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Drug

Bempedoic acid

Approved medicine
ClassATP-citrate synthase inhibitorResearchOngoing clinical research

Also known as Nexletol, Nexlizet.

RxNorm2282403ChEMBLCHEMBL3545313ATCC10AX15UNII1EJ6Z6Q368
8
Active clinical trials
ATP-citrate synthase
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acid in Patients With Hyperlipidemia Not Adequately Controlled by Statins

Clinical trial2026-06-03Results expected Q2 2027 · ClinicalTrials.gov

Bempedoic Acid Therapy for Polycystic Kidney Disease (BEAT-PKD) Randomized Clinical Trial

Clinical trial2026-05-01Results expected Q3 2029 · ClinicalTrials.gov

Triple (Atorvastatin, Ezetimibe, and Bempedoic Acid) Versus Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome: A Randomized Controlled Trial

Clinical trial2026-04-09Results expected Q4 2026 · ClinicalTrials.gov

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

Clinical trial2026-03-27Results posted · ClinicalTrials.gov

Effects of Bempedoic Acid/Ezetimibe/High-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events

Clinical trial2026-03-19Results expected Q2 2028 · ClinicalTrials.gov

A Randomized, Single-center, Open-label, Single-dose, 4-period, 2-sequence, Fully Replicate Crossover Study To Assess The Bioequivalence of A Test Fixed Dose Combination Product Versus The Co-administered Individual Reference Products Containing Bempedoic Acid 180 mg / Ezetimibe 10 mg And Atorvastatin 40 mg In Healthy Participants

Clinical trial2026-02-24Completed · ClinicalTrials.gov

A Randomized, Single-Center, Open-Label, Single-Dose, 4-Period, 2-Sequence, Fully Replicate Crossover Study To Assess The Bioequivalence Of A Test Fixed Dose Combination Product Versus The Co-Administered Individual Reference Products Containing Bempedoic Acid 180 MG, Ezetimibe 10 mg And Atorvastatin 40 mg In Healthy Participants

Clinical trial2026-01-28Completed · ClinicalTrials.gov

Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)

Clinical trial2025-12-17Results expected Q1 2028 · ClinicalTrials.gov

A Randomized, Single-center, Open-label, Single-dose, 4-period, 2-sequence, Fully Replicate Crossover Study to Assess the Bioequivalence of a Test Fixed Dose Combination Product Versus the Co-administered Individual Reference Products Containing Bempedoic Acid 180 mg / Ezetimibe 10 mg and Rosuvastatin 20 mg in Healthy Participants

Clinical trial2025-12-10Completed · ClinicalTrials.gov

A Randomized, Single-Center, Open-Label, Single-dose, 4-Period, 2-Sequence, Fully Replicate Crossover Study To Assess The Bioequivalence Of A Test Fixed Dose Combination Product Versus The Co-Administered Individual Reference Products Containing Bempedoic Acid 180 mg, Ezetimibe 10 mg And Rosuvastatin 20 mg In Healthy Participants

Clinical trial2025-11-24Completed · ClinicalTrials.gov

Bempedoic Acid Versus Statins in Primary-Prevention Patients With Suboptimal Statin Adherence: Effects on LDL-C Reduction and Tolerability

Clinical trial2025-11-20Results expected Q4 2026 · ClinicalTrials.gov

Approval: Nilemdo (EMA)

Regulatory2020-04-01EMA

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Lowers LDL cholesterol in hyperlipidaemia
65%Moderate confidence
Uncertainty ±27%Evidence coverage: SubstantialUpdated 29 October 2025

High point estimate, but substantial uncertainty remains.

