Xeljanz

(Tofacitinib)

ApprovedSmall molecule

Tofacitinib is used to treat rheumatoid arthritis and certain other inflammatory conditions by reducing the immune system's overactive response that causes joint pain and swelling.[2] Xeljanz is currently approved and in use across 46 indications[4].[1]

Xeljanz is one of 748 small molecule programs targeting Hepatic failure. It is currently in Approved.

Indications

166

Total Trials

Active Trials

747

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Hepatic FailureApproved

Blau SyndromeActive, not recruiting

Oral Lichen PlanusRecruiting

ArthritisCompleted

Rheumatic DiseaseRecruiting

Atopic EczemaApproved

AlopeciaActive, not recruiting

Extranodal Nasal NK/T Cell LymphomaApproved

Cutaneous T-Cell LymphomaRecruiting

Psoriasis VulgarisApproved

Hepatic FailureApproved

Approved

Blau SyndromePreclinical

Active, not recruiting

Oral Lichen PlanusApproved

Recruiting

ArthritisApproved

Completed

Rheumatic DiseasePhase 2

Recruiting

Atopic EczemaApproved

Approved

AlopeciaPreclinical

Active, not recruiting

Extranodal Nasal NK/T Cell LymphomaApproved

Approved

Cutaneous T-Cell LymphomaPhase 2

Recruiting

Psoriasis VulgarisApproved

Approved

Showing 10 of 45 indications

Competition

Competitive Landscape

309 competitors in COVID-19

#DrugCompanyPhaseTrials

Xeljanz

PPrism Pharmaceuticals

Approved

2 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Aldactone

Pfizer

Preclinical

1 5

Nexavar

Bayer

Preclinical

1 6

Calciferol

Activella

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 9

Nitrostat

VViatris Specialty LLC

Preclinical

1 10

Tricor

JJagotec

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Study completion

NCT07843693

Recruiting

Efficacy and Safety

NCT06573593

Q2 2027

Phase 2Recruiting

Tocilizumab

NCT05845723

Post-ApprovalRecruiting

Oral Lichen Planus

NCT07131813

Post-ApprovalRecruiting

Efficacy and Safety

NCT06498089

Q3 2027

N/ARecruiting

Erythema

NCT07343635

Clinical

Trials by Indication[1]

Rheumatoid Arthritis28 trials

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Recruiting·UUniversity of Nebraska·Phase 3·NCT03414502·400 enrolled

The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04927000·170 enrolled

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

Completed· Pfizer logo

Pfizer·Phase 2·NCT04413617·460 enrolled

Show 25 more trials

Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

Unknown status·HHanyang University··NCT03011281·378 enrolled

Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients

Unknown status·VVastra Gotaland Region··NCT03440892·2,500 enrolled

IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis

Completed· Pfizer logo

Pfizer··NCT03981900·314 enrolled

Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

Completed· Pfizer logo

Pfizer·Phase 4·NCT02092467·4,372 enrolled

Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints

Completed·—··NCT04772248·105,711 enrolled

To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid Arthritis for 24 Weeks

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT05606107·230 enrolled

The Safety and Efficacy of TLL-018 in Active Rheumatoid Arthritis

Completed·HHangzhou Highlightll Pharmaceutical Co., Ltd·Phase 2·NCT05133297·101 enrolled

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

Completed·—·Phase 3·NCT02566967·20 enrolled

A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis

Completed· Pfizer logo

Pfizer··NCT06418529·21,340 enrolled

A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494

Completed· AbbVie logo

AbbVie·Phase 1·NCT01741493·67 enrolled

A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis

Completed· Pfizer logo

Pfizer·Phase 3·NCT02281552·209 enrolled

Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project

Terminated·UUniversity Hospital, Lille··NCT04175886·10 enrolled

Advanced Therapeutics in Rheumatoid Arthritis (RA)

Recruiting·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 4·NCT03976245·144 enrolled

A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate

Completed· Pfizer logo

Pfizer·Phase 2·NCT02147587·112 enrolled

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)

