Summary
Balsalazide Disodium 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 Disodium 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 1 publication for this pair: 1 clinical trial publication. The dated items are from 2009. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 47.5 (trials 25.5, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 7 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 0 other |
| Linked publications | 1 (1 clinical 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| 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
- 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
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 Balsalazide Disodium approved for Inflammatory Bowel Disease (Crohn's / UC)?
Balsalazide Disodium 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 Disodium in clinical trials for Inflammatory Bowel Disease (Crohn's / UC)?
ClinicalTrials.gov lists 7 registered trials linking Balsalazide Disodium 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 Disodium in Inflammatory Bowel Disease (Crohn's / UC)?
Balsalazide Disodium has 7 completed trials and 1 linked publication for Inflammatory Bowel Disease (Crohn's / UC). Completed trials may or may not have posted results; follow the NCT links to check. 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.