Talzenna
An oral targeted therapy used to treat BRCA-mutated breast cancer.
Where Talazoparib is approved
All regulators →Of the three regulators tracked here, the first to approve Talazoparib was the US, on 16 Oct 2018. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Talazoparib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Talazoparib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 6 listed patents; the last listed expires 20 Oct 2031 (US 10189837).
- Latest patent on the drug substance itself: 20 Oct 2031 (US 10189837).
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Talazoparib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Talazoparib works
All drug targets →- Poly [ADP-ribose] polymerase 2 inhibitor InhibitorTarget: PARP2 poly(ADP-ribose) polymerase 2✓ In ChEMBL and the Guide to Pharmacology
- Poly [ADP-ribose] polymerase-1 inhibitor InhibitorTarget: PARP1 poly(ADP-ribose) polymerase 1✓ In ChEMBL and the Guide to Pharmacology
- Malignant epithelial tumor of ovaryPhase 3
- Ovarian cancerPhase 3
- Ovarian carcinomaPhase 3
- Prostate cancerPhase 3
- Psoriatic arthritisPhase 3
- CancerPhase 2
- Colorectal cancerPhase 2
- Digestive system neoplasmPhase 2
- Endometrial cancerPhase 2
- Fallopian tube cancerPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3137320, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 8313, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Talazoparib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Talazoparib. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Talazoparib with enzalutamide for untreated hormone-relapsed metastatic prostate cancer NICE TA1130 | Optimised | 11 Feb 2026 | Current |
| Talazoparib for treating HER2-negative advanced breast cancer with germline BRCA mutations NICE TA952 | Recommended | 21 Feb 2024 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Talazoparib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: TalzennaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Talazoparib
- ATC code
- L01XX60
- ChEMBL
- CHEMBL3137320
- DrugBank
- DB11760
- PubChem CID
- 135565082
- CAS number
- 1207456-01-6
- FDA UNII
- 9QHX048FRV
- Wikidata
- Q25100990
- Wikipedia
- Talazoparib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Talzenna is used for
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. ( 1.1 ) 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). ( 1.2 ) 1.1 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 epiderm…
How it works
12.1 Mechanism of Action Talazoparib is an inhibitor of PARP enzymes, including PARP1 and PARP2, which play a role in DNA repair. In vitro studies with cancer cell lines that harbored defects in DNA repair genes, including BRCA1 and BRCA2 , have shown that talazoparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, decreased cell proliferation, and apoptosis. Talazoparib anti-tumor activity was observed in patient-derived xenograft breast cancer models bearing mutated BRCA1 or mutated BRCA2 or wild type BRCA1 and BRCA2 .
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 6 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.