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: 24 Mar 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

19 Mar 2025 Alfasigma plans a phase III trial for Ulcerative colitis (In Children, In adolescents, Treatment-experienced) in Belgium, Croatia, France, Germany, Greece, Ireland, Italy, Norway, Poland, Portugal, Romania and Spain (PO) (NCT06865417)
07 Mar 2024 Phase-I clinical trials in Juvenile rheumatoid arthritis (In children, In adolescents, Treatment-experienced) in France, Germany (PO) (NCT06222034) (EudraCT2023-505844-21-00)
31 Jan 2024 Galapagos completes transaction to transfer Jyseleca^® business to Alfasigma

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