Drug Profile

Filgotinib - Galapagos/Gilead Sciences

Alternative Names: Filgotinib hydrochloride; Filgotinib Maleate; G-146034; G-146034-101; GLPG-0634; GS-6034; Jyseleca

Latest Information Update: 31 Jul 2025

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At a glance

Originator Galapagos NV
Developer Eisai Co Ltd; Galapagos NV; Gilead Sciences
Class 2 ring heterocyclic compounds; Amides; Anti-inflammatories; Antipsoriatics; Antirheumatics; Cyclopropanes; Pyridines; Skin disorder therapies; Small molecules; Thiamorpholines; Triazoles; Urologics
Mechanism of Action Janus kinase 1 inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes
Available For Licensing Yes

Marketed Rheumatoid arthritis; Ulcerative colitis
Phase III Axial spondyloarthritis
Phase I Juvenile rheumatoid arthritis
Discontinued Ankylosing spondylitis; Crohn's disease; Cutaneous lupus erythematosus; Lupus nephritis; Non-radiographic axial spondyloarthritis; Psoriatic arthritis; Sjogren's syndrome; Uveitis

28 Jul 2025 Alfasigma plans to file MAA to EMA and MHRA for Axial spondyloarthritis
28 Jul 2025 Efficacy and adverse events data from a phase III OLINGUITO trial in Axial spondyloarthritis released by Alfasigma
16 May 2025 Gilead Sciences and Galapagos NV completes a phase II trial in Rheumatoid arthritis in USA, Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Taiwan, Thailand, Ukraine and United Kingdom (EudraCT2016-003630-25) (NCT03025308)

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