Statin intolerance occurs in up to 15-20% of treated patients. The combined use of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors with ezetimibe is commonly performed in these patients, and has been associated with an estimated LDL-C reduction of 65-70%. This drug combination may be insufficient to reach the LDL-C target in high- and very-high-risk patients with statin intolerance, also considering the goals recommended by the current international guidelines. Also, PCSK9 inhibitor dosage escalations frequently fail to achieve the target. Doubling the dosage of alirocumab from 75 mg to 150 mg, when administrated as monotherapy, determines a further reduction of only 3,6% of LDL-C serum level. The full dose of Evolocumab (420 mg every two weeks), was approved only in the setting of homozygous familiar hypercholesterolemia.
Bempedoic acid is an oral, once-daily prodrug, metabolized in the liver to an active inhibitor of ATP-citrate lyase, blocking cholesterol synthesis upstream of 3-hydroxy-3-methylglutaryl-coenzyme A reductase and thereby increasing hepatic expression of the LDL receptor and decreasing circulating LDL-C levels.
The CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Harmony trial demonstrated that bempedoic acid in addition to maximally tolerated statin therapy did not lead to a higher incidence of adverse events compared to placebo and significantly lowered LDL-C levels. In the CLEAR Serenity study, bempedoic acid showed a safe and effective profile compared with placebo in patients with statin intolerance. In the CLEAR Tranquility, it provided an oral therapeutic option complementary to ezetimibe in patients intolerant to high-dose statins who required additional LDL-C lowering.
The synergistic effect of bempedoic acid plus PCSK9 inhibitors has been investigated by one phase 2 trial (NCT03193047), which showed a statistical superiority of bempedoic acid plus evolocumab strategy versus placebo plus evolocumab in terms of percent change in LDL-C up to 2 months. To date, no randomized phase 3 clinical trial have evaluated the effect of bempedoic acid in association with anti-PCSK9 and ezetimibe in statin-intolerant patients not attaining the recommended LDL-C target.
The investigators hypothesized that the association of bempedoic acid with PCSK9 inhibitors and ezetimibe may be safe and effective in reducing LDL-C in statin-intolerant patients.

Start Date01 May 2024

Sponsor / Collaborator

University of Salerno

100 Clinical Results associated with Bempedoic acid

100 Translational Medicine associated with Bempedoic acid

100 Patents (Medical) associated with Bempedoic acid

351

Literatures (Medical) associated with Bempedoic acid

01 Oct 2024·INTERNATIONAL JOURNAL OF CARDIOLOGY

Safety evaluation of bempedoic acid: A pharmacovigilance analysis using FDA adverse event reporting system data

Article

Author: Wei, Qucheng ; Chen, Yuwen ; Zhang, Jin ; Li, Bing ; Huang, Anan

BACKGROUND:

Bempedoic acid exhibits promising potential in hyperlipidemia therapy and preventing cardiovascular events. However, investigations into its adverse drug reactions remain scant. This study seeks to utilize data mining techniques with the FDA Adverse Event Reporting System (FAERS) database to assess adverse drug events (ADEs) linked to bempedoic acid.

METHODS:

Based on the drug's market release timeline, we extracted data from the FAERS database covering the fourth quarter of 2020 through the fourth quarter of 2023 for disproportionality analysis.

RESULTS:

This study gathered a total of 5,797,543 adverse event case reports, of which 735 were linked to bempedoic acid. These reports covered 19 System Organ Classes (SOCs) and 22 Preferred Terms (PTs). Predominantly, the musculoskeletal and nervous systems were implicated in these adverse events. By conducting PT-level screening, various signals for ADEs were detected, including myalgia (ROR 30.33, PRR 28.51, IC 4.83, EBGM 28.47), arthralgia (n = 34, ROR 6.34, PRR 6.09, IC 2.61, EBGM 6.09), tendon disorders (ROR 99.57, PRR 98.75, IC 6.62, EBGM 98.28), and dizziness (ROR 3.18, PRR 3.13, IC 1.65, EBGM 3.13). Particularly noteworthy was the hypertensive crisis (ROR 28.63, PRR 28.51, IC 4.83, EBGM 28.47), which exhibited a robust signal strength, an observation previously unreported in clinical studies and drug labeling.

