Last update 11 Jul 2024

Niraparib Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Niraparib Tosilate, Niraparib Tosilate Hydrate, niraparib
+ [12]
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 (CN), Special Review Project (CN), Fast Track (US), Breakthrough Therapy (US), Orphan Drug (US), Priority Review (CN)
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Structure

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
CH
03 Oct 2018
Peritoneal Neoplasms
CH
03 Oct 2018
Ovarian Epithelial Carcinoma
EU
16 Nov 2017
Ovarian Epithelial Carcinoma
NO
16 Nov 2017
Ovarian Epithelial Carcinoma
IS
16 Nov 2017
Ovarian Epithelial Carcinoma
LI
16 Nov 2017
Platinum-sensitive epithelial ovarian cancer
EU
16 Nov 2017
Platinum-sensitive epithelial ovarian cancer
IS
16 Nov 2017
Platinum-sensitive epithelial ovarian cancer
NO
16 Nov 2017
Platinum-sensitive epithelial ovarian cancer
LI
16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma
EU
16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma
NO
16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma
IS
16 Nov 2017
Platinum-Sensitive Fallopian Tube Carcinoma
LI
16 Nov 2017
Platinum-Sensitive Primary Peritoneal 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
Fallopian Tube 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
Ovarian Epithelial CarcinomaPhase 1
US
27 Mar 2017
Platinum-Sensitive Ovarian CarcinomaPhase 1
PL
21 Jun 2013
Platinum-Sensitive Ovarian CarcinomaPhase 1
GB
21 Jun 2013
Platinum-Sensitive Ovarian CarcinomaPhase 1
SE
21 Jun 2013
Platinum-Sensitive Ovarian CarcinomaPhase 1
DE
21 Jun 2013
Platinum-Sensitive Ovarian CarcinomaPhase 1
BE
21 Jun 2013
Platinum-Sensitive Ovarian CarcinomaPhase 1
US
21 Jun 2013
Platinum-Sensitive Ovarian CarcinomaPhase 1
IL
21 Jun 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
4
(Niraparib Arm - 100 mg)
qasnvnnprr(vjmugliuli) = bhdbtukoqo ftqapadxff (excnrioqka, drpizxeldl - dunbknpgem)
-
18 Jun 2024
(Niraparib Arm - 200 mg)
xkkasagqhh(rmpzisnzug) = kgecvahjzz zruyufjhhf (bkasrittef, luklkkyeiv - rtrlxiepfe)
Phase 1
Solid tumor
| | | ...
43
(wsjckjgibs) = eegxdpakpr wahbqqfmab (lfvoxzwkqd )
Positive
24 May 2024
Phase 2
37
(nwgxqumzhh) = duodfnramk vlocoxlsgd (tlapoidnrh )
Positive
24 May 2024
(nwgxqumzhh) = vqhwqrxzsv vlocoxlsgd (tlapoidnrh )
Phase 2
HRD-positive Ovarian Cancer
Neoadjuvant
HRD | genomic instability score ≥ 42
127
(xfucudwbcf) = zhelpcedgp ktgjpircjr (yiirdbgfhv )
Positive
24 May 2024
(xfucudwbcf) = velgmuecvg ktgjpircjr (yiirdbgfhv )
Phase 2
-
26
esmjdpiavh(xgrfkqpryo) = lfcxxighxx xgcjrsdajv (jroalcraon, 47.4 - 80.6)
Positive
24 May 2024
Not Applicable
Ovarian Cancer
Maintenance
BRCA mutation | HRD-positive | HRD-negative
-
(eabzqttfix): HR = 0.45 (95% CI, 0.31 - 0.66), P-Value = < 0.0001
Positive
24 May 2024
Placebo
Phase 2
14
Niraparib+aromatase inhibitors
(gBRCAm)
(wqgaenfzcm) = pcpahtiszk tlgknckjkc (lxeexuoeys, 26.4–67.5)
Met
Positive
15 May 2024
Phase 1
236
(Stage 1: Niraparib Tablet)
zkllylgxuj(fbvewemjoi) = wdsurioquh eqrnuvofeb (wzggtjmxag, vaiismabxj - ivvfyecbww)
-
26 Apr 2024
(Stage 1: Niraparib Capsule)
zkllylgxuj(fbvewemjoi) = rbdfmfgclu eqrnuvofeb (wzggtjmxag, rmsnyzynus - vkqzwtbjbg)
Phase 3
Ovarian Cancer
Maintenance
-
(ydewzhgplg) = xvtmwmfknz tigbsskpgv (maopeuwgva )
Positive
19 Mar 2024
Phase 3
-
(ijhiqgwakd) = ywhlgqnmzi dxgavnahoa (csgjcoqjgu )
Met
Positive
16 Mar 2024
Placebo+chemotherapy+placebo
(ijhiqgwakd) = cgkijwcmse dxgavnahoa (csgjcoqjgu )
Met
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