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Repotrectinib - Bristol-Myers Squibb

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Drug Profile

Repotrectinib - Bristol-Myers Squibb

Alternative Names: AUGTYRO; BMS-986472; Ropotrectinib; TPX 0005; ZL-2308

Latest Information Update: 16 Sep 2025

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At a glance

  • Originator TP Therapeutics
  • Developer Bristol-Myers Squibb; Turning Point Therapeutics; ZAI Lab
  • Class Antineoplastics; Aza compounds; Fluorobenzenes; Ketones; Macrocyclic compounds; Pyrazoles; Small molecules
  • Mechanism of Action Anaplastic lymphoma kinase inhibitors; Focal adhesion protein tyrosine kinase inhibitors; Janus kinase 2 inhibitors; ROS1 protein inhibitors; Src-family kinase inhibitors; TrkA receptor antagonists; TrkB receptor antagonists; TrkC receptor antagonists
  • Orphan Drug Status

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

    Yes - Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer
  • Registered Solid tumours
  • Phase II Adenocarcinoma
  • Phase I/II CNS cancer; Lymphoma
  • Preclinical Multiple myeloma

Most Recent Events

  • 25 May 2025 Efficacy, adverse vent and pharmacokinetic data from a phase Ia/Ib trial in Non-small cell lung cancer presented at the 61st Annual Meeting of the American Society of Clinical Oncology (ASCO-2025)
  • 21 Apr 2025 Preregistration for Solid tumours (In adults, Late-stage disease, Metastatic disease) in China (PO) before April 2025
  • 21 Apr 2025 National Medical Products Administration accepts sNDA for Solid tumours (In adults, Late-stage disease, Metastatic disease) in China (PO)

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