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Rowasa (Mesalazine)
Rowasa works by blocking the production of prostaglandins, which are chemicals that cause inflammation in the rectum and colon.
Rowasa (Mesalazine) is a small molecule aminosalicylate medication originally developed by MEDA PHARMS and currently owned by the same company. It targets Prostaglandin G/H synthase 2 to treat chronic ulcerative proctitis, chronic ulcerative rectosigmoiditis, ulcerative colitis, and ulcerative colitis in remission. Rowasa was FDA approved in 1987 and is used to reduce inflammation in the rectum and colon. The medication has a short half-life of 0.61 hours. As a patented medication, its commercial status is not yet generic.
At a glance
| Generic name | Mesalazine |
|---|---|
| Also known as | Asacol, ASACOL, Pentasa, Pentasa®, 5-ASA |
| Sponsor | Meda Pharms |
| Drug class | Aminosalicylate [EPC] |
| Target | Prostaglandin G/H synthase 2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1987 |
Mechanism of action
The mechanism of action of mesalamine (5-ASA) is not fully understood, but appears to be local anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with ulcerative colitis, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites.
Approved indications
- Chronic ulcerative proctitis
- Chronic ulcerative rectosigmoiditis
- Ulcerative colitis
- Ulcerative colitis in remission
Common side effects
- Colitis ulcerative
- Haematochezia
- Frequent bowel movements
- Condition aggravated
- Inappropriate schedule of product administration
- Intentional product use issue
- Faecal calprotectin increased
- Rectal haemorrhage
- Drug level below therapeutic
- Abdominal pain
- Mucous stools
- Blood pressure fluctuation
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)
- Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial (NA)
- 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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |