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 · 14 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed atherosclerotic cardiovascular disease 1 milestone | |||||
| Filed | EU (EMA) | NILEMDO | atherosclerotic cardiovascular disease | — | “submission of an application for expanded indication for NILEMDO ® (bempedoic acid) and NUSTENDI ® (bempedoic acid and ezetimibe) to the European Medicines Agency (EMA)” esperion.com ↗ |
| Filed hypercholesterolemia due to cholesterol 7alpha-hydroxylase deficiency 2 milestones | |||||
| Filed | US (FDA) | — | hypercholesterolemia due to cholesterol 7alpha-hydroxylase deficiency | 2019-02-20 | “submission of two New Drug Applications (NDAs) for bempedoic acid and the bempedoic acid / ezetimibe combination tablet to the U.S. Food and Drug Administration” esperion.com ↗ “We also achieved the filing and acceptance of New Drug Applications in the US and Marketing Authorization Applications in the EU for both bempedoic acid” esperion.com ↗ “our February submissions for marketing approvals of bempedoic acid and the bempedoic acid / ezetimibe combination tablet in both the U.S. and E.U.” esperion.com ↗ |
| Filed | EU (EMA) | — | hypercholesterolemia due to cholesterol 7alpha-hydroxylase deficiency | 2019-02-11 | “We also achieved the filing and acceptance of New Drug Applications in the US and Marketing Authorization Applications in the EU for both bempedoic acid” esperion.com ↗ “The MAAs for bempedoic acid and the bempedoic acid / ezetimibe combination tablet were submitted to the EMA on February 11, 2019.” esperion.com ↗ “The MAAs for bempedoic acid and the bempedoic acid / ezetimibe combination tablet were submitted to the EMA on February 11, 2019.” esperion.com ↗ |
| Filed hypercholesterolemia, autosomal dominant, type B 2 milestones | |||||
| Filed | Japan (PMDA) | NEXLETOL | hypercholesterolemia, autosomal dominant, type B | 2025-03-04 | “submitted a New Drug Application to the Japanese Ministry of Health, Labour and Welfare for the manufacture and sale of bempedoic acid” esperion.com ↗ |
| Filed | Japan (PMDA) | — | hypercholesterolemia, autosomal dominant, type B | 2024-11-26 | “Otsuka Pharmaceutical Co., Ltd. (Otsuka) has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare” esperion.com ↗ “announces the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare” otsuka.co.jp ↗ |
| Filed hyperlipidemia 1 milestone | |||||
| Filed | US (FDA) | — | hyperlipidemia | 2019-05-05 | “the U.S. Food and Drug Administration (FDA) has accepted both New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet for filing” esperion.com ↗ |
| Filed hyperlipidemia, combined, 2 1 milestone | |||||
| Filed | EU (EMA) | — | hyperlipidemia, combined, 2 | — | “our February submissions for marketing approvals of bempedoic acid and the bempedoic acid / ezetimibe combination tablet in both the U.S. and E.U.” esperion.com ↗ |
| Approved Indication not stated 6 milestones | |||||
| Label expansions (2) | US (FDA) | NEXLETOL | — | 2024-03-22 – 2025-11-21 | fda.gov ↗ |
| Rejected | Other | NEXLIZET | — | 2025-11-18 | “has issued a Notice of Non-Compliance ("NON") for NEXLIZET®” hlstherapeutics.com ↗ |
| Filed | Other | NEXLETOL and NEXLIZET | — | 2025-11-06 | “CSL Seqirus, the Company’s partner in Australia and New Zealand, filed a marketing application in Australia for NEXLETOL and NEXLIZET in July 2025” esperion.com ↗ “HLS Therapeutics, Esperion’s commercial partner for NEXLETOL and NEXLIZET in Canada, has filed New Drug Submissions to Health Canada” esperion.com ↗ “Neopharm Israel filed a New Drug Application for marketing approval of NEXLETOL and NEXLIZET in Q1 2025.” esperion.com ↗ “In Q4 2024, Esperion submitted New Drug Submissions to Health Canada for both NEXLETOL and NEXLIZET” hlstherapeutics.com ↗ “The Company filed New Drug Submissions (NDSs) to Health Canada for NEXLETOL and NEXLIZET” esperion.com ↗ “filed a marketing application in Australia for NEXLETOL and NEXLIZET in July 2025” esperion.com ↗ |
| Filed | US (FDA) | NEXLETOL and NEXLIZET | cardiovascular risk reduction, hypercholesterolemia | 2023-06-01 | “submitted Supplemental New Drug Applications (sNDA) to the U.S. Food and Drug Administration (FDA) for the Company’s oral non-statin products NEXLETOL and NEXLIZET.” esperion.com ↗ |