CONCLUSION:

While our results are largely consistent with the drug's specifications, several new adverse reaction signals, such as hypertensive crisis, have not been previously documented. Therefore, further investigations are necessary to assess these unlabeled adverse reactions, offering crucial support for the clinical utilization of bempedoic acid.

22 Sep 2024·Cureus Journal of Medical Science

A Comparative Analysis of Low-Density Lipoprotein Cholesterol (LDL-C)-Lowering Activities of Bempedoic Acid, Inclisiran, and PCSK9 Inhibitors: A Systematic Review

Review

Author: Eerike, Madhavi ; Rajendran, Yazhini ; Kondampati, Nikhila ; Nandhakumar, Madhumita ; Nagireddy, Uma Maheswari ; Konda, Venu Gopala R ; Chalissery, Leo F ; Mali, Kalpana

Newer drugs, such as bempedoic acid, inclisiran, alirocumab, and evolocumab have recently been introduced for dyslipidemia. This systematic review aims to perform a comparative analysis of these drugs' low-density lipoprotein cholesterol (LDL-C)-lowering activities. The PubMed database was utilized to search for randomized controlled trials. Articles were screened and selected based on specific inclusion and exclusion criteria. The primary outcome of this review is to compare the percentage reduction of LDL-C and apolipoprotein-B, along with the number of reported serious adverse events (SAEs) in trials specific to each drug. A total of 14 studies were included, four for bempedoic acid and alirocumab and three for evolocumab and inclisiran. The maximum percentage reduction in LDL-C and apolipoprotein-B from baseline to 12 weeks was observed with alirocumab, administered at 150 mg subcutaneously twice weekly for 12 weeks, achieving reductions of 72.4% and 57.9%, respectively. Lesser reductions were observed with bempedoic acid, administered at 180 mg once daily orally for 12 weeks. The highest number of SAEs were reported with bempedoic acid (216, 10%) and inclisiran (181, 11%; 175, 11%). This systematic review showed that alirocumab achieved the greatest reductions in LDL-C and apolipoprotein-B and a better safety profile. Newer LDL-C-lowering drugs show promise in improving lipid profiles, patient compliance, and safety. However, these findings are not conclusive, as other factors also influence treatment choice.

01 Sep 2024·CORONARY ARTERY DISEASE

Management of dyslipidemia in coronary artery disease: the present and the future

Review

Author: Theofilis, Panagiotis ; Dri, Eirini ; Iliakis, Panagiotis ; Tsioufis, Konstantinos ; Chrysohoou, Christina ; Tsioufis, Panagiotis ; Dimitriadis, Kyriakos ; Soulaidopoulos, Stergios ; Fragkoulis, Christos ; Pyrpyris, Nikolaos ; Sakalidis, Athanasios ; Tsiachris, Dimitrios

Coronary artery disease (CAD) remains a leading cause of global morbidity and mortality, necessitating continuous refinement in the management of dyslipidemia, one of its major risk factors, to mitigate cardiovascular risks. Previous studies have proven the critical role of immediate and robust low-density lipoprotein cholesterol (LDL-C) reduction in the aftermath of acute coronary syndrome (ACS). Emphasizing the evidence supporting this approach, we delve into the impact of early intervention on cardiovascular outcomes and propose optimal strategies for achieving rapid LDL-C lowering, while also providing the rationale for early proprotein convertase subtilisin/kexin 9 inhibitor use after an ACS. Given the importance of the residual lipidemic risk, we present an overview of emerging therapeutic avenues poised to reshape dyslipidemia management, such as bempedoic acid, lipoprotein(a) inhibition, ApoC3 modulation, and angiopoietin-like protein 3 targeting. This comprehensive review amalgamates current evidence with future prospects, offering a holistic perspective on the management of dyslipidemia in CAD. By exploring both the urgency for immediate post-ACS LDL-C reduction and the exciting advancements on the horizon, this article provides a roadmap for clinicians navigating the intricate landscape of lipid-lowering therapies in CAD.

