Nexlizet (bempedoic acid/ezetimibe) / Esperion Therap, Otsuka, Daiichi Sankyo, NeoPharm, CSL Behring, HLS Therap - LARVOL DELTA

Contemporary non-statin therapies for dyslipidemia management: achieving current lipid targets. (PubMed, Front Med (Lausanne)) - "Third evidence indicates that non-statin therapies-including ezetimibe, bempedoic acid, PCSK9 inhibitors (evolocumab and alirocumab), and inclisiran-provide substantial LDL-C reductions and reduce cardiovascular events...Additionally, the fixed-dose combination of bempedoic acid and ezetimibe produces an approximately 36.2% reduction in LDL-C in high-risk patients...Furthermore, inflammation (measured by hsCRP) provides complementary prognostic information beyond LDL-C. This expert position paper proposes practical algorithms for a precision medicine approach in Latin America, matching treatment intensity to individual risk profiles for the primary and secondary prevention of atherosclerotic cardiovascular disease."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Inflammation • Metabolic Disorders • CRP

Comparison chart: Some non-statin lipid-lowering drugs. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Drugs for hypercholesterolemia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dyslipidemia • Metabolic Disorders

Rational Design and Efficacy Evaluation of a Novel Solid Dispersion-Based Bempedoic Acid-Ezetimibe Fixed-Dose Combination Tablet Versus Nexlizet®. (PubMed, Pharmaceutics) - "Furthermore, in vivo evaluation revealed that F30 significantly reduced serum total cholesterol (TC), triglycerides (TG), and low-density lipoprotein (LDL), with an increase in high-density lipoprotein (HDL), in an animal model. These findings confirm that the SD technique is an effective one-step approach to co-formulating both APIs, simplifying manufacturing processes and optimizing the batch size."

Journal • Dyslipidemia

Esperion announced that two new abstracts and three encore abstracts have been accepted for presentation at the European Atherosclerosis Society (EAS) Congress 2026 taking place on May 24-27, 2026, in Athens, Greece (The Manila Times) - "Results from our Phase 2 pediatric study demonstrate LDL C reductions in children with heterozygous familial hypercholesterolemia are consistent with those observed in adults, supporting the advancement of bempedoic acid into Phase 3 development for pediatric patients with HeFH and homozygous familial hypercholesterolemia...In collaboration with our partner, Daiichi Sankyo Europe, we are also presenting a new analysis from the CLEAR Outcomes trial that identifies patient characteristics associated with achieving robust LDL C reductions of 30% or greater, providing additional insight into how bempedoic acid can be optimally utilized in clinical practice."

P2 data • Heterozygous Familial Hypercholesterolemia

Fourth Quarter 2025 Key Accomplishments and Recent Highlights (GlobeNewswire) - "Esperion continues to expect its partner in Israel, Neopharm Israel, to receive regulatory approval to market NEXLETOL and NEXLIZET in the first half of 2026; CSL Seqirus, the Company’s partner in Australia and New Zealand, filed a marketing application in Australia for NEXLETOL and NEXLIZET in July 2025, and expects market approval in Q4 2026."

Approval • Filing • Cardiovascular • Heterozygous Familial Hypercholesterolemia

HLS Therapeutics, Esperion’s strategic partner in Canada, announced NILEMDO (bempedoic acid) is now available in Canada for the reduction of LDL-cholesterol in patients at risk of cardiovascular disease, with approval for NEXLIZET expected in 2026. (GlobeNewswire)

Canada approval • Launch Canada • Cardiovascular • Heterozygous Familial Hypercholesterolemia

Fourth Quarter and Full Year 2025 Financial Results (GlobeNewswire) - "Total revenue for the three months and full year ended December 31, 2025 was $168.4 million and $403.1 million, respectively, compared to $69.1 million and $332.3 million for the comparable periods in 2024, an increase of 144% and an increase of 21%, respectively; U.S. net product revenue for the three months and full year ended December 31, 2025 was $43.7 million and $159.6 million, respectively, compared to $31.6 million and $115.7 million, for the comparable periods in 2024, an increase of approximately 38% in both periods."

Sales • Cardiovascular • Heterozygous Familial Hypercholesterolemia

Advancing the U.S. Commercial Strategy (GlobeNewswire) - "Significantly strengthened access and reimbursement support for NEXLETOL and NEXLIZET, now exceeding 90% of commercial lives and 90% of Medicare beneficiaries covered, with all national commercial and Medicare payers covering all indications; Enabled the expansion of unique healthcare providers prescribing NEXLETOL and NEXLIZET from 36,311 to 44,991, a 24% increase in 2025 with strengthened reimbursement and award-winning marketing and educational initiatives."

