Filgotinib maleate is under clinical development by Alfasigma and currently in Phase I for Polyarticular Juvenile Idiopathic Arthritis (PJIA). According to GlobalData, Phase I drugs for Polyarticular Juvenile Idiopathic Arthritis (PJIA) have a 93% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. 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 Idiopathic arthritis, idiopathic multicentric Castleman's disease, 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.

Alfasigma overview

Alfasigma is a manufacturer and supplier of pharmaceutical products. The company offers prescription and over-the-counter drugs for the treatment of gastrointestinal disorders, drugs for diabetes and vascular diseases, nutraceuticals and medical foods. It also produces medicines to treat cardiology, orthopedics, rheumatology and broncho-pneumology indications. Alfasigma is investigating drugs against gastroenterology, vascular disease and neuroscience disorders. The company operates a contract manufacturing office in Alanno, Pescara, Italy. It has an operational presence in Belgium, China, Czech Republic, France, India, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Slovak Republic, Spain, Switzerland, Tunisia and the US. Alfasigma is headquartered in Bologna, Emilia-Romagna, Italy.

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

This content was updated on 10 June 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.