Terminated· GSK logo

GSK·Phase 3·NCT03970837·1,764 enrolled

Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis

Completed· Pfizer logo

Pfizer··NCT03387423·1,459 enrolled

Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate

Completed· Pfizer logo

Pfizer·Phase 2·NCT02996500·269 enrolled

Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints

Completed·—··NCT04798287·105,711 enrolled

Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

Completed· Pfizer logo

Pfizer··NCT01932372·9,968 enrolled

Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment

Withdrawn· Gilead logo

Gilead·Phase 2·NCT05165771

Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Completed· GSK logo

GSK·Phase 3·NCT03980483·1,537 enrolled

Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients

Completed·UUniversity of California, Los Angeles·Phase 4·NCT02321930·37 enrolled

Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis

Unknown status·—·Phase 4·NCT04464642·110 enrolled

A Phase 3, Randomized, Double-Blind, Positive-controlled, Head-to-Head Monotherapy Study Comparing TLL-018 to Tofacitinib in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Completed·HHangzhou Highlightll Pharmaceutical Co., Ltd·Phase 3·NCT06020144·459 enrolled

JAK Inhibitor Dose TAPering Strategy Study in Low Disease Activity Rheumatoid Arthritis Patients

Recruiting·UUniversity Hospital, Toulouse·Approved·NCT06687551·308 enrolled

Ulcerative Colitis12 trials

Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis

Not yet recruiting·PPost Graduate Institute of Medical Education and Research, Chandigarh·N/A·NCT05112263·96 enrolled

Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management

Active, not recruiting·MMcMaster University·Phase 2·NCT04925973·24 enrolled

A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

Completed· Pfizer logo

Pfizer·Phase 3·NCT01465763·614 enrolled

Show 9 more trials

Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial

Not yet recruiting·—·Phase 2·NCT07297069·60 enrolled

Tofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis

Completed· Pfizer logo

Pfizer··NCT04424303·152 enrolled

A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

Completed· Pfizer logo

Pfizer·Phase 3·NCT01458951·547 enrolled

Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden

Recruiting· Pfizer logo

Pfizer··NCT04338204·120 enrolled

TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS

Not yet recruiting·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT06625450·75 enrolled

Retrospective Observational Comparison Study Between Ustekinumab and Tofacitinib as Third Line Therapy in a Multicenter Cohort of Patients With Refractory Ulcerative Colitis.

Completed·IIRCCS San Raffaele··NCT05728008·100 enrolled

An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy With Tofacitinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis

Active, not recruiting· Takeda logo

Takeda·Approved·NCT06095128·60 enrolled

Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events

Completed·FFundación de Investigación Biomédica - Hospital Universitario de La Princesa·Approved·NCT05313620·32 enrolled

OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT04624230·118 enrolled

Alopecia Areata8 trials

Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Completed·SStanford University·N/A·NCT02312882·40 enrolled

Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Completed·YYale University·Phase 2·NCT02812342·10 enrolled

Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi.

Completed·JJinnah Hospital·Phase 3·NCT06278402·30 enrolled

Show 5 more trials

Efficacy and Safety of Oral Tofacitinib in the Treatment of Alopecia Areata

Completed·SServices Institute of Medical Sciences, Pakistan·Phase 1·NCT06157905·9 enrolled

Tofacitnib for the Treatment of Alopecia Areata and Variants

Completed·YYale University·Phase 2·NCT02197455·30 enrolled

Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata

Completed·—·Phase 4·NCT03800979·19 enrolled

Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)

Not yet recruiting·HHayat Abad Medical Complex, Peshawar·Phase 4·NCT07406204·78 enrolled

Study To Evaluate The Efficacy Of Tofacitinib In Moderate To Severe Alopecia Areata, Totalis And Universalis

Completed·—·Phase 2·NCT02299297·12 enrolled

Psoriatic Arthritis8 trials

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT04610476·270 enrolled

Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

Completed· Pfizer logo

Pfizer·Phase 3·NCT01882439·395 enrolled

Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

Completed· Pfizer logo

Pfizer·Phase 3·NCT01976364·686 enrolled

Show 5 more trials

Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis

Completed· Pfizer logo

Pfizer·Phase 3·NCT03486457·204 enrolled

Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

Completed· Pfizer logo

Pfizer·Phase 3·NCT01877668·422 enrolled

Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis

Recruiting·HHansoh BioMedical R&D Company·Phase 2·NCT06176508·160 enrolled

Tofacitinib for Reduction of Spinal Inflammation in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement

Unknown status·—·Phase 2·NCT04062695·80 enrolled

A Randomized, Placebo- and Active Drug-Controlled, Double-Blind, Multicenter, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQH3906 Capsules in the Treatment of Active Psoriatic Arthritis

Recruiting·CChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.·Phase 2·NCT07406035·156 enrolled

Efficacy and Safety6 trials

Efficacy and Safety of Dupilumab in Combination With Tofacitinib in Moderate to Severe Adult AD Patients

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT06465732·220 enrolled

An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

Completed· Pfizer logo

Pfizer·Phase 4·NCT02187055·1,152 enrolled

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

Recruiting·SShanghai Zhongshan Hospital·Phase 4·NCT06498089·124 enrolled

Show 3 more trials

Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT06573593·150 enrolled

Examination of Efficacy and Safety of Baricitinib in RA Patients

Unknown status·SShinshu University·Phase 2·NCT03755466·90 enrolled

The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA

Completed·QQilu Hospital of Shandong University·Phase 4·NCT04928066·100 enrolled

69 more indications

Pneumonia5 trials

Efficacy and Safety of Tofacitinib in Patients With COVID-19 Pneumonia

Completed·II.M. Sechenov First Moscow State Medical University·Phase 2·NCT04750317·414 enrolled

Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy

Withdrawn· Pfizer logo

Pfizer·Phase 2·NCT04412252

TOFAcitinib in SARS-CoV2 Pneumonia

Unknown status·UUniversità Politecnica delle Marche·Phase 2·NCT04332042·50 enrolled

Show 2 more trials

Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia

Completed·HHospital Israelita Albert Einstein·Phase 3·NCT04469114·289 enrolled

TOFAcitinib Plus Hydroxycloroquine vs Hydroxycloroquine in Patients With COVID-19 Interstitial Pneumonia

Unknown status·UUniversità Politecnica delle Marche·Phase 2·NCT04390061·116 enrolled

Arthritis5 trials

Safety and Efficacy of Tofacitinib in the Treatment of NSAID Refractory Axial Spondyloarthritis:A Clinical Trial

Unknown status·GGlobe Pharmaceuticals Limited·Phase 2/3·NCT03738956·30 enrolled

Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study

Completed·—·Phase 4·NCT06310057·92 enrolled

ToFAcitinib in Early Active Axial SpondyloarThritis:

Recruiting·—·Phase 4·NCT06112665·104 enrolled

Show 2 more trials

Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib

Unknown status·—·Phase 2·NCT06114407·184 enrolled

Risk of Tuberculous and Other Infections in Patients of Spondyloarthritis Treated With Tofacitinib in Bangladesh

Unknown status·—·Phase 4·NCT03504072·174 enrolled

Psoriasis5 trials

Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis

Recruiting·LLahore General Hospital·Phase 1·NCT07261306·75 enrolled

Tofacitinib Ointment For Chronic Plaque Psoriasis

Completed· Pfizer logo

Pfizer·Phase 2·NCT01831466·476 enrolled

Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis

Completed· Pfizer logo

Pfizer·Phase 2·NCT01710046·12 enrolled

Show 2 more trials

A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis

Completed· Pfizer logo

Pfizer·Phase 1·NCT02193815·15 enrolled

Multiple Dose Escalation Study In Medically Stable Subjects With Psoriasis

Completed· Pfizer logo

Pfizer·Phase 1·NCT01736696·59 enrolled

Down syndrome3 trials

Tofacitinib for Immune Skin Conditions in Down Syndrome

Completed·UUniversity of Colorado, Denver·Phase 2·NCT04246372·47 enrolled

Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1

Recruiting·UUniversity of Colorado, Denver·Phase 2·NCT07598643·92 enrolled

Mechanistic Investigation of Therapies for Down Syndrome Regression Disorder

Completed·UUniversity of Colorado, Denver·Phase 2·NCT05662228·66 enrolled

Ankylosing Spondylitis3 trials

Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

Completed· Pfizer logo

Pfizer·Phase 3·NCT03502616·270 enrolled

Efficacy and Safety Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.

