Data updated: May 26, 2026
AZULFIDINE EN-TABS (sulfasalazine)
Immunology
Approved 1950-06-20
AZULFIDINE EN-TABS is indicated for the treatment of Ulcerative Colitis; Rheumatoid Arthritis; Juvenile Rheumatoid Arthritis.
Source: FDA Label • PHARMACIA UPJOHN
2
Indications
--
Phase 3 Trials
1
Priority Reviews
75
Years on Market
Details
- Status
- Prescription
- First Approved
- 1950-06-20
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, DELAYED RELEASE
AZULFIDINE EN-TABS Approval History
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Original
New Indication
New Form
Label Update
65 FDA actions from 1950 to 2022
Nov 2015 SUPPL Priority
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Sep 2000 SUPPL
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Jul 1982 SUPPL Priority
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Jun 1981 SUPPL
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Mar 1981 SUPPL
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Mar 1981 SUPPL Priority
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Jun 1950 ORIGINAL Priority
New Drug
What AZULFIDINE EN-TABS Treats
3 indicationsAZULFIDINE EN-TABS is approved for 3 conditions since its original approval in 1950. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ulcerative Colitis
- Rheumatoid Arthritis
- Juvenile Rheumatoid Arthritis
Source: FDA Label
AZULFIDINE EN-TABS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 8 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in AZULFIDINE EN-TABS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AZULFIDINE EN-TABS treats. First-in-class if their pivotal trials read out positive.
Afimkibart RVT-3101 / PRA023
Hoffmann-La Roche TNFSF15 · monoclonal antibody (anti-TL1A) · 6 Phase 3 trials
Tulisokibart MK-7240 / PRA023
Merck Sharp & Dohme LLC TNFSF15 · monoclonal antibody (anti-TL1A) · 3 Phase 3 trials
Ianalumab VAY736 ✓ Won — Ph3 readout
Novartis Pharmaceuticals TNFRSF13C · monoclonal antibody (anti-BAFF-R, glycoengineered for ADCC) · 8 Phase 3 trials
Rocatinlimab AMG 451 / KHK4083 ✓ Won — Ph3 readout
Amgen TNFRSF4 · monoclonal antibody (anti-OX40, depleting) · 8 Phase 3 trials
Drugs Similar to AZULFIDINE EN-TABS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
33 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03561584 SHIP | 2018P000019 | Ph 2 | completed | Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis |
| NCT03739853 SPEED results posted | 18/SC/0107 | Ph 4 | completed | Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial |
| NCT05703425 | Pro2021001951 | Ph 2 | recruiting | The Effect of Sulfasalazine on CRH Levels in Pregnant Women |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT03254589 | HREC/17/SAC/46 | Ph 4 | completed | Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis |
| NCT03847311 results posted | 1605576856 5R21CA245411-02 | Ph 2 | completed | Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients |
| NCT04720183 | GLPG3970-CL-117 | Ph 1 | completed | Drug-drug Interaction Study with GLPG3970 and Sulfasalazine in Adult, Healthy Subjects |
| NCT02451748 results posted | 2015-0117 | Ph 4 | completed | IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA |
| NCT05580861 SALMA | APHP211176 | Ph 1, Ph 2 | recruiting | Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment |
| NCT05664464 GLUGLIO | 2022-01877 | Ph 1, Ph 2 | recruiting | Glutamate Inhibitors in Glioblastoma |
| NCT06134388 | Sulfasalazine 2023 | Ph 3 | recruiting | Sulfasalazine in Patients With Metastatic Colorectal Cancer |
| NCT04205357 SAS-GKRS | 2019/6834 | Ph 1 | completed | Sulfasalazine and Stereotactic Radiosurgery for Recurrent Glioblastoma |
| NCT05445440 | IM046-003 | Ph 1 | completed | A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine |
| NCT02374021 TARGET results posted | 2014P002747 | Ph 4 | completed | Treatments Against RA and Effect on FDG-PET/CT |
| NCT03449758 SariPRO results posted | SARILL08755 U1111-1197-7699, 2017-002951-27 | Ph 4 | completed | Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis |
| NCT04268394 | CC-99677-CP-002 U1111-1247-0554, 2019-003523-38 | Ph 1 | completed | A Study to Evaluate Potential Cytochrome P450 and Transporter Protein Interactions With CC-99677 |
| NCT02930343 results posted | JIP/IEC/2016/27/893 | Ph 3 | terminated | Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy |
| NCT03797872 POISE results posted | 18/SC/0261 | Ph 4 | completed | Psoriatic Oligoarthritis Intervention With Symptomatic thErapy |
| NCT01198145 results posted | NCCTG-N08C9 NCI-2011-02602, CDR0000684240 | Ph 3 | completed | Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy |
| NCT02433184 VEDERA | RR10/9592 | Ph 4 | completed | Very Early Versus Delayed Etanercept in Patients With RA |
| NCT03801733 | AKB 6548 CI 0030 | Ph 1 | completed | Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin |
| NCT01172639 results posted | CareRA 2008-007225-39 | Ph 4 | completed | Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. |
| NCT01941095 results posted | ML28695 2013-000359-42 | Ph 3 | completed | A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis |
| NCT01667029 results posted | 2012-p-001443 | Ph 2 | terminated | Study of Sulfasalazine in Treating Painful Neuropathy |
| NCT02373202 results posted | LTS13618 U1111-1160-6525 | Ph 3 | completed | A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) |
| NCT01709578 results posted | EFC10832 U1111-1115-8466, 2011-003538-16 | Ph 3 | completed | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) |
| NCT01768572 results posted | SFY13370 2012-003536-23, U1111-1133-7839 | Ph 3 | completed | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) |
| NCT02057250 SARIL-RA-EASY results posted | MSC12665 2012-004339-21, U1111-1130-9931 | Ph 3 | completed | To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis |
| NCT00637780 results posted | A0031005 | Ph 4 | terminated | Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis |
| NCT03012763 | GIT-Physiol_2016 | Ph 1 | completed | Oral Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan Using Different Administration Mediums |
| NCT01596777 LOP-MNTX-2009 | LOP-MNTX-2009 | Ph 1 | completed | 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 |
| NCT02434861 | PR-11-5021-C | Ph 1 | completed | An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects |
| NCT01596764 | LOP-MNTX-2011 | Ph 1 | completed | Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time. |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AZULFIDINE EN-TABS FDA Label Details
Indications & Usage
FDA Label (PDF)AZULFIDINE EN-TABS is indicated for the treatment of Ulcerative Colitis; Rheumatoid Arthritis; Juvenile Rheumatoid Arthritis.
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Ulcerative Colitis Drug Landscape 2026
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.