News (Medical) associated with Bempedoic acid

27 Sep 2024

·www.businesswire.com

Final Real-World Results from MILOS German Cohort Demonstrate Strong Increase in LDL-C Goal Achievement With Addition of Bempedoic Acid

MUNICH--( BUSINESS WIRE )--For EU media only Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced final 2-year follow-up data from the German cohort of the multinational, European observational MILOS study. 1 The study evaluated the real-world use of bempedoic acid, marketed as NILEMDO ® ▼ and its FDC with ezetimibe, NUSTENDI ® ▼, in patients with primary hypercholesterolaemia or mixed dyslipidaemia. The results, presented in Hamburg, Germany at DGK Hertztage 2024, demonstrated the effectiveness and safety profile of bempedoic acid, both alone and in combination with other lipid-lowering therapies (LLTs) in clinical practice. 1 Raised LDL-C is a key modifiable contributor to risk of major cardiovascular events, with studies showing that every 1 mmol/L reduction in LDL-C is associated with a 22% reduction in major cardiovascular events after one year. 5,6 The German cohort of MILOS study comprising 973 patients from 125 sites in Germany, is one of the most comprehensive assessments of bempedoic acid in a real-world clinical setting to-date in Germany. 1 Patients were followed-up for two years, with LDL-C levels assessed at pre-treatment, one year (1Y) and two years (2Y). Overall, 638 of 973 patients (65.6%) completed 2Y follow up, with LDL-C values at pre-treatment, 1Y and 2Y available for 451 patients. In these 451 patients, a mean reduction of LDL-C levels from 3.1 mmol/L (121.4 mg/dL) at pre-treatment, to 2.0 mmol/L (77.2 mg/dL) was observed, representing an average relative reduction of 30.3% in the overall population. 1 Additionally, the percentage of patients reaching their LDL-C goals increased from 4.9% at pre-treatment to 35.3% at the 2Y follow-up – an approximately 7-fold increase. 1 The proportions of high-risk and very high-risk patients reaching LDL-C goals increased from 5.6% to 32.5%, and 3.6% to 35.2%, respectively. 1 Overall, more than 80% of patients received bempedoic acid in combination with other LLTs at pre-treatment and 2Y, including statins and ezetimibe. The safety profile of bempedoic acid in this real-world population was assessed at 1Y and 2Y and was consistent with that observed in the CLEAR clinical trial programme. 2,3,4 “By significantly lowering LDL-C levels toward guideline goals, we are taking a vital step in reducing the risk of cardiovascular events, which can have a profound impact on a person’s long-term health and quality of life,” said Professor Ioanna Gouni-Berthold, University of Cologne, Center for Endocrinology, Diabetes, and Preventive Medicine and Executive Board Member of the International Atherosclerosis Society . “Cardiovascular disease remains Europe’s leading cause of death, yet the majority of premature CV events are preventable,” 7,8 said Dr. Stefan Seyfried, Vice President Medical Affairs, Specialty Medicines, at Daiichi Sankyo Europe GmbH . “ The findings from this cohort reinforce the benefit provided by bempedoic acid for reducing LDL-C levels. Our long-term goal is to empower the medical community with real-world insights to improve CVD prevention and, ultimately, improve patient care.” -ENDS- About MILOS MILOS (NCT04579367) is an ongoing, multinational, European observational study in adult patients diagnosed with primary hypercholesterolaemia or mixed dyslipidaemia. The aim is to evaluate the real-world use of bempedoic acid and bempedoic plus ezetimibe FDC. Patients in the German cohort were recruited from 125 sites between January 2021 and January 2022 and were followed up for 2 years after baseline measurements. 1 Change in LDL-C levels and the proportion of patients achieving LDL-C goal were assessed in patients at pre-treatment, 1Y and 2Y visits. Analyses were stratified by investigator-assessed CV risk, based on the ESC/EAS dyslipidaemia guidelines. 1 Beyond Germany, MILOS has sites in Austria, Belgium, Italy, the Netherlands, Spain, Switzerland and the UK. 9 About Bempedoic Acid and its Fixed-Dose Combination with Ezetimibe Bempedoic acid (NILEMDO ® ) is a first-in-class, oral, once-daily treatment to lower cholesterol, and can be combined with other oral treatments to help lower cholesterol even further. 10 Bempedoic acid inhibits ATP citrate lyase (ACL), an enzyme which is involved in the production of cholesterol in the liver. 10 Bempedoic acid acts on the well-known cholesterol synthesis pathway, upstream of the statin target in the liver, which allows additional LDL-C lowering when added to statin or other LDL-C-lowering therapies. 11 Bempedoic acid is not activated in skeletal muscle. 10 Bempedoic acid is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet: 10 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 or, 10 alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. 10 Bempedoic acid is indicated in adults with established or at high risk for atherosclerotic CV disease to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: 10 in patients on a maximum tolerated dose of statin with or without ezetimibe or, 10 alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin in contraindicated. 10 The bempedoic acid / ezetimibe FDC (NUSTENDI ® ) combines two complementary ways of reducing cholesterol in a once-daily tablet. Bempedoic acid / ezetimibe FDC is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet: 12 in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe, 12 alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone, 12 in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin. 12 Bempedoic acid / ezetimibe FDC is indicated in adults with established or at high risk for atherosclerotic CV disease to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: 12 in patients on a maximum tolerated dose of statin and not adequately controlled with additional ezetimibe treatment or, 12 in patients who are either statin-intolerant, or for whom a statin in contraindicated, and not adequately controlled with ezetimibe treatment or, 12 in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets. 12 Daiichi Sankyo Europe has licensed exclusive commercialisation rights to bempedoic acid and its FDC with ezetimibe (marketed as NILEMDO ® and NUSTENDI ® ) in the European Economic Area, UK, Turkey and Switzerland from Esperion and is the full Marketing Authorisation Holder in these territories. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical need. For more information, please visit https://www.daiichi-sankyo.eu/ ▼ This medicinal product is subject to additional monitoring. References 1 DGK Hertztage 2024 Abstract. Real-world effectiveness and safety of bempedoic acid in Europe: final 2-year results from the MILOS German cohort. Gouni-Berthold, I et al. 2 Nissen SE, et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med . 2023;388:1353–64 3 Ray KK, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med . 2019; 380:1022–32 4 Ballantyne CM, et al . Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol . 2020; 27(6): 593–603 5 Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170 000 participants in 26 randomised trials. Lancet. 2010. 376(9753): 1670–1681 6 NHS England. Improving lipid management to reduce cardiovascular disease and save lives. Available at: https://www.england.nhs.uk/long-read/improving-lipid-management-to-reduce-cardiovascular-disease-and-save-lives/#:~:text=Raised%20LDL%20cholesterol%20is%20one,vascular%20events%20after%201%20year . Last accessed September 2024. 7 Eurostat. (2023) Causes of death statistics. Available at: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Causes_of_death_statistics#Major_causes_of_death_in_the_EU_in_2020 . Last accessed September 2024. 8 World Heart Federation. Prevention. Available at: https://world-heart-federation.org/what-we-do/prevention/#:~:text=An%20estimated%2080%25%20of%20cardiovascular,and%20“knowing%20your%20numbers ”. Last accessed September 2024 9 ClinicalTrials.gov. Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia (MILOS). Available at: https://clinicaltrials.gov/study/NCT04579367#contacts-and-locations . Last accessed September 2024. 10 European Medicines Agency. Nilemdo – Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf . Last accessed September 2024. 11 Pinkosky, S.L., et al . Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun . 2016. 7: 13457. 12 European Medicines Agency. Nustendi –Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nustendi-epar-product-information_en.pdf . Last accessed September 2024 HQ/BIL/09/24/0001

