Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enteric coated sevelamer · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 ECS | EXPERIMENTAL | Low dose treatment |
| 2 ECS | EXPERIMENTAL | High dose treatment |
| 3 Colesevelam | ACTIVE_COMPARATOR | Active control treatment |
| 4 Placebo | PLACEBO_COMPARATOR | Placebo matched to low dose treatment |
| 5 Placebo | PLACEBO_COMPARATOR | Placebo matched to high dose treatment |
| Name | Type | Description |
|---|---|---|
| Enteric coated sevelamer | DRUG | Drug treatment |
| Colesevelam Cholestagel | DRUG | Drug comparator |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Males and females 18 years of age or older * Clinical diagnosis of mild to moderate hypercholesterolemia 1)LDL cholesterol greater than or equal to 130 mg/dL and less than or equal to 220 mg/dL 2) Triglycerides less than or equal to 300 mg/dL Exclusion Criteria: * Women who ...
Enteric coated sevelamer is an investigational small molecule being developed for the treatment of hypercholesterolemia, a condition of elevated cholesterol levels in the blood. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Enteric coated sevelamer is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 2 clinical trials for the treatment of hypercholesterolemia.
Enteric coated sevelamer is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. A Phase 2 trial has been completed to evaluate its safety and efficacy in patients with mild to moderate hypercholesterolemia.
Enteric coated sevelamer has one completed clinical trial, identified as NCT00690937. This was a Phase 2, multicenter, placebo-controlled study conducted in India, enrolling 120 patients with mild to moderate hypercholesterolemia. The trial was randomized but not double-blind.
Enteric coated sevelamer is a specific formulation of sevelamer, designed with an enteric coating. While sevelamer is a known phosphate binder used for other conditions, this enteric coated version is being investigated specifically for hypercholesterolemia and is in Phase 2 development by Sanofi.