Overview
Mavacamten is a myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM). It received initial US FDA approval in 2022, and it is one of the first myosin inhibitors to be used in humans. Mavacamten was also approved by Health Canada in October 2022 and by EMA in July 2023 for the same indication.
Background
Mavacamten is a myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM). It received initial US FDA approval in 2022, and it is one of the first myosin inhibitors to be used in humans. Mavacamten was also approved by Health Canada in October 2022 and by EMA in July 2023 for the same indication.
Indication
Mavacamten is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms by the FDA, Health Canada, and the EMA.
Associated Conditions
- Symptomatic Obstructive Hypertrophic Cardiomyopathy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/04 | Phase 4 | Not yet recruiting | |||
2025/04/27 | Not Applicable | Active, not recruiting | Xu Liu | ||
2025/03/04 | Not Applicable | Not yet recruiting | |||
2024/08/13 | N/A | Recruiting | |||
2024/08/12 | N/A | Active, not recruiting | |||
2024/04/18 | N/A | Active, not recruiting | |||
2024/03/29 | N/A | Not yet recruiting | |||
2024/02/12 | Phase 3 | Active, not recruiting | |||
2023/11/27 | N/A | Recruiting | |||
2023/11/01 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/26/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CAMZYOS CAPSULES 15MG | SIN16807P | CAPSULE | 15.0mg | 6/14/2023 | |
| CAMZYOS CAPSULES 10MG | SIN16806P | CAPSULE | 10.0mg | 6/14/2023 | |
| CAMZYOS CAPSULES 5MG | SIN16805P | CAPSULE | 5mg | 6/14/2023 | |
| CAMZYOS CAPSULES 2.5MG | SIN16804P | CAPSULE | 2.5MG | 6/14/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Mavacamten Capsules | 国药准字HJ20240014 | 化学药品 | 胶囊剂 | 4/24/2024 | |
| Mavacamten Capsules | 国药准字HJ20240013 | 化学药品 | 胶囊剂 | 4/24/2024 | |
| Mavacamten Capsules | 国药准字HJ20240012 | 化学药品 | 胶囊剂 | 4/24/2024 | |
| Mavacamten Capsules | 国药准字HJ20240015 | 化学药品 | 胶囊剂 | 4/24/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CAMZYOS mavacamten 2.5 mg capsule blister pack | 386129 | Medicine | A | 9/19/2022 | |
| CAMZYOS mavacamten 10 mg capsule blister pack | 386127 | Medicine | A | 9/19/2022 | |
| CAMZYOS mavacamten 15 mg capsule blister pack | 373115 | Medicine | A | 9/19/2022 | |
| CAMZYOS mavacamten 5 mg capsule blister pack | 386128 | Medicine | A | 9/19/2022 |