AKEEGA

Growth

niraparib tosylate monohydrate and abiraterone acetate

NDAORALTABLETPriority Review
Approved
Aug 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
68

Mechanism of Action

enzymes, including PARP-1 and PARP-2, that play a role in DNA repair. In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis, and cell death. Increased…

Clinical Trials (5)

NCT06392841Phase 2Withdrawn

Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations

Started Oct 2025
0
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Deleterious HRR Gene MutationBRCA1 Gene Mutation+7 more
NCT06527690Phase 2Withdrawn

Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer

Started Apr 2025
0
Prostate CancerCastrate Resistant Prostate CancerHomologous Recombination Deficiency
NCT06329830Phase 1/2Withdrawn

177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer

Started Oct 2024
0
Metastatic Prostate CancerCastration-resistant Prostate CancerMetastatic Castration-resistant Prostate Cancer
NCT06212583Phase 2Recruiting

High-Risk Metachronous Oligometastatic Prostate Cancer Trial

Started Apr 2024
88 enrolled
Prostate CancerOligometastatic Disease
NCT05818683Phase 1Recruiting

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

Started Apr 2023
277 enrolled
Metastatic Castration-resistant Prostate NeoplasmsMetastatic Hormone-sensitive Prostate Cancer

Loss of Exclusivity

LOE Date
Mar 27, 2038
146 months away
Patent Expiry
Mar 27, 2038
Exclusivity Expiry
Dec 12, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
8071579
Aug 12, 2027
U-4368
8143241
Aug 12, 2027
U-4368
8436185
Apr 24, 2029
SubstanceProduct
8071623
Mar 27, 2031
SubstanceProduct
8859562
Aug 4, 2031
U-4368