Overview
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/04/11 | Phase 2 | Not yet recruiting | Qiong Fu | ||
2024/03/05 | Not Applicable | Recruiting | |||
2023/11/18 | Phase 3 | Recruiting | |||
2023/09/29 | Phase 3 | Active, not recruiting | |||
2023/01/30 | Phase 2 | Recruiting | |||
2022/12/23 | Phase 1 | Recruiting | |||
2024/06/14 | Phase 1/2 | Recruiting | |||
2022/07/06 | Phase 1 | Completed | |||
2021/09/21 | N/A | Completed | |||
2021/01/26 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Blenheim Pharmacal, Inc. | 10544-288 | ORAL | 500 mg in 1 1 | 2/25/2015 | |
Pfizer Laboratories Div Pfizer Inc | 0013-0101 | ORAL | 500 mg in 1 1 | 10/26/2022 | |
A-S Medication Solutions | 50090-6936 | ORAL | 500 mg in 1 1 | 10/31/2022 | |
REMEDYREPACK INC. | 70518-0185 | ORAL | 500 mg in 1 1 | 1/4/2024 | |
Actavis Pharma, Inc. | 0591-0796 | ORAL | 500 mg in 1 1 | 2/28/2022 | |
Aphena Pharma Solutions - Tennessee, LLC | 43353-495 | ORAL | 500 mg in 1 1 | 7/3/2014 | |
Greenstone LLC | 59762-5000 | ORAL | 500 mg in 1 1 | 10/31/2022 | |
Aidarex Pharmaceuticals LLC | 33261-756 | ORAL | 500 mg in 1 1 | 2/1/2014 | |
Aphena Pharma Solutions - Tennessee, LLC | 71610-706 | ORAL | 500 mg in 1 1 | 5/16/2023 | |
Pfizer Laboratories Div Pfizer Inc | 0013-0102 | ORAL | 500 mg in 1 1 | 10/27/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
PMS-SULFASALAZINE E.C.TABLET 500 mg | SIN06512P | ENTERIC COATED TABLET | 500 mg | 8/19/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Sulfasalazine Enteric-Coated Tablets | 国药准字H14022874 | 化学药品 | 片剂(肠溶) | 6/22/2020 | |
Sulfasalazine Enteric-Coated Tablets | 国药准字H31020450 | 化学药品 | 片剂(肠溶) | 8/13/2024 | |
Sulfasalazine Enteric-Coated Tablets | 国药准字H11020475 | 化学药品 | 片剂 | 2/26/2020 | |
Sulfasalazine Enteric-Coated Tablets | 国药准字H31020557 | 化学药品 | 片剂(肠溶) | 11/26/2019 | |
Sulfasalazine Enteric-Coated Tablets | 国药准字H20054246 | 化学药品 | 片剂(肠溶糖衣) | 12/11/2020 | |
Sulfasalazine Enteric-Coated Tablets | 国药准字H11020818 | 化学药品 | 片剂 | 6/16/2020 | |
Sulfasalazine Enteric-Coated Tablets | 国药准字H31020840 | 化学药品 | 片剂(肠溶薄膜衣) | 1/10/2020 | |
Sulfasalazine Suppositories | 国药准字H19994081 | 化学药品 | 栓剂 | 6/16/2020 | |
Sulfasalazine Suppositories | 国药准字H20058244 | 化学药品 | 栓剂 | 7/13/2020 | |
Sulfasalazine Suppositories | 国药准字H20074194 | 化学药品 | 栓剂 | 8/18/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
SARIDINE-E ENTERIC COATED TAB 500MG | N/A | N/A | N/A | 8/3/2011 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Salazopyrin EN - TABS sulfasalazine 500mg tablet | 14485 | Medicine | A | 9/5/1991 | |
Salazopyrin sulfasalazine 500mg tablet | 14486 | Medicine | A | 9/5/1991 | |
PYRALIN EN Sulfasalazine 500mg tablet | 58398 | Medicine | A | 2/27/1997 |
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