| Approved | EU (EMA) | Nustendi | — | 2020-03-27 | europa.eu ↗ |
| Approved | US (FDA) | NEXLETOL | — | 2020-02-21 | fda.gov ↗ |
Trials 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02044627 | Dec 2013 → Jan 2014 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01485146 | Oct 2011 → Jan 2012 | — | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01105598 | Apr → Oct 2010 | — | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 214 trials · 8 met primary | ||||||
| Phase 2 | NCT05488431 | Mar 2023 → Mar 2028 expected | HIV infectious disease, atherosclerosis, hyperlipidemia | Priscilla Hsue, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05694260 | Jan 2023 → Jun 2025 | familial hypercholesterolemia | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04784442 | Mar 2021 → Apr 2022 | hyperlipidemia | Otsuka Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 2 | NCT03531905 | May 2018 → Jun 2019 | hyperlipidemia, type 2 diabetes mellitus | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT03193047 | Apr 2017 → Jan 2018 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT03051100 | Jan → Jun 2017 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT02659397 | Dec 2015 → Jul 2016 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02178098 | Jun 2014 → May 2015 | hyperlipidemia, hypertensive disorder | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT02072161 | Mar 2014 → Jan 2015 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01941836 | Sep 2013 → Oct 2014 | hyperlipoproteinemia | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01779453 | Dec 2012 → Aug 2013 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01751984 | Oct 2012 → May 2013 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT01607294 | Apr → Oct 2012 | hyperlipidemia, type 2 diabetes mellitus | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT01262638 | Dec 2010 → Aug 2011 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 313 trials · 6 met primary | ||||||
| Phase 3 | NCT07474649 | Sep 2026 → Jun 2028 expected | coronary atherosclerosis, hyperlipidemia, combined, 2 | Daiichi Sankyo | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07440381 | Sep 2026 → Aug 2027 expected | acute coronary syndrome | Heart Care Foundation | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07623915 | Jun 2026 → Jun 2027 expected | hyperlipoproteinemia | CSPC Ouyi Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06780410 | Dec 2024 → Oct 2025 overdue | hyperlipoproteinemia | Gan & Lee Pharmaceuticals. | Recruiting | No outcome recorded |
| Phase 3 | NCT05687071 | Feb 2023 → Oct 2024 | low density lipoprotein cholesterol, mild elevation of | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05683340 | Feb 2023 → Feb 2024 | low density lipoprotein cholesterol, mild elevation of | Otsuka Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03337308 | Oct 2017 → Jun 2018 | hyperlipidemia | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT03067441 | Feb 2017 → Nov 2019 | atherosclerotic cardiovascular disease, familial hypercholesterolemia | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02993406 | Dec 2016 → Nov 2022 | cardiovascular disorder, statin toxicity | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT03001076 | Nov 2016 → Jan 2018 | atherosclerosis, hyperlipidemia, statin toxicity | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT02991118 | Nov 2016 → Aug 2018 | atherosclerotic cardiovascular disease, hyperlipidemia | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT02988115 | Nov 2016 → Mar 2018 | atherosclerotic cardiovascular disease, hyperlipidemia, statin toxicity | Esperion Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT02666664 | Jan 2016 → Feb 2018 | atherosclerotic cardiovascular disease, hyperlipidemia | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07824323 | Aug 2026 → Mar 2028 expected | acute coronary syndrome, hyperlipidemia | Taipei Medical University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07508254 | May → Oct 2026 expected | acute coronary syndrome, hyperlipidemia | Punjab Institute of Cardology | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06925100 | Apr → Oct 2025 | hyperlipoproteinemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT06381947 | May 2024 → Jun 2025 | cardiovascular disorder, cholesterol metabolism disease, hyperlipidemia, statin toxicity | University of Salerno | Unknown | No outcome recorded |
