NDAORALCAPSULE, DELAYED RELEASEPriority Review
Approved
Feb 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
21
Data completeness
5/8 — Partial
Priority Review
DELZICOL (mesalamine) by AbbVie is unknown, but appears to be topical rather than systemic. Approved for ulcerative colitis. First approved in 2013.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DELZICOL is an oral delayed-release mesalamine capsule indicated for ulcerative colitis, Crohn's disease, proctitis, and related inflammatory bowel conditions. The mechanism is not fully elucidated but appears to work topically in the colon by inhibiting cyclooxygenase and blocking prostaglandin production to reduce mucosal inflammation. It targets patients with chronic inflammatory bowel disease seeking oral maintenance and acute treatment options.
$2MPart D
PeakModest Part D footprint ($2M) indicates mature, stable positioning within the IBD oral anti-inflammatory category with limited growth leverage for commercial expansion.
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 (1)
Clinical Trials (21)
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
Worked on DELZICOL at AbbVie? Share your interview experience or compensation data (+7 days Pro)
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.