Completed·JJiangsu vcare pharmaceutical technology co., LTD·Phase 2·NCT05814939·180 enrolled

Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

Completed· Pfizer logo

Pfizer·Phase 2·NCT01786668·208 enrolled

Methotrexate3 trials

Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis

Recruiting·SShanghai Zhongshan Hospital·Phase 4·NCT05102448·76 enrolled

Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT04299971·130 enrolled

Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPA

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT04944524·66 enrolled

Interstitial Lung Disease3 trials

Tofacitinib in the Treatment of Rheumatoid Arthritis-related Interstitial Lung Disease.

Unknown status·NNational Institute of Respiratory Diseases, Mexico·Phase 2·NCT05246293·60 enrolled

Correlation Between the Change of Peripheral Lymphocyte Subsets and Clinically Amyopathic Dermatomyositis Combined With Rapidly Progressive Interstitial Lung Disease

Unknown status·JJing Liang··NCT04613219·80 enrolled

Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease

Terminated·VVastra Gotaland Region·Phase 4·NCT04311567·3 enrolled

Atopic Dermatitis3 trials

Tolerability and Effectiveness of CGB-500 Topical Ointment, 1% Tofacitinib, for the Treatment of Atopic Dermatitis

Completed·CCAGE Bio Inc.·Phase 1/2·NCT05487963·40 enrolled

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

Completed· Pfizer logo

Pfizer·Phase 2·NCT02001181·69 enrolled

Systemic Sclerosis3 trials

Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate

Completed·—·Phase 4·NCT07472166·34 enrolled

Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Completed·UUniversity of Michigan·Phase 1/2·NCT03274076·15 enrolled

Effectiveness of Tofacitinib in Systemic Sclerosis

Unknown status·—·Phase 2·NCT06044844·44 enrolled

Dermatomyositis2 trials

Study of Tofacitinib in Refractory Dermatomyositis

Completed·JJohns Hopkins University·Phase 1·NCT03002649·10 enrolled

3T Therapy in the Treatment of MDA5-positive Dermatomyositis

Enrolling by invitation·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT06438679·133 enrolled

COVID-192 trials

COVID-19 VaccinE Response in Rheumatology Patients

Completed·JJeffrey Curtis·Phase 4·NCT05080218·841 enrolled

Tofacitinib for Treatment of Moderate COVID-19

Terminated·YYale University·Phase 2·NCT04415151·24 enrolled

MPA2 trials

PK and Bioavailability Comparison of Tofacitinib Between a Modified Release and The Immediate Release Formulation

Completed· Pfizer logo

Pfizer·Phase 1·NCT04403776·26 enrolled

Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

Completed· Pfizer logo

Pfizer·Phase 1·NCT01599377·50 enrolled

Systemic Lupus Erythematosus2 trials

Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)

Terminated·TTufts Medical Center·Phase 1·NCT03159936·5 enrolled

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus

Completed·NNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·Phase 1·NCT02535689·34 enrolled

Adult2 trials

Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus

Completed·—·Phase 1/2·NCT03288324·13 enrolled

A Study In Adult Healthy Volunteers To Asses Once Daily (QD) Dosing With The Selected Age-Appropriate Modified Release (MR) Formulations

Completed· Pfizer logo

Pfizer·Phase 1·NCT04338711·23 enrolled

ART2 trials

A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 3

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04985955·12 enrolled

A Study of JNJ-64251330 in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04552197·36 enrolled

Primary Sjogren's Syndrome2 trials

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome

Active, not recruiting·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 1/2·NCT04496960·23 enrolled

Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome

Unknown status·PPeking University People's Hospital·Phase 2·NCT05087589·10 enrolled

Phase 12 trials

A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT01499004·30 enrolled

A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT01731327·20 enrolled

Spondyloarthropathy1 trial

Real-world Effectiveness of Tofacitinib on Ulcerative Colitis Associated Spondyloarthropathy

