TheraRadar
Data updated: May 26, 2026

DELZICOL (mesalamine)

Immunology Approved 2013-02-01
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
1
Priority Reviews
13
Years on Market

Details

Status
Discontinued
First Approved
2013-02-01
Routes
ORAL
Dosage Forms
CAPSULE, DELAYED RELEASE

Companies

AbbVie
Active Ingredient: MESALAMINE

DELZICOL Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
13 FDA actions from 2013 to 2023 · 2 indication expansions
Oct 2023 SUPPL
Label · Labeling
FDA Letter Label
Nov 2022 SUPPL
Label · Labeling
FDA Letter Label
Nov 2021 SUPPL
Label · Labeling
FDA Letter Label

What DELZICOL Treats

3 FDA approvals

Originally approved for its first indication in 2013 . Covers 3 distinct patient populations.

  • Other (3)
📋

Clinical Trial Registry

31 trials
Trial Sponsor ID Phase Status Title
NCT05753267 R.23 Ph 2, Ph 3 completed Fenofibrate in Ulcerative Colitis
NCT07349472 87459 Ph 2 recruiting Pentoxifylline in Patients With Ulcerative Colitis
NCT05986136 Tanta 1234 Ph 2, Ph 3 recruiting Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease
NCT07333716 UC 12/2025 TRop1 Ph 2 recruiting Desloratadine in Patients With Ulcerative Colitis
NCT07064707 5555 Ph 2 recruiting Rupatadine in Patients With Ulcerative Colitis
NCT05567068 3433 Ph 2 completed Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis
NCT05988528 8/2023 Ph 2, Ph 3 completed Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis
NCT05316220 M21-517 Ph 3 withdrawn A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis
NCT06993974 4444 Ph 2 recruiting Nitazoxanide in Patients With Ulcerative Colitis
NCT05663775 IMPACT 1 IIT-0007 Ph 2 recruiting Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
NCT05781698 1-2023 Ph 2 completed Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis
NCT06213857 Silymarin in UC Ph 2 recruiting Beneficial Effect of Silymarin in Ulcerative Colitis
NCT05119140 GCO 20-0187 Ph 1, Ph 2 active not recruiting Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis
NCT04920149 MesaCAPP MesaCAPP Ph 2 recruiting Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
NCT02522780 results posted 000175 2015-002558-11 Ph 3 completed Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
NCT02125292 results posted SHP429-102 Ph 1 completed Taste Assessment Study of SHP429 in Healthy Adult Subjects
NCT02522767 results posted 000174 2015-002557-35 Ph 3 completed Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
NCT01412372 Mesalamine results posted 39402 Ph 3 completed The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
NCT02280629 PROTECT-2 PCG-4/UCR 2013-001205-84 Ph 3 completed Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)
NCT00622375 MPPK1003 Ph 1 completed PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers
NCT01088243 results posted HS-2360B Ph 1, Ph 2 completed Targeting Oxidative Stress in Chronic Beryllium Disease
NCT01696942 results posted 36497 Ph 4 terminated Cimzia Versus Mesalamine for Crohn's Recurrence
NCT01209208 BUG-1/LMC 2008-005994-36 Ph 3 completed Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis
NCT01172444 MESA-ULP3125 Ph 3 terminated Clinical Trial With Mesalamine 1g Suppositories
NCT01201122 MUPPIT 0052-10-WOMC Ph 4 completed Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis
NCT00652145 DEAR results posted K24DK078228 K24DK078228 Ph 4 completed Dose Escalation and Remission (DEAR)
NCT02196662 IBD98-M 110200 Ph 1 completed Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers
NCT01841099 KEMRI_CT_2013/0016 SSC 2223 Ph 1, Ph 2 completed Mesalamine in Environmental Enteropathy
NCT01327300 IBS results posted 106-2010 Ph 2 completed Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)
NCT01020708 ALTH12-003 Ph 1 completed Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
NCT01045018 EMET 001 Ph 3 completed A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DELZICOL FDA Label Details

Track DELZICOL with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA204412 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.