Clinical Trials

Tofacitinib has undergone numerous clinical trials spanning early- to late-phase studies across conditions such as rheumatoid arthritis, ulcerative colitis, alopecia areata, checkpoint inhibitor-induced colitis, and ANCA-associated vasculitis. Sponsored by pharmaceutical entities including Pfizer and Gilead Sciences alongside academic centers such as Columbia University and Shanghai Zhongshan Hospital, these evaluations encompass recruitment statuses ranging from active, recruiting protocols to completed studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07281456 RECRUITING
Sjogren's Syndrome
National Institute of Dental and Craniofacial Research (NIDCR)
 2025-12-18 PHASE2
NCT07598643 RECRUITING
Down Syndrome
University of Colorado, Denver
 2026-05-28 PHASE2
NCT07352566 NOT_YET_RECRUITING
Psoriasis; Atopic Dermatitis
University of California, San Francisco
 2026-08-01 PHASE4
NCT06301373 RECRUITING
Rheumatoid Arthritis
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2024-09-01
NCT07522801 NOT_YET_RECRUITING
LAL
Philippe ROUSSELOT
 2026-09-01 PHASE2
NCT06654882 RECRUITING
Polyarticular Course Juvenile Idiopathic Arthritis (JIA)
Duke University
 2026-01-09 PHASE3
NCT06687551 RECRUITING
Rheumatoid Arthritis (RA
University Hospital, Toulouse
 2025-06-06 PHASE4
NCT04871191 RECRUITING
Granulomatosis With Polyangiitis; Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
Assistance Publique - Hôpitaux de Paris
 2025-06-06 PHASE3
NCT07530367 NOT_YET_RECRUITING
Palmoplantar Pustulosis (PPP)
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2026-08-01 PHASE3
NCT03414502 RECRUITING
Rheumatoid Arthritis
University of Nebraska
 2007-12-10 PHASE3
NCT07138898 RECRUITING
Rheumatic Disease
NYU Langone Health
 2025-12-12 PHASE2
NCT07547930 RECRUITING
Thyroid Eye Disease, TED; Graves Ophthalmopathy; Graves Orbitopathy
The First Affiliated Hospital of Xiamen University
 2026-04-24 PHASE2
NCT06660329 ENROLLING_BY_INVITATION
Blau Syndrome
Peking Union Medical College Hospital
 2024-10-01 PHASE4
NCT07406035 RECRUITING
Psoriatic Arthritis
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
 2026-07-16 PHASE2
NCT06095128 RECRUITING
Ulcerative Colitis
Takeda
 2024-06-12 PHASE4
NCT07343635 RECRUITING
Erythematotelangiectatic Rosacea
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
 2026-02-01
NCT06698822 RECRUITING
Cutaneous T-Cell Lymphoma
M.D. Anderson Cancer Center
 2025-03-10 PHASE2
NCT07297069 NOT_YET_RECRUITING
Acute Severe Ulcerative Colitis
Asian Institute of Gastroenterology, India
 2026-01-01 PHASE2
NCT04624230 ACTIVE_NOT_RECRUITING
Ulcerative Colitis
Pfizer
 2021-08-12 PHASE3
NCT07636057 NOT_YET_RECRUITING
Rheumatoid Arthritis (RA)
Sheikh Zayed Federal Postgraduate Medical Institute
 2026-07-05 PHASE4
NCT06945666 NOT_YET_RECRUITING
Rheumatoid Arthritis (RA
Jie Chang
 2025-08-01 PHASE4
NCT07131813 RECRUITING
Oral Lichen Planus
All India Institute of Medical Sciences, Bhubaneswar
 2025-10-10 PHASE4
NCT07313072 NOT_YET_RECRUITING
Nail Psoriasis
Hexsel Dermatology Clinic
 2026-03 PHASE2
NCT07055529 NOT_YET_RECRUITING
Vitiligo, Generalized
Hayat Abad Medical Complex, Peshawar
 2026-06-01 EARLY_PHASE1
