NEXLETOL
Peakbempedoic acid
NDAORALTABLET
Approved
Feb 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
16
Data completeness
5/8 — Partial
NEXLETOL (bempedoic acid) is adenosine triphosphate-citrate lyase inhibitors [moa]. First approved in 2020.
Drug data last refreshed 19h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEXLETOL (bempedoic acid) is an oral small-molecule adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers LDL cholesterol by reducing hepatic cholesterol synthesis. It is indicated for patients with elevated cholesterol who cannot tolerate or have contraindications to statins, addressing an underserved patient population in dyslipidemia management.
$46MPart D
Peak13.6 years to LOEProduct is in peak commercial phase with modest Medicare utilization; brand team is likely stable-to-growing in size as market penetration remains selective.
Mechanism of Action
Adenosine Triphosphate-Citrate Lyase Inhibitors
Pharmacologic Class:
Adenosine Triphosphate-Citrate Lyase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
Started Sep 2026
103 enrolled
Coronary AtherosclerosisMixed DyslipidemiaHypercholesterolemia
triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE
Started Sep 2026
600 enrolled
Acute Coronary SyndromesSecondary PreventionLipids
Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days
Started May 2026
426 enrolled
Mixed DyslipidemiaHypercholesterolaemia
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Started Mar 2026
2,120 enrolled
Primary HypercholesterolaemiaMixed Dyslipidemia
Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin
Started Dec 2025
58 enrolled
Healthy Subjects
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.