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Nexletol (BEMPEDOIC ACID)
NEXLIZET reduces LDL-C by inhibiting cholesterol synthesis in the liver and absorption in the intestine.
Nexletol (bempedoic acid) is a small molecule adenosine triphosphate-citrate lyase inhibitor developed by Esperion Therapeutics Inc. It targets ATP-citrate synthase to reduce cholesterol production in the liver. Nexletol is FDA-approved for the treatment of atherosclerotic occlusive disease and familial hypercholesterolemia in heterozygous patients. The commercial status of Nexletol is patented, with no generic manufacturers available. Key safety considerations include monitoring for muscle pain and liver function abnormalities.
At a glance
| Generic name | BEMPEDOIC ACID |
|---|---|
| Sponsor | Esperion Theraps Inc |
| Drug class | Adenosine Triphosphate-Citrate Lyase Inhibitor [EPC] |
| Target | ATP-citrate lyase (ACL), Niemann-Pick C1-Like 1 (NPC1L1) |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
NEXLIZET works by using two active components: bempedoic acid and ezetimibe. Bempedoic acid inhibits an enzyme called ATP-citrate lyase (ACL) in the liver, reducing cholesterol production. Ezetimibe blocks the absorption of cholesterol in the small intestine by targeting a protein called NPC1L1, leading to lower cholesterol levels in the blood.
Approved indications
- Atherosclerotic occlusive disease
- Familial hypercholesterolemia - heterozygous
Common side effects
- upper respiratory tract infection
- muscle spasms
- hyperuricemia
- back pain
- abdominal pain or discomfort
- bronchitis
- pain in extremity
- anemia
- elevated liver enzymes
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn) (PHASE3)
- Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
- A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events (PHASE3)
- A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin (PHASE1)
- triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE (PHASE3)
- A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia (PHASE3)
- A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nexletol CI brief — competitive landscape report
- Nexletol updates RSS · CI watch RSS
- Esperion Theraps Inc portfolio CI