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Abiraterone acetate/niraparib - Janssen

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Drug Profile

Abiraterone acetate/niraparib - Janssen

Alternative Names: AKEEGA; CJNJ-67652000

Latest Information Update: 05 Feb 2026

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At a glance

  • Originator Janssen
  • Class Androstenols; Antiandrogens; Antineoplastics; Benzamides; Indazoles; Phenanthrenes; Piperidines; Pyridines; Small molecules
  • Mechanism of Action CYP17A1 protein inhibitors; Poly(ADP-ribose) polymerase 2 inhibitors; Poly(ADP-ribose) polymerase-1 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Prostate cancer

Most Recent Events

  • 30 Jan 2026 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopts positive opinion for Abiraterone acetate/niraparib (AKEEGA®) in Prostate cancer (Combination therapy, Metastatic disease)
  • 12 Dec 2025 Registered for Prostate cancer (Combination therapy, Metastatic disease) in USA (PO)
  • 12 Dec 2025 Efficacy and adverse events data from the phase III AMPLITUDE trial in BRCA2-mutated metastatic castration-sensitive Prostate cancer released by Johnson & Johnson

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