NDAORALCAPSULE, DELAYED RELEASEPriority Review
Approved
Feb 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
DELZICOL (mesalamine) by AbbVie is unknown, but appears to be topical rather than systemic. First approved in 2013.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DELZICOL is an oral delayed-release mesalamine capsule approved for ulcerative colitis, a chronic inflammatory bowel disease. The mechanism is incompletely understood but appears to work topically in the colon by inhibiting prostaglandin production and blocking cyclooxygenase and lipoxygenase pathways to reduce mucosal inflammation. It is a small-molecule anti-inflammatory agent.
$0.002BPart D
PeakPeak-stage product with modest Part D volume suggests stable but mature commercial footprint; brand teams focus on retention and niche indications.
Mechanism of Action
unknown, but appears to be topical rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, that is, prostanoids, and through the lipoxygenase pathways, that is, leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with…
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.