Tofacitinib citrate is under clinical development by Pfizer and currently in the Phase I and Phase II 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 Tofacitinib citrate’s likelihood of approval (LoA) and phase transition for Chronic Granulomatous Disease took place on 17 Aug 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

In addition, the same event on 17 Aug 2022 increased Tofacitinib citrate’s LoA and PTSR for Hidradenitis Suppurativa.

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

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 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, 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, 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.

Quick View Tofacitinib citrate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Tofacitinib citrate
Administration Pathway
  • Oral
  • Topical
Therapeutic Areas
  • Cardiovascular
  • Dermatology
  • Gastrointestinal
  • Genetic Disorders
  • Immunology
  • Infectious Disease
  • Musculoskeletal Disorders
  • Oncology
  • 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.