Lowers the risk of major adverse cardiovascular events (cardiovascular death, myocardial…. Sold as Nexlizet. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Bempedoic Acid; Ezetimibe (sold as Nexlizet), first approved Feb 26, 2020, with 3 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Nexlizet | Part D | $109M | +54% | 37,779 |
| Lipid Management Gaps in Mexican Patients at High and Very High Cardiovascular RiskDyslipidemias, Hypercholesterolemia · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | — | Not yet recruiting | Nov 12, 2026 |
| Early Triple Lipid-Lowering Therapy With Bempedoic Acid After Acute Coronary SyndromeAcute Coronary Syndromes, Dyslipidemia · Taipei Medical University Hospital | Phase 4 | Recruiting | Sep 17, 2026 |
| Triple vs Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary SyndromeAcute Coronary Syndromes (ACS), Hypercholesterolemia · Punjab Institute of Cardology | Phase 4 | Not yet recruiting | Apr 2, 2026 |
| A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular EventsCoronary Atherosclerosis, Mixed Dyslipidemia · Daiichi Sankyo | Phase 3 | Not yet recruiting | Mar 16, 2026 |
| triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromEAcute Coronary Syndromes, Secondary Prevention · Heart Care Foundation | Phase 3 | Not yet recruiting | Feb 27, 2026 |
| COAST Study - Cholesterol Optimization After StrokeStroke (CVA) or Transient Ischemic Attack, Cerebral Hemorrhage · Fondazione Policlinico Universitario Agostino Gemelli IRCCS | — | Not yet recruiting | Dec 1, 2025 |
| A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed DyslipidaemiaPrimary Hypercholesterolaemia, Mixed Dyslipidemia · Daiichi Sankyo | — | Recruiting | Oct 3, 2025 |
| A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed DyslipidemiaPrimary Hypercholesterolemiia, Mixed Dyslipidemia · Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | — | Active, not recruiting | Nov 13, 2024 |
| Feb 26, 2020 | NexlizetNDA 211617 · New molecular entity, new combination | Esperion Theraps Inc | 8 | Marketed |
| — | Bempedoic Acid And EzetimibeANDA 219421 | Alkem Laboratories Limited | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
