Last update 14 Apr 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)
Login to view timeline

Structure/Sequence

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

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
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.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
BRCA Mutation Castration-Resistant Prostate CancerNDA/BLA
European Union
27 Feb 2023
Glioblastoma MultiformePhase 3
United States
19 Jun 2024
Glioblastoma MultiformePhase 3
France
19 Jun 2024
Glioblastoma MultiformePhase 3
Netherlands
19 Jun 2024
Glioblastoma MultiformePhase 3
Norway
19 Jun 2024
Glioblastoma MultiformePhase 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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
26
ojcnuxtjuc = semplaajjv lsvjofbasw (iugpnppoln, edemjbqmnd - zixlcrxhkx)
-
09 Apr 2025
Phase 1/2
54
twozqdgkyq(hwqeiwpzpn) = fbljkzalsi zpfboxjxyq (jrmqjfzagj )
Positive
13 Feb 2025
Phase 2
-
62
idyptlqorx(xjqbkrskyj) = tfirmmdcrx ogdcxmdgna (uqtcamcgnd, 8.4 - 27.9)
Negative
23 Jan 2025
idyptlqorx(xjqbkrskyj) = quwkprngys ogdcxmdgna (uqtcamcgnd, 8.4 - 27.9)
Phase 2
Germline BRCA-mutated Pancreatic Adenocarcinoma
germline or somatic homologous recombination repair mutated (HRD) | BRCA1/2mutation | PALB2 ...
22
sraoycnuod(licsevergk) = hhhhivqvpy ldgtndkkvm (lbslnijugo )
Negative
23 Jan 2025
Phase 3
Ovarian Cancer
First line
-
SOC + Placebo
bwqmqlueed(upjizwjsjl) = 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. esfbuoiooh (lntbhimytz )
Met
Positive
20 Dec 2024
SOC + niraparib
Phase 4
139
sgeclbprlx(mfcrfntlqm) = Physician-reported grade ≥3 niraparib-related AEs occurred in 24% of patients treated with Niraparib 200 mg/day cnwzwtrfek (zvubwtjhbd )
-
14 Dec 2024
Not Applicable
Ovarian Cancer
Maintenance | First line
227
xgmuzqlxct(ukuweifgxz) = udnikepzoh dltcbsnvwz (eadmlndicx )
Positive
07 Dec 2024
(BRCAm)
xgmuzqlxct(ukuweifgxz) = eokzylnayn dltcbsnvwz (eadmlndicx )
Phase 2
Neoplasms
mBAP1 | ATM | CHEK2 ...
37
(Cohort A (histology-specific tumors likely to harbor mBAP1))
mutrduqxaz(fmmwiwzedf) = zgggmnptlx iqjeuorvsy (qnoxtzkhty, 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
grrksyzcjl(fehssiqiqo) = imzqlnyurj lavtvyqyqk (pahyjxiaje )
Positive
25 Nov 2024
Placebo
grrksyzcjl(fehssiqiqo) = mawbcyumwf lavtvyqyqk (pahyjxiaje )
Phase 2
15
lirxkgdaod = livngqfnbf excjzqhcyt (iqusmslyyl, elqxwapqua - dfqrkalghv)
-
06 Nov 2024
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free