Overview
Talazoparib is an inhibitor of mammalian polyadenosine 5’-diphosphoribose polymerases (PARPs), enzymes responsible for regulating essential cellular functions, such as DNA transcription and DNA repair. Developed by Pfizer, talazoparib was first approved by the FDA in October 2018 and by the EMA in June 2019. It was approved by Health Canada in September 2020. Talazoparib is currently used in the treatment of BRCA-mutated breast cancer and HRR-mutated prostate cancer.
Background
Talazoparib is an inhibitor of mammalian polyadenosine 5’-diphosphoribose polymerases (PARPs), enzymes responsible for regulating essential cellular functions, such as DNA transcription and DNA repair. Developed by Pfizer, talazoparib was first approved by the FDA in October 2018 and by the EMA in June 2019. It was approved by Health Canada in September 2020. Talazoparib is currently used in the treatment of BRCA-mutated breast cancer and HRR-mutated prostate cancer.
Indication
Talazoparib is indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. This indication is approved by the FDA, EMA, and Health Canada. In the US, talazoparib is also indicated in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Associated Conditions
- HRR gene-mutated (HRRm) metastatic castration-resistant prostate cancer (mCRPC)
- Metastatic Breast Cancer
- Locally Advanced Breast Cancer (LABC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/25 | Phase 2 | Not yet recruiting | Prostate Cancer Clinical Trials Consortium | ||
2025/01/08 | Phase 2 | Not yet recruiting | |||
2024/01/23 | Phase 1 | Recruiting | |||
2024/01/05 | Phase 2 | Recruiting | |||
2023/05/24 | Phase 2 | Not yet recruiting | |||
2023/02/13 | Phase 2 | Recruiting | Oslo University Hospital | ||
2022/12/14 | N/A | AVAILABLE | |||
2022/06/21 | Phase 1 | Suspended | Peter MacCallum Cancer Centre, Australia | ||
2022/04/14 | Phase 2 | Recruiting | |||
2022/04/08 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| U.S. Pharmaceuticals | 63539-295 | ORAL | 1 mg in 1 1 | 6/19/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-1031 | ORAL | 0.1 mg in 1 1 | 6/19/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0655 | ORAL | 0.75 mg in 1 1 | 6/19/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-1235 | ORAL | 0.35 mg in 1 1 | 6/19/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0757 | ORAL | 1.0 mg in 1 1 | 6/19/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-1501 | ORAL | 0.5 mg in 1 1 | 6/19/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0353 | ORAL | 0.25 mg in 1 1 | 6/19/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0252 | ORAL | 0.1 mg in 1 1 | 6/19/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0546 | ORAL | 0.5 mg in 1 1 | 6/19/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-1195 | ORAL | 1 mg in 1 1 | 6/19/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/20/2019 | ||
Authorised | 6/20/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TALZENNA CAPSULE 0.25MG | SIN15944P | CAPSULE | 0.25 mg | 5/22/2020 | |
| TALZENNA CAPSULE 1MG | SIN15945P | CAPSULE | 1 mg | 5/22/2020 | |
| TALZENNA CAPSULE 0.1MG | SIN17238P | CAPSULE | 0.1 mg | 5/21/2025 | |
| TALZENNA CAPSULE 0.35MG | SIN17239P | CAPSULE | 0.35 mg | 5/21/2025 | |
| TALZENNA CAPSULE 0.5MG | SIN17240P | CAPSULE | 0.5 mg | 5/21/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Talazoparib Tosylate Capsules | 国药准字HJ20240121 | 化学药品 | 胶囊剂 | 10/29/2024 | |
| Talazoparib Tosylate Capsules | 国药准字HJ20240122 | 化学药品 | 胶囊剂 | 10/29/2024 | |
| Talazoparib Tosylate Capsules | 国药准字HJ20240124 | 化学药品 | 胶囊剂 | 10/29/2024 | |
| Talazoparib Tosylate Capsules | 国药准字HJ20240123 | 化学药品 | 胶囊剂 | 10/29/2024 |
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 |
|---|---|---|---|---|---|
| TALZENNA talazoparib (as tosilate) 0.5 mg capsule bottle | 407814 | Medicine | A | 8/14/2024 | |
| TALZENNA talazoparib (as tosilate) 1 mg capsule blister pack | 310752 | Medicine | A | 11/18/2019 | |
| TALZENNA talazoparib (as tosilate) 0.25 mg capsule blister pack | 310750 | Medicine | A | 11/18/2019 | |
| TALZENNA talazoparib (as tosilate) 0.25 mg capsule bottle | 310751 | Medicine | A | 11/18/2019 | |
| TALZENNA talazoparib (as tosilate) 0.35 mg capsule bottle | 407813 | Medicine | A | 8/14/2024 | |
| TALZENNA talazoparib (as tosilate) 1 mg capsule bottle | 310749 | Medicine | A | 11/18/2019 | |
| TALZENNA talazoparib (as tosilate) 0.1 mg capsule bottle | 407812 | Medicine | A | 8/14/2024 |