mavacamten 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5511 1642288-47-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • mavacamten
  • camzyos
  • MYK-461
  • SAR-439152
Mavacamten is an allosteric and reversible inhibitor selective for cardiac myosin. Mavacamten modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation. Excess myosin actin cross-bridge formation and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM. Mavacamten shifts the overall myosin population towards an energy-sparing, recruitable, super-relaxed state. In HCM patients, myosin inhibition with mavacamten reduces dynamic LVOT obstruction and improves cardiac filling pressures.
  • Molecular weight: 273.34
  • Formula: C15H19N3O2
  • CLOGP: 2.32
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 61.44
  • ALOGS: -3.08
  • ROTB: 4
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
June 26, 2023 EMA Bristol-Myers Squibb Pharma EEIG
April 28, 2022 FDA MYOKARDIA INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cardiac failure 55.84 49.20 22 328 154820 79589218

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C01EB24 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
OTHER CARDIAC PREPARATIONS
Other cardiac preparations

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Obstructive hypertrophic cardiomyopathy (HCM) indication 233873004 DOID:11984




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL 9585883 June 19, 2034 TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS
15MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL 9585883 June 19, 2034 TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS
2.5MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL 9585883 June 19, 2034 TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS
5MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL 9585883 June 19, 2034 TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL June 15, 2026 LABELING CHANGES BASED ON RESULTS FROM CLINICAL STUDY MYK-461-017
15MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL June 15, 2026 LABELING CHANGES BASED ON RESULTS FROM CLINICAL STUDY MYK-461-017
2.5MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL June 15, 2026 LABELING CHANGES BASED ON RESULTS FROM CLINICAL STUDY MYK-461-017
5MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL June 15, 2026 LABELING CHANGES BASED ON RESULTS FROM CLINICAL STUDY MYK-461-017
10MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL April 28, 2027 NEW CHEMICAL ENTITY
15MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL April 28, 2027 NEW CHEMICAL ENTITY
2.5MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL April 28, 2027 NEW CHEMICAL ENTITY
5MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL April 28, 2027 NEW CHEMICAL ENTITY
10MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL April 28, 2029 TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS
15MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL April 28, 2029 TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS
2.5MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL April 28, 2029 TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS
5MG CAMZYOS BRISTOL N214998 April 28, 2022 RX CAPSULE ORAL April 28, 2029 TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Myosin-7 Enzyme INHIBITOR IC50 6.25 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEMBL4297517 ChEMBL_ID
C000605992 MESH_SUPPLEMENTAL_RECORD_UI
11265 IUPHAR_LIGAND_ID
DB14921 DRUGBANK_ID
019044 NDDF
4041391 VANDF
C4742219 UMLSCUI
D12265 KEGG_DRUG
10492 INN_ID
117761397 PUBCHEM_CID
2600867 RXNORM
359022 MMSL
40677 MMSL
d09890 MMSL
QX45B99R3J UNII

Pharmaceutical products:

None