NCT07581418 NOT_YET_RECRUITING
Chronic Plaque Psoriasis
Pak Emirates Military Hospital
 2026-06-01
NCT06707246 RECRUITING
Hidradenitis Suppurativa
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2024-12-15
NCT07008846 ACTIVE_NOT_RECRUITING
Moderate to Severe Rheumatoid Arthritis
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2025-05-10 PHASE3
NCT07554820 RECRUITING
Rheumatoid Arthritis; Major Adverse Cardiac Events
Shaikh Zayed Hospital, Lahore
 2025-12-06 PHASE4
NCT07406204 NOT_YET_RECRUITING
Alopecia Areata; Alopecia Totalis (AT); Alopecia Universalis
Hayat Abad Medical Complex, Peshawar
 2026-02-15 PHASE4
NCT06119490 RECRUITING
Toxic Epidermal Necrolysis
Peng Zhang
 2023-07-05 EARLY_PHASE1
NCT06498089 RECRUITING
Takayasu Arteritis
Shanghai Zhongshan Hospital
 2024-06-28 PHASE4
NCT05845723 RECRUITING
Aneurysm; Behcet Syndrome, Vascular Type
Peking Union Medical College Hospital
 2023-06-01 PHASE2
NCT05662228 COMPLETED
Down Syndrome; Regression
University of Colorado, Denver
 2023-06-29 PHASE2
NCT05104723 COMPLETED
Chronic Granulomatous Disease; Inflammatory Gastrointestinal Disease; Inflammatory Skin Disease; Inflammatory Lung Disease
National Institute of Allergy and Infectious Diseases (NIAID)
 2022-08-12 PHASE1; PHASE2
NCT06176508 UNKNOWN
Psoriatic Arthritis
Hansoh BioMedical R&D Company
 2024-02-26 PHASE2
NCT05151848 UNKNOWN
Takayasu Arteritis
Chinese SLE Treatment And Research Group
 2022-01-05 PHASE4
NCT06020144 ACTIVE_NOT_RECRUITING
Rheumatoid Arthritis
Hangzhou Highlightll Pharmaceutical Co., Ltd
 2023-11-15 PHASE3
NCT05102448 RECRUITING
Takayasu Arteritis
Shanghai Zhongshan Hospital
 2021-11-01 PHASE4
NCT07261306 RECRUITING
Psoriasis
Lahore General Hospital
 2025-08-29 EARLY_PHASE1
NCT05112263 UNKNOWN
Ulcerative Colitis
Post Graduate Institute of Medical Education and Research, Chandigarh
 2023-07-01
NCT06689982 NOT_YET_RECRUITING
Amyotrophic Lateral Sclerosis
Beijing Tiantan Hospital
 2024-12-01 EARLY_PHASE1
NCT04743518 RECRUITING
Ulcerative Colitis
Centre Hospitalier Universitaire, Amiens
 2021-02-02 PHASE4
NCT05313620 RECRUITING
Ulcerative Colitis; Thromboembolism
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
 2022-04-01 PHASE4
NCT06625450 NOT_YET_RECRUITING
Ulcerative Colitis
Post Graduate Institute of Medical Education and Research, Chandigarh
 2024-10 PHASE4
NCT03681275 RECRUITING
Diaphragm Injury
Stanford University
 2019-09-03 PHASE2
NCT06393972 NOT_YET_RECRUITING
Glucocorticoid Resistant ICIs-related Myocarditis
Shanghai Zhongshan Hospital
 2024-07-01 PHASE2
NCT06465732 UNKNOWN
Atopic Dermatitis
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2025-01 PHASE4
NCT06998875 RECRUITING
Primary Cutaneous Amyloidosis
Army Medical University, China
 2025-03-01 PHASE4
NCT07044141 ACTIVE_NOT_RECRUITING
Vitiligo
Lahore General Hospital
 2025-03-01 PHASE1
NCT06172361 RECRUITING
Polymyalgia Rheumatica
Zhejiang University
 2024-01-20 PHASE3
NCT06810050 COMPLETED
Atopic Dermatitis (AD)
CAGE Bio Inc.
 2024-12-18 PHASE2
NCT07472166 COMPLETED
Scleroderma, Systemic
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2024-12-21 PHASE4
NCT06923228 COMPLETED
Atopic Dermatitis (AD)
CAGE Bio Inc.
