All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

mavacamten 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
	5511	1642288-47-8

Description:

Molecule

Description

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:

Dose	Unit	Route
5	mg	O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
kinase-safety-class	ACVR2A,ACVR2B,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,ERBB2,FLT3,GRK2,ITK,JAK1,MAP3K21,MAP3K7,MAPK7,MARK4,MET,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CD,PRKCD,PRKDC,SIK2,SIK3,STK33,TEK,TTK,ULK1	39
kinase-selectivity-class	AXL,BMX,BRAF,CAMK2B,CAMK2D,CDK16,CDK9,DDR1,GRK2,IRAK1,JAK1,MAPK7,MARK4,PDK1,PRKDC,SIK2,SIK3,STK33,TEK,ZAP70	20
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
April 28, 2022	FDA	MYOKARDIA INC
June 26, 2023	EMA	Bristol-Myers Squibb Pharma EEIG

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Atrial fibrillation	177.90	34.50	79	2118	133532	90492718
Ejection fraction decreased	173.79	34.50	51	2146	26202	90600048
Cardiac failure	97.01	34.50	49	2148	109447	90516803
Transvalvular pressure gradient increased	96.30	34.50	10	2187	0	90626250
Dizziness	95.04	34.50	92	2105	589192	90037058
Dyspnoea	78.77	34.50	101	2096	880854	89745396
Mitral valve incompetence	67.47	34.50	24	2173	22500	90603750
Palpitations	65.77	34.50	41	2156	136687	90489563
Acquired left ventricle outflow tract obstruction	59.08	34.50	7	2190	16	90626234
Dyspnoea exertional	54.31	34.50	29	2168	72259	90553991
Product supply issue	44.34	34.50	11	2186	2981	90623269
Therapy interrupted	40.15	34.50	21	2176	50087	90576163
Chest pain	38.72	34.50	43	2154	319602	90306648
Fatigue	38.19	34.50	85	2112	1153938	89472312
Mitral valve calcification	36.99	34.50	8	2189	1190	90625060
Stress cardiomyopathy	35.37	34.50	13	2184	13342	90612908
Left atrial volume increased	35.17	34.50	5	2192	62	90626188
Echocardiogram abnormal	34.69	34.50	8	2189	1591	90624659

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Ejection fraction decreased	177.83	38.92	48	822	22039	42598426
Atrial fibrillation	124.50	38.92	59	811	139534	42480931
Dizziness	48.28	38.92	40	830	249214	42371251

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Atrial fibrillation	235.73	34.25	115	2697	229527	110356960
Ejection fraction decreased	230.82	34.25	71	2741	40809	110545678
Dizziness	117.43	34.25	114	2698	698079	109888408
Cardiac failure	115.49	34.25	67	2745	187559	110398928
Transvalvular pressure gradient increased	93.19	34.25	10	2802	3	110586484
Dyspnoea	89.70	34.25	124	2688	1106748	109479739
Mitral valve incompetence	81.59	34.25	31	2781	33298	110553189
Palpitations	80.11	34.25	50	2762	159162	110427325
Acquired left ventricle outflow tract obstruction	74.27	34.25	9	2803	25	110586462
Therapy interrupted	53.94	34.25	26	2786	49796	110536691
Product distribution issue	53.93	34.25	14	2798	4332	110582155
Product dose omission issue	52.69	34.25	52	2760	321730	110264757
Fatigue	50.37	34.25	101	2711	1215857	109370630
Chest pain	47.63	34.25	53	2759	376322	110210165
Product supply issue	46.03	34.25	12	2800	3774	110582713
Dyspnoea exertional	45.62	34.25	30	2782	104030	110482457
Echocardiogram abnormal	45.04	34.25	11	2801	2663	110583824

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	C01EB24	CARDIOVASCULAR SYSTEM CARDIAC THERAPY OTHER CARDIAC PREPARATIONS Other cardiac preparations
FDA EPC	N0000194047	Cardiac Myosin Inhibitor
FDA MoA	N0000194048	Cardiac Myosin Inhibitors
CHEBI has role	CHEBI:35554	cardiovascular drug

Related Drugs by ATC class:

C01EB Other cardiac preparations 15 drugs

acadesineacoramidisadenosinecamphorcreatinolfosfateibuprofenindomethacinivabradinemeldoniumphosphocreatineranolazineregadenoson show all 15 →

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

Disease	Relation	SNOMED_ID	DOID
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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Myosin-7	Enzyme	P12883	MYH7_HUMAN	INHIBITOR	IC50	6.25		DRUG LABEL	DRUG LABEL

External reference:

ID	Source
CHEBI:756998	CHEBI
XB2	PDB_CHEM_ID
CHEMBL4297517	ChEMBL_ID
C000605992	MESH_SUPPLEMENTAL_RECORD_UI
11265	IUPHAR_LIGAND_ID
DB14921	DRUGBANK_ID
42202311000001109	SNOMEDCT_US
4041391	VANDF
C4742219	UMLSCUI
D12265	KEGG_DRUG
10492	INN_ID
117761397	PUBCHEM_CID
359022	MMSL
40677	MMSL
d09890	MMSL
019044	NDDF
QX45B99R3J	UNII
2600867	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CAMZYOS	HUMAN PRESCRIPTION DRUG LABEL	1	73625-111	CAPSULE, GELATIN COATED	2.50 mg	ORAL	NDA	30 sections
CAMZYOS	HUMAN PRESCRIPTION DRUG LABEL	1	73625-112	CAPSULE, GELATIN COATED	5 mg	ORAL	NDA	30 sections
CAMZYOS	HUMAN PRESCRIPTION DRUG LABEL	1	73625-113	CAPSULE, GELATIN COATED	10 mg	ORAL	NDA	30 sections
CAMZYOS	HUMAN PRESCRIPTION DRUG LABEL	1	73625-114	CAPSULE, GELATIN COATED	15 mg	ORAL	NDA	30 sections