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Delayed and mesalazine · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Delayed and extended release mesalazine | DRUG | - |
Inclusion Criteria: * newly diagnosed or diagnosis of relapsing (relapsed \<= 6 weeks to baseline) mild to moderate ulcerative colitis * women not of childbearing potential or WOCP who agreed to use an effective contraceptive method Exclusion Criteria: * severe ulcerative colitis or relapsed for ...
Delayed and mesalazine is an investigational small molecule being studied for the treatment of ulcerative colitis, a form of inflammatory bowel disease. It is in Phase 3 clinical development for this gastrointestinal condition. The drug is being evaluated in patients with acute mild to moderate ulcerative colitis.
Delayed and mesalazine is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with ulcerative colitis.
Delayed and mesalazine is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating ulcerative colitis.
Delayed and mesalazine has one completed Phase 3 clinical trial, identified as NCT00503243. This study evaluated the safety and efficacy of the drug given twice daily at 2.4 g/day versus a single dose of 4.8 g/day in 280 subjects with acute mild to moderate ulcerative colitis in the United States.
Delayed and mesalazine is a formulation of mesalazine, also known as 5-aminosalicylic acid. The drug is being developed as a delayed-release oral formulation for the treatment of ulcerative colitis, and the clinical trial evaluates different dosing regimens of this mesalazine product.