Unknown status·IItalian Group for the study of Inflammatory Bowel Disease (IG-IBD)··NCT05431283·100 enrolled

Idiopathic Inflammatory Myopathies1 trial

Clinical Characteristics and Mechanism Research of Inhibitors of Janus Kinase in the Idiopathic Inflammatory Myopathies

Unknown status·PPeking University People's Hospital·Phase 2·NCT05400889·10 enrolled

Juvenile Idiopathic Arthritis1 trial

Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

Completed· Pfizer logo

Pfizer·Phase 2/3·NCT01500551·302 enrolled

Drug Repurposing1 trial

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tofacitinib vs Abatacept

Completed·—··NCT04529876·29,464 enrolled

Kidney Transplant1 trial

Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients

Completed· Pfizer logo

Pfizer··NCT01375127·83 enrolled

Amyloidosis1 trial

A Prospective Cohort Study on Primary Cutaneous Amyloidosis

Recruiting·—·Phase 4·NCT06998875·56 enrolled

Targeted Therapy1 trial

Comparative Effectiveness of Targeted Therapy in RA Patients

Unknown status·HHanyang University··NCT04449224·506 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma

Recruiting·RRuijin Hospital·Phase 2·NCT05348213·76 enrolled

Prevention1 trial

Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT05048238·7 enrolled

Toxic Epidermal Necrolysis1 trial

Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis

Recruiting·PPeng Zhang·Phase 1·NCT06119490·30 enrolled

Vitiligo1 trial

Efficacy of Oral Tofacitinib in Combination of Narrow Band UVB in Treatment of Vitiligo

Active, not recruiting·LLahore General Hospital·Phase 1·NCT07044141·20 enrolled

Corticosteroids1 trial

Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients

Completed·—·Phase 4·NCT04485325·92 enrolled

Efficacy1 trial

Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN

Completed·—·N/A·NCT06474078·20 enrolled

IgG4 Related Disease1 trial

Tofatib Treatment for IgG4-related Disease

Unknown status·—··NCT05625581·40 enrolled

Blau syndrome1 trial

Effective Treatment of Jak1/3 Inhibitor in Blau Syndrome

Enrolling by invitation·TTongji Hospital··NCT06688838·24 enrolled

Tocilizumab1 trial

Tocilizumab and Tofacitinib in the Treatment of Vascular Behçet's Syndrome

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT05845723·81 enrolled

Necrosis1 trial

Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.

Completed· Pfizer logo

Pfizer··NCT04721821·7,807 enrolled

Pancreatic Adenocarcinoma1 trial

Mesothelin-Targeted Immunotoxin LMB-100 in Combination With Tofacitinib in Persons With Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expressing Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT04034238·19 enrolled

Effectiveness1 trial

Rhofanib® (Tofacitinib) Safety and Effectiveness Evaluation

Completed·NNanoAlvand··NCT07101471·296 enrolled

Myasthenia Gravis1 trial

Safety And Efficacy Of Tofacitinib In Patients With Refractory Myasthenia Gravis: A Pilot Study

Completed·HHuashan Hospital·Phase 1·NCT04431895·19 enrolled

Prednisolone1 trial

Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis

Unknown status·CChinese SLE Treatment And Research Group·Phase 3·NCT05749666·50 enrolled

Colitis1 trial

Tofacitinib for the Treatment of Refractory Immune-related Colitis from Checkpoint Inhibitor Therapy- TRICK Study

Terminated·KKhashayar Esfahani·Phase 2·NCT04768504·2 enrolled

Depression1 trial

Tofacitinib in Depression (TIDE)

Terminated·UUniversity of Oxford·Phase 1/2·NCT04141904·2 enrolled

Sarcoidosis1 trial

Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis

Completed·OOregon Health and Science University·Phase 1·NCT03793439·5 enrolled

Prurigo Nodularis1 trial

Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·N/A·NCT06201715·24 enrolled

Granuloma Annulare1 trial

Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare

Completed·YYale University·Phase 1·NCT03910543·15 enrolled

Polymyalgia Rheumatica1 trial

Tofacitinib as a GC Sparing Agent for Polymyalgia Rheumatica

Completed·RRenJi Hospital·Phase 2·NCT04799262·14 enrolled

Pouchitis1 trial

Tofacitinib For Treatment Of Chronic Pouchitis

Terminated·—·Phase 2·NCT04580277·6 enrolled

Alopecia1 trial

Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study

Completed·—·N/A·NCT06202560·11 enrolled

Oral1 trial

A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.

