Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate sulfasalazine across indications including inflammatory bowel disease, rheumatoid arthritis, metastatic colorectal cancer, glioblastoma, and preterm birth. Encompassing active, recruiting, and completed statuses, these studies are led by academic medical centers, university hospitals, and pharmaceutical sponsors such as Tanta University, Haukeland University Hospital, and Galapagos NV. Key investigations—such as a Phase 3 trial in metastatic colorectal cancer and a Phase 1 study combining sulfasalazine with radiosurgery for recurrent glioblastoma—assess both its traditional anti-inflammatory mechanisms and emerging oncologic applications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02714634 RECRUITING
Rheumatoid Arthritis; Insufficient Response to Methotrexate or Leflunomide
University Hospital, Strasbourg, France
 2016-03-30 PHASE4
NCT06293378 RECRUITING
Cirrhosis, Liver; Fibrosis, Liver
The Second Affiliated Hospital of Chongqing Medical University
 2024-02-01
NCT03414502 RECRUITING
Rheumatoid Arthritis
University of Nebraska
 2007-12-10 PHASE3
NCT05703425 RECRUITING
Preterm Birth
Rutgers, The State University of New Jersey
 2023-03-01 PHASE2
NCT07138898 RECRUITING
Rheumatic Disease
NYU Langone Health
 2025-12-12 PHASE2
NCT07726368 NOT_YET_RECRUITING
Non-alcoholic Fatty Liver Disease (NAFLD); Dyslipidaemia
Eccogene
 2026-07 PHASE1
NCT05664464 RECRUITING
Glioblastoma
University of Zurich
 2023-01-01 PHASE1; PHASE2
NCT03561584 COMPLETED
Primary Sclerosing Cholangitis
Brigham and Women's Hospital
 2018-07-01 PHASE2
NCT05580861 RECRUITING
Acute Myeloid Leukemia
Assistance Publique - Hôpitaux de Paris
 2023-05-17 PHASE1; PHASE2
NCT06134388 RECRUITING
Metastatic Colorectal Cancer
Tanta University
 2023-09-01 PHASE3
NCT06360068 UNKNOWN
Systemic Lupus Erythematosus
Qiong Fu
 2024-05-06 PHASE2
NCT03739853 COMPLETED
Psoriatic Arthritis
University of Oxford
 2019-05-14 PHASE4
NCT04610476 UNKNOWN
Psoriatic Arthritis; Withdrawal; Reduction
University of Erlangen-Nürnberg Medical School
 2020-10-19 PHASE3
NCT06060301 UNKNOWN
Oral Lichen Planus; Topical Sulfasalazine; Corticosteroids
Cairo University
 2023-03-01 PHASE3
NCT03254589 COMPLETED
Rheumatoid Arthritis; Stiffness, Aortic; Endothelial Dysfunction; Cardiovascular Risk Factor
Flinders University
 2017-10-01 PHASE4
NCT03847311 COMPLETED
Breast Cancer; Chronic Pain Due to Malignancy (Finding)
University of Arizona
 2021-05-03 PHASE2
NCT06134388 Recruiting
Metastatic Colorectal Cancer
Tanta University
 2023-09-01 Phase 3
NCT03813771 UNKNOWN
Rheumatoid Arthritis
University of Leeds
 2019-03 PHASE4
NCT05445440 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2022-09-06 PHASE1
NCT05749068 COMPLETED
Healthy
Envivo Bio Inc
 2022-09-01
NCT04205357 COMPLETED
Glioma; Glioblastoma; Recurrent Glioblastoma
Haukeland University Hospital
 2020-03-01 PHASE1
NCT03487926 Active not recruiting
Major Depressive Episode|Inflammatory Bowel Diseases
Centre for Addiction and Mental Health|McMaster University
 2022-09-14 --
NCT04528056 UNKNOWN
Pulmonary Arterial Hypertension
RenJi Hospital
 2020-08-01 PHASE1; PHASE2
NCT04077957 UNKNOWN
Ankylosing Spondylitis; Spondyloarthritis
Nanfang Hospital, Southern Medical University
 2019-10-07 PHASE4
NCT04268394 COMPLETED
Healthy Volunteer
Celgene
 2020-03-13 PHASE1
NCT02374021 COMPLETED
Arthritis, Rheumatoid
Brigham and Women's Hospital
 2016-07 PHASE4
NCT04720183 COMPLETED
Healthy
Lakefront Biotherapeutics NV
 2021-01-11 PHASE1
NCT04720183 Completed
Healthy
Galapagos NV
 2021-01-11 Phase 1
NCT03797872 COMPLETED
Psoriatic Arthritis
University of Oxford
 2019-04-17 PHASE4
NCT02456363 UNKNOWN
Ankylosing Spondylitis
Chung Shan Medical University
 2009-11 PHASE2
NCT03449758 COMPLETED
Rheumatoid Arthritis
Sanofi
 2018-03-05 PHASE4
NCT06985134 COMPLETED
Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh; Condition ...Moderate to Severe Axial Spondyloarthopathy
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2017-01-01 PHASE3
NCT03801733 COMPLETED
Drug Interaction Potentiation
Akebia Therapeutics
 2018-06-17 PHASE1
NCT02930343 TERMINATED
Rheumatoid Arthritis
Jawaharlal Institute of Postgraduate Medical Education & Research
 2016-09 PHASE3
NCT02451748 COMPLETED
Rheumatoid Arthritis
University of Illinois at Chicago
 2015-08 PHASE4
NCT01667029 TERMINATED
Painful Neuropathy
Massachusetts General Hospital
 2013-05 PHASE2
NCT02433184 COMPLETED
Rheumatoid Arthritis
University of Leeds
 2011-07 PHASE4
NCT02320630 UNKNOWN
Recurrence (Disease Attribute)
Peking University First Hospital
 2015-10
NCT02638896 UNKNOWN
Ankylosing Spondylitis
Zhixiang Huang
 2016-01 PHASE4
NCT03012763 COMPLETED
Pharmacokinetics; Magnetic Resonance Imaging; Administration, Oral
University Medicine Greifswald
 2016-04 PHASE1
NCT02373202 COMPLETED
Rheumatoid Arthritis
Sanofi
 2015-02 PHASE3
NCT01941095 COMPLETED
Rheumatoid Arthritis
Hoffmann-La Roche
 2013-11-20 PHASE3
NCT02434861 COMPLETED
Chemotherapy-induced Nausea and Vomiting
Tesaro, Inc.