| Phase 4 | NCT06021951 | Aug 2023 → Feb 2024 | — | Esperion Therapeutics, Inc. | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT06742853 Background | Dec 2024 → Oct 2025 | hyperlipidemia | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT07282821 Comparator | Sep 2026 → Sep 2029 expected | autosomal dominant polycystic kidney disease | Kenneth Hallows | Recruiting | No outcome recorded |
| 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 | Met primary |
| 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 64
| Date | Issuer | Release |
|---|---|---|
| 2026-05-26 | Esperion Therapeutics, Inc. | Results Esperion Presents New Data from CLEAR Outcomes and the CLEAR PATH Phase 2 Pediatric Study at the European Atherosclerosis Society Congress 2026 esperion.com ↗
Esperion (NASDAQ: ESPR) today announced the presentation of results from a Phase 2 study of bempedoic acid in children, along with an additional post hoc analysis from CLEAR Outcomes describing patient traits associated an enhanced LDL-C lowering with bempedoic acid. |
| 2026-05-13 | Esperion Therapeutics, Inc. | Results Esperion Announces Two New Analyses Supporting Bempedoic Acid to Reduce LDL-C Levels to be Presented at the European Atherosclerosis Society (EAS) Congress 2026 esperion.com ↗
New Analyses from CLEAR Outcomes Trial Identified Factors Associated With Enhanced LDL-C Reductions in Adult Patients |
| 2026-03-30 | Merck Sharp & Dohme LLC | Results MSD’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Demonstrated Significantly Greater LDL-C Reductions at Eight Weeks Compared to Guideline-Recommended Oral Non-Statin Therapies When Added to Background Statins msd.com ↗
In the study, treatment with enlicitide resulted in statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol (LDL-C) compared to bempedoic acid, ezetimibe or bempedoic acid with ezetimibe at eight weeks (day 56) of treatment. |
| 2026-03-30 | Esperion Therapeutics, Inc. | Results Esperion Showcases New Data from CLEAR Outcomes Highlighting Value of NEXLETOL® (bempedoic acid) at the American College of Cardiology’s Annual Scientific Session 2026 esperion.com ↗
Analysis Demonstrated 22% Reduced Risk of Ischemic Stroke for Patients Taking Bempedoic Acid Compared to Placebo |
| 2025-11-21 | Esperion Therapeutics, Inc. | Regulatory Esperion Partner Otsuka Launches NEXLETOL® in Japan for the Treatment of Hypercholesterolemia esperion.com ↗
We are thrilled that Otsuka, our partner in Japan, has received national pricing approval and launched NEXLETOL. |
| 2025-11-18 | Esperion Therapeutics, Inc. | Regulatory Esperion Partner HLS Therapeutics Announces Approval of NILEMDO® for the Reduction of LDL-Cholesterol in Canadians at Risk of Cardiovascular Disease esperion.com ↗
This approval marks another important milestone in our global strategy to expand access to bempedoic acid products for patients who urgently need better options to manage their LDL-C and reduce cardiovascular risk. |
| 2025-11-18 | HLS Therapeutics, Inc | Regulatory HLS Therapeutics Announces Health Canada Approval of NILEMDO® for the Reduction of LDL-Cholesterol in Canadians at Risk of Cardiovascular Disease hlstherapeutics.com ↗
HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focused on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces that Health Canada has approved NILEMDO® (bempedoic acid) for use in Canada and has issued a Notice of Non-Compliance ("NON") for NEXLIZET® (bempedoic acid and ezetimibe). |
| 2025-11-10 | Esperion Therapeutics, Inc. | Results Esperion Announces New Data from CLEAR Outcomes Highlighting Value of NEXLETOL® (bempedoic acid) in Oral and Poster Presentations at the AHA Scientific Sessions 2025 esperion.com ↗ |
| 2025-09-19 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Receives Approval in Japan for NEXLETOLas a Treatment for Hypercholesterolemia® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the Japanese Ministry of Health, Labour and Welfare（MHLW）has approved NEXLETOL（bempedoic acid） for the treatment of hypercholesterolemia and familial hypercholesterolemia. |
