Drugs / Talazoparib
Talazoparib
also known as
BMN-673 · Talzenna · MDV3800 · BMN 673ts · LT-673 · PF-06944076 · TALAZOPARIB (BMN 673) · Talazoparib 1 MG Oral Capsule [Talzenna] · +2 more
Small molecule targets PARP1, PARP2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (6) | US (FDA) | TALZENNA | — | 2019-09-24 – 2025-06-12 | fda.gov ↗ |
| Approved | EU (EMA) | Talzenna | — | 2019-06-20 | europa.eu ↗ |
| Approved | US (FDA) | TALZENNA | — | 2018-10-16 | fda.gov ↗ |
Trials 104 · started per year
today
US approved 2018
EU approved 2019
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Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02392793 Comparator | Mar 2015 → Feb 2019 | childhood malignant neoplasm | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04901702 Comparator | Jun 2021 → Dec 2026 expected | Ewing sarcoma, Wilms tumor, hepatoblastoma, malignant germ cell tumor +5 | St. Jude Children's Research Hospital | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06844383 Comparator | May 2026 → Mar 2029 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | Prostate Cancer Clinical Trials Consortium | Recruiting | No outcome recorded |
Press releases naming this drug 15 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Pfizer | FDA Grants Priority Review for Pfizer’s TALZENNA Plus XTANDI for the Treatment of Metastatic Prostate Cancer pfizer.com ↗ |
| 2026-05-30 | Pfizer | TALZENNA Plus XTANDI Improves Radiographic Progression-Free Survival by More Than 50% in Metastatic Prostate Cancer pfizer.com ↗ |
| 2026-03-19 | Pfizer | TALZENNA Plus XTANDI Significantly Improves Radiographic Progression-Free Survival in Metastatic Prostate Cancer pfizer.com ↗ |
| 2025-02-13 | Pfizer | Pfizer’s TALZENNA® in Combination with XTANDI® Improves Survival Outcomes in Metastatic Castration Resistant Prostate Cancer pfizer.com ↗ |
| 2024-10-10 | Pfizer | Pfizer’s TALZENNA® in Combination with XTANDI® Prolongs Overall Survival in Phase 3 TALAPRO-2 Trial pfizer.com ↗ |
| 2024-01-08 | Pfizer | European Commission Approves Pfizer’s TALZENNA® in Combination with XTANDI® for Adult Patients with Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗ |
| 2023-06-20 | Pfizer | Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval pfizer.com ↗ |
| 2023-02-16 | Pfizer | Pfizer Announces Positive TALZENNA® and XTANDI® Combination Data from Phase 3 TALAPRO-2 Study pfizer.com ↗ |
| 2021-06-23 | Pfizer | First Participant Dosed in Pfizer’s Pivotal Phase 3 TALAPRO-3 Combination Study of Talazoparib and Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (mCSPC) pfizer.com ↗ |
| 2019-06-21 | Pfizer | European Commission Approves TALZENNA® (talazoparib) for Patients with Inherited (Germline) BRCA-Mutated Locally Advanced or Metastatic Breast Cancer pfizer.com ↗ |
| 2019-04-26 | Pfizer | Pfizer Receives Positive CHMP Opinion for TALZENNA® (talazoparib) for Patients with Inherited (Germline) BRCA-Mutated Locally Advanced or Metastatic Breast Cancer pfizer.com ↗ |
| 2018-10-16 | Pfizer | U.S. FDA Approves TALZENNA® (talazoparib) pfizer.com ↗ |
| 2018-06-07 | Pfizer | U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation pfizer.com ↗ |
| 2017-12-08 | Pfizer | Talazoparib Significantly Extends Progression-Free Survival in Phase 3 EMBRACA Trial of Patients with Metastatic Breast Cancer pfizer.com ↗ |
| 2017-06-03 | Pfizer | Pfizer Presents Final Phase 2 Data on Investigational PARP Inhibitor Talazoparib in Patients with Germline BRCA-Positive Advanced Breast Cancer pfizer.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 109 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | talazoparib | “Participants will receive standard of care PARPi (Olaparib or Talazoparib) therapy in Step 2 and Step 3.” NCT05826964 ↗98“the PARP inhibitor, talazoparib, in patients with advanced triple negative breast cancer” PMID 40471518 ↗ Jun 2025 “Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect.” NCT05406999 ↗ |
| Known as | BMN 673ts | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137320 ↗ |
| Known as | BMN-673 | “The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's...” NCT01945775 ↗11“The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or...” NCT02034916 ↗ “The new experimental drug is called talazoparib (also known as BMN-673), and it is not approved by the Federal Drug Administration (FDA).” NCT02878785 ↗ “Talazoparib (formerly MDV3800 and BMN673) is an oral small molecule, selective inhibitor of PARP-1 and PARP-2.” NCT03964532 ↗ |
| Known as | LT-673 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137320 ↗ |
| Known as | MDV3800 | “Pharmacodynamic effects of the PARP inhibitor talazoparib (MDV3800, BMN 673) in patients with BRCA-mutated advanced solid tumors.” PMID 38010394 ↗ Nov 20231“Talazoparib (formerly MDV3800 and BMN673) is an oral small molecule, selective inhibitor of PARP-1 and PARP-2.” NCT03964532 ↗ |
| Known as | PF-06944076 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137320 ↗ |
| Known as | TALAZOPARIB (BMN 673) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137320 ↗ |
| Known as | Talazoparib 1 MG Oral Capsule [Talzenna] | “Talazoparib 1 MG Oral Capsule [Talzenna]” NCT06193525 ↗ |
| Known as | Talazoparib tosilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137320 ↗ |
| Known as | Talazoparib Tosylate | “Drug: Talazoparib Tosylate” NCT04173507 ↗ |
| Known as | Talzenna | “This arm of the Strata PATH trial will assess the clinical benefit of Talzenna® (talazoparib) in patients with advanced solid tumors harboring deep deletions or deleterious...” NCT05097599 ↗3“The purpose of this study is to evaluate how effective the study drugs, nivolumab (also known as Opdivo®) and talazoparib (also known as Talzenna®) are when given as a...” NCT04187833 ↗ “This is an open label, non randomised, investigator-initiated Phase II study of single agent talazoparib (Talzenna®) in metastatic triple negative breast cancer patients with...” NCT05288127 ↗ “Talazoparib 1 MG [Talzenna]” NCT05319249 ↗ |
| Action | Inhibit | “Poly [ADP-ribose] polymerase-1 inhibitor” CHEMBL3137320 ↗ |
| Modality | Small molecule | “Talazoparib (formerly MDV3800 and BMN673) is an oral small molecule” NCT03964532 ↗ |
| Route | Oral | “Orally Administered Talazoparib” NCT01286987 ↗ |
| Target | PARP1 | “Poly [ADP-ribose] polymerase-1 inhibitor” CHEMBL3137320 ↗ |
| Target | PARP2 | “Poly [ADP-ribose] polymerase 2 inhibitor” CHEMBL3137320 ↗ |