Bempedoic Acid
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Also known as Acide bempedoiqueAcido bempedoicoBempedoic acid component of nexlizetESP-55016ETC-1002ETC1002NexletolNilemdo
Summary
Bempedoic Acid (CHEMBL3545313) is an approved small-molecule antilipemic drug (ATC C10AX15) targeting ACLY; indicated across 9 conditions including cardiovascular disorder and familial hypercholesterolemia.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: C10AX15
- Targets: 1 (ACLY)
- Indications: 9 conditions
- Clinical trials: 36
- Chemistry: 344.5 Da · C19H36O5
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL3545313 |
| Name | Bempedoic Acid |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 10472693 |
| ChEBI | CHEBI:149601 |
| ATC | C10AX15 |
| Molecular formula | C19H36O5 |
| Molecular weight | 344.5 |
| InChIKey | HYHMLYSLQUKXKP-UHFFFAOYSA-N |
SMILES: CC(C)(CCCCCC(CCCCCC(C)(C)C(=O)O)O)C(=O)O
IUPAC name: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
ChEBI definition: An α,ω-dicarboxylic acid that is pentadecanedioic acid which is substituted by methyl groups groups at positions 2 and 14, and by a hydroxy group at position 8. It is a drug used for the treatment of high LDL cholesterol, which is sometimes referred to as ‘bad cholesterol’.
Pharmacological roles (ChEBI): antilipemic drug, EC 2.3.3.8 (ATP citrate synthase) inhibitor, prodrug.
Also known as: Acide bempedoique, Acido bempedoico, Bempedoic acid, Bempedoic acid component of nexlizet, ESP-55016, ETC-1002, ETC1002, Nexletol, Nilemdo, BEMPEDOIC ACID, bempedoic acid
Parent form; salt/anhydrous children: CHEMBL5397694, CHEMBL5410861, CHEMBL5412638, CHEMBL5418282
Patent coverage: 306 distinct patent families (787 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| ACLY | ATP citrate lyase | Inhibition | 5.7 | 47.4% | P53396 |
Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Acetyl-CoA carboxylase.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): ACLY.
Top Reactome pathways
9 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Metabolism | 1 | ACLY |
| Integration of energy metabolism | 1 | ACLY |
| ChREBP activates metabolic gene expression | 1 | ACLY |
| Innate Immune System | 1 | ACLY |
| Immune System | 1 | ACLY |
| Metabolism of lipids | 1 | ACLY |
| Neutrophil degranulation | 1 | ACLY |
| Fatty acyl-CoA biosynthesis | 1 | ACLY |
| Fatty acid metabolism | 1 | ACLY |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| acetyl-CoA biosynthetic process | 1 |
| citrate metabolic process | 1 |
| oxaloacetate metabolic process | 1 |
| fatty acid biosynthetic process | 1 |
| cholesterol biosynthetic process | 1 |
| lipid biosynthetic process | 1 |
| coenzyme A metabolic process | 1 |
| negative regulation of ferroptosis | 1 |
| lipid metabolic process | 1 |
Indications & clinical
Indications
9 indications (6 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| cardiovascular disorder | 4 | MONDO:0004995 | EFO:0000319 |
| familial hypercholesterolemia | 4 | MONDO:0005439 | EFO:0004911 |
| coronary artery disorder | 4 | MONDO:0005010 | EFO:0001645 |
| atherosclerosis | 4 | MONDO:0005311 | EFO:0003914 |
| hyperlipidemia | 3 | MONDO:0021187 | MONDO:0021187 |
| type 2 diabetes mellitus | 2 | MONDO:0005148 | MONDO:0005148 |
3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 36.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 13 |
| PHASE3 | 9 |
| PHASE1 | 6 |
| Not specified | 6 |
| PHASE4 | 2 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT07255820 | PHASE4 | NOT_YET_RECRUITING | Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol |
| NCT05263778 | PHASE4 | UNKNOWN | Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome Study |
| NCT07474649 | PHASE3 | NOT_YET_RECRUITING | A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events |
| NCT07614958 | PHASE3 | RECRUITING | 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 |
| NCT02666664 | PHASE3 | COMPLETED | Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony) |
| NCT02988115 | PHASE3 | COMPLETED | Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant |
| NCT02991118 | PHASE3 | COMPLETED | Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk |
| NCT03001076 | PHASE3 | 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) |
| NCT03067441 | PHASE3 | COMPLETED | Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE) |
| NCT03337308 | PHASE3 | 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 |
| NCT06450366 | PHASE3 | 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) |
| NCT05488431 | PHASE2 | RECRUITING | Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial) |
| NCT01262638 | PHASE2 | COMPLETED | A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides |
| NCT01607294 | PHASE2 | COMPLETED | A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes |
| NCT01751984 | PHASE2 | COMPLETED | A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance |
| NCT01779453 | PHASE2 | COMPLETED | A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia |
| NCT01941836 | PHASE2 | COMPLETED | Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients |
| NCT02072161 | PHASE2 | COMPLETED | Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy |
| NCT02178098 | PHASE2 | COMPLETED | Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension |
| NCT02659397 | PHASE2 | COMPLETED | A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg |
| NCT03051100 | PHASE2 | COMPLETED | Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C |
| NCT03193047 | PHASE2 | COMPLETED | Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy |
| NCT03531905 | PHASE2 | COMPLETED | Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C |
| NCT05694260 | PHASE2 | 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) |
| NCT01485146 | PHASE1 | COMPLETED | A Multiple Ascending Dose Study of ETC-1002 in Healthy Subjects |
| NCT06742853 | PHASE1 | COMPLETED | A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C. |
| NCT07182383 | PHASE1 | COMPLETED | Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin |
| NCT07201545 | PHASE1 | COMPLETED | Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin |
| NCT07235189 | PHASE1 | COMPLETED | A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin |
| NCT07268625 | PHASE1 | COMPLETED | Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin |
| NCT05103254 | Not specified | RECRUITING | Bempedoic Acid Pregnancy Surveillance Program |
| NCT05587621 | Not specified | NOT_YET_RECRUITING | Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target) |
| NCT06035874 | Not specified | RECRUITING | Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes |
| NCT06686615 | Not specified | RECRUITING | A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia |
| NCT07256171 | Not specified | NOT_YET_RECRUITING | COAST Study - Cholesterol Optimization After Stroke |
| NCT07374861 | Not specified | RECRUITING | Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).