Data updated: Jun 28, 2026
TOFACITINIB · ANNORA PHARMA PRIVATE LIMITED
Trial Activity: Expansion 21 active trials
Immunology
Development Insights
Pfizer conducting 22 trials (34%)
50 indications explored (Broad Platform)
→ rheumatoid arthritis (11 trials)
→ psoriatic arthritis (7 trials)
→ ulcerative colitis (6 trials)
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- ORAL
- Dosage Forms
- TABLET
TOFACITINIB Approval History
No approval records found
📋
Clinical Trial Registry
58 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07547930 TOFA-GO | XMFHIIT-2026SL001 | Ph 2 | recruiting | Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease |
| NCT06654882 SMART-JIA | Pro00115808 PLACER-2022C3-30331, EPM #8533 | Ph 3 | recruiting | Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis |
| NCT07530367 | 2026-0173 | Ph 3 | not yet recruiting | A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib in Patients With Moderate-to-Severe Palmoplantar Pustulosis |
| NCT07281456 | 10002290 002290-D | Ph 2 | recruiting | Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease |
| NCT04871191 SATELITE | P200026 | Ph 3 | recruiting | Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis |
| NCT01500551 results posted | A3921145 JIA, 2023-509651-14-00 | Ph 2, Ph 3 | completed | Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis |
| NCT06095128 | Vedolizumab-4054 | Ph 4 | recruiting | A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC) |
| NCT07472166 | 5230 | Ph 4 | completed | Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate |
| NCT03288324 results posted | WI211648 | Ph 1, Ph 2 | completed | Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus |
| NCT05662228 | 22-1992 | Ph 2 | active not recruiting | Therapies for Down Syndrome Regression Disorder |
| NCT04624230 | A3921210 2018-002378-30, OVATION | Ph 3 | active not recruiting | Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis |
| NCT07406204 TOFA-MTX-AA | HMC-DERM-TOFA-MTX-AA | Ph 4 | not yet recruiting | Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA) |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT07297069 | CINTO 1 | Ph 2 | not yet recruiting | Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial |
| NCT04496960 results posted | 200131 20-D-0131 | Ph 1, Ph 2 | active not recruiting | Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome |
| NCT04246372 results posted | 19-1362 R33AR077495 | Ph 2 | completed | Tofacitinib for Immune Skin Conditions in Down Syndrome |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT05048238 results posted | DAIT ALE11 | Ph 1 | completed | Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus |
| NCT07044141 NB-UVB | Dermatology LGH | Ph 1 | active not recruiting | Efficacy of Oral Tofacitinib in Combination of Narrow Band UVB in Treatment of Vitiligo |
| NCT05080218 COVER | COVER-Main | Ph 4 | completed | COVID-19 VaccinE Response in Rheumatology Patients |
| NCT05313620 | GIS-2021-JAKihemo | Ph 4 | recruiting | Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events |
| NCT04985955 | CR109020 2020-006066-37, NOPRODPANAP1003 | Ph 1 | completed | A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 3 |
| NCT03976245 | RAJP0001 | Ph 4 | recruiting | Advanced Therapeutics in Rheumatoid Arthritis (RA) |
| NCT06498089 | B2024-200R | Ph 4 | recruiting | A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis |
| NCT05102448 | TACTIC-TM | Ph 4 | recruiting | Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis |
| NCT06625450 | TOME | Ph 4 | not yet recruiting | TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS |
| NCT04485325 AcceleRAte | TMP-0731-2018 | Ph 4 | completed | Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients |
| NCT05845723 | TCZ/TOF-VBS-PUMCH | Ph 2 | recruiting | Tocilizumab and Tofacitinib in the Treatment of Vascular Behçet's Syndrome |
| NCT06465732 | IR2024072 | Ph 4 | not yet recruiting | Efficacy and Safety of Dupilumab in Combination With Tofacitinib in Moderate to Severe Adult AD Patients |
| NCT04311567 PULMORA | EudraCT 2019-004179-38 | Ph 4 | terminated | Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease |
| NCT06310057 | 4139 | Ph 4 | completed | Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study |
| NCT06278402 | JinnahH | Ph 3 | completed | Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi. |
| NCT03486457 results posted | A3921234 | Ph 3 | completed | Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis |
| NCT03970837 contRAst 2 results posted | 201791 | Ph 3 | terminated | Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs) |
| NCT04928066 | Tofacitinib-RA QiluH | Ph 4 | completed | The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA |
| NCT05133297 | TLL-018-201 | Ph 2 | completed | The Safety and Efficacy of TLL-018 in Active Rheumatoid Arthritis |
| NCT04034238 results posted | 190128 19-C-0128 | Ph 1 | completed | Mesothelin-Targeted Immunotoxin LMB-100 in Combination With Tofacitinib in Persons With Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expressing Solid Tumors |
| NCT04413617 results posted | B7921023 2019-002676-14 | Ph 2 | completed | TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE |
| NCT04552197 | CR108808 2020-000167-24, 64251330EDI1003 | Ph 1 | completed | A Study of JNJ-64251330 in Healthy Participants |
| NCT03800979 results posted | IRB/IEB 004/2562 | Ph 4 | completed | Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata |
| NCT03502616 results posted | A3921120 AS, 2018-000226-58 | Ph 3 | completed | Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS) |
| NCT02092467 results posted | A3921133 2013-003177-99 | Ph 4 | completed | Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis |
| NCT04750317 TOFA-COV-2 | 107892 | Ph 2 | completed | Efficacy and Safety of Tofacitinib in Patients With COVID-19 Pneumonia |
| NCT03002649 STIR | IRB00084227 | Ph 1 | completed | Study of Tofacitinib in Refractory Dermatomyositis |
| NCT04412252 | A3921377 | Ph 2 | withdrawn | Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy |
| NCT01976364 OPAL BALANCE results posted | A3921092 2011-002169-39, OPAL BALANCE | Ph 3 | completed | Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis |
| NCT03274076 TOFA-SSc results posted | HUM00131837 | Ph 1, Ph 2 | completed | Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc) |
| NCT02996500 results posted | B7921005 2016-002337-30, IRAK 4 | Ph 2 | completed | Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate |
| NCT02566967 | RA-012015 | Ph 3 | completed | An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective |
| NCT02299297 results posted | AAAO1502 | Ph 2 | completed | Study To Evaluate The Efficacy Of Tofacitinib In Moderate To Severe Alopecia Areata, Totalis And Universalis |
Showing 50 of 58 trials
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TOFACITINIB FDA Label Details
Track TOFACITINIB with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment