Disease × agent evidence record

Mesalamine for Inflammatory Bowel Disease (Crohn's / UC): evidence, trials and status

Mesalamine 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.

8 registered trials 1 recruiting 12 publications Evidence tier A · Strong Score 76.0
Research Tracker › Pairs › Inflammatory Bowel Disease (Crohn's / UC) › Mesalamine
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Mesalamine 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 8 registered trials linking Mesalamine to Inflammatory Bowel Disease (Crohn's / UC): 1 is currently recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT03283085). It plans or enrolled 557 participants. Registration activity spans 2007 to 2025. The literature layer holds 12 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 1 systematic review and 5 clinical trial publications. Publication years run from 2022 to 2026. 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.

Open in Repurposing ExplorerInflammatory Bowel Disease (Crohn's / UC) hubInflammatory Bowel Disease (Crohn's / UC) biomarkers & interventions

Evidence table

Evidence tierA · Strong
Evidence score76.0 (trials 26.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 1 recruiting, 0 active / not yet recruiting, 4 completed, 3 other
Linked publications12 (5 Cochrane reviews, 5 clinical trial publications, 1 meta-analysis, 1 systematic review)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classinhibitor
Data sourcesDGIdb
Linked via biomarker / targetALOX5
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 IDTitleStatusPhaseEnrolment
NCT03283085A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
2018
completedPhase 3557
NCT00245505The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active "Drug: Crohn's Disease"
2009
terminatedPhase 33
NCT01016262Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
2009
terminatedPhase 3119
NCT01004185Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
2009
terminatedPhase 339
NCT01036022Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis
2009
completedPhase 2120
NCT00867438Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy
2007
completedPhase 2133
NCT06213857Beneficial Effect of Silymarin in Ulcerative Colitis
2025
recruitingPhase 244
NCT03327558Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
2017
completedPhase 160

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Published literature

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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 Mesalamine approved for Inflammatory Bowel Disease (Crohn's / UC)?

Mesalamine 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 Mesalamine in clinical trials for Inflammatory Bowel Disease (Crohn's / UC)?

ClinicalTrials.gov lists 8 registered trials linking Mesalamine to Inflammatory Bowel Disease (Crohn's / UC): 1 is currently recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT03283085). It plans or enrolled 557 participants. Registration activity spans 2007 to 2025.

What does the evidence show for Mesalamine in Inflammatory Bowel Disease (Crohn's / UC)?

Mesalamine 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

Open Source Medicine Foundation. Mesalamine for Inflammatory Bowel Disease (Crohn's / UC): evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/inflammatory-bowel-disease/mesalamine.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.