| 2025-09-19 | Esperion Therapeutics, Inc. | Regulatory Esperion Partner Otsuka Receives Regulatory Approval to Market NEXLETOL® in Japan for the Treatment of Hypercholesterolemia esperion.com ↗ |
| 2025-06-16 | Daiichi Sankyo | Regulatory Anvisa aprova novo tratamento para colesterol alto daiichisankyo.com.br ↗
A Agência Nacional de Vigilância Sanitária (Anvisa) acaba de anunciar a aprovação do medicamento Nustendi® |
| 2025-03-20 | Esperion Therapeutics, Inc. | Regulatory Esperion Aligns with U.S. Food and Drug Administration to Initiate Phase 3 Clinical Trials of Bempedoic Acid in Pediatric Heterozygous and Homozygous Familial Hypercholesterolemia esperion.com ↗
Based on these discussions with the FDA, the Company plans to initiate Phase 3 clinical studies this year. |
| 2024-12-02 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces New Drug Submissions in Canada for NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) Treatments to Reduce LDL-C and Cardiovascular Risk esperion.com ↗
Esperion (NASDAQ: ESPR) today announced that it has filed New Drug Submissions (NDSs) to Health Canada for NEXLETOL and NEXLIZET, once-daily, accessible, oral non-statin medications that reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk. |
| 2024-11-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Submits New Drug Application in Japan for Bempedoic Acid in the Treatment of Hypercholesterolemia otsuka.co.jp ↗ |
| 2024-11-26 | Esperion Therapeutics, Inc. | Regulatory Otsuka Submits New Drug Application in Japan for Bempedoic Acid in the Treatment of Hypercholesterolemia esperion.com ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for the manufacture and sale of bempedoic acid in Japan for the treatment of hypercholesterolemia and familial hypercholesterolemia. |
| 2024-11-18 | Esperion Therapeutics, Inc. | Results Esperion Highlights New Exploratory Data from CLEAR Outcomes Trial Highlighting Value of NEXLETOL® (bempedoic acid) in Oral Featured Science Session and Multiple Poster Presentations at AHA Scientific Sessions 2024 esperion.com ↗
An Exploratory Analysis Reports Patients with PAD Who Took Bempedoic Acid Were 36% Less Likely to Experience a Major Adverse Limb Event Compared to Placebo |
| 2024-10-02 | Esperion Therapeutics, Inc. | Results Esperion EU Partner Reports Final Real-World Results from MILOS German Cohort Demonstrating Strong Increase in LDL-C Goal Achievement With Addition of Bempedoic Acid esperion.com ↗
The results, presented in Hamburg, Germany at DGK Herztage 2024, demonstrated the effectiveness and safety profile of bempedoic acid, both alone and in combination with other lipid-lowering therapies (LLTs) in clinical practice. |
| 2024-05-22 | Esperion Therapeutics, Inc. | Regulatory First-In-Class Cholesterol-Lowering Treatment NILEMDO® (NEXLETOL® in the U.S.) and Its Combination with Ezetimibe, NUSTENDI® (NEXLIZET® in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk esperion.com ↗
NILEMDO (bempedoic acid), a First-In-Class, Oral Treatment and NUSTENDI (bempedoic Acid / Ezetimibe Fixed-Dose Combination) Receive Label Update Approval from The European Commission as Treatments to Reduce Cardiovascular Risk by Lowering Low-Density Lipoprotein Cholesterol (LDL-C) Levels |
| 2024-05-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Bempedoic Acid Met Primary Endpoint of Phase 3 Trial in Japan for the Treatment of Hypercholesterolemia otsuka.co.jp ↗
The trial demonstrated statistically siginficant outcomes and highlighted its potential future value of bempedoic acid to patients in Japan. |
| 2024-05-20 | Esperion Therapeutics, Inc. | Results Bempedoic Acid Met Primary Endpoint of Phase 3 Trial in Japan for the Treatment for Hypercholesterolemia esperion.com ↗
The trial demonstrated statistically significant outcomes on the primary endpoint for bempedoic acid and highlighted its potential future value to patients in Japan. |
| 2024-04-07 | Esperion Therapeutics, Inc. | Results Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity esperion.com ↗
Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. |
| 2024-03-22 | Esperion Therapeutics, Inc. | Regulatory CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events esperion.com ↗ |
| 2023-12-13 | Esperion Therapeutics, Inc. | Regulatory U.S. FDA Updates LDL-C Lowering Indication for Esperion’s NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet esperion.com ↗
Esperion (NASDAQ: ESPR) announced today that the U.S. Food and Drug Administration (FDA) has approved an updated LDL-cholesterol lowering indication for NEXLETOL and NEXLIZET to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations. |
| 2023-11-13 | Esperion Therapeutics, Inc. | Results Esperion Presents CLEAR Outcomes Analysis of Inflammation as Predictor of Cardiovascular Risk at American Heart Association Scientific Sessions 2023 esperion.com ↗
Esperion (NASDAQ: ESPR) today announced the presentation of results from a pre-specified, exploratory analysis of CLEAR Outcomes at the 2023 American Heart Association (AHA) Scientific Sessions. |
| 2023-08-26 | Esperion Therapeutics, Inc. | Results Esperion Presents Two CLEAR Outcomes Study Late-Breakers at European Society of Cardiology Congress 2023 esperion.com ↗
Although bempedoic acid works in the same pathway as statins no signal for increased risk of diabetes was noted, providing assurance for the use of bempedoic acid in people without diabetes that cardiovascular benefits do not come at the cost of worsening glucose control. |
| 2023-06-28 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces Submission of Application for Expanded Indication with the European Medicines Agency (EMA) for NILEMDO® (bempedoic acid) Tablet and NUSTENDI® (bempedoic acid and ezetimibe) Tablet esperion.com ↗
today announced that the application was filed for a Type II(a) variation with the European Medicines Agency (EMA) for the Company’s oral non-statin products marketed as NILEMDO and NUSTENDI in Europe. |
| 2023-06-24 | Esperion Therapeutics, Inc. | Results Esperion Presents Results from CLEAR Outcomes Primary Prevention Analysis at 83rd American Diabetes Association Scientific Sessions esperion.com ↗
Bempedoic acid is the first LDL-lowering therapy since statins to demonstrate cardiovascular risk reduction in a primary prevention population |
| 2023-06-15 | Esperion Therapeutics, Inc. | Results Esperion Presents Results from New Analysis on Cardiovascular Benefits with Bempedoic Acid Treatment at ENDO 2023 esperion.com ↗
Cardiovascular risk reduction with bempedoic acid shown via the Cholesterol Treatment Trialists’ (CTT) Major Vascular Event endpoint is comparable to the normalized risk reduction with statins observed in the CTT meta-analyses |
| 2023-06-01 | Synthon BV | Results Synthon announces successful bioequivalence studies for Bempedoic acid synthon.com ↗
In two pivotal BE studies for the US, bioequivalence has been shown between Synthon’s Bempedoic acid 180 mg film-coated tablets and Nexletol 180 mg tablets. |
| 2023-06-01 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces Submission of Supplemental New Drug Applications to U.S. FDA for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet esperion.com ↗
Esperion (NASDAQ: ESPR) today announced that it has submitted Supplemental New Drug Applications (sNDA) to the U.S. Food and Drug Administration (FDA) for the Company’s oral non-statin products NEXLETOL and NEXLIZET. |
| 2023-03-04 | Esperion Therapeutics, Inc. | Results Landmark CLEAR Outcomes Study Demonstrates NEXLETOL® (bempedoic acid) Tablet is the Only LDL-C Lowering Therapy Since Statins to Reduce Hard Ischemic Events in a Broad Population of Both Primary Prevention and Secondary Prevention Patients esperion.com ↗
The study showed that NEXLETOL significantly reduced the risk of hard MACE-4 and MACE-3 by 13% and 15%, respectively, and significantly reduced the risk of heart attack and coronary revascularization by 23% and 19%, respectively, as compared to placebo. |
| 2022-12-19 | Esperion Therapeutics, Inc. | Results CLEAR Outcomes Accepted as Late-Breaking Clinical Trial at ACC.23 Annual Scientific Session & Expo together with the World Congress of Cardiology (ACC.23/WCC) esperion.com ↗
Bempedoic acid becomes the first ATP citrate lyase inhibitor and first oral non-statin to meet the major adverse cardiovascular events ( MACE-4) primary endpoint |
| 2022-12-07 | Esperion Therapeutics, Inc. | Results Esperion Announces CLEAR Cardiovascular Outcomes Trial of NEXLETOL® (bempedoic acid) Meets Primary Endpoint esperion.com ↗ |
| 2022-05-02 | Esperion Therapeutics, Inc. | Results Esperion Announces Publication of CLEAR Harmony Open-Label Extension Study Data for Bempedoic Acid in the American Journal of Cardiology esperion.com ↗
Additionally, bempedoic acid produced stable reductions in LDL-C which remained durable for up to 130 weeks. |
| 2022-04-13 | Esperion Therapeutics, Inc. | Results Esperion Announces Publication of Phase 3 Data for Bempedoic Acid in the Journal of Clinical Lipidology esperion.com ↗
Analysis of pooled Phase 3 data demonstrated 26.5% reduction vs. placebo in LDL-C from bempedoic acid monotherapy and 39.2% reduction vs. placebo in LDL-C from bempedoic acid and ezetimibe fixed-dose combination in patients not taking statins |
| 2022-04-03 | Esperion Therapeutics, Inc. | Results Esperion Announces Two NEXLETOL® (bempedoic acid) Data Presentations at the American College of Cardiology’s 71st Annual Scientific Session & Expo esperion.com ↗
This analysis of a total of 3,619 patients included in four Phase 3 studies demonstrated that bempedoic acid 180 mg significantly lowered low-density lipoprotein cholesterol (LDL-C) (p<0.0001) regardless of renal function. |
| 2021-11-12 | Esperion Therapeutics, Inc. | Results Esperion Presents Important New Science Highlighting Potential Benefits of NEXLETOL® (bempedoic acid) Tablets at American Heart Association Scientific Sessions 2021 esperion.com ↗
Overall, from baseline to Week 12, BA lowered LDL-C levels comparable to that of a moderate- or high-intensity statin (≥ 30%) in 28.9% of patients. |
| 2021-05-15 | Esperion Therapeutics, Inc. | Results Simulation Model based on Pooled Phase 3 Data Demonstrating NEXLETOL® (bempedoic acid) Tablet’s Potential to Lower Absolute Cardiovascular Event Risk Presented at ACC.21 esperion.com ↗
Patients with atherosclerotic cardiovascular disease (ASCVD) on maximally tolerated statins and treated with NEXLETOL predicted to experience a 3.3% further absolute reduction in 10-year cardiovascular event risk compared with statins alone (p<0.0001) |
| 2021-03-17 | Esperion Therapeutics, Inc. | Results NEXLETOL® (bempedoic acid) Tablet, ezetimibe and atorvastatin combination lowered bad cholesterol by 60.5% vs. placebo in Phase 2 study esperion.com ↗ |
| 2020-12-16 | Esperion Therapeutics, Inc. | Regulatory First-in-class cholesterol-lowering treatment NILEMDO® * (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI® * (bempedoic acid and ezetimibe) tablet approved in Switzerland esperion.com ↗ |
| 2020-11-13 | Esperion Therapeutics, Inc. | Results NEXLETOL® (bempedoic acid) Tablets Highlighted at AHA 2020 with Presentations of Analyses Demonstrating Significant Low-Density Lipoprotein Cholesterol (LDL-C) Lowering vs. Placebo in Phase 3 Study Subgroups esperion.com ↗ |
| 2020-10-07 | Esperion Therapeutics, Inc. | Results NEXLETOL® (bempedoic acid) Tablets Highlighted in EAS 2020 Presentation of Analysis Demonstrating Significant Cholesterol Lowering in People with Familial Hypercholesterolemia esperion.com ↗
During the EAS presentation, it was highlighted that NEXLETOL significantly reduced low-density lipoprotein cholesterol (LDL-C) by a mean of 22% compared to placebo in people with HeFH taking maximally tolerated statins with or without other lipid-lowering therapies (LLTs). |
| 2020-07-01 | Esperion Therapeutics, Inc. | Results Esperion Announces Publication in the Journal of the American Medical Association Cardiology of Pooled Efficacy Analysis from the Phase 3 LDL-C Lowering Clinical Development Program of NEXLETOL® (bempedoic acid) Tablets esperion.com ↗
In patients on background statin therapy, NEXLETOL lowered LDL-cholesterol (LDL-C) by a mean of 18 percent compared to placebo (p<0.001). |
| 2020-06-14 | Esperion Therapeutics, Inc. | Results Esperion Announces Pooled Analysis from Phase 3 LDL-C Lowering Clinical Development Program of NEXLETOL™ (Bempedoic Acid) Tablets Presented at the American Diabetes Association 80th Scientific Sessions esperion.com ↗
