Filgotinib maleate is under clinical development by Galapagos and currently in Phase III for Ulcerative Colitis. According to GlobalData, Phase III drugs for Ulcerative Colitis have a 64% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Filgotinib maleate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Filgotinib maleate overview

Filgotinib maleate (Jyseleca) acts as an antirheumatic agent. It is formulated as film-coated tablets for oral route of administration. Jyseleca is indicated for the treatment of rheumatoid arthritis (RA) in patients who have had an inadequate response to conventional therapies, including the prevention of structural joint damage. Jyseleca is indicated for the treatment of active moderate to severe ulcerative colitis. Filgotinib maleate (GLPG-0634, G146034) is under development for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis.  It is a small molecule administered orally as a film-coated tablet. It targets JAK 1. It is developed based on Adenoviral technology.

It was also under development for the treatment of Sjogren syndrome, psoriatic arthritis, ankylosing spondylitis and non-infectious uveitis, lupus membranous nephropathy, ankylosing spondylitis, cutaneous lupus erythematosus, psoriatic arthritis and non-infectious uveitis.

Galapagos overview

Galapagos is a biotechnology company that discovers and develops small molecule medicines for the treatment of inflammatory and fibrotic diseases. It offers Filgotinib medication targeting rheumatoid arthritis (RA). The company is investigating GLPG3667 compound against autoimmune indications; GLPG2737, a cystic fibrosis transmembrane conductance regulator (CFTR) inhibitor to treat autosomal dominant polycystic kidney disease; GLPG1690, an oral autotaxin inhibitor targeting idiopathic pulmonary fibrosis (IPF); and GLPG1972 drug to treat osteoarthritis. Galapagos is also evaluating Filgotinib against Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, Sjogren’s syndrome, cutaneous lupus and uveitis. It has operational presence in the Netherlands, France, Germany, Italy, Spain, Switzerland, the United States and the United Kingdom. The company works in collaboration with disease foundations, pharmaceutical and biotechnology companies. Galapagos is headquartered in Mechelen, Belgium.

For a complete picture of Filgotinib maleate’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.