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SPD476 · 2 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine | DRUG | - |
| Mesalazine | DRUG | - |
Inclusion Criteria: * newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of =\> 1 and a PGA \<=2) with compatible histology * females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy t...
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SPD476 is an investigational oral formulation of mesalazine, also known as a polymeric matrix formulation that provides both delayed and extended release of mesalazine. It is being developed by Takeda Pharmaceutical Company Limited for ulcerative colitis, a gastrointestinal condition. The drug is a small molecule and has completed Phase 3 testing.
SPD476 is intended for the treatment of ulcerative colitis, specifically studied in adults with acute, mild to moderate disease. It delivers mesalazine, an anti-inflammatory agent, to the colon. The formulation is designed to provide delayed and extended release of mesalazine to maintain therapeutic levels throughout the colon.
SPD476 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical trials evaluating SPD476 for ulcerative colitis. The company holds the rights to this mesalazine formulation.
SPD476 has completed Phase 3 clinical development. Two trials are listed: a Phase 3 study and a Phase 2 dose-ranging study, both completed. SPD476 is not approved by the FDA and remains an investigational therapy for ulcerative colitis.
SPD476 has been studied in two completed trials. NCT00548574 was a Phase 3 trial comparing two doses of SPD476 (2.4g and 4.8g once daily) with Asacol 0.8g three times daily in 343 subjects with acute, mild to moderate ulcerative colitis. NCT00545389 was a Phase 2 dose-ranging study in 38 subjects with mild to moderate ulcerative colitis.
SPD476 is a polymeric matrix formulation of mesalazine, so it contains mesalazine as the active ingredient. The formulation is designed to provide both delayed and extended release of mesalazine. Therefore, SPD476 is not a different drug but a specific delivery form of mesalazine.