Product Description
Bempedoic acid is a new class of nonstatin LDL-lowering therapy that, like statins, targets the cholesterol biosynthesis pathway in the liver.3 Whereas statins inhibit HMG CoA reductase, bempedoic acid inhibits ATP-citrate lyase (ACL), two steps upstream of HMG CoA reductase. Unlike statins, bempedoic acid is administered as a prodrug and is converted to active coenzyme A form by enzymes found only in the liver and not in muscles. (Sourced from: https://www.acc.org/latest-in-cardiology/articles/2020/08/10/08/21/bempedoic-acid-for-ldl-c-lowering)
Mechanisms of Action: Cholesterol Synthesis Reducer
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Austria | Bangladesh | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | Germany | Hong Kong | Hungary | Iceland | India | Ireland | Italy | Latvia | Lithuania | Luxembourg | Netherlands | Poland | Portugal | Slovakia | Spain | Sweden | Switzerland | Turkey | United Kingdom | United States
Approved Indications: Hypercholesterolemia
Known Adverse Events: Abdominal Pain | Back Pain | Pain Unspecified | Spasm | Anemia | Respiratory Tract Infections | Bronchitis
Company: Daiichi Sankyo
Company Location: TOKYO M0 103-8426
Company CEO:
Additonal Commercial Interests: Esperion
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Estonia, Germany, Hungary, India, Japan, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Turkey, Ukraine, United Kingdom, United States
Active Clinical Trial Count: 12
Highest Development Phases
Phase 3: Coronary Artery Disease|Hypercholesterolemia|Myocardial Infarction|Other
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 1002-041 | P2 |
Unknown Status |
Hypercholesterolemia |
2025-05-31 |
|
| HACOL-ACS | P3 |
Unknown Status |
Myocardial Infarction|Coronary Artery Disease |
2025-03-31 |
|
| NCT05687071 | P3 |
Active, not recruiting |
Other |
2024-10-31 |
66% |
| jRCT2031220563 | P3 |
Recruiting |
Unknown |
2024-09-30 |