Commercial • Cardiovascular • Heterozygous Familial Hypercholesterolemia

A real-world pharmacovigilance study of bempedoic acid plus ezetimibe fixed-dose combination based on the FDA FAERS database. (PubMed, Medicine (Baltimore)) - "Based on the FAERS database, this study provides the first comprehensive and systematic analysis of adverse drug events associated with BAPEFC. It newly identifies several adverse drug reactions not mentioned in the prescribing information, such as blood triglycerides increased, pancreatitis, and pancreatitis acute, thereby offering evidence for clinical monitoring and identification of potential risks associated with BAPEFC."

Adverse events • Journal • Real-world evidence • Dyslipidemia • Musculoskeletal Diseases • Musculoskeletal Pain • Pancreatitis • Rheumatology

Expanded indication for PCSK9 inhibitors. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular

LDL-C targets after administration of the combination of bempedoic acid and ezetimibe in patients with acute coronary syndrome: an observational study with simulation analysis. (ESC-WCC 2025) - "At hospital discharge, all patients were prescribed high-intensity statins (atorvastatin 80 mg in 54.8% and rosuvastatin 40 mg in 45.2%)...The simulation analysis showed that after the administration of a fixed-dose combination of bempedoic acid and ezetimibe, the mean LDL-C could be reduced to 41.8 (14.8) mg/dL, with 79.5% of patients reaching the lipid goal. Despite receiving high-intensity statins, a considerable proportion of patients did not reach the LDL-C goal recommended by current guidelines. The systematic and early use of the combination of bempedoic acid and ezetimibe could enable a greater number of patients, following an ACS, to achieve LDL-C targets at 6 weeks."

Clinical • Observational data • Acute Coronary Syndrome • Cardiovascular

Esperion Reports First Quarter 2025 Financial Results (GlobeNewswire) - "Q1 2025 Total Revenue of $65.0 Million, a Decrease of 53% Y/Y; Adjusting for One Time Milestone Received in Q1 2024, Total Revenue Grew 63% Y/Y; Q1 2025 U.S. Net Product Revenue Grew 41% Y/Y to $34.9 Million; Bempedoic Acid Earned Level 1a Recommendations in the 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients with Acute Coronary Syndromes; Esperion’s European partner Daiichi Sankyo Europe (DSE) continues to show strong revenue growth and market penetration for NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid and ezetimibe), providing increased royalty revenue and underscoring the significant market opportunity for Esperion’s bempedoic acid products worldwide."

Commercial • Dyslipidemia

Esperion Partners with HLS Therapeutics to Commercialize NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) in Canada (GlobeNewswire) - "Esperion Therapeutics...announced it has entered into a license and distribution agreement with HLS Therapeutics...for the exclusive rights to commercialize NEXLETOL and NEXLIZET in Canada. Under the terms of the agreement, Esperion will receive an upfront payment, near-term milestone and tiered royalties on product sales. Esperion will be responsible for supplying finished product to HLS Therapeutics at a profitable transfer price...Under the terms of the license and distribution agreement, Esperion will grant HLS Therapeutics exclusive commercialization rights to NEXLETOL and NEXLIZET in Canada. HLS Therapeutics will be responsible for commercialization, including reimbursement and marketing....Esperion will receive an upfront payment and be eligible for milestone payments of up to approximately $5 million along with tiered royalties on product sales."

Licensing / partnership • Cardiovascular

ARTCAP: Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: University of Louisville | N=200 ➔ 0 | Trial completion date: Jan 2029 ➔ Jan 2025 | Recruiting ➔ Withdrawn | Trial primary completion date: Jan 2029 ➔ Jan 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Myocardial Infarction

CSL Seqirus and Esperion Sign Licensing Agreement to commercialise Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe) in Australia and New Zealand (CSL Behring Press Release) - "CSL Seqirus and Esperion Therapeutics have today announced the signing of an exclusive license and distribution agreement to commercialize Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe) in Australia and New Zealand...Bempedoic acid inhibits adenosine triphosphate-citrate lyase, a factor in low-density lipoprotein cholestrol (LDL-C) synthesis in the liver. It works on a different pathway to current cholesterol lowering therapies....Under the terms of the agreement, Esperion will be responsible for product supply and CSL Seqirus will be responsible for commercialisation, including regulatory approval, reimbursement and marketing."

