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Mavacamten

Phase 3

Cardiomyopathy, Hypertrophic | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Dec 19, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment624
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06253221A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic CardiomyopathyPHASE3 ACTIVE NOT_RECRUITING 44 — — Apr 17, 2024Mar 28, 2031Dec 19, 202547 United States, Australia +7
NCT05582395A Study of Mavacamten in Non-Obstructive Hypertrophic CardiomyopathyPHASE3 COMPLETED 580 — — Dec 14, 2022Oct 20, 2025Nov 14, 2025224 United States, Australia +21
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Study Endpoints
Primary Endpoints
Change from baseline in Valsalva left ventricular outflow tract (LVOT) (VLVOT) gradient
At Week 28
Change from baseline in Kansas City Cardiomyopathy Questionnaire (23-item) Clinical Summary Score (KCCQ-23 CSS) at Week 48
Up to Week 48
Change from baseline in peak oxygen consumption (pVO2) at Week 48
Up to Week 48
Secondary Endpoints
Change from baseline in resting LVOT gradient
At Week 28
Change from baseline in post-exercise peak LVOT gradient
At Week 28
Change from baseline in maximal wall thickness
At Week 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MavacamtenEXPERIMENTALParticipants assigned to this arm will receive mavacamten (1 mg to 15 mg) from day 1 to end of treatment at week 200.
PlaceboEXPERIMENTALParticipants assigned to this arm will receive mavacamten (1 mg to 15 mg) from week 28 to end of treatment at week 200.
Interventions
NameTypeDescription
MavacamtenDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range12 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites47

Inclusion Criteria: * Diagnosis of HCM * Presence of LVOT obstruction * Presence of symptoms Exclusion Criteria: * Phenocopy diseases resulting in myocardial hypertrophy not related to sarcomere dysfunction * Evidence of LVEF \<50% in prior 6 months * Planned escalation in HCM therapy or upcoming...

Countries:United StatesAustraliaCanadaFranceGermanyIrelandItalySpainUnited KingdomAustriaBelgiumBrazilChinaCzechiaDenmarkHungaryIndiaIsraelJapanNetherlandsNorwayPolandPortugalSouth Korea
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06253221primaryCompletionDate: changed
LOWMay 24, 2026NCT06253221studyFirstPostDate: changed