NEXLETOL (bempedoic acid)
Nexletol helps patients with high cholesterol, including those with heterozygous familial hypercholesterolemia, lower their LDL-C levels. It is used for adults at high risk of cardiovascular events like heart attacks or strokes who are unable to take standard statin therapy. This medication works alongside diet and exercise, either on its own or with other cholesterol-lowering drugs, to improve heart health outcomes.
How NEXLETOL Works
This drug works by inhibiting an enzyme called adenosine triphosphate-citrate lyase (ACL) in the liver, which is a step earlier in the cholesterol-making process than where statins work. Once activated in the liver, it decreases the production of cholesterol, which causes the body to increase the number of LDL receptors. This process effectively pulls more LDL-C out of the bloodstream.
Details
- Status
- Prescription
- First Approved
- 2020-02-21
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- TABLET
NEXLETOL Approval History
What NEXLETOL Treats
2 indicationsNEXLETOL is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypercholesterolemia
- Heterozygous Familial Hypercholesterolemia
NEXLETOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NEXLETOL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06450366 results posted | 0616-018 MK-0616-018, 2023-504920-25-00 | Ph 3 | completed | 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) |
| NCT07474649 | DSE-BMP-0005-CIS-MA 2025-524625-41 | Ph 3 | not yet recruiting | A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events |
| NCT07268625 | DSE-BMP-0003-CIS-MA 2024-519851-27-00 | Ph 1 | completed | Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin |
| NCT07235189 | DSE-BMP-0001-CIS-MA 2024-519849-29-00 | Ph 1 | completed | A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin |
| NCT07201545 | DSE-BMP-0004-CIS-MA 2024-519852-10-00 | Ph 1 | completed | Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin |
| NCT05488431 | 1.0 | Ph 2 | recruiting | Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial) |
| NCT07182383 | DSE-BMP-0002-CIS-MA 2024-519850-35-00 | Ph 1 | completed | Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin |
| NCT06742853 | D7960C00017 | Ph 1 | completed | A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C. |
| NCT05694260 CLEAR Path 1 | 1002-041 | Ph 2 | completed | A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1) |
| NCT03067441 results posted | 1002-050 2016-004115-12 | Ph 3 | completed | Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE) |
| NCT03001076 results posted | 1002-048 | Ph 3 | completed | Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility) |
| NCT02991118 CLEAR Wisdom results posted | 1002-047 2016-003486-26 | Ph 3 | completed | Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk |
| NCT03337308 results posted | 1002FDC-053 | Ph 3 | completed | A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy |
| NCT02988115 CLEAR Serenity results posted | 1002-046 | Ph 3 | completed | Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NEXLETOL FDA Label Details
Indications & Usage
FDA Label (PDF)NEXLETOL is indicated for the treatment of Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia.
NEXLETOL Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for NEXLETOL
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 7 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.