 2025-04-21 PHASE2
NCT05749666 UNKNOWN
Takayasu Arteritis
Chinese SLE Treatment And Research Group
 2023-01-20 PHASE3
NCT06201715 UNKNOWN
Prurigo Nodularis; Itch
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2024-05-01
NCT06474078 COMPLETED
Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis
Chang Gung Memorial Hospital
 2022-08-01
NCT05348213 RECRUITING
Diffuse Large B Cell Lymphoma
Ruijin Hospital
 2022-05-16 PHASE2
NCT06112665 RECRUITING
Axial Spondyloarthritis
Charite University, Berlin, Germany
 2023-11-10 PHASE4
NCT03976245 RECRUITING
Rheumatoid Arthritis
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2020-03-01 PHASE4
NCT05326464 COMPLETED
Glioblastoma
University of Texas Southwestern Medical Center
 2022-10-07 PHASE3
NCT01500551 COMPLETED
Juvenile Idiopathic Arthritis
Pfizer
 2013-03-18 PHASE2; PHASE3
NCT05803135 UNKNOWN
Rheumatoid Arthritis
Nanfang Hospital, Southern Medical University
 2023-03-31 PHASE4
NCT04496960 ACTIVE_NOT_RECRUITING
Sjogren's Syndrome
National Institute of Dental and Craniofacial Research (NIDCR)
 2021-05-18 PHASE1; PHASE2
NCT03885713 COMPLETED
Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
 2019-09-10 PHASE4
NCT04246372 COMPLETED
Down Syndrome; Alopecia Areata; Atopic Dermatitis / Eczema; Hidradenitis Suppurativa; Vitiligo; Psoriasis
University of Colorado, Denver
 2020-10-21 PHASE2
NCT04610476 UNKNOWN
Psoriatic Arthritis; Withdrawal; Reduction
University of Erlangen-Nürnberg Medical School
 2020-10-19 PHASE3
NCT06011343 UNKNOWN
Cutaneous Leishmaniasis, American
Hospital Universitário Professor Edgard Santos
 2023-10-01 PHASE2; PHASE3
NCT06438679 ENROLLING_BY_INVITATION
Dermatomyositis
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2024-03-19 PHASE4
NCT06202560 COMPLETED
Frontal Fibrosing Alopecia; Lichen Planopilaris of Scalp
Institute of Dermatology, Thailand
 2023-11-29
NCT03591770 TERMINATED
Inflammatory Bowel Diseases
Boston Medical Center
 2019-07-31 PHASE4
NCT04944524 UNKNOWN
Granulomatosis With Polyangiitis
Shanghai Zhongshan Hospital
 2021-07-01 PHASE4
NCT06114407 UNKNOWN
Spondyloarthritis, Axial
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2023-10-30 PHASE2
NCT05606107 UNKNOWN
Rheumatoid Arthritis
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2022-05-20 PHASE4
NCT05814939 COMPLETED
Active Ankylosing Spondylitis
Jiangsu vcare pharmaceutical technology co., LTD
 2023-04-26 PHASE2
NCT06044844 UNKNOWN
Efficacy of Tofacitinib in the Systemic Sclerosis
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2023-11 PHASE2
NCT05080218 COMPLETED
Rheumatoid Arthritis; Psoriatic Arthritis; Spondylarthritis
Jeffrey Curtis
 2021-11-15 PHASE4
NCT04485325 COMPLETED
Rheumatic Arthritis
Dr. Frank Behrens
 2019-11-04 PHASE4
NCT03000439 COMPLETED
Arthritis Juvenile Idiopathic
Pfizer
 2018-05-10 PHASE3
NCT04431895 COMPLETED
Myasthenia Gravis, Generalized
Huashan Hospital
 2020-06-11 EARLY_PHASE1
NCT05246293 UNKNOWN
Rheumatoid Arthritis; Interstitial Lung Disease
National Institute of Respiratory Diseases, Mexico
 2022-08-08 PHASE2
NCT06310057 COMPLETED
Axial Spondyloarthritis
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2022-01-01 PHASE4
NCT05048238 COMPLETED
Cutaneous Lupus
National Institute of Allergy and Infectious Diseases (NIAID)
 2022-09-30 PHASE1
NCT04768504 TERMINATED
Immune-Mediated Colitis
Khashayar Esfahani
 2022-03-22 PHASE2
NCT06278402 COMPLETED
Alopecia Areata; Alopecia Totalis; Alopecia Universalis
Jinnah Hospital
 2023-07-01 PHASE3
NCT04062695 UNKNOWN
Psoriatic Arthritis; Spondylitis; Sacroilitis
Charite University, Berlin, Germany
 2020-08-04 PHASE2
NCT04925973 ACTIVE_NOT_RECRUITING
Ulcerative Colitis Acute
McMaster University
 2021-06-01 PHASE2
NCT04311567 TERMINATED
Rheumatoid Arthritis; Interstitial Lung Disease Due to Systemic Disease (Disorder); RA; ILD
Vastra Gotaland Region
 2020-11-07 PHASE4
NCT03755466 UNKNOWN
Rheumatoid Arthritis
Shinshu University
 2018-11-21 PHASE2
NCT06202560 Enrolling by invitation
Frontal Fibrosing Alopecia|Lichen Planopilaris
Institute of Dermatology Thailand
 2023-11-29 Not Applicable
NCT04928066 COMPLETED
Arthritis, Rheumatoid
Qilu Hospital of Shandong University
 2020-03-01 PHASE4
NCT05487963 COMPLETED
Atopic Dermatitis
CAGE Bio Inc.
