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: 22 Dec 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; Hypochondroplasia
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

19 Nov 2025 Phase-II clinical trials in Achondroplasia (In children, In infants, In neonates) in Norway, USA, United Kingdom, Spain, Canada, Australia, Singapore (PO, Tablet) (NCT07169279)
19 Nov 2025 Phase-II clinical trials in Achondroplasia (In children, In infants, In neonates) in USA, United Kingdom, Spain, Singapore, Norway, Canada, Australia (PO, Capsule) (NCT07169279)
29 Oct 2025 Infigratinib - Helsinn/QED Therapeutics receives Orphan Drug status for Hypochondroplasia in Europe

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