Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 used to treat acute mild to moderate ulcerative colitis, a form of inflammatory bowel disease affecting the colon. It is being developed by Takeda Pharmaceutical Company Limited as a small molecule therapy in the gastrointestinal therapeutic area.
Delayed and mesalazine is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor behind the clinical development program for this ulcerative colitis treatment.
Delayed and mesalazine is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 program includes one completed trial evaluating the treatment in patients with ulcerative colitis.
Delayed and mesalazine has been studied in one Phase 3 trial, NCT00503243, titled Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis. The trial enrolled 280 participants in the United States and is completed.
The Phase 3 trial NCT00503243 was a randomized, double-blind study enrolling 280 adults aged 18 years and older with acute mild to moderate ulcerative colitis. It compared mesalazine given twice daily at 2.4 g per day against a single 4.8 g daily dose, and the trial is completed.