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MESALAMINE
Mesalamine reduces inflammation in the colon by blocking cyclooxygenase and inhibiting prostaglandin production.
At a glance
| Generic name | MESALAMINE |
|---|---|
| Also known as | mesalazine |
| Drug class | Aminosalicylate [EPC] |
| Target | Cyclooxygenase |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1987 |
Mechanism of action
Mesalamine is a topical anti-inflammatory agent that primarily targets the colonic epithelial cells. It works by reducing the production of arachidonic acid metabolites, such as prostanoids and leukotrienes, which are increased in patients with ulcerative colitis. By inhibiting cyclooxygenase, mesalamine decreases the production of prostaglandins, thereby reducing inflammation in the colon.
Approved indications
- Moderately active ulcerative colitis — 1L
Pipeline indications
- Pediatric ulcerative colitis — Phase 3
Common side effects
- Headache
- Nausea
- Nasopharyngitis
- Abdominal pain
- Diarrhea
- Dyspepsia
- Vomiting
- Flatulence
- Influenza
- Pyrexia
- Cough
Drug interactions
- Nephrotoxic agents including NSAIDs
- Azathioprine or 6-mercaptopurine
Key clinical trials
- Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis (NA)
- Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease (PHASE2, PHASE3)
- Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine (NA)
- Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis. (NA)
- Desloratadine in Patients With Ulcerative Colitis (PHASE2)
- Determination of the Optimal Treatment Target in Ulcerative Colitis (PHASE4)
- Pentoxifylline in Patients With Ulcerative Colitis (PHASE2)
- Confirmatory Clinical Study in Active Ulcerative Colitis (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8865688 | 2030-05-01 | Method of Use |
| 7645801 | 2027-07-24 | Compound |
| 8217083 | 2028-06-06 | Formulation |
| 8436051 | 2028-06-06 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |