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colesevelam + prednisolone
- Development stage
- Discontinued
- Lead developer
- Alizyme Therapeutics
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
COLAL-PRED is a combination drug product consisting of prednisolone metasulfobenzoate sodium, a corticosteroid, and colesevelam hydrochloride, a bile acid sequestrant. Developed by Alizyme Therapeutics, the drug utilizes the proprietary COLAL® colonic drug delivery system, which features a starch-based coating (amylose and ethylcellulose) designed to resist degradation in the upper gastrointestinal tract. Upon reaching the colon, the coating is broken down by bacterial amylases, allowing for the targeted, topical release of prednisolone. This mechanism aims to provide high local anti-inflammatory efficacy for the treatment of moderate to severe acute ulcerative colitis while minimizing systemic steroid exposure and associated side effects such as adrenal suppression. Although Phase III trials demonstrated a superior safety profile regarding adrenal function, the drug failed to meet its primary efficacy endpoint of non-inferiority to conventional oral prednisolone, leading to the cessation of its development.
- Brand names
- COLAL-PRED
- Other names
- prednisolone metasulfobenzoate sodium + colesevelam hydrochlorideprednisolone metasulfobenzoate + colesevelam
02
Targets
GR (Glucocorticoid receptor)
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