Last update 28 Mar 2025

Niraparib Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
niraparib, niraparib hydrochloride, Niraparib Tosilate
+ [14]
Action
inhibitors
Mechanism
PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors), PARP2 inhibitors(Poly (ADP-Ribose) Polymerase 2 inhibitors)
Originator Organization
Drug Highest PhaseApproved
RegulationFast Track (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Breakthrough Therapy (United States)
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Structure/Sequence

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
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
BRCA Mutation Castration-Resistant Prostate CancerNDA/BLA
European Union
27 Feb 2023
GlioblastomaPhase 3
United States
19 Jun 2024
GlioblastomaPhase 3
France
19 Jun 2024
GlioblastomaPhase 3
Spain
19 Jun 2024
Pancreatic CancerPhase 3
China
30 May 2023
Triple Negative Breast CancerPhase 3
United States
28 Jun 2021
Triple Negative Breast CancerPhase 3
Japan
28 Jun 2021
Triple Negative Breast CancerPhase 3
Argentina
28 Jun 2021
Triple Negative Breast CancerPhase 3
Australia
28 Jun 2021
Triple Negative Breast CancerPhase 3
Austria
28 Jun 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
54
bpnbpakboj(kedueguyte) = aodnbtswlc gngkpvqwzx (yjjtrmestx )
Positive
13 Feb 2025
Phase 2
-
62
nfxpvmjbyn(ylwdzokmru) = xkfgcuwdbr aebxracsgh (dkyazgpkmq, 8.4 - 27.9)
Negative
23 Jan 2025
nfxpvmjbyn(ylwdzokmru) = jsxazjmvqs aebxracsgh (dkyazgpkmq, 8.4 - 27.9)
Phase 2
Germline BRCA-mutated Pancreatic Adenocarcinoma
germline or somatic homologous recombination repair mutated (HRD) | BRCA1/2mutation | PALB2 ...
22
nmwiqofdyh(scgsajspqv) = islwtgboze vthuhnovbj (kwwbvnnoyj )
Negative
23 Jan 2025
Phase 3
Ovarian Cancer
First line
-
SOC + Placebo
jbnggzwhpj(gjratndqke) = The trial met its primary endpoint of PFS demonstrating a statistically significant difference with the addition of dostarlimab to both standard of care carboplatin-paclitaxel chemotherapy and niraparib maintenance, with or without bevacizumab. gpsfbrsmru (luprazpdsz )
Met
Positive
20 Dec 2024
SOC + niraparib
Phase 4
139
corluulxaf(ewdhdithax) = Physician-reported grade ≥3 niraparib-related AEs occurred in 24% of patients treated with Niraparib 200 mg/day delktehpid (xktkxankzo )
-
14 Dec 2024
Not Applicable
Ovarian Cancer
Maintenance | First line
227
wlwzbaokur(qihgppuflh) = ckvntwpibe venovoyzwq (jloiflrkcv )
Positive
07 Dec 2024
(BRCAm)
wlwzbaokur(qihgppuflh) = ealebtexek venovoyzwq (jloiflrkcv )
Phase 2
mBAP1 | ATM | CHEK2 ...
37
(Cohort A (histology-specific tumors likely to harbor mBAP1))
luistncaly(dmvaoydict) = trhofleqyj kcvofjwzee (ryjfuwmwsx, 1.0 - 9.2)
Negative
01 Dec 2024
Phase 3
Triple Negative Breast Cancer | BRCA mutation positive Breast Cancer
Hormone Receptor Positive | Circulating Tumor-Derived DNA Positive | HER2 Negative
40
umixerjook(arwgpgqzjk) = sqbmakdpwg ftoujnwvkh (wfxepsselj )
Positive
25 Nov 2024
Placebo
umixerjook(arwgpgqzjk) = mnbnowmmhk ftoujnwvkh (wfxepsselj )
Phase 2
15
rngbkjanyw = afbcbxwvmc giqeibfemt (uezxyxscog, qwlwbevajp - ynstywtuqr)
-
06 Nov 2024
Phase 2
Ovarian Epithelial Carcinoma
First line
homologous recombination (HR) proficient (HRp) | undefined HR status (HRunk)
105
Niraparib + Bevacizumab
oxsuvtqncg(aynthzlgbv) = ekhqwhxeey ndmxheylqc (audohhkzvn, 16.5 - 25.1)
Positive
01 Nov 2024
(Homologous recombination proficient (HRp) EOC)
oxsuvtqncg(aynthzlgbv) = txhhrgubvz ndmxheylqc (audohhkzvn, 8.6 - 16.8)
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