Last reviewed · How we verify
Mesalazine tablets
Mesalazine reduces inflammation in the colon and rectum by inhibiting prostaglandin and leukotriene production, thereby suppressing inflammatory mediators.
Mesalazine reduces inflammation in the colon and rectum by inhibiting prostaglandin and leukotriene production, thereby suppressing inflammatory mediators. Used for Ulcerative colitis (induction and maintenance of remission), Crohn's disease (colonic involvement), Inflammatory bowel disease.
At a glance
| Generic name | Mesalazine tablets |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | 5-aminosalicylic acid (5-ASA) derivative |
| Target | Prostaglandin and leukotriene synthesis inhibition; NF-κB pathway modulation |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Immunology |
| Phase | Phase 3 |
Mechanism of action
Mesalazine (5-aminosalicylic acid) is a topical anti-inflammatory agent that acts locally in the gastrointestinal tract. It inhibits the production of inflammatory mediators including prostaglandins and leukotrienes, and may also have antioxidant properties. The drug is used to treat and maintain remission of inflammatory bowel disease by reducing mucosal inflammation.
Approved indications
- Ulcerative colitis (induction and maintenance of remission)
- Crohn's disease (colonic involvement)
- Inflammatory bowel disease
Common side effects
- Headache
- Abdominal pain
- Diarrhea
- Nausea
- Rash
- Nephrotoxicity (rare)
Key clinical trials
- Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial (NA)
- Role of Roflumilast in Ulcerative Colitis (PHASE4)
- Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (PHASE4)
- Abdominal Ultrasound With Doppler and Peripheral Hemogram in Assesment Inflammatory Bowel Disease
- the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis (PHASE3)
- Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis (PHASE1, PHASE2)
- The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer (PHASE3)
- Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis (PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Mesalazine tablets CI brief — competitive landscape report
- Mesalazine tablets updates RSS · CI watch RSS
- AstraZeneca portfolio CI