Tofacitinib citrate is under clinical development by Pfizer and currently in Phase III for Systemic-Onset Juvenile Idiopathic Arthritis (Still Disease). According to GlobalData, Phase III drugs for Systemic-Onset Juvenile Idiopathic Arthritis (Still Disease) have an 89% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Tofacitinib citrate’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.

Tofacitinib citrate overview

Tofacitinib (Xeljanz, Jaquinus) is an immunosuppressant. It is formulated as film coated tablets, tablets, coated tablets and solution for oral route of administration. Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease- modifying antirheumatic drugs (DMARDs) and for the treatment of adults with moderately to severely active ulcerative colitis.  It is also indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers and Celiac Disease. It is also indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers or other disease-modifying antirheumatic drugs (DMARDs). XELJANZ is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers.
The drug candidate is under development for inflammatory complications (gastrointestinal [GI], skin, lung) related to chronic granulomatous disease (CGD) and allograft pancreatitis, pouchitis, ulcerative colitis, hidradenitis suppurativa, psoriatic arthritis, rheumatoid arthritis, systemic idiopathic juvenile arthritis, systemic lupus erythematosus, corticosteroid-dependent sarcoidosis and SARS-COv2 related interstitial pneumonia, glioblastoma and low-grade glioma. It is administered orally as a tablet. It was also under development for transplant rejection, Crohn's disease, chronic plaque psoriasis, keratoconjunctivitis sicca (dry eye) and atopic dermatitis as an ointment which is applied topically. It was also under development for ankylosing spondylitis (Bekhterev's disease), discoid lupus erythematosus, ischaemia reperfusion injury and diffuse cutaneous systemic sclerosis.

Pfizer overview

Pfizer discovers, develops, manufactures, and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, women’s health, cancer, inflammation, immune disorders, and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, individual provider offices, clinics, government agencies and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa, and the Middle East. Pfizer is headquartered in New York, the US.

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

This content was updated on 10 June 2024

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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.