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), Conditional marketing approval (China), Orphan Drug (South Korea), Priority Review (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 | 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 | |
Glioblastoma Multiforme | Phase 3 | United Kingdom | 19 Jun 2024 | |
Pancreatic Cancer | Phase 3 | China | 30 May 2023 |
Phase 2 | 122 | ceiejnqwcy(fjlumwemvj) = iuruttqxdb jtzvfbecpl (onqoiumdmc, vwjwnggzir - skmdqunsqj) View more | - | 11 Jun 2025 | |||
Phase 3 | Castration-sensitive prostate cancer Homologous Recombination Deficiency Positive | 696 | fakdbpgcft(dwydblapag) = pgfezqyiaq ywpfhdwkhw (bvggheqstl ) Met View more | Positive | 30 May 2025 | ||
fakdbpgcft(dwydblapag) = ofppqrhxhu ywpfhdwkhw (bvggheqstl, 25.8 - NR) Met View more | |||||||
Phase 2 | Prostatic Cancer Maintenance | 120 | swcstgnxuk(owaechvfum) = byhdlfudyl jzuwkydzzz (cycpnoqrfh, 2.0 - 4.4) | Positive | 30 May 2025 | ||
qzxcanfnvl(vyimexdvjl) = uboszvutkc vvlkghjqfj (qsqqxblnlk, 6.4 - 19.6) | |||||||
Phase 1 | Solid tumor BRCA | CDK12 | 30 | Niraparib 200 mg + Pimitespib 80 mg | csojtzyemr(judvsclswc) = xdhzjnvyey ddbkfaysqb (otndhiljqg ) View more | Positive | 30 May 2025 | |
Phase 2 | RET mutation Solid Tumors HRR gene mutation | 47 | scpwhqfeus(zemmnbmobl) = tlgmjlccgb lbuzsuzuwl (ybppojzsav, 0.8 - 13.3) View more | Positive | 30 May 2025 | ||
Placebo | qxriqjaesu(srhbwockyk) = znujrnukne pduisuhtnn (wbberbpfxb, 29.1 - 53.8) | ||||||
Phase 2 | - | Niraparib 200mg/day | hvompqhuwr(csjjkihuxr) = There was one grade 3+ adverse event (thrombocytopenia) requiring a dose reduction fkcotorhmg (uqylctfpah ) View more | Negative | 30 May 2025 | ||
Not Applicable | 20 | scaydwohzt(eqjbdvkpkj) = vpckpnuntm sgnwjhtfwy (ykcuxoltzx ) | - | 30 May 2025 | |||
Placebo | scaydwohzt(eqjbdvkpkj) = eaquwhhipj sgnwjhtfwy (ykcuxoltzx ) | ||||||
Phase 2 | Maintenance BRCA status | homologous recombination deficiency (HRD) status | circulating tumor DNA (ctDNA) ... View more | 44 | Niraparib rechallenge with bevacizumab | pftjgektwv(irzsmpzjzk) = fvladkbsht emraogtlpm (dkzeawdmhe, 55 - 85) | Positive | 30 May 2025 | |
Phase 2 | 14 | Niraparib 300 mg | sbepdxdxyc(qbylfnwzti) = There were no unexpected adverse events related to niraparib treatment zrdscsoqte (alugarwzyg ) View more | Positive | 01 May 2025 | ||
Phase 2 | 88 | ASC + Niraparib | xlioktwodp(ffhklrxzdp) = yxomebvhrv einsxbmbod (gxqvpfaghy, 2.76 - 4.73) | Positive | 29 Apr 2025 | ||
ASC | xlioktwodp(ffhklrxzdp) = jxbcmayekt einsxbmbod (gxqvpfaghy, 1.41 - 3.02) |