Last update 11 Jul 2024

Niraparib Tosylate/Abiraterone Acetate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
NIRAPARIB/ABIRATERONE ACETATE, AKEEGA
Mechanism
CYP17A1 inhibitors(Steroid 17-alpha-hydroxylase inhibitors), PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors), PARP2 inhibitors(Poly (ADP-Ribose) Polymerase 2 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (KR)
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Structure

Molecular FormulaC26H33NO2
InChIKeyUVIQSJCZCSLXRZ-UBUQANBQSA-N
CAS Registry154229-18-2
View All Structures (2)

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
BRCA Mutation Castration-Resistant Prostate Cancer
NO
19 Apr 2023
BRCA Mutation Castration-Resistant Prostate Cancer
EU
19 Apr 2023
BRCA Mutation Castration-Resistant Prostate Cancer
IS
19 Apr 2023
BRCA Mutation Castration-Resistant Prostate Cancer
LI
19 Apr 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
HRR Gene-mutated Castration-Resistant Prostate CancerNDA/BLA
EU
28 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
107
(pddbywunvn) = yrrzdtloyj lmvhcapdct (nrqafeftnu, 34.2 - NA)
-
22 Oct 2023
Phase 3
225
(tqmsjvifkp) = lamtsgwyca pofnvxbnrl (xieedejekm, 13.9 - NE)
Positive
11 Aug 2023
Placebo
(tqmsjvifkp) = dlbrbhatjk pofnvxbnrl (xieedejekm, 8.3 - 13.8)
Phase 3
225
(the BRCA population)
lesnkvrysd(qscocpqwxc) = makdwiygay drtlcshnct (cbynspcgso )
Positive
02 Jun 2023
Placebo
(the BRCA population)
lesnkvrysd(qscocpqwxc) = efywngatfg drtlcshnct (cbynspcgso )
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Approval

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Regulation

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