Drug ApprovalClinical ResultAHAClinical StudyLicense out/in

03 Sep 2024

·www.fiercepharma.com

Daiichi study finds gender inequality in European cardiovascular care

Daiichi Sankyo sells Esperion Therapeutics’ lipid-lowering drugs Nilemdo and Nustendi in Europe. Daiichi Sankyo has identified inequalities in cardiovascular disease treatment and outcomes, finding that women in Europe are less likely than men to receive lipid-lowering therapies and achieve LDL cholesterol goals.The findings come from a subanalysis of SANTORINI, an observational study Daiichi funded to shed light on the care of people with high and very high cardiovascular risk in Europe. Investigators looked at how physicians assess risk and approach lipid-lowering regimens as well as the extent to which their decisions would enable the attainment of lipid goals set by cardiology groups.Daiichi used the European Society of Cardiology Congress in London to share more data from the SANTORINI study. The subanalysis looked at 5,197 men and 2,013 women with similar mean ages, 65 years and 66 years, respectively. Daiichi said guideline recommendations for the men and women are similar.At baseline, physicians opted against prescribing a lipid-lowering therapy to 23.9% of women, compared to 20.7% of men. Most of the untreated women had received a lipid-lowering drug one year later, but the gap with men persisted. The proportion of women not on lipid-lowering therapy after one year was 3.9%. The figure for men was 2.7%. Women were less likely to achieve cholesterol targets. The proportion of patients reaching LDL-C goals improved from baseline to one-year follow-up in both cohorts but was greater in men, 22.9% and 33.3%, respectively, than in women. The figures for women were 16.9% and 24.6%.“This new sub-analysis of the SANTORINI study further suggests that in clinical practice, women as a group were being disproportionally undertreated and do not always reach recommended LDL-C level goals,” the University of Lausanne’s David Nanchen, M.D., said in a statement. “These findings underscore the need for more widespread attention to better manage the risk of cardiovascular disease in women.”Daiichi, which sells Esperion Therapeutics’ lipid-lowering drugs Nilemdo and Nustendi in Europe, said its commitment to addressing key unmet needs and barriers in cardiovascular care is reinforced after seeing the data. Nilemdo and Nustendi were approved to reduce the risk of adverse cardiovascular events in Europe in May. Daiichi named the drugs as growth drivers at its EU specialty unit in its first quarter.

