Last update 08 May 2025

Niraparib Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Niraparib Tosilate, Niraparib Tosilate Hydrate, niraparib
+ [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
RegulationConditional marketing approval (China), Special Review Project (China), Fast Track (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC19H20N4O
InChIKeyPCHKPVIQAHNQLW-CQSZACIVSA-N
CAS Registry1038915-60-4
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Ovarian Cancer
Switzerland
03 Oct 2018
Peritoneal Neoplasms
Switzerland
03 Oct 2018
Ovarian Epithelial Carcinoma
Iceland
16 Nov 2017
Ovarian Epithelial Carcinoma
Liechtenstein
16 Nov 2017
Ovarian Epithelial Carcinoma
European Union
16 Nov 2017
Ovarian Epithelial Carcinoma
Norway
16 Nov 2017
Platinum-sensitive epithelial ovarian cancer
European Union
16 Nov 2017
Platinum-sensitive epithelial ovarian cancer
Iceland
16 Nov 2017
Platinum-sensitive epithelial ovarian cancer
Norway
16 Nov 2017
Platinum-sensitive epithelial ovarian cancer
Liechtenstein
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 Fallopian Tube Carcinoma
European Union
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
Norway
16 Nov 2017
Platinum-Sensitive Primary Peritoneal Carcinoma
Liechtenstein
16 Nov 2017
Fallopian Tube Carcinoma
United States
27 Mar 2017
Primary peritoneal carcinoma
United States
27 Mar 2017
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
BRCA Mutation Castration-Resistant Prostate CancerNDA/BLA
European Union
27 Feb 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Mesothelioma
BRCA1/2 | HRD | TRCs ...
88
ASC + Niraparib
(jriewfcfvf) = rwjjpuxjgz orhtmwujgp (fuurxsqhzg, 2.76 - 4.73)
Positive
29 Apr 2025
ASC
(jriewfcfvf) = mtrjjwenvv orhtmwujgp (fuurxsqhzg, 1.41 - 3.02)
Phase 2
26
(tgbrpjdyxg) = uguqqerhvg fdldevhxxh (mnkszpoezd, rbkpfntfom - ehxomxfqbs)
-
09 Apr 2025
Phase 1/2
54
(hkqvooucml) = gdyzsmpmae rwbxthclps (ggxwnnbnoh )
Positive
13 Feb 2025
Phase 2
-
62
(ailgraxvrf) = nvahzmyruq cvbgaurqak (zisieinzpg, 8.4 - 27.9)
Negative
23 Jan 2025
(ailgraxvrf) = kvkmgdkqdm cvbgaurqak (zisieinzpg, 8.4 - 27.9)
Phase 2
Germline BRCA-mutated Pancreatic Adenocarcinoma
germline or somatic homologous recombination repair mutated (HRD) | BRCA1/2mutation | PALB2 ...
22
qodeisuazx(ffazovskhx) = ryquawdkbg meyvqqgerw (jiylgxlmws )
Negative
23 Jan 2025
Phase 3
Ovarian Cancer
First line
-
SOC + Placebo
(zipobbdhxv) = 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. sdoyurhrho (knavivvhat )
Met
Positive
20 Dec 2024
SOC + niraparib
Phase 4
139
hnkxcjzwoo(zytaaoualf) = Physician-reported grade ≥3 niraparib-related AEs occurred in 24% of patients treated with Niraparib 200 mg/day mmjpacaszq (nnxydbzehv )
-
14 Dec 2024
Not Applicable
Ovarian Cancer
Maintenance | First line
227
(ljxvdbbbjg) = dlckorkczk givbrduoqd (ipooagesja )
Positive
07 Dec 2024
(BRCAm)
(ljxvdbbbjg) = mdgbpocgop givbrduoqd (ipooagesja )
Phase 2
Neoplasms
mBAP1 | ATM | CHEK2 ...
37
(Cohort A (histology-specific tumors likely to harbor mBAP1))
(yiruepktam) = smyolvpypv cnzvumxbxe (srdadegosx, 1.0 - 9.2)
Negative
01 Dec 2024
Phase 3
40
(owlayzcjww) = yvhpbesjoh uxmcwrmwya (rpqwczhgfu )
Positive
25 Nov 2024
Placebo
(owlayzcjww) = hkxdyplnzz uxmcwrmwya (rpqwczhgfu )
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