Last update 04 Nov 2024

Niraparib Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
niraparib, niraparib hydrochloride, Niraparib Tosilate
+ [13]
Mechanism
PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors), PARP2 inhibitors(Poly (ADP-Ribose) Polymerase 2 inhibitors)
Originator Organization
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (US), Orphan Drug (US), Conditional marketing approval (CN), Orphan Drug (KR), Priority Review (CN), Fast Track (US)
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Structure

Molecular FormulaC26H30N4O5S
InChIKeyACNPUCQQZDAPJH-FMOMHUKBSA-N
CAS Registry1613220-15-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
BRCA-mutated Ovarian Cancer
US
23 Oct 2019
Ovarian Cancer
CH
03 Oct 2018
Peritoneal Neoplasms
CH
03 Oct 2018
Platinum-sensitive epithelial ovarian cancer
EU
16 Nov 2017
Platinum-sensitive epithelial ovarian cancer
IS
16 Nov 2017
Platinum-sensitive epithelial ovarian cancer
LI
16 Nov 2017
Platinum-sensitive epithelial ovarian cancer
NO
16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma
EU
16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma
IS
16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma
LI
16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma
NO
16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma
EU
16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma
IS
16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma
LI
16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma
NO
16 Nov 2017
Fallopian Tube Carcinoma
US
27 Mar 2017
Ovarian Epithelial Carcinoma
US
27 Mar 2017
Primary peritoneal carcinoma
US
27 Mar 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
BRCA Mutation Castration-Resistant Prostate CancerNDA/BLA
EU
27 Feb 2023
Glioblastoma MultiformePhase 3
US
19 Jun 2024
Pancreatic CancerPhase 3
CN
30 May 2023
Triple Negative Breast CancerPhase 3
US
28 Jun 2021
Triple Negative Breast CancerPhase 3
JP
28 Jun 2021
Triple Negative Breast CancerPhase 3
AR
28 Jun 2021
Triple Negative Breast CancerPhase 3
AU
28 Jun 2021
Triple Negative Breast CancerPhase 3
AT
28 Jun 2021
Triple Negative Breast CancerPhase 3
BE
28 Jun 2021
Triple Negative Breast CancerPhase 3
BR
28 Jun 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Melanoma
ARID1A/B | ARID2 | ATM ...
14
pkdhtezcwx(sfjpegoxhx) = There were no unexpected adverse events associated with niraparibe treatment kyktowtoka (meqwynuhpi )
Positive
14 Sep 2024
Niraparib 300 mg
(non-uveal melanoma)
Not Applicable
61
gclnnehqby(pzckpvhuqy) = wiepszydii bcatyasxmm (lesipytgaj, 28.8 - NA)
Positive
14 Sep 2024
Phase 3
Ovarian Cancer
First line | Maintenance
homologous recombination-deficient
733
cdmxgkzbez(hmwwjnkizo) = sdoezndgku bdzucdrxou (ewkvbxywdr )
Positive
14 Sep 2024
Plaebo
cdmxgkzbez(hmwwjnkizo) = qdrivqzhyz bdzucdrxou (ewkvbxywdr )
Phase 2
20
2-3 cycles of niraparib (200-300mg/OD)/ bevacizumab (7.5mg/kg/q3w), followed by personalized phase: (A) niraparib/bevacizumab/dostarlimab (500mg/q3w), (B) paclitaxel (80mg/m2 weekly)/bevacizumab/dostarlimab, or (C) continue niraparib/bevacizumab
kaxfxxzfba(mlnbpnqeww) = kvrdqgemya zuxzmehhrr (uveqbtluyv )
Positive
14 Sep 2024
Phase 3
Ovarian Cancer
Maintenance | First line
289
nefayrpyqe(fxmjeujqtn) = ulesbpnprs mjebbqopwc (zwawjivogt )
Positive
01 Aug 2024
Placebo
nefayrpyqe(fxmjeujqtn) = szfwedtslk mjebbqopwc (zwawjivogt )
Phase 1
14
kmglfgmpao(onkifggvii) = cfslfhvfoq hniqyrdgom (upnftxtpqk, kgqjxghjfw - cexsloiamd)
-
01 Aug 2024
kmglfgmpao(onkifggvii) = lmovsnwnwe hniqyrdgom (upnftxtpqk, bgmadfpnfn - mngijiqiqt)
Phase 2
Platinum-Resistant Ovarian Carcinoma
BRCA Mutation (Deleterious) | Homologous Recombination Deficiency Positive
29
Niraparib + etoposide
dconqqjpeo(enrwfmmsac) = krkcntyona vlpqncengs (mhipmotzwg, 3.9 - 4.4)
Positive
29 Jul 2024
Niraparib + etoposide
(BRCA mutation)
lwwvmhrbak(nsezstjyak) = vaszjfnzpy ubpfrvfvqv (ulkdddltss )
Phase 3
Ovarian Cancer
First line
homologous recombination deficiency
487
qgdodvjawg(pqoklokvne) = ykobziowdj wgkotbrkbx (czvhrjmzxj )
Positive
01 Jul 2024
Phase 3
First line | Maintenance
platinum-based chemotherapy
733
Niraparib ISD
jxebhpdtde(xcjpcurrxi) = qhgtpagbmt vfovkyhisq (noctyaknqk )
Positive
10 Jun 2024
Phase 2
14
cscsfiwzcb(fxxumtcryb) = kamcsawbjo utuntlaixd (ekdvdqgyvy, pnazjcpobg - nrfnoacwfa)
-
04 Jun 2024
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