Drug ApprovalAHA

28 Jun 2024

·www.biopharmadive.com

PTC faces another Duchenne drug rejection; Coherus sells Humira biosimilar

Today, a brief rundown of news from PTC Therapeutics, Esperion Therapeutics and Coherus Biosciences, as well as updates from Sanofi, Lantheus Holdings and Forbion that you may have missed.Drug regulators in Europe have, for a third time, recommended against renewing the approval of PTC TherapeuticsDuchenne muscular dystrophy medicine Translarna. The European Medicines Agency panel had been asked to re-evaluate PTCs application after the European Commission, in an unusual step, rejected its recommendation and suggested it consider data from patient registries and real-world use. That evidence still doesnt prove Translarna is effective, the panel said Friday. PTC will again seek another opinion, during which time Translarna will remain on the market in Europe. Ben FidlerEsperion Therapeutics said Friday it has sold rights to sales royalties in Europe for its cholesterol-lowering pill bempedoic acid to Omers Life Sciences for $305 million.Omers will own those royalties until its received 1.7-times its initial investment, after which Esperion will reclaim rights. Esperion will use some of the proceeds to pay off a loan from Oberland Capital, and is still eligible to receive up to $300 million in sales-based milestone payments under a licensing deal with Daiichi Sankyo. Jonathan GardnerCoherus BioSciences is selling rights to Yusimry, a biosimilar version of Humira, to Hong Kong King-Friend Industrial for $40 million in cash. The biosimilaris the second Coherus has divested this year as part of a plan to focus its business on branded cancer drugs. It won U.S. approval for its first, a cancer immunotherapy called Loqtorzi, in 2023. Jonathan GardnerSanofi is investing $40 million in Vigil Neuroscience, a biotech developing drugs for neurodegenerative diseases. The deal gives Sanofi an exclusive right of first negotiation to license from Vigil an experimental antibody aimed at the protein TREM2. Vigil has one such medicine in early-stage testing for Alzheimers disease treatment. The biotech, which went public in 2022but has lost much of its value since, said the deal will extend its cash runway into 2026. Gwendolyn WuLantheus Holdings, a developer of radiopharmaceutical drugs and diagnostics, paid $35 million to acquire rights to what it calls a radiotheranostic pair from Life Molecular Imaging. The pair consists of a lutetium-based treatment and a gallium-based diagnostic for prostate cancer, both aimed at the gastrin-releasing peptide receptor. Discovered at the Universities Bern and Basel, the pair was initially developed by Bayer and then licensed to Life Molecular. Lantheus plans to start a Phase 1/2a study of the radiopharmaceutical next year, with the gallium-based agent used as a companion diagnostic. Ned PagliaruloEuropean venture capital firm Forbion has hired former Dyne Therapeutics CEO Josh Brumm to help expand its presence in the U.S. Brumm will serve as a general partner and support Forbions current portfolio companies as well as source new opportunities in the U.S. and Europe, the firm said Thursday. Though Forbion is based in the Netherlands, about 30% of its investments are in the U.S. and Canada. Gwendolyn Wu '

