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Onvansertib - Cardiff Oncology

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Drug Profile

Onvansertib - Cardiff Oncology

Alternative Names: NMS-1286937; NMS-P937; Onvansertib-fumarate; PCM-075; PCM-075H

Latest Information Update: 21 Aug 2026

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At a glance

  • Originator Nerviano Medical Sciences
  • Developer Cardiff Oncology
  • Class Antineoplastics; Piperazines; Pyrazoles; Quinazolines; Small molecules
  • Mechanism of Action Polo-like kinase 1 inhibitors
  • Orphan Drug Status

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

    Yes - Acute myeloid leukaemia
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase II Acute myeloid leukaemia; Adenocarcinoma; Colorectal cancer; Prostate cancer; Small cell lung cancer
  • Phase I/II Triple negative breast cancer
  • Preclinical Bladder cancer; Breast cancer; Endometrial cancer
  • No development reported Chronic myelomonocytic leukaemia; Lung cancer; Medulloblastoma; Non-Hodgkin's lymphoma; Ovarian cancer; Solid tumours

Most Recent Events

  • 12 Aug 2026 Cardiff Oncology plans a phase III registrational trial for Colorectal cancer (Combination-therapy, First-line therapy, Metastatic disease) (PO) in the first quarter of 2027
  • 28 Jun 2026 No recent reports of development identified for phase-I development in Chronic-myelomonocytic-leukaemia(Recurrent, Second-line therapy or greater, Treatment-resistant) in USA (PO)
  • 02 Jun 2026 Updated adverse events and efficacy data from a phase-II trial in Colorectal cancer presented at the 62nd Annual Meeting of the American Society of Clinical Oncology (ASCO-2026)

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