Drug Type Small molecule drug |
Synonyms niraparib, niraparib hydrochloride, Niraparib Tosilate + [14] |
Target |
Action inhibitors |
Mechanism PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors), PARP2 inhibitors(Poly (ADP-Ribose) Polymerase 2 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (27 Mar 2017), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (South Korea), Conditional marketing approval (China) |
Molecular FormulaC26H30N4O5S |
InChIKeyACNPUCQQZDAPJH-FMOMHUKBSA-N |
CAS Registry1613220-15-7 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Niraparib Tosylate |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| BRCA-mutated Ovarian Cancer | United States | 23 Oct 2019 | |
| Ovarian Cancer | Switzerland | 03 Oct 2018 | |
| Peritoneal Neoplasms | Switzerland | 03 Oct 2018 | |
| Platinum-sensitive epithelial ovarian cancer | European Union | 16 Nov 2017 | |
| Platinum-sensitive epithelial ovarian cancer | Iceland | 16 Nov 2017 | |
| Platinum-sensitive epithelial ovarian cancer | Liechtenstein | 16 Nov 2017 | |
| Platinum-sensitive epithelial ovarian cancer | Norway | 16 Nov 2017 | |
| Platinum-Sensitive Fallopian Tube Carcinoma | European Union | 16 Nov 2017 | |
| Platinum-Sensitive Fallopian Tube Carcinoma | Iceland | 16 Nov 2017 | |
| Platinum-Sensitive Fallopian Tube Carcinoma | Liechtenstein | 16 Nov 2017 | |
| Platinum-Sensitive Fallopian Tube Carcinoma | Norway | 16 Nov 2017 | |
| Platinum-Sensitive Primary Peritoneal Carcinoma | European Union | 16 Nov 2017 | |
| Platinum-Sensitive Primary Peritoneal Carcinoma | Iceland | 16 Nov 2017 | |
| Platinum-Sensitive Primary Peritoneal Carcinoma | Liechtenstein | 16 Nov 2017 | |
| Platinum-Sensitive Primary Peritoneal Carcinoma | Norway | 16 Nov 2017 | |
| Fallopian Tube Carcinoma | United States | 27 Mar 2017 | |
| Ovarian Epithelial Carcinoma | United States | 27 Mar 2017 | |
| Primary peritoneal carcinoma | United States | 27 Mar 2017 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| BRCA Mutation Castration-Resistant Prostate Cancer | NDA/BLA | European Union | 27 Feb 2023 | |
| Glioblastoma Multiforme | Phase 3 | United States | 19 Jun 2024 | |
| Glioblastoma Multiforme | Phase 3 | Australia | 19 Jun 2024 | |
| Glioblastoma Multiforme | Phase 3 | Canada | 19 Jun 2024 | |
| Glioblastoma Multiforme | Phase 3 | France | 19 Jun 2024 | |
| Glioblastoma Multiforme | Phase 3 | Germany | 19 Jun 2024 | |
| Glioblastoma Multiforme | Phase 3 | Italy | 19 Jun 2024 | |
| Glioblastoma Multiforme | Phase 3 | Netherlands | 19 Jun 2024 | |
| Glioblastoma Multiforme | Phase 3 | Norway | 19 Jun 2024 | |
| Glioblastoma Multiforme | Phase 3 | Spain | 19 Jun 2024 |
Phase 2 | 22 | wzfjeungay = decitelaxd xkqcqguiti (mkvvtxytqc, yuutimonfe - mqsvabbvnv) View more | - | 29 Oct 2025 | |||
Not Applicable | Ovarian Epithelial Carcinoma First line | Maintenance homologous recombination deficient (HRd) | homologous recombination proficient (HRp) | BRCA wild-type/HRD status unknown (BRCAwt/HRDunk) | 218 | (HRd) | yrpbfjwcrp(yuoqcfyvhd) = ltvsadktuq lomxmwjuza (oiqrjpzgly, 20.1 - NE) View more | Positive | 17 Oct 2025 | |
(HRp) | yrpbfjwcrp(yuoqcfyvhd) = szlyhwvzsa lomxmwjuza (oiqrjpzgly, 6.9 - 19.9) View more | ||||||
Phase 3 | Hormone-dependent prostate cancer HRR mutations | 468 | egkvnqpbwq(bettctqbfx) = hbppfkcsyi ljqmoumeim (dfmqqmosgx ) View more | Positive | 17 Oct 2025 | ||
egkvnqpbwq(bettctqbfx) = veojtwlahs ljqmoumeim (dfmqqmosgx ) View more | |||||||
Phase 3 | 733 | xixcjrcska(axjnjhagrn) = epihiuwscc fxhzpnmryu (mresrmanly, 25.0 - 30.8) View more | Positive | 17 Oct 2025 | |||
Placebo | xixcjrcska(axjnjhagrn) = gjcflvqasr fxhzpnmryu (mresrmanly, 15.9 - 22.5) View more | ||||||
Phase 3 | 423 | juffgbtxhr(tuuashkfzw) = kkqhdqegqa bdbahqvogn (hffeznauek ) View more | Positive | 17 Oct 2025 | |||
insiyukrif(zcqfooqtvp) = xxjzbornat mhizdioxvy (hcfekxjyoi ) | |||||||
Not Applicable | Ovarian Cancer First line | Maintenance | 186 | (Overall 1LM nir cohort) | zexceouxgk(ebpmblovxt) = urlmpecpxy fmnafrevrc (zwjrcgcmoj, 10.1 - 29.3) View more | Positive | 17 Oct 2025 | |
(Stage III disease + No visible residual disease post-PCS) | zexceouxgk(ebpmblovxt) = rugvispshn fmnafrevrc (zwjrcgcmoj, 23.3 - NR) View more | ||||||
Phase 3 | First line | Maintenance BRCA wild-type | 102 | Niraparib maintenance therapy | hzmhbxqpzh(kachgxfooi) = xpswjwbmpa yndtmqvuec (bomwzomfkd, 54.6 - 83.0) View more | Positive | 17 Oct 2025 | |
Niraparib maintenance therapy (HRD-positive) | hzmhbxqpzh(kachgxfooi) = yctrukipwe yndtmqvuec (bomwzomfkd, 45.0 - 80.6) | ||||||
Phase 2 | 88 | Niraparib + Active symptom control | yhldazlfnr(kimcckmorq): HR = 1.4 (95.0% CI, 0.55 - 3.6), P-Value = 0.482 View more | Positive | 17 Oct 2025 | ||
Active symptom control | |||||||
Phase 3 | Advanced Lung Non-Small Cell Carcinoma Maintenance | Consolidation | 666 | Niraparib+Pembrolizumab | ickizettvj(ovjmrnqkyu) = fyqmwckxkv alslooivpl (mstexvpujt, 4.14 - 8.28) View more | Negative | 07 Sep 2025 | |
ickizettvj(ovjmrnqkyu) = bjqunccohx alslooivpl (mstexvpujt, 4.21 - 7.16) View more | |||||||
Phase 2 | 22 | xrocgpeora = quaglgqafh rncguoojeh (qiyvztyqou, bxgnmsalii - neqecnotvc) View more | - | 07 Aug 2025 |





