Filgotinib maleate is under clinical development by Galapagos and currently in Phase III for Axial Spondyloarthritis. According to GlobalData, Phase III drugs for Axial Spondyloarthritis have a 75% 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  juvenile arthritis, rheumatoid arthritis.  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, Crohn’s disease and non-infectious uveitis, lupus membranous nephropathy, ankylosing spondylitis, cutaneous lupus erythematosus, psoriatic arthritis and non-infectious uveitis, ulcerative colitis.

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 the GLPG3667 compound against autoimmune indications. The company offers its products in the therapeutic areas of immunology and oncology. It partners with academic organizations and universities to accelerate development and boost innovation in discovery, preclinical and clinical development. The company operates in Belgium, the Netherlands, France, Germany, Austria, Italy, Spain, the Nordics, Switzerland, the UK and the US. Galapagos is headquartered in Mechelen, Belgium.

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

This content was updated on 7 February 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.