Summary
Sulfasalazine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Bowel Disease (Crohn's / UC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Bowel Disease (Crohn's / UC). ClinicalTrials.gov lists 6 registered trials linking Sulfasalazine to Inflammatory Bowel Disease (Crohn's / UC): 1 is active or not yet recruiting; 5 have completed. The most advanced is Phase 3 (NCT01532648). The largest enrolment is 11385 participants (NCT04499495). Registration activity spans 2009 to 2025. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 2 systematic reviews, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2010 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Inflammatory Bowel Disease ranks 200 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Disease course unchanged in ~85% of patients at 10 years on standard care; ~23% (CD) and ~12% (UC) relapse within 12 months of thiopurine withdrawal in sustained remission.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 67.5 (trials 17.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 6 total: 0 recruiting, 1 active / not yet recruiting, 5 completed, 0 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 2 systematic reviews, 1 meta-analysis, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor |
| Data sources | DGIdb |
| Linked via biomarker / target | ALOX5 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01532648 | Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA) 2012 | completed | Phase 3 | 510 |
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty 2025 | not yet recruiting | Phase 2 | 80 |
| NCT02376478 | On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection 2009 | completed | Not applicable | 222 |
| NCT06637683 | Efficacy of LiveSpo COLON as a Supportive Treatment for Inflammatory Bowel Disease (IBD) 2019 | completed | Not applicable | 60 |
| NCT05458531 | Monitoring of Inflammatory Conditions 2022 | completed | Not applicable | 664 |
| NCT04499495 | Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea 2021 | completed | Not applicable | 11,385 |
Published literature
- Meta-analysis Meta-analysis and systematic review on Sulfasalazine/5-ASA use during pregnancy: Impact on neonatal and pregnancy outcomesAsthana R, Hamandi B, Brnabic A et al. · Reproductive toxicology (Elmsford, N.Y.) · 2025 · PMID 40334871
- Systematic review Pyodermatitis-pyostomatitis vegetans: a case report and systematic review focusing on oral involvementChrcanovic BR, Martins-Chaves RR, Pontes FSC et al. · Oral and maxillofacial surgery · 2024 · PMID 38467949
- Systematic review Spotlight on the treatment armamentarium of concomitant psoriasis and inflammatory bowel disease: a systematic reviewConforti C, Dianzani C, Zalaudek I et al. · The Journal of dermatological treatment · 2022 · PMID 33074781
- Cochrane review Efficacy and safety of oral Pentasa (prolonged-release mesalazine) in mild-to-moderate ulcerative colitis: a systematic review and meta-analysisParidaens K, Fullarton JR, Travis SPL · Current medical research and opinion · 2021 · PMID 34404286
- Cochrane review Interventions for the management of abdominal pain in ulcerative colitisSinopoulou V, Gordon M, Dovey TM et al. · The Cochrane database of systematic reviews · 2021 · PMID 34291816
- Cochrane review Acupuncture for ulcerative colitis: a systematic review and meta-analysis of randomized clinical trialsWang X, Zhao NQ, Sun YX et al. · BMC complementary medicine and therapies · 2020 · PMID 33054760
- Cochrane review Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitisMurray A, Nguyen TM, Parker CE et al. · The Cochrane database of systematic reviews · 2020 · PMID 32856298
- Cochrane review Oral 5-aminosalicylic acid for induction of remission in ulcerative colitisMurray A, Nguyen TM, Parker CE et al. · The Cochrane database of systematic reviews · 2020 · PMID 32786164
- Clinical trial publication Reappraisal of antibodies against Saccharomyces cerevisiae (ASCA) as persistent biomarkers in quiescent Crohn's diseaseDuarte-Silva M, Afonso PC, de Souza PR et al. · Autoimmunity · 2019 · PMID 30884988
- Clinical trial publication [Observation on clinical effect of ZHUANG medicine mediated thread moxibustion combined with medication for patients with ulcerative colitis]Zhang LC, Zhang S, Zhong W et al. · Zhen ci yan jiu = Acupuncture research · 2013 · PMID 24308188
- Clinical trial publication Efficacy and tolerability of oral budesonide in Japanese patients with active Crohn's disease: a multicentre, double-blind, randomized, parallel-group Phase II studySuzuki Y, Motoya S, Takazoe M et al. · Journal of Crohn's & colitis · 2013 · PMID 22766525
- Clinical trial publication [Ozone therapy combined with sulfasalazine delivered via a colon therapy system for treatment of ulcerative colitis]Geng Y, Wang W, Ma Q et al. · Nan fang yi ke da xue xue bao = Journal of Southern Medical University · 2010 · PMID 21177179
- Clinical trial publication Effect of probiotics on pro-inflammatory cytokines and NF-kappaB activation in ulcerative colitisHegazy SK, El-Bedewy MM · World journal of gastroenterology · 2010 · PMID 20806430
- Randomized controlled trial Clinical observations on 100 cases of ulcerative colitis treated with the method of clearing away heat, expelling dampness, promoting blood circulation and healing ulcerYe B, Shen H, Lu Y et al. · Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan · 2010 · PMID 20653164
Mechanism and notes
Recorded mechanism or class: inhibitor.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ALOX5. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sulfasalazine approved for Inflammatory Bowel Disease (Crohn's / UC)?
Sulfasalazine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Bowel Disease (Crohn's / UC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Bowel Disease (Crohn's / UC). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Sulfasalazine in clinical trials for Inflammatory Bowel Disease (Crohn's / UC)?
ClinicalTrials.gov lists 6 registered trials linking Sulfasalazine to Inflammatory Bowel Disease (Crohn's / UC): 1 is active or not yet recruiting; 5 have completed. The most advanced is Phase 3 (NCT01532648). The largest enrolment is 11385 participants (NCT04499495). Registration activity spans 2009 to 2025.
What does the evidence show for Sulfasalazine in Inflammatory Bowel Disease (Crohn's / UC)?
Sulfasalazine has both completed registered trials and synthesis-level publications linked to Inflammatory Bowel Disease (Crohn's / UC). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ALOX5. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.