Mavacamten
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2022
- First approval year
- 2022
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Mavacamten
- Molecular weight
- 273.34
- Structure (SMILES)
- CC(C)n1c(=O)cc(N[C@@H](C)c2ccccc2)[nH]c1=O
- camzyos
- Camzyos
- camzyos
- Camzyos
- Camzyos (Mavacamten)
- camzyos mavacamten
- mavacamten
- Mavacamten
- Mavacamten [INN]
- Mavacamten [MI]
- Mavacamten [USAN]
- Mavacamten [WHO-DD]
- mavacamten inn
- mavacamten mi
- mavacamten usan
- mavacamten who dd
- myk 461
- Myk-461
- MYK-461
- sar 439152
- SAR-439152
- CAS registry numbers
- 1642288-47-8
- ChEMBL ID
- CHEMBL4297517
- InChIKey
- RLCLASQCAPXVLM-NSHDSACASA-N
- PubChem compound IDs
- 117761397
- RxNorm IDs (RxCUI)
- 2600867
- FDA ingredient codes (UNII)
- QX45B99R3J
- C01EB
- C01EB24
Sources for recorded values
- Applicant
- BRISTOL
- Approval date
- 28 Apr 2022
- Application number
- NDA214998
- Status
- Authorised
- Status date
- 26 Jun 2023
- Authorisation date
- 26 Jun 2023
- Approved indications
- Treatment of symptomatic obstructive hypertrophic cardiomyopathy.
- Product number
- EMEA/H/C/005457
- Authorisation holder
- Bristol-Myers Squibb Pharma EEIG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Cardiomyopathy, Hypertrophic
European medicines record
- Patents
- 2
- Designations
- 4
- Earliest recorded loss of exclusivity
- 28 Apr 2036
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- mavacamten
- Type
- Synthetic organic
- Drug name stem
- -camten
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Mechanism
- Cardiac myosin inhibitor
- Action type
- Inhibitor
- Target
- Cardiac myosin
- Protein identifier
- A7E2Y1
- Mechanism
- Cardiac myosin inhibitor
- Action type
- Inhibitor
- Target
- Cardiac myosin
- Protein identifier
- P08590
- Mechanism
- Cardiac myosin inhibitor
- Action type
- Inhibitor
- Target
- Cardiac myosin
- Protein identifier
- P10916
- Mechanism
- Cardiac myosin inhibitor
- Action type
- Inhibitor
- Target
- Cardiac myosin
- Protein identifier
- P12829
- Mechanism
- Cardiac myosin inhibitor
- Action type
- Inhibitor
- Target
- Cardiac myosin
- Protein identifier
- P12883
- Mechanism
- Cardiac myosin inhibitor
- Action type
- Inhibitor
- Target
- Cardiac myosin
- Protein identifier
- P13533
- Mechanism
- Cardiac myosin inhibitor
- Action type
- Inhibitor
- Target
- Cardiac myosin
- Protein identifier
- Q01449
Open Targets mechanisms
- Mechanism
- Cardiac myosin inhibitor
- Action type
- Inhibitor
- Target
- Cardiac myosin
- Condition
- Cardiovascular Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000319
- Subject identifier
- D002318
- Condition
- Cardiomyopathy, Hypertrophic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000538
- Subject identifier
- D002312
- Condition
- Heart Failure
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition identifier
- EFO_0000319
- Condition identifier
- EFO_0000538
- Condition identifier
- EFO_0000556
- Condition identifier
- EFO_0003144
- Highest recorded phase
- 2
- Condition identifier
- HP_0000822
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004995
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005045
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005252
- Highest recorded phase
- 2
Warnings
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Country
- United States
- Event
- anticholinergic effect
- Reports
- 2
- Reporting signal score
- 22.0102
- Event
- drug interaction
- Reports
- 9
- Reporting signal score
- 20.1075
- Event
- left ventricular dysfunction
- Reports
- 3
- Reporting signal score
- 12.4393
- Event
- left ventricular outflow tract gradient increased
- Reports
- 1
- Reporting signal score
- 10.989
- NCT02329184
- NCT02842242
- NCT03442764
- NCT03470545
- NCT03496168
- NCT03723655
- NCT04349072
- NCT05135871
- NCT05174416
- NCT05414175
- NCT05582395
- NCT06112743
- NCT06253221
- NCT04766892
- Dose
- 5 mg
- Route
- Oral
- How often
- Once daily
- Hydrogen bond acceptors
- 4
- Hydrogen bond donors
- 2
- Polar surface area
- 66.89
- Calculated partition coefficient (ALogP)
- 2.29
- Calculated partition coefficient (XLogP)
- 2.1
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 4
- Heavy atoms
- 20
- Molecular formula
- C15H19N3O2
- Monoisotopic mass
- 273.147726857
- Natural product
- No
- 73625-111
- 73625-112
- 73625-113
- 73625-114
- Recorded assays
- 52
- Active assays
- 12
Active assay types
- Confirmatory
Liver toxicity assay
- Median
- 3,650
- Mean
- 3,650
- Minimum
- 2,200
- Maximum
- 5,100
- Unit
- nM
- Assays
- 2
- Standard deviation
- 2,050.61
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- EC50
Related records
Trials (41)
- A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
- A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
- A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)
- A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)
- A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada
- A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER)
- A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
- A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy
- A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT
- A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
- A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
- A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
- A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US
- A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
- A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy
- A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
- A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
- A Study to Evaluate the Effects of Mavacamten in Healthy Participants
- A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
- A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM
Approved for (2)
In development for (1)
- Heart failure Phase 2