Niraparib
Poly (Adp-Ribose) Polymerase (Parp) Inhibitors
Sold as ZEJULA · AKEEGA
- Drug class
- Poly (Adp-Ribose) Polymerase (Parp) Inhibitors
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 8
Overview
Niraparib is an active pharmaceutical ingredient in the Poly (Adp-Ribose) Polymerase (Parp) Inhibitors group (L01XK). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 3 | May 26, 2026 |
| EU European Union | EMA | 2 | March 17, 2026 |
| GB United Kingdom | MHRA | 3 | December 19, 2025 |
CACanada· Health Canada
3 products
Uses
PrAKEEGA® (niraparib and abiraterone acetate) is indicated with prednisone or prednisolone for: The treatment of adult patients with deleterious or suspected deleterious BRCA mutated (germline and/or somatic) metastatic castration resistant prostate cancer (mCRPC), who are asymptomatic/mildly symptomatic, and in whom chemotherapy is not clinically indicated.
Patients must have confirmation of BRCA mutation before AKEEGA treatment is initiated. The efficacy of AKEEGA in patients with visceral metastases is uncertain (See 14 CLINICAL TRIALS). 1 Pediatrics (<18 years of age) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics (≥65 years of age) No overall differences in safety and efficacy of niraparib and abiraterone acetate combination therapy were observed between these patients and younger patients, however, greater sensitivity of some older individuals cannot be ruled out (see 7 WARNINGS AND PRECAUTIONS).
EUEuropean Union· EMA
2 products
Uses
Akeega is indicated with prednisone or prednisolone: in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic).
for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
How to take
GBUnited Kingdom· MHRA
3 products
3 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Drug interactions
Known interactions involving Niraparib. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 301. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 02538555 · revised April 8, 2025
- [2]European Medicines Agency · EMEA/H/C/005932 · revised March 17, 2026
- [3]MHRA (UK) · PLPI459850598 · revised December 19, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.