Product Description
Ezetimibe is a medication used in the management and treatment of hypercholesterolemia. It is among a novel class of selective cholesterol-absorption inhibitors. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK532879/)
Mechanisms of Action: Cholesterol Absorption Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Daiichi Sankyo
Company Location: TOKYO M0 103-8426
Company CEO:
Additonal Commercial Interests: Esperion
Clinical Description
Countries in Clinic: Canada, China, Czech Republic, Hungary, Italy, Korea, Netherlands, Poland, Spain, United States
Active Clinical Trial Count:
Highest Development Phases
Phase 3: Coronary Artery Disease|Coronary Disease|Dyslipidemia|Hypercholesterolemia|Hyperlipidemia|Hyperlipoproteinemia Type II
Phase 1: Healthy Volunteers|Hypertension
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| REMBRANDT | P3 |
Recruiting |
Hyperlipidemia|Coronary Artery Disease |
2026-12-01 |
|
| OBEZ-302 | P3 |
Unknown Status |
Coronary Disease |
2026-11-18 |
|
| TA-8995-14 | P1 |
Completed |
Healthy Volunteers |
2024-11-12 |
|
| TANDEM | P3 |
Completed |
Dyslipidemia|Hypercholesterolemia|Hyperlipoproteinemia Type II |
2024-09-25 |