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: 18 Sep 2025

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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
New Molecular Entity Yes

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

18 Sep 2025 BridgeBio Pharma plans a phase IIb PROPEL Infant & Toddler trial for Achondroplasia (In neonates, In infants, In Children) in USA, Australia, Canada, Norway, Singapore, Spain and United Kingdom (PO, Tablet) (PO, Capsule), in October 2025 (NCT07169279)
06 Aug 2025 BridgeBio-Pharma aligns meeting with US FDA to plan clinical trial for Achondroplasia (In neonates, In infants, In Fetus, In Children)
02 May 2025 Infigratinib - Helsinn/QED Therapeutics receives Fast Track designation for Hypochondroplasia [PO] (In adolescents, In children) in USA before May 2025

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