Talazoparib
Poly (Adp-Ribose) Polymerase (Parp) Inhibitors
Sold as Talzenna
- Drug class
- Poly (Adp-Ribose) Polymerase (Parp) Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 9
- FDA reports (12 mo)
- 265
Overview
Talazoparib is an active pharmaceutical ingredient in the Poly (Adp-Ribose) Polymerase (Parp) Inhibitors group (L01XK). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | June 19, 2025 |
| EU European Union | EMA | 1 | August 29, 2025 |
| CA Canada | Health Canada | 5 | March 11, 2026 |
| GB United Kingdom | MHRA | 2 | January 23, 2026 |
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer.
Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. 1 ) HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene ( BRCA )-mutated (g BRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
EUEuropean Union· EMA
1 product
Uses
Breast cancer Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. 1). Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
Prostate cancer Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
How to take
CACanada· Health Canada
5 products
5 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Brands in Canada (1)
GBUnited Kingdom· MHRA
2 products
2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [4].
Drug interactions
Known interactions involving Talazoparib. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 13839d4f-6acf-4f… · revised June 19, 2025 [PDF]
- [2]European Medicines Agency · EMEA/H/C/004674 · revised August 29, 2025
- [3]Health Canada (DPD) · 02492032 · revised March 11, 2026
- [4]MHRA (UK) · PLPI459851122 · revised January 23, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.