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Tibremciclib - Betta Pharmaceuticals

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Drug Profile

Tibremciclib - Betta Pharmaceuticals

Alternative Names: BPI-16350

Latest Information Update: 15 Jul 2025

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At a glance

  • Originator Betta Pharmaceuticals Co Ltd
  • Class 3-ring heterocyclic compounds; Amines; Antineoplastics; Benzimidazoles; Fluorinated hydrocarbons; Piperazines; Pyridines; Pyrimidines; Small molecules
  • Mechanism of Action Cyclin-dependent kinase 4 inhibitors; Cyclin-dependent kinase 6 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 Yes

Highest Development Phases

  • Registered HER2 negative breast cancer
  • Phase III Solid tumours

Most Recent Events

  • 15 Jul 2025 Chemical structure information added.
  • 30 Jun 2025 Registered for HER2-negative-breast-cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO) - First global approval (Betta Pharmaceuticals pipeline, July 2025)
  • 23 May 2025 Updated efficacy, adverse events and pharmacokinetics data from a phase Ia/Ib trial in Solid tumours and HER2-negative breast cancer released by Betta Pharmaceuticals

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