This section highlights FDA-related milestones and regulatory updates for drugs developed by Esperion Therapeutics (ESPR).
Over the past two years, Esperion Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
bempedoic and NEXLETOL. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
bempedoic acid - FDA Regulatory Timeline and Events
bempedoic acid is a drug developed by Esperion Therapeutics for the following indication: For the Treatment for Hypercholesterolemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- bempedoic acid
- Announced Date:
- March 20, 2025
- Indication:
- For the Treatment for Hypercholesterolemia
Announcement
Esperion announced that following meetings with the U.S. Food and Drug Administration (FDA), it has gained alignment on a regulatory path forward for initiating Phase 3 studies of bempedoic acid alone and in combination with ezetimibe in pediatric patients with heterozygous and homozygous familial hypercholesterolemia (HeFH and HoFH, respectively). Based on these discussions with the FDA, the Company plans to initiate Phase 3 clinical studies this year.
AI Summary
Esperion announced that, following recent meetings with the FDA, the company has reached an agreement on a regulatory path for starting Phase 3 clinical studies. These studies will evaluate both bempedoic acid alone and in combination with ezetimibe for pediatric patients suffering from heterozygous (HeFH) and homozygous familial hypercholesterolemia (HoFH). The decision to move forward is based on data discussions with the FDA, which confirmed that there is sufficient evidence to support these advanced trials. Esperion plans to begin these Phase 3 studies later this year, marking an important milestone in expanding treatment options for children with FH. This step not only reinforces the company’s commitment to improving therapies for rare and underdiagnosed genetic cholesterol disorders, but it also aligns with their longer-term lifecycle management strategy for ongoing patent protection.
Read Announcement- Drug:
- bempedoic acid
- Announced Date:
- November 26, 2024
- Indication:
- For the Treatment for Hypercholesterolemia
Announcement
Esperion announced that 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.
AI Summary
Otsuka Pharmaceutical Co., Ltd. has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare for the manufacture and sale of bempedoic acid. This medicine is intended for treating hypercholesterolemia and familial hypercholesterolemia. Bempedoic acid works by targeting ATP citrate lyase, an enzyme involved in cholesterol synthesis in the liver, offering a novel approach compared to traditional treatments.
Otsuka, which acquired exclusive rights to develop and commercialize the drug in Japan from Esperion in 2020, is moving forward after promising results from a Phase 3 trial. The trial demonstrated that patients experienced a significant reduction in LDL cholesterol levels when treated with bempedoic acid, highlighting its potential as a new treatment option. This submission marks a key step toward providing an alternative for patients who have a poor response to statins or cannot tolerate them.
Read Announcement- Drug:
- bempedoic acid
- Announced Date:
- May 20, 2024
- Indication:
- For the Treatment for Hypercholesterolemia
Announcement
Esperion and Otsuka Pharmaceutical Co., Ltd (Otsuka) announced that the primary endpoint was achieved in the Phase 3 trial in Japan for bempedoic acid as a potential treatment for patients with hypercholesterolemia.
AI Summary
Esperion and Otsuka Pharmaceutical Co., Ltd recently announced that the primary endpoint was met in a Phase 3 clinical trial in Japan for bempedoic acid, a promising new treatment for hypercholesterolemia. The trial involved 96 patients with high LDL cholesterol levels who were either unable to tolerate or did not respond well to statin therapy. Participants received either a daily oral dose of 180 mg bempedoic acid or a placebo over 12 weeks. The results demonstrated a statistically significant reduction in LDL cholesterol in the bempedoic acid group compared to the placebo group. The drug works by inhibiting ATP citrate lyase, an enzyme involved in the liver’s cholesterol synthesis pathway. These positive outcomes underline the potential benefits of bempedoic acid for patients in Japan, and Otsuka plans to submit a New Drug Application later this year based on these encouraging findings.