 2022-11-09 PHASE1; PHASE2
NCT05293119 UNKNOWN
Vitiligo; Effect of Drug
Pi Research Consultancy Center, Bangladesh
 2022-05-30 EARLY_PHASE1
NCT03815578 COMPLETED
Rheumatoid Arthritis
University Hospital, Bordeaux
 2019-06-17
NCT05400889 UNKNOWN
Idiopathic Inflammatory Myopathies
Peking University People's Hospital
 2022-06-10 PHASE2
NCT06157905 COMPLETED
Extensive Alopecia Areata
Services Institute of Medical Sciences, Pakistan
 2022-08-06 EARLY_PHASE1
NCT05165771 WITHDRAWN
Rheumatoid Arthritis
Gilead Sciences
 2022-07 PHASE2
NCT05087589 UNKNOWN
Primary Sjögren's Syndrome
Peking University People's Hospital
 2021-11-20 PHASE2
NCT04299971 UNKNOWN
Takayasu Arteritis; Methotrexate; Inhibition; Treatment
Shanghai Zhongshan Hospital
 2020-03-01 PHASE4
NCT05133297 COMPLETED
Rheumatoid Arthritis
Hangzhou Highlightll Pharmaceutical Co., Ltd
 2022-02-16 PHASE2
NCT04580277 TERMINATED
Pouchitis; Ileal Pouchitis; Ileal Pouch
Cedars-Sinai Medical Center
 2021-01-25 PHASE2
NCT03288324 COMPLETED
Cutaneous Lupus; Systemic Lupus Erythematosus
Children's Hospital Medical Center, Cincinnati
 2017-08-23 PHASE1; PHASE2
NCT05487703 Completed
Arthritis Rheumatoid
Pfizer
 2022-11-14 --
NCT04927000 UNKNOWN
Rheumatoid Arthritis
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2021-05-31 PHASE4
NCT04141904 TERMINATED
Depression; Inflammation
University of Oxford
 2020-02-10 PHASE1; PHASE2
NCT05082428 Completed
Ulcerative Colitis
Pfizer
 2022-05-30 --
NCT05728008 Completed
Ulcerative Colitis
IRCCS San Raffaele
 2022-04-05 --
NCT04799262 COMPLETED
Polymyalgia Rheumatica; Effect of Drug; Safety Issues
RenJi Hospital
 2021-01-01 PHASE2
NCT04768504 Recruiting
Immune-Mediated Colitis
Khashayar Esfahani|Sir Mortimer B. Davis - Jewish General Hospital
 2022-03-22 Phase 2
NCT04413617 COMPLETED
Rheumatoid Arthritis
Pfizer
 2020-07-29 PHASE2
NCT03970837 TERMINATED
Arthritis, Rheumatoid
GlaxoSmithKline
 2019-06-05 PHASE3
NCT04985955 COMPLETED
Healthy
Janssen Research & Development, LLC
 2021-07-30 PHASE1
NCT03980483 COMPLETED
Arthritis, Rheumatoid
GlaxoSmithKline
 2019-05-16 PHASE3
NCT03910543 COMPLETED
Cutaneous Sarcoidosis; Granuloma Annulare
Yale University
 2019-04-11 PHASE1
NCT03486457 COMPLETED
Psoriatic Arthritis
Pfizer
 2018-08-10 PHASE3
NCT04415151 TERMINATED
COVID-19 Pneumonia
Yale University
 2020-10-14 PHASE2
NCT04973033 COMPLETED
ANCA Associated Vasculitis; Drug Use; JAK-STAT Pathway Deregulation
Shanghai Zhongshan Hospital
 2019-12-01
NCT03800979 COMPLETED
Alopecia Areata
Institute of Dermatology, Thailand
 2019-01-12 PHASE4
NCT04469114 COMPLETED
Covid19
Hospital Israelita Albert Einstein
 2020-09-16 PHASE3
NCT04552197 COMPLETED
Healthy
Janssen Research & Development, LLC
 2020-09-02 PHASE1
NCT04468425 COMPLETED
Healthy Subjects
TWi Biotechnology, Inc.
