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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 |
|---|---|
|
Synonyms:
|
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.
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
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 | 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 |