Licensing / partnership • Cardiovascular

Bempedoic Acid: A Review in Cardiovascular Risk Reduction in Statin-Intolerant Patients. (PubMed, Am J Cardiovasc Drugs) - "Oral bempedoic acid (NEXLETOL® in the USA; Nilemdo® in the EU) and the fixed dose combination (FDC) of bempedoic acid/ezetimibe (NEXLIZET® in the USA; Nustendi® in the EU) are approved to reduce cardiovascular (CV) risk in statin-intolerant patients who are at high risk for, or have, CV disease. Bempedoic acid was generally well tolerated and, unlike statins, was associated with a low incidence of musculoskeletal adverse events (AEs). In conclusion, bempedoic acid as a monotherapy or adjunctive to other lipid-lowering therapies expands the treatment options available for the pharmacological reduction of CV risk in statin-intolerant patients, supporting achievement of low-density lipoprotein cholesterol (LDL-C) targets required for CV risk reduction."

Journal • Review • Cardiovascular • Dyslipidemia • Musculoskeletal Diseases • Myocardial Infarction

Esperion Partners with Neopharm to Commercialize NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) in Israel (Esperion Therapeutics Press Release) - "Esperion Therapeutics...announced it has entered into a licensing agreement with Neopharm Israel for the exclusive rights to commercialize NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) in Israel. Under the terms of the agreement, Esperion will receive an upfront and near-term milestone payments and will be eligible to receive tiered royalties on sales of NEXLETOL/NEXLIZET in Israel."

Licensing / partnership • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

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 (GlobeNewswire) - "Esperion...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."

Canada filing • Cardiovascular • Dyslipidemia

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 Therapeutics Press Release) - "Esperion...announced the presentation of an analysis from the CLEAR Outcomes study focused on patients with Peripheral Artery Disease (PAD) who were unable or unwilling to take statin medications....Additionally, two exploratory analyses from the CLEAR Outcomes trial and a real-world analysis of bempedoic acid usage were presented at the conference....Bempedoic acid reduced MALE (e.g. worsening PAD symptoms leading to revascularization, chronic limb threatening ischemia, and acute limb ischemia events) by 36% compared to placebo....After 3 months 67% of patients on bempedoic acid and ezetimibe had LDL-C <100 mg/dL, a significant increase over the 30% at baseline, and by 12 months 55% had maintained LDL-C levels <100 mg/dL."

P3 data • Real-world evidence • Cardiovascular • Dyslipidemia

Esperion Reports Third Quarter 2024 Financial Results and Provides a Business Update (Esperion Therapeutics Press Release) - "'We also have a significant market opportunity in Japan where our partner, Otsuka Pharmaceutical, is advancing toward filing for regulatory approval of our bempedoic acid product by the end of 2024 with approval and pricing anticipated in 2025'....Updated utilization management criteria for over 165 million lives now aligned to our new labels across Commercial, Medicare and Medicaid payers....With key restrictions and access barriers reduced, including prior authorization in some cases, physicians can now prescribe NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) with increased confidence, positioning the products for higher sales growth in the upcoming quarters and beyond."

Commercial • Filing • Pricing • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

Esperion Announces a Featured Presentation in the Late Breaker/Featured Science Track and Three Poster Presentations Accepted for the 2024 American Heart Association (AHA) Scientific Sessions (GlobeNewswire) - "Esperion...announced that one featured presentation in the Late Breaker/Featured Science track and three poster presentations have been accepted for the AHA Scientific Sessions 2024 in Chicago, IL, November 16-18, 2024."

P3 data • Real-world • Cardiovascular • Dyslipidemia

Final Real-World Results from MILOS German Cohort Demonstrate Strong Increase in LDL-C Goal Achievement With Addition of Bempedoic Acid (Businesswire) - P=NA | N=5,000 | MILOS (NCT04579367) | Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | "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....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....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. 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."

Observational data • Real-world • Cardiovascular • Dyslipidemia • Heterozygous Familial Hypercholesterolemia

Esperion Secures Additional Commercial and Medicare Formulary Coverage for NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) (GlobeNewswire) - "Esperion today announced that NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) have achieved additional coverage on national and large regional formularies since the U.S. Food and Drug Administration’s (FDA) approval of the expanded indications, increasing total coverage to more than 136 million commercially insured lives (92% of all commercial lives) and 34 million Medicare lives (65% of all Medicare lives). Additionally, many payers have accelerated alignment of utilization management criteria since the FDA approval of the expanded indications to the new labels."

Reimbursement • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

Esperion Reports Second Quarter 2024 Financial Results and Provides a Business Update (GlobeNewswire) - "The Company expects this expanded payer coverage to drive further increases in physician confidence to prescribe NEXLETOL and NEXLIZET, ultimately leading to higher product sales in the upcoming quarters and beyond....Research and development expenses for the three and six months ended June 30, 2024, were $11.5 million and $24.9 million, compared to $22.1 million and $53.5 million for the comparable periods in 2023, a decrease of 48% and approximately 53%, respectively. The decrease is primarily related to the close-out of our CLEAR Outcomes study."

Commercial • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia