Drugs / Bempedoic acid
Bempedoic acid
also known as
ETC-1002 · BPA · 8-Hydroxy-2,2,14,14-tetramethylpentadecanedioic acid · Acide bempedoique · Acido bempedoico · Bempedoic acid component of nexlizet · ESP-55016 · Nexletol · +1 more
Small molecule targets ACLY via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | NEXLETOL | — | 2024-03-22 – 2025-11-21 | fda.gov ↗ |
| Approved | EU (EMA) | Nustendi | — | 2020-03-27 | europa.eu ↗ |
| Approved | US (FDA) | NEXLETOL | — | 2020-02-21 | fda.gov ↗ |
Trials 34 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06742853 Background | Dec 2024 → Oct 2025 | hyperlipidemia | AstraZeneca | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07282821 Comparator | Jul 2026 → Aug 2029 expected | autosomal dominant polycystic kidney disease | Kenneth Hallows | Not yet recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07614958 Comparator | May 2026 → Jan 2027 expected | hyperlipidemia, combined, 2 | A. Menarini International Licensing S.A. | Recruiting | No outcome recorded |
| Phase 3 | NCT07239414 Comparator | Nov 2025 → Nov 2026 expected | cardiovascular disorder | Sohaib Ashraf | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06450366 Comparator | Jul 2024 → Feb 2025 | hyperlipidemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07611747 Background | Apr 2026 → Apr 2031 expected | atherosclerosis, carotid artery disorder, psoriatic arthritis, spondyloarthropathy +1 | Marqués de Valdecilla Research Institute (IDIVAL) | Recruiting | No outcome recorded |
| Phase 4 | NCT07255820 Comparator | Jan → Mar 2026 overdue | hyperlipoproteinemia, type 2 diabetes mellitus | Bahria University | Recruiting | No outcome recorded |
| Phase 4 | NCT06431763 Comparator | Jun 2024 → Dec 2025 | hyperlipidemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT05263778 Comparator | Mar 2022 → Jun 2023 | ST-elevation myocardial infarction | Kaiser Permanente | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05587621 Comparator | Apr 2024 → Apr 2026 overdue | ST-elevation myocardial infarction, low density lipoprotein cholesterol, mild elevation of | Jena University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06035874 Comparator | Oct 2023 → Nov 2024 overdue | NAFLD1, type 2 diabetes mellitus | Medanta, The Medicity, India | Recruiting | No outcome recorded |
Press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-01-08 | Organon and Co | Organon Enters into a Commercialization Agreement for Daiichi Sankyo’s Nilemdo® in France, Denmark, Iceland, Sweden, Finland and Norway organon.com ↗ |
| 2025-11-21 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka launches NEXLETOL in Japan® otsuka.co.jp ↗ |
| 2025-03-03 | CSL Behring | CSL Seqirus and Esperion Sign Licensing Agreement to commercialise Nexletol® (bempedoic acid) and Nexlizet® (bempedoic acid/ezetimibe) in Australia and New Zealand csl.com ↗ |
| 2024-11-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Submits New Drug Application in Japan for Bempedoic Acid in the Treatment of Hypercholesterolemia otsuka.co.jp ↗ |
| 2024-05-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Bempedoic Acid Met Primary Endpoint of Phase 3 Trial in Japan for the Treatment of Hypercholesterolemia otsuka.co.jp ↗ |
| 2020-04-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Enters into Licensing Agreement in Japan for Bempedoic Acid, a Treatment for Hypercholesterolemia otsuka.co.jp ↗ |
| 2019-01-07 | Daiichi Sankyo | Daiichi Sankyo Europe Enters into European Licensing Agreement with Esperion for Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet daiichisankyo.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bempedoic acid | “Treatment includes high-intensity statins (atorvastatin 40-80mg, rouvastatin 20-40mg), with possible addition of azetimibe, bempedoic acid, and/or PCSK9 inhibitors if target is...” NCT07611747 ↗32“This study is a phase IV, open-label, randomized study designed to evaluate the efficacy of Inclisiran vs. bempedoic acid (BPA) in 400 adult subjects” NCT06431763 ↗ “Bempedoic acid is an oral ATP citrate lyase inhibitor that lowers LDL-c upstream of HMG-CoA reductase.” NCT07440381 ↗ “180mg of ETC-1002(bempedoic acid)” NCT04784442 ↗ |
| Known as | 8-Hydroxy-2,2,14,14-tetramethylpentadecanedioic acid | “8-Hydroxy-2,2,14,14-tetramethylpentadecanedioic acid (ETC-1002) is a small molecule with a unique mechanism of action shown in nonclinical studies to modulate pathways of...” PMID 24385236 ↗ Jan 2014 |
| Known as | Acide bempedoique | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545313 ↗ |
| Known as | Acido bempedoico | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545313 ↗ |
| Known as | Bempedoic acid component of nexlizet | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545313 ↗ |
| Known as | BPA | “This study is a phase IV, open-label, randomized study designed to evaluate the efficacy of Inclisiran vs. bempedoic acid (BPA) in 400 adult subjects” NCT06431763 ↗1“obicetrapib (OBI) compared to bempedoic acid (BPA)” NCT07614958 ↗ |
| Known as | ESP-55016 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545313 ↗ |
| Known as | ETC-1002 | “bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe” NCT03193047 ↗16“Bempedoic acid (ETC-1002), a ATP citrate lyase (ACLY) inhibitor that lowers the LDL cholesterol” PMID 34909677 ↗ Sep 2021 “180mg of ETC-1002(bempedoic acid)” NCT05687071 ↗ “180mg of ETC-1002(bempedoic acid)” NCT05683340 ↗ |
| Known as | Nexletol | “Bempedoic Acid 180 MG Oral Tablet \[Nexletol\]” NCT06021951 ↗ |
| Known as | Nilemdo | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545313 ↗ |
| Action | Inhibit | “Bempedoic acid, a prodrug that is activated by a hepatic enzyme not present in skeletal muscle, inhibits ATP -citrate lyase” PMID 30922146 ↗ Apr 2019 |
| Modality | Small molecule | “ETC-1002 is a small molecule that modulates pathways of cholesterol, fatty acid, and carbohydrate metabolism” PMID 23770179 ↗ Jun 2013 |
| Route | Oral | “once daily oral treatment with ETC-1002” PMID 24385236 ↗ Jan 2014 |
| Target | ACLY | “Background Bempedoic acid (BA) inhibits ATP-citrate lyase in the cholesterol synthesis pathway and lowers low-density lipoprotein cholesterol (LDL-C).” PMID 35916348 ↗ Aug 2022 |