypertrophic Cardiomyopathy at Upcoming American College of Cardiology’s 70th Annual Scientific Session bms.com ↗
Findings from the interim analysis demonstrated that in patients with oHCM, mavacamten was well tolerated and showed durable improvement in left ventricular outflow tract (LVOT) gradients, diastolic function, N-terminal-pro hormone B-type natriuretic peptide (NT-proBNP) and symptoms. |
| 2021-03-19 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) bms.com ↗ |
All press releases naming this drug 29 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mavacamten | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07120776 ↗ |
| 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 ↗ |
| 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 ↗ |