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Infigratinib - Helsinn/QED Therapeutics

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Drug Profile

Infigratinib - Helsinn/QED Therapeutics

Alternative Names: BBP-831; BGJ-398; BGJ-398 phosphate; Febseltiq; Infigratinib phosphate; KK-8398; NVP-BGJ398; TRUSELTIQ

Latest Information Update: 05 Mar 2026

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At a glance

  • Originator Novartis
  • Developer Array BioPharma; Helsinn; Kyowa Kirin; 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 - Achondroplasia; Cholangiocarcinoma; Hypochondroplasia
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Cholangiocarcinoma
  • Phase III Achondroplasia; Bladder cancer; Urogenital cancer
  • Phase II/III Hypochondroplasia
  • Phase II Adenocarcinoma; Gastric cancer; Head and neck cancer; Oesophageal cancer
  • Phase I/II Solid tumours
  • No development reported Breast cancer; Glioma
  • Discontinued Glioblastoma; Haematological malignancies; Malignant melanoma

Most Recent Events

  • 25 Feb 2026 BridgeBio Pharma announces intention to launch for achondroplasia in early to mid 2027
  • 12 Feb 2026 BridgeBio Pharma plans to file NDA and MAA application for achondroplasia in second half of 2026
  • 12 Feb 2026 Top-line efficacy and adverse event data from a phase III PROPEL3 trial trial in Achondroplasia released by BridgeBio Pharma

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