License out/inDrug Approval

100 Deals associated with Bempedoic acid

External Link

KEGG	Wiki	ATC	Drug Bank
D10691	Bempedoic acid	C10AX15	DB11936

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cardiovascular Diseases	US	Esperion Therapeutics, Inc.	22 Mar 2024
Myocardial Infarction	US	Esperion Therapeutics, Inc.	22 Mar 2024
Primary Hyperlipidemia	US	Esperion Therapeutics, Inc.	22 Mar 2024
Dyslipidemias	EU	Daiichi Sankyo Europe GmbH	01 Apr 2020
Dyslipidemias	IS	Daiichi Sankyo Europe GmbH	01 Apr 2020
Dyslipidemias	LI	Daiichi Sankyo Europe GmbH	01 Apr 2020
Dyslipidemias	NO	Daiichi Sankyo Europe GmbH	01 Apr 2020
Primary hypercholesterolemia	EU	Daiichi Sankyo Europe GmbH	01 Apr 2020
Primary hypercholesterolemia	IS	Daiichi Sankyo Europe GmbH	01 Apr 2020
Primary hypercholesterolemia	LI	Daiichi Sankyo Europe GmbH	01 Apr 2020
Primary hypercholesterolemia	NO	Daiichi Sankyo Europe GmbH	01 Apr 2020
Atherosclerosis	US	Esperion Therapeutics, Inc.	21 Feb 2020
Heterozygous familial hypercholesterolemia	US	Esperion Therapeutics, Inc.	21 Feb 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyper LDL cholesterolaemia	Phase 3	JP	Otsuka Pharmaceutical Co., Ltd.	13 Feb 2023
Hyperlipidemias	Phase 3	US	Esperion Therapeutics, Inc.	23 Oct 2017
Hypercholesterolemia	Phase 3	US	Esperion Therapeutics, Inc.	21 Jan 2016
Hypercholesterolemia	Phase 3	CA	Esperion Therapeutics, Inc.	21 Jan 2016
Hypercholesterolemia	Phase 3	DE	Esperion Therapeutics, Inc.	21 Jan 2016
Hypercholesterolemia	Phase 3	NL	Esperion Therapeutics, Inc.	21 Jan 2016
Hypercholesterolemia	Phase 3	PL	Esperion Therapeutics, Inc.	21 Jan 2016
Hypercholesterolemia	Phase 3	GB	Esperion Therapeutics, Inc.	21 Jan 2016
Hypertension	Phase 2	US	Esperion Therapeutics, Inc.	16 Jun 2014
Diabetes Mellitus, Type 2	Phase 2	US	Esperion Therapeutics, Inc.	01 Apr 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05683340 (Company_Website) Manual	Phase 3	Hypercholesterolemia	96	Bempedoic acid 180 mg	yjzvxxrzyw(bptankosor) = zlkbyhwwoo ywtpoylcsw (rlfjackbpu ) Met	Positive	20 May 2024
				Placebo	yjzvxxrzyw(bptankosor) = dumlobqthx ywtpoylcsw (rlfjackbpu ) Met
NCT04784442 (CTgov)	Phase 2	Hypercholesterolemia	188	Placebo	dmbycsezxv(jyiystspzg) = wgrskzjrdl hbedgcavms (pgnzxkddzn, slgzcatpdt - eaqaetmwuz) View more	-	04 Mar 2024
NCT02993406 (CLEAR Outcomes, CTgov)	Phase 3	Cardiovascular Diseases	13,970	Bempedoic acid 180 mg tablet (Bempedoic Acid 180 mg)	fbpewhbyvc(ugroenechl) = gbyytvhjpg cgobynegzm (kapjsoknpa, xfqrzdlmoc - zeafumzqiq) View more	-	03 Jan 2024
				Matching placebo tablet (Placebo Comparator)	fbpewhbyvc(ugroenechl) = njgmekkpkc cgobynegzm (kapjsoknpa, qkrvzirsnw - txwpkacsqh) View more
MILOS (ESC2023)	Not Applicable	-	992	Bempedoic acid	txajcogrnl(kskcndyyig) = fixtldfytc ujcepbnnfh (sspqqgeasa, (84.1)) View more	-	26 Aug 2023
				Bempedoic acid + ezetimibe	txajcogrnl(kskcndyyig) = mjgfbzxlmw ujcepbnnfh (sspqqgeasa, (123.6)) View more
NCT02993406 (Pubmed)	Phase 3	-	4,206	Bempedoic Acid	uwvjhxirkt(ppfycyuaqb): HR = 0.61 (95% CI, 0.39 - 0.98) View more	Positive	24 Jun 2023
				Placebo
NCT02178098 (CTgov)	Phase 2	Hypertension \| Hypercholesterolemia	143	Placebo	xnqxmtmbte(mwccrvynus) = hvhcyocutv izyfwazahd (ysqwlyfsjh, mbrksepeqy - gwruoxdiyr) View more	-	04 Apr 2023
NCT02993406 (CLEAR Outcomes, Pubmed)	Phase 3	-	14,014	Bempedoic acid	gsjudmoque(hptqiwzstz) = 2.2% vs. 1.2% bfpeawmuyp (yeyqqqufcn ) View more	Positive	04 Mar 2023
				Placebo
NCT02666664 (CLEAR Harmony, Pubmed)	Phase 3	Inflammation	817	Bempedoic acid 180 mg	dgdhqjrskq(wxwmfchetb) = tqabfkmssj gbqnikqljr (zhbmyonvbb, -10.1 to -6.6) View more	-	14 Feb 2023
NCT02993406 (CLEAR Outcomes, BusinessWire) Manual	Phase 3	-	14,014	Bempedoic acid	belstpuwmk(anxoyytdks) = significant relative risk reduction in major adverse CV events (MACE-4) in patients treated with 180 mg/day bempedoic acid compared to placebo (with no or very low statin background qnvswgzqzx (bzyrwglfke )	Positive	08 Dec 2022
				Placebo
ESC2022	Not Applicable	Cardiovascular Diseases	-	Bempedoic acid	ssxsikilko(umxxzhwlem) = tgbndyqiyb tqmrwdbgil (hmqofzfkaq )	-	27 Aug 2022

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