The presentation demonstrated that patients treated with NEXLETOL experienced a significant lowering of LDL-Cholesterol compared with placebo in all glycemic status subgroups. |
| 2020-04-06 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces European Commission Approval of the NUSTENDI™ (bempedoic acid and ezetimibe) Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia esperion.com ↗
Esperion (NASDAQ: ESPR) announced today the European Commission approved the NUSTENDI™ (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicine for hypercholesterolemia and dyslipidemia in Europe. |
| 2020-04-06 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces European Commission Approval of the NILEMDO™ (bempedoic acid) Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia esperion.com ↗
Esperion (NASDAQ: ESPR) announced today the European Commission approved the NILEMDO™ (bempedoic acid) tablet, an oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicine. |
| 2020-03-28 | Esperion Therapeutics, Inc. | Results Esperion Announces Three Data Presentations of the NEXLETOL™ (bempedoic acid) Tablet and the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet at the American College of Cardiology’s 69th Annual Scientific Session Together with World Congress of Cardiology esperion.com ↗
The poster highlighted that in the Phase 2 (1002-058) study, NEXLIZET significantly lowered LDL-Cholesterol (LDL-C) by a mean 40% compared to placebo, reduced high-sensitivity C-reactive protein (hsCRP) by 25% compared to baseline and resulted in no worsening of glycemic control. |
| 2020-02-26 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine esperion.com ↗
Esperion (NASDAQ:ESPR) today announced that the U.S. Food and Drug Administration (FDA) approved NEXLIZET™ (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-Cholesterol (LDL-C), lowering medicine. |
| 2020-02-21 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces FDA Approval of NEXLETOL™ (bempedoic acid) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine esperion.com ↗
Esperion (NASDAQ:ESPR) announced today that the U.S. Food and Drug Administration (FDA) approved NEXLETOL™ (bempedoic acid) tablet, an oral, once-daily, non-statin LDL-Cholesterol (LDL-C) lowering medicine. |
| 2020-01-31 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces Positive CHMP Opinion for the Marketing Authorisation Application for Bempedoic Acid for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia esperion.com ↗
The CHMP recommended granting the bempedoic acid tablet marketing authorisation for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: |
| 2020-01-31 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces Positive CHMP Opinion for the Marketing Authorisation Application for the Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet for the Treatment of Hypercholesterolemia and Mixed Dyslipidemia esperion.com ↗
Esperion (NASDAQ: ESPR) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the MAA for the bempedoic acid / ezetimibe fixed dose combination tablet, recommending approval for the treatment of hypercholesterolemia and mixed dyslipidemia. |
| 2019-11-17 | Esperion Therapeutics, Inc. | Results Esperion Announces Pooled Analyses from Phase 3 LDL-C Lowering Clinical Development Program of Bempedoic Acid Presented at the American Heart Association 2019 Scientific Sessions esperion.com ↗
The presentation highlighted that bempedoic acid reduced hemoglobin A1c (HbA1c) by 0.19% versus placebo in patients with diabetes (n=1,134) at 12 weeks. |
| 2019-11-12 | Esperion Therapeutics, Inc. | Results Esperion Announces Publication in the Journal of the American Medical Association of Bempedoic Acid Phase 3 Study 2 Results esperion.com ↗
Study 2 Demonstrated that Bempedoic Acid Significantly Lowered LDL-Cholesterol and Reduced hsCRP |
| 2019-08-29 | Esperion Therapeutics, Inc. | Results Esperion Announces Positive Top-Line Results from Phase 2 Study of Bempedoic Acid / Ezetimibe Combination Tablet in Patients with Hypercholesterolemia and Type 2 Diabetes esperion.com ↗
Esperion (NASDAQ: ESPR) today announced positive top-line results from the Phase 2 bempedoic acid / ezetimibe combination tablet study (1002-058). |
| 2019-05-05 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review esperion.com ↗
