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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: 09 Oct 2026

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At a glance

  • Originator Novartis
  • Developer Array BioPharma; Helsinn; Kyowa Kirin; LianBio; LianMedical; 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
  • Preregistration Achondroplasia
  • Phase III 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

  • 09 Oct 2026 US FDA accepts NDA for infigratinib for achondroplasia(In children) for review
  • 06 Oct 2026 FDA assigns PDUFA action date of 4/02/2027 for Infigratinib for Achondroplasia (In children)
  • 09 Sep 2026 BridgeBio Pharma announces intention to launch Infigratinib for Achondroplasia in USA, in mid-2027

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