Confidence has a moderate point estimate but a wide uncertainty band — the evidence is still sponsor-concentrated.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Bempedoic acid
Aliases & brands
NexletolNexlizet
RxNorm CUI
2282403
ChEMBL ID
CHEMBL3545313
ATC codes
C10AX15
UNII
1EJ6Z6Q368
Primary mechanism
ATP-citrate synthase inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

ATP-citrate synthase
ACLY · P53396
INHIBITORATP-citrate synthase inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2020-04-01
Latest approval
2020-04-01
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2020-04-01Approval
Approval: Nilemdo (EMA)
Indication: Hypercholesterolaemia and mixed dyslipidaemiaNilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as… Show full indication

Hypercholesterolaemia and mixed dyslipidaemiaNilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin (see sections 4.2, 4.3, and 4.4) or,• alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.Cardiovascular diseaseNilemdo is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:• in patients on a maximum tolerated dose of a statin with or without ezetimibe or,• alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

25 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
25
registered trials across all phases
LATEST COMPLETION 2026
8
Active studies
8
Recruiting
15
Late-stage (III+)
17
Completed
PHASE DISTRIBUTIONn = 25
Phase 15Phase 25Phase 311Phase 43Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Triple (Atorvastatin, Ezetimibe, and Bempedoic Acid) Versus Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome: A Randomized Controlled Trial

Not yet recruitingPH IVPunjab Institute of Cardologyn=1202026

A Multicenter, Prospective, Phase IV, Interventional Study to Investigate the Effectiveness and Safety of Bempedoic Acid in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia in Taiwan - The CLEAR Taiwan Study

CompletedPH IVDaiichi Sankyon=1802025

An Open-Label Postmarking Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid and Ezetimibe in the Breast Milk of Healthy Lactating Women Administered Therapeutic Doses of Bempedoic Acid or Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP)

CompletedPH IVEsperion Therapeutics, Inc.n=162024

Effects of Bempedoic Acid/Ezetimibe/High-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events

Not yet recruitingPH IIIDaiichi Sankyon=1032028

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acid in Patients With Hyperlipidemia Not Adequately Controlled by Statins

Not yet recruitingPH IIICSPC Ouyi Pharmaceutical Co., Ltd.n=2222027

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Single-center, Open-label, Single-dose, 4-period, 2-sequence, Fully Replicate Crossover Study To Assess The Bioequivalence of A Test Fixed Dose Combination Product Versus The Co-administered Individual Reference Products Containing Bempedoic Acid 180 mg / Ezetimibe 10 mg And Atorvastatin 40 mg In Healthy Participants

CompletedPH IDaiichi Sankyon=582026

A Randomized, Single-Center, Open-Label, Single-Dose, 4-Period, 2-Sequence, Fully Replicate Crossover Study To Assess The Bioequivalence Of A Test Fixed Dose Combination Product Versus The Co-Administered Individual Reference Products Containing Bempedoic Acid 180 MG, Ezetimibe 10 mg And Atorvastatin 40 mg In Healthy Participants

CompletedPH IDaiichi Sankyon=582026

A Randomized, Single-center, Open-label, Single-dose, 4-period, 2-sequence, Fully Replicate Crossover Study to Assess the Bioequivalence of a Test Fixed Dose Combination Product Versus the Co-administered Individual Reference Products Containing Bempedoic Acid 180 mg / Ezetimibe 10 mg and Rosuvastatin 20 mg in Healthy Participants

CompletedPH IDaiichi Sankyon=582025

A Randomized, Single-Center, Open-Label, Single-dose, 4-Period, 2-Sequence, Fully Replicate Crossover Study To Assess The Bioequivalence Of A Test Fixed Dose Combination Product Versus The Co-Administered Individual Reference Products Containing Bempedoic Acid 180 mg, Ezetimibe 10 mg And Rosuvastatin 20 mg In Healthy Participants

CompletedPH IDaiichi Sankyon=582025

A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 in Combination With Ezetimibe, Ezetimibe/Rosuvastatin, or Ezetimibe/Bempedoic Acid in Healthy Male and Female Participants 18 to 75 Years of Age With Elevated LDL-C.

CompletedPH IAstraZenecan=812025

A Multicenter, Prospective, Phase IV, Interventional Study to Investigate the Effectiveness and Safety of Bempedoic Acid in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia in Taiwan - The CLEAR Taiwan Study

CompletedPH IVDaiichi Sankyon=1802025
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.