Mesalamine: clinical trials recruiting now
7
Recruiting trials
12
Conditions studied
0
US states with sites
4
Countries
FDA drug label
- FDA-approved
- Yes. Mesalamine appears in the FDA drug-label database. Marketed as Mesalamine.
- Drug class
- Aminosalicylate (FDA established pharmacologic class)
FDA-approved use
Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. Limitations of Use : Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. Mesalamine delayed-release tablets are an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. (1) Limitation of Use : Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established (1)
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Failed Dissolution Specifications: Out of specification for dissolution. — SUN PHARMACEUTICAL INDUSTRIES INC | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2024-02-05 |
| Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules — Shire PLC | Class III (FDA: unlikely to cause harm) | Terminated | 2016-12-02 |
| CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. — SUN PHARMACEUTICAL INDUSTRIES INC | Class II (FDA: may cause temporary or reversible harm) | Completed | 2024-01-18 |
| Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. — Teva Pharmaceuticals USA | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2020-10-28 |
| Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. — Teva Pharmaceuticals USA | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2020-02-20 |
Phase breakdown
Phase 2 7
Conditions being studied
Recruiting trials involving Mesalamine
- Beneficial Effect of Silymarin in Ulcerative Colitis
- Desloratadine in Patients With Ulcerative Colitis
- Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
- Nitazoxanide in Patients With Ulcerative Colitis
- Pentoxifylline in Patients With Ulcerative Colitis
- Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
- Rupatadine in Patients With Ulcerative Colitis
Common questions
Is Mesalamine FDA-approved?
Yes, marketed as Mesalamine.
How many recruiting trials involve Mesalamine?
7 recruiting trials across 12 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.