Esperion (Nasdaq: ESPR) announced today that the U.S. Food and Drug Administration (FDA) has accepted both New Drug Applications for bempedoic acid and the bempedoic acid / ezetimibe combination tablet for filing and regulatory review. |
| 2019-04-01 | Esperion Therapeutics, Inc. | Results Esperion Announces Publication in The Journal of the American Heart Association of Bempedoic Acid Study 3 Results esperion.com ↗
Esperion (NASDAQ:ESPR) announced today that results from the 345 patient, 24-week, Phase 3, double-blind, placebo-controlled study of bempedoic acid (CLEAR Serenity, also known as Study 3) were published today in the Journal of the American Heart Association (JAHA) . |
| 2019-03-18 | Esperion Therapeutics, Inc. | Results Esperion Announces Late-Breaking Presentation of Final Results of Bempedoic Acid Pivotal Phase 3 Study 2 at the American College of Cardiology 2019 Scientific Sessions esperion.com ↗
Esperion (NASDAQ:ESPR) today announced the Phase 3 results from Study 2 (1002-047, also known as CLEAR Wisdom) of bempedoic acid were presented at the American College of Cardiology Scientific Sessions & Expo in New Orleans. |
| 2019-03-13 | Esperion Therapeutics, Inc. | Results Esperion Announces Publication of Bempedoic Acid Study 1 Results in The New England Journal of Medicine esperion.com ↗
Esperion (NASDAQ:ESPR) announced that results from the 2,230 patient, 52-week, Phase 3 long-term safety study of bempedoic acid (CLEAR Harmony, also known as Study 1 or 1002-040) were published today in The New England Journal of Medicine (NEJM) . |
| 2019-02-28 | Esperion Therapeutics, Inc. | Regulatory Esperion Announces Submissions of Two NDAs and Official Completion of Two MAA Validations for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet esperion.com ↗
Esperion also announced that the European Medicines Agency (EMA) has completed formal validation of Esperion’s two Marketing Authorization Applications (MAAs) and officially started the review procedure for both bempedoic acid and the bempedoic acid / ezetimibe combination tablet. |
| 2018-11-10 | Esperion Therapeutics, Inc. | Results Esperion Announces Late-Breaking Oral Presentation of Final Study 3 Results (1002-046) of Bempedoic Acid at the American Heart Association Scientific Sessions 2018 esperion.com ↗
ANN ARBOR, Mich., Nov. 10, 2018 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR), today announced that the final Phase 3 results from Study 3 (1002-046, also known as CLEAR Serenity) were presented at the American Heart Association (AHA) Scientific Sessions in Chicago. |
| 2018-10-28 | Esperion Therapeutics, Inc. | Results Esperion Announces Positive Top-Line Results from Final Pivotal Phase 3 Study of Bempedoic Acid esperion.com ↗
Esperion (NASDAQ: ESPR) today announced positive top-line results from its global, pivotal Phase 3 clinical study (Study 2 or 1002-047). |
| 2018-10-28 | Esperion Therapeutics, Inc. | Results Esperion Announces Completion of Phase 3 LDL-C Lowering Development Program of Bempedoic Acid and Positive Cumulative Results esperion.com ↗
Esperion (NASDAQ: ESPR) today announced completion of the Phase 3 LDL-C Lowering Development Program of bempedoic acid and positive cumulative results. |
| 2018-08-27 | Esperion Therapeutics, Inc. | Results Esperion Announces Positive Top-Line Results from Pivotal Phase 3 Bempedoic Acid / Ezetimibe Combination Pill Study esperion.com ↗
Esperion (NASDAQ: ESPR) today announced positive top-line results from the pivotal Phase 3 bempedoic acid / ezetimibe combination pill study (1002-053). |
| 2018-08-25 | Esperion Therapeutics, Inc. | Results Esperion Announces Late-Breaking Oral Presentation of Final Results of Phase 3 Long-Term Safety Study of Bempedoic Acid at the European Society of Cardiology Congress esperion.com ↗ |
All press releases naming this drug 108 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 108 releases opens the full record — a long page | ||
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 52 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 ↗33“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)” NCT05683340 ↗ “180mg of ETC-1002(bempedoic acid)” NCT05687071 ↗ |
| 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 |