Summary
Balsalazide 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 7 registered trials linking Balsalazide to Inflammatory Bowel Disease (Crohn's / UC): 7 have completed. The most advanced is Phase 3 (NCT01532648). The largest enrolment is 11385 participants (NCT04499495). Registration activity spans 2004 to 2021. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 3 meta-analyses and 5 clinical trial publications. Publication years run from 2002 to 2020. 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 | 75.5 (trials 25.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 7 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 0 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00269438 | New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis 2005 | completed | Phase 3 | 225 |
| 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 |
| NCT00408174 | Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis 2006 | completed | Phase 3 | 400 |
| NCT00486031 | Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study 2006 | completed | Phase 3 | 443 |
| NCT00618228 | Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions 2004 | completed | Not applicable | 52 |
| NCT04499495 | Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea 2021 | completed | Not applicable | 11,385 |
| NCT00618202 | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions 2005 | completed | Not applicable | 52 |
Published literature
- 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
- Cochrane review Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitisWang Y, Parker CE, Feagan BG et al. · The Cochrane database of systematic reviews · 2016 · PMID 27158764
- Cochrane review Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitisFeagan BG, Macdonald JK · The Cochrane database of systematic reviews · 2012 · PMID 23076890
- Clinical trial publication Safety, efficacy, and pharmacokinetics of balsalazide in pediatric patients with mild-to-moderate active ulcerative colitis: results of a randomized, double-blind studyQuiros JA, Heyman MB, Pohl JF et al. · Journal of pediatric gastroenterology and nutrition · 2009 · PMID 19633577
- Clinical trial publication Safety and efficacy of a new 3.3 g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis: a multicenter, randomized, double-blind, placebo-controlled studyScherl EJ, Pruitt R, Gordon GL et al. · The American journal of gastroenterology · 2009 · PMID 19491859
- Cochrane review Balsalazide: a novel 5-aminosalicylate prodrug for the treatment of active ulcerative colitisWiggins JB, Rajapakse R · Expert opinion on drug metabolism & toxicology · 2009 · PMID 19743890
- Meta-analysis A meta-analysis of the efficacy of sulfasalazine in comparison with 5-aminosalicylates in the induction of improvement and maintenance of remission in patients with ulcerative colitisNikfar S, Rahimi R, Rezaie A et al. · Digestive diseases and sciences · 2009 · PMID 18770034
- Meta-analysis Comparison of mesalazine and balsalazide in induction and maintenance of remission in patients with ulcerative colitis: a meta-analysisRahimi R, Nikfar S, Rezaie A et al. · Digestive diseases and sciences · 2009 · PMID 18683049
- Meta-analysis Pregnancy outcome in women with inflammatory bowel disease following exposure to 5-aminosalicylic acid drugs: a meta-analysisRahimi R, Nikfar S, Rezaie A et al. · Reproductive toxicology (Elmsford, N.Y.) · 2008 · PMID 18242053
- Clinical trial publication Low-dose balsalazide plus a high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitisTursi A, Brandimarte G, Giorgetti GM et al. · Medical science monitor : international medical journal of experimental and clinical research · 2004 · PMID 15507864
- Clinical trial publication Patient-led variable dosing with balsalazide as long-term therapy for maintenance in ulcerative colitis: a 3-year prospective observational studyGreen JR, Swan CH, Gibson JA et al. · Alimentary pharmacology & therapeutics · 2004 · PMID 14871283
- Clinical trial publication Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute mild-to-moderate ulcerative colitisPruitt R, Hanson J, Safdi M et al. · The American journal of gastroenterology · 2002 · PMID 12492193
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
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 Balsalazide approved for Inflammatory Bowel Disease (Crohn's / UC)?
Balsalazide 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 Balsalazide in clinical trials for Inflammatory Bowel Disease (Crohn's / UC)?
ClinicalTrials.gov lists 7 registered trials linking Balsalazide to Inflammatory Bowel Disease (Crohn's / UC): 7 have completed. The most advanced is Phase 3 (NCT01532648). The largest enrolment is 11385 participants (NCT04499495). Registration activity spans 2004 to 2021.
What does the evidence show for Balsalazide in Inflammatory Bowel Disease (Crohn's / UC)?
Balsalazide 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.