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Pharmacokinetics, Dosage of Niraparib
Niraparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes, preventing DNA repair in cancer cells and leading to cell death.
Niraparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes, preventing DNA repair in cancer cells and leading to cell death. Used for Ovarian cancer (platinum-sensitive recurrent, BRCA-mutated, and homologous recombination deficient), Metastatic breast cancer (BRCA-mutated), Prostate cancer (BRCA-mutated, metastatic castration-resistant).
At a glance
| Generic name | Pharmacokinetics, Dosage of Niraparib |
|---|---|
| Sponsor | Hospices Civils de Lyon |
| Drug class | PARP inhibitor |
| Target | PARP1, PARP2 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Niraparib is a PARP inhibitor that blocks PARP1 and PARP2, enzymes critical for single-strand DNA break repair. By inhibiting PARP, the drug causes accumulation of DNA damage in cancer cells, particularly those with BRCA1/2 mutations or homologous recombination deficiency, triggering apoptosis. This mechanism is especially effective in ovarian and breast cancers with defective DNA repair pathways.
Approved indications
- Ovarian cancer (platinum-sensitive recurrent, BRCA-mutated, and homologous recombination deficient)
- Metastatic breast cancer (BRCA-mutated)
- Prostate cancer (BRCA-mutated, metastatic castration-resistant)
Common side effects
- Anemia
- Thrombocytopenia
- Nausea
- Fatigue
- Vomiting
- Constipation
- Leukopenia
Key clinical trials
- A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors (PHASE1, PHASE2)
- A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors (PHASE1, PHASE2)
- A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors (PHASE1)
- NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients. (PHASE4)
- PEN-866 in Patients With Advanced Solid Malignancies (PHASE1, PHASE2)
- Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients (PHASE1)
- A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) (PHASE1)
- The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pharmacokinetics, Dosage of Niraparib CI brief — competitive landscape report
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- Hospices Civils de Lyon portfolio CI