 2015-05 PHASE1
NCT01172639 COMPLETED
Rheumatoid Arthritis
P. Verschueren
 2009-02 PHASE4
NCT01689532 COMPLETED
Arthritis, Rheumatoid
Janssen Pharmaceutical K.K.
 2012-11 PHASE3
NCT01709578 COMPLETED
Rheumatoid Arthritis
Sanofi
 2012-10 PHASE3
NCT02057250 COMPLETED
RA
Sanofi
 2014-03 PHASE3
NCT01577966 COMPLETED
Brain Tumor
University of Alabama at Birmingham
 2012-01
NCT01768572 COMPLETED
Rheumatoid Arthritis
Sanofi
 2013-03 PHASE3
NCT00637780 TERMINATED
Arthritis, Juvenile Rheumatoid
Pfizer
 2010-06 PHASE4
NCT01198145 COMPLETED
Diarrhea; Gastrointestinal Complications; Unspecified Adult Solid Tumor, Protocol Specific
Alliance for Clinical Trials in Oncology
 2011-04 PHASE3
NCT00844142 UNKNOWN
Moderate to Severe Active Axial Spondyloarthritis
Charite University, Berlin, Germany
 2005-11 PHASE2
NCT01659242 TERMINATED
Rheumatoid Arthritis
Singapore General Hospital
 2012-07 PHASE4
NCT01040195 COMPLETED
Seronegative Spondyloarthropathies
Sanjay Gandhi Postgraduate Institute of Medical Sciences
 2009-06 PHASE3
NCT01577966 Completed
Brain Tumor
University of Alabama at Birmingham
 2012-01 Not Applicable
NCT00405275 COMPLETED
Rheumatoid Arthritis
US Department of Veterans Affairs
 2007-07
NCT01312129 COMPLETED
Alcohol Dependence
The Mind Research Network
 2010-03
NCT01596764 COMPLETED
Intestinal Obstruction
University Medicine Greifswald
 2011-05 PHASE1
NCT00579878 COMPLETED
Rheumatoid Arthritis
University of Nebraska
 2001-03-27 PHASE3
NCT01596777 COMPLETED
Intestinal Obstruction
University Medicine Greifswald
 2010-01 PHASE1
NCT00889694 UNKNOWN
Early Ankylosing Spondylitis
Sun Yat-sen University
 2008-10 PHASE2; PHASE3
NCT00259610 COMPLETED
Rheumatoid Arthritis
University of Alabama at Birmingham
 2004-05 PHASE4
NCT00422227 COMPLETED
Rheumatoid Arthritis
Wyeth is now a wholly owned subsidiary of Pfizer
 2007-06 PHASE4
NCT00521924 TERMINATED
Rheumatoid Arthritis
Merck Sharp & Dohme LLC
 2007-06 PHASE3
NCT00554203 COMPLETED
Coronary Artery Disease
Boston University
 2003-07
NCT00062465 COMPLETED
Rheumatoid Arthritis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 2003-06 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-03-12)

Check the Sulfasalazine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sulfasalazine acts as a potent inhibitor of nuclear factor kappa B (NF-κB), TGF-β, and COX-2 signaling pathways, suppressing downstream pro-inflammatory gene transcription while inducing cell death via apoptosis, autophagy, and ferroptosis. This targeted inhibition of inflammatory cascades and cellular survival mechanisms provides the mechanistic basis for reducing disease activity in chronic inflammatory conditions like inflammatory bowel disease and rheumatoid arthritis, as well as limiting tumor growth in colorectal cancer and glioblastoma.

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.