TALZENNA (talazoparib tosylate)
Talzenna treats adults with specific forms of advanced breast and prostate cancers that involve genetic mutations. It is used as a standalone therapy for patients with HER2-negative breast cancer that is locally advanced or has spread, provided they have a germline BRCA mutation. In cases of metastatic castration-resistant prostate cancer, it is used in combination with enzalutamide for patients with HRR gene mutations. Healthcare providers use specialized diagnostic tests to identify the specific genetic markers required for this therapy.
How TALZENNA Works
Talzenna works by inhibiting PARP enzymes, specifically PARP1 and PARP2, which are essential for repairing damaged DNA. By blocking these enzymes and trapping them on DNA, the drug causes significant DNA damage and prevents cancer cells from multiplying. This process eventually leads to programmed cell death, particularly in tumors with existing DNA repair deficiencies.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-10-16
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- CAPSULE
TALZENNA Approval History
What TALZENNA Treats
2 indicationsTALZENNA is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
- Prostate Cancer
TALZENNA Target & Pathway
ProTarget
TALZENNA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TALZENNA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TALZENNA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TALZENNA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04511039 | I 650120 R37CA282430 | Ph 1 | recruiting | Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer |
| NCT04693468 | 2020-0436 NCI-2020-06041, 2020-0436 | Ph 1 | recruiting | Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial |
| NCT04756765 | IRB-59141 BRS0126, NCI-2023-01961 | Ph 2 | withdrawn | Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer |
| NCT04207190 | I 435819 NCI-2019-07826, I 435819 | Ph 1 | completed | Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia |
| NCT04173507 results posted | S1900C NCI-2019-07142, S1900C | Ph 2 | completed | Combination Treatment (Talazoparib Plus Avelumab) for Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer With STK11 Gene Mutation (A LUNG-MAP Treatment Trial) |
| NCT02401347 results posted | IRB-31913 NCI-2015-00036, BRS0050 | Ph 2 | completed | Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TALZENNA FDA Label Details
Indications & Usage
FDA Label (PDF)TALZENNA is indicated for the treatment of Breast Cancer; Prostate Cancer.
TALZENNA Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TALZENNA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 420 active patents
Trial Analysis
- • 6 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment