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ONO 4578

Drug Profile

ONO 4578

Alternative Names: BMS 986310; ONO-4578

Latest Information Update: 08 Mar 2024

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At a glance

  • Originator Ono Pharmaceutical
  • Developer Bristol-Myers Squibb; Ono Pharmaceutical
  • Class Antineoplastics; Small molecules
  • Mechanism of Action Prostaglandin E EP4 receptor antagonists
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Gastric cancer
  • Phase I/II Solid tumours
  • Phase I Colorectal cancer; HER2 negative breast cancer; Non-small cell lung cancer; Pancreatic cancer

Most Recent Events

  • 18 Jan 2024 Efficacy and adverse event data from a phase I trial in Solid tumours presented at the 2024 Gastrointestinal Cancers Symposium (ASCO-GCS-2024)
  • 06 Dec 2023 Phase-II clinical trials in Gastric cancer (Combination therapy, First-line therapy, Inoperable/Unresectable, Late-stage disease, Recurrent) in Japan (PO) (NCT06256328)
  • 20 Oct 2023 ONO 4578 is still in phase I trials for Solid tumours (Late-stage disease, Metastatic disease, Combination therapy) in Japan (PO) (NCT03155061)
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