Filgotinib maleate is under clinical development by Galapagos and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Filgotinib maleate’s likelihood of approval (LoA) and phase transition for Crohn’s Disease (Regional Enteritis) took place on 21 Dec 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Filgotinib maleate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Quick View Filgotinib maleate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Filgotinib maleate
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Immunology
  • Musculoskeletal Disorders
  • Ophthalmology
Key Developers
Highest Development Stage
  • Marketed

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.