 2020-10-14 PHASE1
NCT04034238 COMPLETED
Neoplasms With Mesothelin Expression; Epithelioid Mesothelioma; Cholangiocarcinoma, Extrahepatic; Adenocarcinoma, Pancreatic
National Cancer Institute (NCI)
 2019-08-29 PHASE1
NCT03002649 COMPLETED
Dermatomyositis
Johns Hopkins University
 2017-01 PHASE1
NCT04412252 WITHDRAWN
COVID-19
Pfizer
 2020-07-06 PHASE2
NCT04338711 COMPLETED
Healthy
Pfizer
 2020-06-17 PHASE1
NCT04390061 UNKNOWN
Pneumonitis, Interstitial; COVID-19
Università Politecnica delle Marche
 2020-06 PHASE2
NCT04750317 COMPLETED
COVID-19
I.M. Sechenov First Moscow State Medical University
 2020-05-11 PHASE2
NCT04464642 UNKNOWN
Rheumatoid Arthritis
Dr. Mohammad Mamun Khan
 2019-07-10 PHASE4
NCT02092467 COMPLETED
Arthritis, Rheumatoid
Pfizer
 2014-03-14 PHASE4
NCT03793439 COMPLETED
Sarcoidosis, Pulmonary; Sarcoidosis Lung; Sarcoidosis
Oregon Health and Science University
 2019-05-15 PHASE1
NCT04332042 UNKNOWN
SARS-COv2 Related Interstitial Pneumonia
Università Politecnica delle Marche
 2020-04-10 PHASE2
NCT03159936 TERMINATED
Discoid Lupus Erythematosus; Systemic Lupus Erythematosus
Tufts Medical Center
 2017-04-03 EARLY_PHASE1
NCT03281304 TERMINATED
Ulcerative Colitis
Pfizer
 2017-11-16 PHASE4
NCT03598959 UNKNOWN
Extranodal NK/T-cell Lymphoma
Sichuan University
 2019-01-01 PHASE2
NCT03502616 COMPLETED
Ankylosing Spondylitis
Pfizer
 2018-06-07 PHASE3
NCT04111614 COMPLETED
Healthy
Pfizer
 2019-10-11 PHASE1
NCT03580343 UNKNOWN
Uveitis; Scleritis
Washington University School of Medicine
 2019-04-04 PHASE2
NCT03736161 COMPLETED
Psoriatic Arthritis
Globe Pharmaceuticals Limited
 2017-09-15 PHASE3
NCT03016884 UNKNOWN
Herpes Zoster
HaEmek Medical Center, Israel
 2017-01 PHASE4
NCT03504072 UNKNOWN
Spondyloarthritis
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2018-01-16 PHASE4
NCT01976364 COMPLETED
Arthritis, Psoriatic
Pfizer
 2014-02-17 PHASE3
NCT02592434 COMPLETED
Juvenile Idiopathic Arthritis
Pfizer
 2016-06-10 PHASE3
NCT03274076 COMPLETED
Systemic Sclerosis; Scleroderma
University of Michigan
 2017-09-25 PHASE1; PHASE2
NCT03868072 COMPLETED
Rheumatoid Arthritis
Chong Kun Dang Pharmaceutical
 2019-02-22 PHASE1
NCT04403776 COMPLETED
Healthy
Pfizer
 2018-12-03 PHASE1
NCT03738956 UNKNOWN
Axial Spondyloarthritis
Globe Pharmaceuticals Limited
 2017-09-01 PHASE2; PHASE3
NCT02831855 COMPLETED
Rheumatoid Arthritis
Pfizer
 2016-09-01 PHASE4
NCT02996500 COMPLETED
Rheumatoid Arthritis
Pfizer
 2016-11-10 PHASE2
NCT02812342 COMPLETED
Alopecia Areata; Alopecia Totalis; Alopecia Universalis
Yale University
 2016-09 PHASE2
NCT02535689 COMPLETED
Systemic Lupus Erythematosus
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 2015-08-28 PHASE1
NCT02299297 COMPLETED
Alopecia Areata
