NDARECTALSUPPOSITORYPriority Review
Approved
Jan 2001
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
CANASA (mesalamine) by AbbVie is understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. First approved in 2001.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CANASA is a rectal suppository containing mesalamine, a topical aminosalicylate anti-inflammatory agent approved in 2001 for treating ulcerative colitis, Crohn's disease, proctitis, and colitis. It works by inhibiting cyclooxygenase and blocking prostaglandin production in the colon to reduce mucosal inflammation. The drug delivers localized anti-inflammatory effects directly to colonic epithelial tissue.
$0.001BPart D
LOE ApproachingDeclining
2.1 years to LOEWith loss of exclusivity in 2.1 years and modest Part D spending of $1M, the CANASA brand team faces significant headwinds and likely contraction in commercial headcount.
Mechanism of Action
understood, but appears to be a topical 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,…
Pharmacologic Class:
Aminosalicylate
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis
Started Sep 2025
0Ulcerative Colitis (UC)
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Started Mar 2022
150 enrolled
Lynch SyndromeColon CancerColon Neoplasm
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
Started Nov 2017
8 enrolled
Colorectal Cancer
A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)
Started Jul 2016
25 enrolled
Ulcerative Colitis
Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
Started Feb 2016
276 enrolled
Ulcerative Colitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.