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Delayed and extended release mesalazine
Mesalazine (5-aminosalicylic acid) reduces intestinal inflammation by inhibiting prostaglandin and leukotriene production and scavenging reactive oxygen species in the colon.
Mesalazine (5-aminosalicylic acid) reduces intestinal inflammation by inhibiting prostaglandin and leukotriene production and scavenging reactive oxygen species in the colon. Used for Ulcerative colitis (induction and maintenance of remission), Crohn's disease (colonic involvement).
At a glance
| Generic name | Delayed and extended release mesalazine |
|---|---|
| Sponsor | Shire |
| Drug class | 5-aminosalicylic acid (5-ASA) derivative |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Mesalazine is a topical anti-inflammatory agent that acts locally in the gastrointestinal tract. The delayed and extended release formulation allows the drug to be released in the distal small intestine and colon, where it exerts its anti-inflammatory effects by suppressing inflammatory mediators and reducing immune cell activation in the mucosa.
Approved indications
- Ulcerative colitis (induction and maintenance of remission)
- Crohn's disease (colonic involvement)
Common side effects
- Headache
- Abdominal pain
- Diarrhea
- Nausea
- Mesalamine-induced acute intolerance syndrome
Key clinical trials
- Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (PHASE2)
- Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis (PHASE3)
- Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis (PHASE3)
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:
- Delayed and extended release mesalazine CI brief — competitive landscape report
- Delayed and extended release mesalazine updates RSS · CI watch RSS
- Shire portfolio CI