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Onapristone - Context Therapeutics

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Drug Profile

Onapristone - Context Therapeutics

Alternative Names: Apristor; AR-18; ER onapristone; IVV-1001; ONA-XR; Onapristone - Arno Therapeutics; Onapristone extended-release; ZK-299; ZK-98299

Latest Information Update: 26 May 2025

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At a glance

  • Originator Bayer Schering Pharma
  • Developer Arno Therapeutics; Bayer HealthCare Pharmaceuticals; Bayer Schering Pharma; Context Therapeutics; Jefferson Health; Memorial Sloan-Kettering Cancer Center
  • Class Antineoplastics; Antiprogestogens; Dimethylamines; Gonanes; Small molecules
  • Mechanism of Action Progesterone receptor antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Discontinued Breast cancer; Endometrial cancer; Endometriosis; HER2 negative breast cancer; Ovarian cancer; Peritoneal cancer; Pregnancy; Prostate cancer; Uterine cancer

Most Recent Events

  • 09 May 2025 Context Therapeutics terminates a phase Ib/II ELONA trial in Breast cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (PO) because sponsor decided to discontinue the development of onapristone (NCT05618613)
  • 22 Apr 2025 Context Therapeutics withdraws a phase I trial in Breast cancer (Late-stage disease, Metastatic disease, Combination therapy) due to strategic considerations (NCT06078202)
  • 03 Sep 2024 Context Therapeutics completes a phase II BASKET trial in Endometrial cancer (Second-line therapy or greater), Peritoneal cancer (Second-line therapy or greater) and Ovarian cancer (Second-line therapy or greater) in USA (PO, Controlled release) (NCT03909152)

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