MESALAMINE
MESALAMINE is indicated for the treatment of Ulcerative Colitis.
How MESALAMINE Works
The exact mechanism of action of mesalamine is not fully understood but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mesalamine likely diminishes inflammation by inhibiting both the cyclooxygenase and lipoxygenase pathways, thereby reducing the production of prostaglandins, leukotrienes, and other arachidonic acid metabolites that are typically elevated in the colonic mucosa of patients with ulcerative colitis.
Details
- Status
- Prescription
- First Approved
- 2004-09-17
- Routes
- ORAL, RECTAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE, TABLET, DELAYED RELEASE, CAPSULE, EXTENDED RELEASE, SUPPOSITORY, ENEMA
Companies
MESALAMINE Approval History
What MESALAMINE Treats
1 indicationsMESALAMINE is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ulcerative Colitis
MESALAMINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 MESALAMINE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MESALAMINE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to MESALAMINE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
30 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05753267 | R.23 | Ph 2, Ph 3 | completed | Fenofibrate in Ulcerative Colitis |
| NCT07349472 | 87459 | Ph 2 | recruiting | Pentoxifylline in Patients With Ulcerative Colitis |
| NCT05986136 | Tanta 1234 | Ph 2, Ph 3 | recruiting | Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease |
| NCT07333716 UC | 12/2025 TRop1 | Ph 2 | recruiting | Desloratadine in Patients With Ulcerative Colitis |
| NCT07064707 | 5555 | Ph 2 | recruiting | Rupatadine in Patients With Ulcerative Colitis |
| NCT05567068 | 3433 | Ph 2 | completed | Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis |
| NCT05988528 | 8/2023 | Ph 2, Ph 3 | completed | Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis |
| NCT05316220 | M21-517 | Ph 3 | withdrawn | A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis |
| NCT06993974 | 4444 | Ph 2 | recruiting | Nitazoxanide in Patients With Ulcerative Colitis |
| NCT05663775 IMPACT 1 | IIT-0007 | Ph 2 | recruiting | Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo) |
| NCT05781698 | 1-2023 | Ph 2 | completed | Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis |
| NCT06213857 | Silymarin in UC | Ph 2 | recruiting | Beneficial Effect of Silymarin in Ulcerative Colitis |
| NCT05119140 | GCO 20-0187 | Ph 1, Ph 2 | active not recruiting | Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis |
| NCT04920149 MesaCAPP | MesaCAPP | Ph 2 | recruiting | Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome |
| NCT02522780 results posted | 000175 2015-002558-11 | Ph 3 | completed | Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC) |
| NCT02125292 results posted | SHP429-102 | Ph 1 | completed | Taste Assessment Study of SHP429 in Healthy Adult Subjects |
| NCT02522767 results posted | 000174 2015-002557-35 | Ph 3 | completed | Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC) |
| NCT01412372 Mesalamine results posted | 39402 | Ph 3 | completed | The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study |
| NCT02280629 PROTECT-2 | PCG-4/UCR 2013-001205-84 | Ph 3 | completed | Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2) |
| NCT00622375 | MPPK1003 | Ph 1 | completed | PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers |
| NCT01088243 results posted | HS-2360B | Ph 1, Ph 2 | completed | Targeting Oxidative Stress in Chronic Beryllium Disease |
| NCT01696942 results posted | 36497 | Ph 4 | terminated | Cimzia Versus Mesalamine for Crohn's Recurrence |
| NCT01209208 | BUG-1/LMC 2008-005994-36 | Ph 3 | completed | Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis |
| NCT01172444 | MESA-ULP3125 | Ph 3 | terminated | Clinical Trial With Mesalamine 1g Suppositories |
| NCT01201122 MUPPIT | 0052-10-WOMC | Ph 4 | completed | Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis |
| NCT00652145 DEAR results posted | K24DK078228 K24DK078228 | Ph 4 | completed | Dose Escalation and Remission (DEAR) |
| NCT01841099 | KEMRI_CT_2013/0016 SSC 2223 | Ph 1, Ph 2 | completed | Mesalamine in Environmental Enteropathy |
| NCT01327300 IBS results posted | 106-2010 | Ph 2 | completed | Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS) |
| NCT01020708 | ALTH12-003 | Ph 1 | completed | Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis |
| NCT01045018 | EMET 001 | Ph 3 | completed | A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
MESALAMINE FDA Label Details
Indications & Usage
FDA Label (PDF)MESALAMINE is indicated for the treatment of Ulcerative Colitis.
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ROWASA
Full clinical data, patents, trials, and competitive landscape for mesalamine.
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.