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Sulfasalazine

Generic Name
Sulfasalazine
Brand Names
Azulfidine, Salazopyrin, Salazopyrin En-tabs
Drug Type
Small Molecule
Chemical Formula
C18H14N4O5S
CAS Number
599-79-1
Unique Ingredient Identifier
3XC8GUZ6CB
Background

Sulfasalazine is an anti-inflammatory drug structurally related to salicylates and other non-steroidal anti-inflammatory drugs. It is indicated for managing inflammatory diseases such as ulcerative colitis and rheumatoid arthritis (RA). Metabolized by intestinal bacteria, sulfasalazine is broken down into mesalazine and sulfapyridine, 2 compounds that carry out the main pharmacological activity of sulfasalazine.

Sulfasalazine was first used in 1940 for rheumatic polyarthritis, and has been firmly established itself as one fo the most useful disease-modifying antirheumatic drug (DMARD). Compared to the first line treatment of RA like methotrexate, sulfasalazine is almost as efficacious as methotrexate although with slightly less tolerability. However, sulfasalazine has less teratogenic side effects and faster onset of action compared to conventional DMARD. Sulfasalazine fell out of favor as the drug of choice for RA due to poorly designed clinical trials in 1950 but regained interest from the clinical community in the late 1970.

Although sulfasalazine is only approved by the FDA for ulcerative colitis, research have shown that sulfasalazine is also beneficial for patients with Crohn's disease. Meta-analysis of 19 randomized controlled trials indicated that sulfasalazine is superior to placebo in inducing remission; however, with no supported evidence of mucosal healing, sulfasalazine is not FDA-recommmended for treatment of Crohn's disease.

Indication

In the US, sulfasalazine is indicated to treat mild to moderate ulcerative colitis and to prolong the remission period between acute attacks of ulcerative colitis. Sulfasalazine is also indicated as an adjunct therapy in severe ulcerative colitis.For the delayed-release tablet formulation, sulfasalazine is also indicated to treat rheumatoid arthritis in pediatric patients who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs or polyarticular-course juvenile rheumatoid arthritis with the same patients' characteristics.

Associated Conditions
Crohn's Disease (CD), Distal Ulcerative Colitis, Mild to Moderate Ulcerative Colitis, Polyarticular juvenile rheumatoid arthritis, chronic or unspecified, Proctitis, Rheumatoid Arthritis, Severe Ulcerative Colitis, Ulcerative Colitis in Remission

A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus

Phase 2
Not yet recruiting
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2024-04-11
Last Posted Date
2024-04-11
Lead Sponsor
Qiong Fu
Target Recruit Count
20
Registration Number
NCT06360068

Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.

Not Applicable
Recruiting
Conditions
Fibrosis, Liver
Cirrhosis, Liver
Interventions
First Posted Date
2024-03-05
Last Posted Date
2025-02-20
Lead Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Target Recruit Count
330
Registration Number
NCT06293378
Locations
🇨🇳

Chongqing Medical University, Chongqing, Chongqing, China

🇨🇳

Chongqing, Chongqing, Chongqing, China

Sulfasalazine in Patients With Metastatic Colorectal Cancer

Phase 3
Recruiting
Conditions
Metastatic Colorectal Cancer
Interventions
First Posted Date
2023-11-18
Last Posted Date
2023-11-18
Lead Sponsor
Tanta University
Target Recruit Count
50
Registration Number
NCT06134388
Locations
🇪🇬

Tanta University Hospital, Tanta, El-Gharbia Governorate, Egypt

Topical Sulfasalazine and Oral Lichen Planus

Phase 3
Active, not recruiting
Conditions
Oral Lichen Planus
Topical Sulfasalazine
Corticosteroids
Interventions
Drug: corticosteroids
First Posted Date
2023-09-29
Last Posted Date
2024-08-01
Lead Sponsor
Cairo University
Target Recruit Count
46
Registration Number
NCT06060301
Locations
🇪🇬

Faculty of Dentistry, Cairo University, Cairo, Egypt

The Effect of Sulfasalazine on CRH Levels in Pregnant Women

Phase 2
Recruiting
Conditions
Preterm Birth
Interventions
First Posted Date
2023-01-30
Last Posted Date
2024-04-17
Lead Sponsor
Rutgers, The State University of New Jersey
Target Recruit Count
50
Registration Number
NCT05703425
Locations
🇺🇸

Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States

Glutamate Inhibitors in Glioblastoma

Phase 1
Recruiting
Conditions
Glioblastoma
Interventions
First Posted Date
2022-12-23
Last Posted Date
2024-05-10
Lead Sponsor
University of Zurich
Target Recruit Count
120
Registration Number
NCT05664464
Locations
🇨🇭

University Hospital Zurich, Zürich, Zurich, Switzerland

Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment

Phase 1
Recruiting
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2022-10-14
Last Posted Date
2024-05-29
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
64
Registration Number
NCT05580861
Locations
🇫🇷

CHU Nice, Nice, France

🇫🇷

CHU Caen, Caen, France

🇫🇷

CHU Henri Mondor, Créteil, France

and more 10 locations

A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2022-07-06
Last Posted Date
2023-02-08
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
30
Registration Number
NCT05445440
Locations
🇺🇸

Quotient Sciences Miami, Miami, Florida, United States

Real-World Emulation of the SWEFOT Trial

Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2021-09-21
Last Posted Date
2021-09-28
Lead Sponsor
Karolinska Institutet
Target Recruit Count
509
Registration Number
NCT05051137
Locations
🇸🇪

Karolinska Institutet, Department of Medicine Solna, Clinical Epidemiology Unit, Stockholm, Sweden

CHronic Nonbacterial Osteomyelitis International Registry

First Posted Date
2021-01-26
Last Posted Date
2024-07-30
Lead Sponsor
Seattle Children's Hospital
Target Recruit Count
2000
Registration Number
NCT04725422
Locations
🇺🇸

Seattle Children's Hospital, Seattle, Washington, United States

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