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Tinengotinib - TransThera Biosciences

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Drug Profile

Tinengotinib - TransThera Biosciences

Alternative Names: TT 00420

Latest Information Update: 14 Jan 2026

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At a glance

  • Originator TransThera Biosciences
  • Class 3-ring heterocyclic compounds; Antineoplastics; Chlorobenzenes; Morpholines; Pyrazoles; Pyridones; Small molecules
  • Mechanism of Action Aurora kinase A inhibitors; Aurora kinase B inhibitors; Fibroblast growth factor receptor antagonists; Janus kinase inhibitors; Vascular endothelial growth factor receptor antagonists
  • Orphan Drug Status

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

    Yes - Cholangiocarcinoma; Biliary cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Cholangiocarcinoma
  • Phase I/II Prostate cancer; Solid tumours
  • No development reported Triple negative breast cancer

Most Recent Events

  • 09 Jan 2026 TransThera Sciences plans a phase III trial for Cholangiocarcinoma (Late-stage, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater) in China (PO, Tablet) in January 2026 (NCT07328919)
  • 18 Dec 2025 Preregistration for Cholangiocarcinoma (Late-stage disease, Metastatic disease, Inoperable/Unresectable, Second-line therapy or greater, Monotherapy) in China (PO)
  • 18 Dec 2025 NMPA accepts NDA for Tinengotinib for Cholangiocarcinoma for review

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