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NIRAPARIB
Niraparib inhibits PARP enzymes, causing DNA damage and cell death, while abiraterone inhibits CYP17, reducing androgen production.
Niraparib is a marketed PARP inhibitor primarily indicated for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). Its key strength lies in its mechanism of action, which effectively causes DNA damage and cell death in cancer cells, providing a targeted therapy option. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | NIRAPARIB |
|---|---|
| Target | PARP-1, PARP-2, CYP17 |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
Niraparib works by blocking PARP enzymes, which are involved in DNA repair. This leads to DNA damage, apoptosis, and cell death, especially in cells with BRCA1/2 deficiencies. Abiraterone, on the other hand, inhibits the CYP17 enzyme, which is crucial for androgen production, thereby reducing androgen levels and slowing tumor growth in androgen-sensitive prostate cancer.
Approved indications
- BRCA2-mutated mCSPC
- BRCA-mutated mCRPC
Common side effects
- anemia
- pneumonia
- sudden death
- COVID-19 pneumonia
- pneumocystis jirovecii pneumonia
- pneumonia
- cardio-respiratory arrest
- hypertension
- musculoskeletal pain
- constipation
- nausea
- fatigue
Drug interactions
- Strong CYP3A4 Inducers
- CYP2D6 Substrates
- CYP2C8 Substrates
Key clinical trials
- A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors (PHASE1, PHASE2)
- Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma (PHASE2)
- Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer (PHASE2)
- A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer (PHASE2)
- Niraparib in Patients With Pancreatic Cancer (PHASE2)
- Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer (PHASE3)
- A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (PHASE3)
- A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NIRAPARIB CI brief — competitive landscape report
- NIRAPARIB updates RSS · CI watch RSS