NDAORALCAPSULEPriority Review
Approved
Oct 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
44
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TALZENNA (talazoparib) is an oral small-molecule PARP inhibitor approved in 2018 for treatment of BRCA-mutated advanced breast cancer and other DNA repair-deficient malignancies. It works by inhibiting poly(ADP-ribose) polymerase, blocking tumor cell repair pathways and triggering apoptosis in cancer cells with homologous recombination deficiency. The drug is administered as an oral capsule and represents a precision oncology approach targeting genetic vulnerabilities.
$15MPart D
Peak5.3 years to LOEAt peak lifecycle with modest Part D utilization, suggesting a mature, stable commercial footprint with likely smaller, specialized brand teams focused on genetic testing partnerships and specialist engagement.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (44)
Korea Post Marketing Surveillance (PMS) Study of Talzenna®
Started Jun 2027
600 enrolled
Breast Neoplasms
A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate
Started May 2026
126 enrolled
Prostate Cancer (Adenocarcinoma)mCRPC (Metastatic Castration-resistant Prostate Cancer)
A Study to Learn About the Safety of TALZENNA in People With Prostate Cancer.
Started Jul 2025
1 enrolled
Prostate Cancer
A Study to Learn About the Safety of TALZENNA for the Treatment of Breast Cancer
Started Apr 2025
3 enrolled
Breast Cancer
ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
Started Apr 2023
33 enrolled
Ovarian CancerPeritoneal CancerFallopian Tube Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.