Completed· Pfizer logo

Pfizer·Phase 1·NCT04111614·12 enrolled

Amyotrophic Lateral Sclerosis1 trial

Tofacitinib in Patients With Amyotrophic Lateral Sclerosis

Not yet recruiting·—·Phase 1·NCT06689982·12 enrolled

Oral Lichen Planus1 trial

Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus

Recruiting·—·Phase 4·NCT07131813·60 enrolled

Takayasu arteritis1 trial

Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis

Unknown status·CChinese SLE Treatment And Research Group·Phase 4·NCT05151848·100 enrolled

Cutaneous Leishmaniasis1 trial

Tofacitinib Associated With Meglumine Antimoniate in Cutaneous Leishmaniasis

Unknown status·HHospital Universitário Professor Edgard Santos·Phase 2/3·NCT06011343·22 enrolled

Chidamide1 trial

Tofacitinib Combined With Chidamide in R/R ENKTCL

Unknown status·SSichuan University·Phase 2·NCT03598959·20 enrolled

Eye Disease1 trial

Tofacitinib for Inflammatory Eye Disease

Unknown status·WWashington University School of Medicine·Phase 2·NCT03580343·5 enrolled

ANCA-Associated Vasculitis1 trial

Effect of Tofacitinib in Treating ANCA-associated Vasculitis

Completed·SShanghai Zhongshan Hospital·N/A·NCT04973033·10 enrolled

Erythema1 trial

The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib and Doxycycline in Chinese Adult Patients With Mild to Moderate Erythematous Telangiectatic Rosacea

Recruiting·TThe Fourth Affiliated Hospital of Zhejiang University School of Medicine·N/A·NCT07343635·186 enrolled

Granulomatosis with Polyangiitis1 trial

Study of Salvage Therapy to Treat Patients with Granulomatosis with Polyangiitis

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04871191·42 enrolled

Completed·SShanghai Zhongshan Hospital·Phase 2·NCT06393972·25 enrolled

Polyarticular Course Juvenile Idiopathic Arthritis1 trial

Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis

Recruiting·DDuke University·Phase 3·NCT06654882·400 enrolled

Diaphragm Injury1 trial

A Clinical Trial of JAK Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

Active, not recruiting·SStanford University·Phase 2·NCT03681275·70 enrolled

Immunoglobulin G4-related Disease1 trial

A Randomized Open Label Clinical Study on the Efficacy of Tofacitinib in the Treatment of IgG4 Related Diseases

Completed·PPeking University People's Hospital·Preclinical·NCT07827469·58 enrolled

Active Moderate to Severe Rheumatoid Arthritis1 trial

KOREAN POST-MARKETING SURVEILLANCE FOR XELJANZ XR (REGISTERED)

Recruiting· Pfizer logo

Pfizer··NCT04876781·200 enrolled

Arthritis, Juvenile1 trial

KOREAN POST-MARKETING SURVEILLANCE FOR XELJANZ® 5 MG FILM-COATED TABLETS AND XELJANZ® 1 MG/ML ORAL SOLUTION IN PATIENTS WITH ACTIVE PJIA AND JPSA

Recruiting· Pfizer logo

Pfizer··NCT05754710·10 enrolled

Palmoplantar Pustulosis (PPP)1 trial

A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib (Investigational Therapy) in Patients With Moderate-to-Severe Palmoplantar Pustulosis

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 3·NCT07530367·135 enrolled

Cutaneous T-cell lymphoma1 trial

A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIA

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06698822·20 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Glioblastoma1 trial

Tofacitinib: Suppressing Tumor Invasion in Recurrent GBM Patients

Completed·UUniversity of Texas Southwestern Medical Center·Phase 3·NCT05326464·18 enrolled

