Drug intelligence / Profile preview

niraparib + abiraterone acetate + prednisone + androgen deprivation therapy

Development stage
Unknown
Lead developer
Janssen Research & Development
Modality
Small Molecules
Administration
Oral, Intravenous, Intramuscular, Subcutaneous
01

Overview

This combination therapy regimen is being investigated in the Phase II HARMONY trial (NCT06392841) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in patients with deleterious homologous recombination repair (HRR) gene alterations. The regimen consists of niraparib (a PARP inhibitor), abiraterone acetate (an androgen biosynthesis inhibitor), and prednisone, administered alongside standard androgen deprivation therapy (ADT). Niraparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes, which are critical for DNA repair, particularly in cells with HRR deficiencies. Abiraterone acetate inhibits CYP17A1, a key enzyme in androgen synthesis. The combination of niraparib and abiraterone acetate is often administered as a dual-action tablet (Akeega). The trial, led by Dr. Qian Qin at UT Southwestern Medical Center, specifically focuses on Hispanic/Latino and non-Hispanic Black patient populations to address disparities in clinical trial representation and outcomes.

Brand names
AkeegaZejulaZytiga
Other names
androgen deprivation therapy-Qian Qin-metastatic hormone-sensitive prostate cancerHARMONY regimenNiraparib/Abiraterone Acetate DAT + Prednisone + ADT
02

Targets

GR (Glucocorticoid receptor)CYP17A1 (Steroid 17-alpha-hydroxylase/C17,20 lyase)GnRHR (Gonadotropin-releasing hormone receptor)PARP2 (Poly (adp-ribose) polymerase 2)

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