Product Description
Tofacitinib is used alone or with other medications to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) in people who did not respond to methotrexate (Otrexup, Rasuvo, Trexall). It is also used along with methotrexate, sulfasalazine (Azulfidine), or leflunomide (Arava) to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in people who did not respond to these medications alone.
Mechanisms of Action: JAK1 Inhibitor,JAK2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela
Approved Indications: Oral Ulcer | Colitis | Arthritis, Juvenile | Arthritis, Psoriatic | Arthritis, Rheumatoid | Spondylitis, Ankylosing | Colitis, Ulcerative | Spondylitis | Arthritis
Known Adverse Events: Headache | Nasopharyngitis | Pharyngitis | Colitis | Arthritis, Juvenile | Arthritis, Psoriatic | Arthritis, Rheumatoid | Spondylitis, Ankylosing | Colitis, Ulcerative | Respiratory Tract Infections | Spondylitis | Arthritis | Acute Respiratory Distress Syndrome | Diarrhea | Herpes Zoster
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Czech Republic, Finland, France, Georgia, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russia, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count:
Highest Development Phases
Phase 3: Arthritis, Juvenile|Colitis, Ulcerative|Giant Cell Arteritis|Glioblastoma|Polymyalgia Rheumatica
Phase 2: Arthritis, Psoriatic|Arthritis, Rheumatoid|Inflammation|Lupus Erythematosus, Cutaneous|Lupus Erythematosus, Systemic|Pouchitis
Phase 1: Granuloma Annulare
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2071210075 | P3 |
Recruiting |
Colitis, Ulcerative |
2029-03-12 |
|
| A3921210 | P3 |
Unknown Status |
Colitis, Ulcerative |
2029-03-12 |
|
| 2017-002018-29 | P3 |
Active, not recruiting |
Arthritis, Juvenile |
2027-09-08 |
|
| A3921210 | P3 |
Recruiting |
Colitis, Ulcerative |
2026-12-21 |