Combines ATP-citrate lyase inhibition by activated bempedoic acid with intestinal NPC1L1 inhibition by ezetimibe. Source
Adults with HeFH, CVD or multiple CVD risk factors
Study contextSelected approval record (2024-03-22): FDA expanded the Nexlizet label on the basis of CLEAR Outcomes, adding cardiovascular-risk reduction and broadening LDL-C lowering. This regulatory extension used outcomes evidence for bempedoic acid rather than a dedicated event trial of the fixed combination.
Status sourceStatus & indicationsLDL-C: 38 percentage-point reduction vs placebo · 12 weeks
Fixed-combination trial (NCT03337308) · Phase 3 · regulatory-label · 180 mg + 10 mg daily · ANCOVA with adherence-sensitive multiple imputation; exploratory TG uses median change.
Evidence & limitationsLabel risks include hyperuricemia/gout, tendon rupture, muscle injury and elevated liver enzymes.
Safety contextA next milestone is not summarized for this therapy.
Milestone detailsStudy results apply to their own population, dose and analysis. They do not establish a ranking between therapies.
Each result belongs to its own study population, dose and analysis. Open a result for its chart, comparator, safety findings and limitations.
LDL-C: 38 percentage-point reduction vs placebo · 12 weeks
180 mg + 10 mg daily
Adults with HeFH, CVD or multiple CVD risk factors
ANCOVA with adherence-sensitive multiple imputation; exploratory TG uses median change.
Label risks include hyperuricemia/gout, tendon rupture, muscle injury and elevated liver enzymes.
Limitations: Combination effect, not an additional 38% beyond each component separately. HDL and TG were exploratory.
Status in this atlas: Selected approval record (2024-03-22): FDA expanded the Nexlizet label on the basis of CLEAR Outcomes, adding cardiovascular-risk reduction and broadening LDL-C lowering. This regulatory extension used outcomes evidence for bempedoic acid rather than a dedicated event trial of the fixed combination. Status source
Combines ATP-citrate lyase inhibition by activated bempedoic acid with intestinal NPC1L1 inhibition by ezetimibe.
Mechanism sourceMechanism & side effects: Ezetimibe · Bempedoic acid (component classes; combination risks can differ)
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
Two chemically distinct active ingredients in a fixed-dose combination. Display the two component molecules separately; the combination does not have one combined molecular structure.
Chemical structure of bempedoic acid.
Shown: Neutral bempedoic acid parent molecule.
The parent drug is shown, not the intracellular CoA-activated derivative. The optional 3D view is a computed PubChem conformer, not an experimentally measured or protein-bound shape.
PubChem CID 10472693Chemical structure of ezetimibe.
Shown: Neutral ezetimibe parent molecule.
The parent drug is shown; its glucuronide metabolite is not included. The optional 3D view is a computed PubChem conformer, not an experimentally measured or protein-bound shape.
PubChem CID 150311Bempedoic acid + ezetimibe · compound history across indications
Selected sourced milestones, not a complete development history. Dates distinguish study starts, publications, announcements and approvals; the first listed date is not necessarily when development began.
A phase 2b trial tested ETC-1002 with ezetimibe as coadministered medicines, reporting greater LDL-C lowering than ezetimibe alone. This established the combination rationale; it did not test the later fixed-dose tablet.
Thompson et al., ETC-1002 alone and with ezetimibe — Journal of Clinical Lipidology (2016)NCT03337308 evaluated the bempedoic acid 180 mg/ezetimibe 10 mg fixed-dose tablet against the individual components and placebo for 12 weeks. The tablet lowered LDL-C more than either component alone in the reported analysis.
Ballantyne et al., fixed-dose combination trial — European Journal of Preventive Cardiology (2019 online publication)FDA approved the fixed-dose tablet for additional LDL-C lowering in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease, alongside diet and maximally tolerated statin therapy. The initial label did not establish cardiovascular outcomes benefit.
FDA Nexlizet approval package and letter (2020)CLEAR Outcomes demonstrated fewer primary cardiovascular events with bempedoic acid in statin-intolerant patients. It randomized bempedoic acid versus placebo; it was not a cardiovascular outcomes trial of the bempedoic acid/ezetimibe fixed tablet.
CLEAR Outcomes — NEJM (2023)FDA expanded the Nexlizet label on the basis of CLEAR Outcomes, adding cardiovascular-risk reduction and broadening LDL-C lowering. This regulatory extension used outcomes evidence for bempedoic acid rather than a dedicated event trial of the fixed combination.
Esperion announcement of FDA label expansions (2024)Selected sources checked Sep 14, 2026. This is not an exhaustive history.