Unspecified4 trials

A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT02487433·18 enrolled

A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT02084875·24 enrolled

Open-label, Fixed-sequence, Two-period Comparative Bioavailability Study of Tofacitinib From Repeated Topical Applications of Tofacitinib Citrate Topical Gel 3.2% to Single Oral Administration of Xeljanz 5 mg Tablet in Healthy Subjects

Completed·TTWi Biotechnology, Inc.·Phase 1·NCT04468425·20 enrolled

Show 1 more trial

A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers

Recruiting· AbbVie logo

AbbVie·Phase 1·NCT07843693·60 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 6, 2012

XELJANZ

NDA NDA203214

Feb 23, 2016

XELJANZ XR

NDA NDA208246

Sep 25, 2020

XELJANZ

NDA NDA213082

Sources

References

[1]
ClinicalTrials.gov — 166 trial records for Tofacitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Xeljanz drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tofacitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tofacitinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213082). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Xeljanz. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Prism Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Janus Kinase (JAK) Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPrism Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Mar 14, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE41783Dec 8, 2025

RE41783*PEDJun 8, 2026

10639309Mar 14, 2034

11253523Mar 14, 2034

9937181Mar 14, 2034

3 more patents

9937181*PEDSep 14, 2034

10639309*PEDSep 14, 2034

11253523*PEDSep 14, 2034

Xeljanz

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Rheumatoid Arthritis28 trials

Ulcerative Colitis12 trials

Alopecia Areata8 trials

Psoriatic Arthritis8 trials

Efficacy and Safety6 trials

Pneumonia5 trials

Arthritis5 trials

Psoriasis5 trials

Down syndrome3 trials

Ankylosing Spondylitis3 trials

Methotrexate3 trials

Interstitial Lung Disease3 trials

Atopic Dermatitis3 trials

Systemic Sclerosis3 trials

Dermatomyositis2 trials

COVID-192 trials

MPA2 trials

Systemic Lupus Erythematosus2 trials

Adult2 trials

ART2 trials

Primary Sjogren's Syndrome2 trials

Phase 12 trials

Spondyloarthropathy1 trial

Idiopathic Inflammatory Myopathies1 trial

Juvenile Idiopathic Arthritis1 trial

Drug Repurposing1 trial

Kidney Transplant1 trial

Amyloidosis1 trial

Targeted Therapy1 trial

Diffuse Large B-Cell Lymphoma1 trial

Prevention1 trial

Toxic Epidermal Necrolysis1 trial

Vitiligo1 trial

Corticosteroids1 trial

Efficacy1 trial

IgG4 Related Disease1 trial

Blau syndrome1 trial

Tocilizumab1 trial

Necrosis1 trial

Pancreatic Adenocarcinoma1 trial

Effectiveness1 trial

Myasthenia Gravis1 trial

Prednisolone1 trial

Colitis1 trial

Depression1 trial

Sarcoidosis1 trial

Prurigo Nodularis1 trial

Granuloma Annulare1 trial

Polymyalgia Rheumatica1 trial

Pouchitis1 trial

Alopecia1 trial

Oral1 trial

Amyotrophic Lateral Sclerosis1 trial

Oral Lichen Planus1 trial

Takayasu arteritis1 trial

Cutaneous Leishmaniasis1 trial

Chidamide1 trial

Eye Disease1 trial

ANCA-Associated Vasculitis1 trial

Erythema1 trial

Granulomatosis with Polyangiitis1 trial

Sjogren's Syndrome1 trial

Juvenile Idiopathic Arthritis (JIA)1 trial

Glucocorticoid Resistant ICIs-related Myocarditis1 trial

Polyarticular Course Juvenile Idiopathic Arthritis1 trial

Diaphragm Injury1 trial

Immunoglobulin G4-related Disease1 trial

Active Moderate to Severe Rheumatoid Arthritis1 trial

Arthritis, Juvenile1 trial

Palmoplantar Pustulosis (PPP)1 trial

Cutaneous T-cell lymphoma1 trial

Rheumatic Disease1 trial