Columbia University
 2015-01 PHASE2
NCT02566967 COMPLETED
Rheumatoid Arthritis
Norman B. Gaylis, MD
 2015-05 PHASE3
NCT03112148 COMPLETED
Healthy
Pfizer
 2017-09-11 PHASE1
NCT03103412 COMPLETED
Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
Theravance Biopharma
 2017-05-04 PHASE1
NCT02321930 COMPLETED
Rheumatoid Arthritis
University of California, Los Angeles
 2016-02-16 PHASE4
NCT02281552 COMPLETED
Rheumatoid Arthritis
Pfizer
 2014-11-18 PHASE3
NCT02187055 COMPLETED
Rhematoid Arthritis
Pfizer
 2014-08 PHASE4
NCT00413699 COMPLETED
Arthritis, Rheumatoid
Pfizer
 2007-02-05 PHASE3
NCT01882439 COMPLETED
Psoriatic Arthritis
Pfizer
 2013-08 PHASE3
NCT01877668 COMPLETED
Psoriatic Arthritis
Pfizer
 2014-01-20 PHASE3
NCT02312882 COMPLETED
Alopecia Areata; Alopecia Totalis; Alopecia Universalis
Stanford University
 2014-12
NCT02487433 COMPLETED
Healthy
Pfizer
 2015-06 PHASE1
NCT02197455 COMPLETED
Alopecia Areata (AA); Alopecia Totalis (AT); Alopecia Universalis (AU)
Yale University
 2014-07 PHASE2
NCT02147587 COMPLETED
Rheumatoid Arthritis
Pfizer
 2014-06 PHASE2
NCT01458951 COMPLETED
Ulcerative Colitis
Pfizer
 2012-06 PHASE3
NCT01465763 COMPLETED
Ulcerative Colitis
Pfizer
 2012-04 PHASE3
NCT01786668 COMPLETED
Ankylosing Spondylitis
Pfizer
 2013-04 PHASE2
NCT02193815 COMPLETED
Psoriasis Vulgaris
Pfizer
 2014-09 PHASE1
NCT01831466 COMPLETED
Psoriasis Vulgaris; Psoriasis
Pfizer
 2013-05 PHASE2
NCT02001181 COMPLETED
Dermatitis, Atopic
Pfizer
 2013-12 PHASE2
NCT02084875 COMPLETED
Healthy
Pfizer
 2014-04-11 PHASE1
NCT01741493 COMPLETED
Rheumatoid Arthritis
AbbVie (prior sponsor, Abbott)
 2012-11 PHASE1
NCT01710046 COMPLETED
Plaque Psoriasis
Pfizer
 2013-03 PHASE2
NCT01164579 COMPLETED
Rheumatoid Arthritis
Pfizer
 2010-10 PHASE2
NCT01731327 COMPLETED
Healthy
Pfizer
 2012-11 PHASE1
NCT01599377 COMPLETED
Healthy
Pfizer
 2012-05 PHASE1
NCT01499004 COMPLETED
Healthy
Pfizer
 2011-11 PHASE1
NCT01745055 COMPLETED
Rheumatoid Arthritis
Pfizer
 2005-04 PHASE1
NCT01736696 COMPLETED
Psoriasis; Immunomodulation
Pfizer
 2002-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-21)

Check the Tofacitinib (CP-690550) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tofacitinib selectively binds to and inhibits Janus kinase 3 (JAK3), thereby blocking downstream cytokine receptor signaling pathways and reducing the expression of anti-apoptotic proteins BCL-A1 and BCL-XL in immune cells. This targeted suppression of intracellular lymphocyte activation and induction of cell apoptosis mitigates hyper-inflammatory responses, providing clinical relevance in the treatment of autoimmune diseases such as rheumatoid arthritis and ulcerative colitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.