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Infigratinib - Helsinn/QED Therapeutics

Drug Profile

Infigratinib - Helsinn/QED Therapeutics

Alternative Names: BBP-831; BGJ-398; BGJ-398 phosphate; Infigratinib phosphate; NVP-BGJ398; TRUSELTIQ

Latest Information Update: 12 Aug 2022

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At a glance

  • Originator Novartis
  • Developer Array BioPharma; Helsinn; LianBio; Novartis; Novartis Oncology; QED Therapeutics
  • Class Aniline compounds; Antineoplastics; Chlorobenzenes; Methylurea compounds; Phenyl ethers; Piperazines; Pyrimidines; Small molecules
  • Mechanism of Action Type 1 fibroblast growth factor receptor antagonists; Type 3 fibroblast growth factor receptor antagonists; Type 4 fibroblast growth factor receptor antagonists; Type-2 fibroblast 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
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Cholangiocarcinoma
  • Phase III Bladder cancer; Urogenital cancer
  • Phase II Achondroplasia; Gastric cancer; Head and neck cancer; Oesophageal cancer
  • Phase I/II Solid tumours
  • Phase I Breast cancer
  • Phase 0 Glioblastoma
  • Discontinued Haematological malignancies; Malignant melanoma

Most Recent Events

  • 12 Aug 2022 BridgeBio Pharma filed patent applications to provide market protection as late as 2041
  • 10 Aug 2022 QED Therapeutics withdrawn a phase-I BLASST-3 trial in Bladder cancer (Neoadjuvant therapy) in USA (PO) prior enrolment due to low accrual (NCT04972253)
  • 04 Aug 2022 BridgeBio Pharma plans pivotal phase III trial in the first half of 2023
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