Abiraterone acetate - Churchill Pharmaceuticals

Drug Profile

Abiraterone acetate - Churchill Pharmaceuticals

Alternative Names: AAFP; Abiraterone acetate fine particle ; submicron abiraterone acetate; Yonsa

Latest Information Update: 22 Jul 2017

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At a glance

  • Originator Churchill Pharmaceuticals
  • Class Androstenols; Antiandrogens; Antineoplastics; Small molecules
  • Mechanism of Action CYP17A1 protein 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

  • Preregistration Prostate cancer

Most Recent Events

  • 22 Jul 2017 Planned Prescription Drug User Fee Act (PDUFA) date for Prostate cancer (Combination therapy, Metastatic disease) in USA (PO) is 2018-03-19
  • 20 Jul 2017 The US FDA accepts NDA for abiraterone acetate for Prostate cancer (Combination therapy, Metastatic disease) for review
  • 02 Jun 2017 Pharmacokinetics and safety data from a phase I trial in healthy volunteers presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO-2017)
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