MedPath

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

Study of Sulfasalazine in Treating Painful Neuropathy

Phase 2
Terminated
Conditions
Painful Neuropathy
Interventions
Drug: placebo
First Posted Date
2012-08-17
Last Posted Date
2018-08-22
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
8
Registration Number
NCT01667029
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.

Phase 1
Completed
Conditions
Intestinal Obstruction
Interventions
First Posted Date
2012-05-11
Last Posted Date
2012-05-11
Lead Sponsor
University Medicine Greifswald
Target Recruit Count
16
Registration Number
NCT01596764
Locations
🇩🇪

Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany

Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects

First Posted Date
2012-05-11
Last Posted Date
2016-10-26
Lead Sponsor
University Medicine Greifswald
Target Recruit Count
15
Registration Number
NCT01596777
Locations
🇩🇪

Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany

Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma

Not Applicable
Completed
Conditions
Brain Tumor
Interventions
First Posted Date
2012-04-16
Last Posted Date
2016-12-08
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
9
Registration Number
NCT01577966
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

Effects of Sulfasalazine on BOLD Response to Alcohol Cues

Not Applicable
Completed
Conditions
Alcohol Dependence
Interventions
Drug: Placebo
First Posted Date
2011-03-10
Last Posted Date
2014-09-22
Lead Sponsor
The Mind Research Network
Target Recruit Count
23
Registration Number
NCT01312129
Locations
🇺🇸

The Mind Research Network, Albuquerque, New Mexico, United States

Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

Phase 3
Completed
Conditions
Gastrointestinal Complications
Diarrhea
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Other: placebo
First Posted Date
2010-09-09
Last Posted Date
2020-05-12
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
87
Registration Number
NCT01198145
Locations
🇺🇸

Boulder Community Hospital, Boulder, Colorado, United States

🇺🇸

Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States

🇺🇸

St. Joseph Hospital, Denver, Colorado, United States

and more 252 locations

Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2010-07-30
Last Posted Date
2019-01-22
Lead Sponsor
P. Verschueren
Target Recruit Count
400
Registration Number
NCT01172639
Locations
🇧🇪

Reuma instituut Hasselt, Hasselt, Belgium

🇧🇪

ZNA Jan Palfijn, Merksem, Belgium

🇧🇪

Henri Serruys ziekenhuis, Oostende, Belgium

and more 14 locations

Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

Phase 2
Conditions
Early Ankylosing Spondylitis
First Posted Date
2009-04-29
Last Posted Date
2009-04-29
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
80
Registration Number
NCT00889694

Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS)

Phase 2
Conditions
Moderate to Severe Active Axial Spondyloarthritis
Interventions
First Posted Date
2009-02-13
Last Posted Date
2009-02-13
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
80
Registration Number
NCT00844142
Locations
🇩🇪

Charité Campus Mitte, Rheumatology, Berlin, Germany

🇩🇪

Praxis Mielke, Berlin, Germany

🇩🇪

Waldkrankenhaus, Berlin, Germany

and more 6 locations

Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis

Phase 4
Terminated
Conditions
Arthritis, Juvenile Rheumatoid
Interventions
First Posted Date
2008-03-18
Last Posted Date
2017-02-23
Lead Sponsor
Pfizer
Target Recruit Count
2
Registration Number
NCT00637780
Locations
🇲🇽

Private Office, Guadalajara, Jalisco, Mexico

🇺🇸

University Hospitals Case Medical Center, Cleveland, Ohio, United States

© Copyright 2025. All Rights Reserved by MedPath