Read Announcement
NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin - FDA Regulatory Timeline and Events
NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin is a drug developed by Esperion Therapeutics for the following indication: Hypercholesterolemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin
- Announced Date:
- May 8, 2025
- Indication:
- Hypercholesterolemia
Announcement
HLS Therapeutics partners with Esperion Therapeutics to commercialize NEXLETOL® and NEXLIZET® in Canada
AI Summary
Esperion Therapeutics has partnered with HLS Therapeutics to bring its approved therapies, NEXLETOL® and NEXLIZET®, to the Canadian market. Under the agreement, HLS Therapeutics obtains exclusive commercialization rights to these cardiovascular treatments in Canada. Esperion will receive an upfront payment, near-term milestone payments, and tiered royalties based on product sales, while supplying finished products at a profitable transfer price.
This collaboration aims to improve access to innovative, preventative treatments for the approximately 2.6 million Canadians living with diagnosed heart disease. Both companies are enthusiastic about the opportunity: Esperion is excited to extend its global reach and offer life-saving therapies, and HLS Therapeutics is committed to utilizing its expertise in product commercialization, reimbursement, and marketing to support cardiovascular health in Canada.
Read Announcement- Drug:
- NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin
- Announced Date:
- March 3, 2025
- Indication:
- Hypercholesterolemia
Announcement
Esperion Therapeutics announced it has entered into a license and distribution agreement with CSL Seqirus (ASX:CSL) for the exclusive rights to commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Australia and New Zealand.
AI Summary
Esperion Therapeutics has entered into a license and distribution agreement with CSL Seqirus to secure the exclusive rights to commercialize NEXLETOL (bempedoic acid) and NEXLIZET (a combination of bempedoic acid and ezetimibe) in Australia and New Zealand. Under the agreement, Esperion will benefit from an upfront payment along with near-term milestone payments and will supply the finished products to CSL Seqirus at a profitable transfer price.
CSL Seqirus will be responsible for the regulatory approval, reimbursement, and marketing efforts for both medications in these regions. This strategic partnership aims to expand treatment options for patients with high LDL cholesterol and reduce the risk of cardiovascular disease. By broadening its market reach, Esperion continues to work towards alleviating the impact of cardiovascular issues in Australia and New Zealand.
Read Announcement- Drug:
- NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin
- Announced Date:
- December 12, 2024
- Indication:
- Hypercholesterolemia
Announcement
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.
AI Summary
Esperion Therapeutics announced a licensing agreement with Neopharm Israel to exclusively commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Israel, Gaza, and the West Bank. Under the agreement, Esperion will receive an upfront payment within 30 days of signing, plus additional near-term milestone payments following marketing approval and inclusion in the National Healthcare Reimbursement Basket. The company will also earn tiered royalties based on net sales of the products. Neopharm, boasting over 80 years of experience in successfully launching pharmaceutical products in Israel, is confident that these therapies will play a key role in reducing cardiovascular risk. This partnership aims to expand the global reach of Esperion’s innovative medicines, helping patients at risk of heart disease achieve their LDL-C goals and lower the risk of cardiovascular events.
Read Announcement- Drug:
- NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin
- Announced Date:
- December 2, 2024
- Indication:
- Hypercholesterolemia
Announcement
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.
AI Summary
Esperion Therapeutics announced that it has filed New Drug Submissions (NDSs) to Health Canada for its once-daily non-statin medications, NEXLETOL and NEXLIZET. These oral drugs are designed to lower low-density lipoprotein cholesterol (LDL-C) levels and help reduce cardiovascular risk, offering a new treatment option for patients who cannot take statins or need additional cholesterol management.
This filing represents a major milestone for the company as it works to bring innovative, lifesaving medicines to millions affected by heart disease—a leading cause of death worldwide. By seeking approval in Canada, Esperion aims to provide healthcare providers and patients with more options for effectively managing cholesterol and reducing the risk of heart-related illnesses.
Read Announcement - Drug:
- NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin
- Announced Date:
- November 18, 2024
- Indication:
- Hypercholesterolemia
Announcement
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.
AI Summary
Esperion announced an analysis from the CLEAR Outcomes study that focused on patients with Peripheral Artery Disease (PAD) who cannot or choose not to use statin medications. The study found that patients treated with bempedoic acid had a 36% lower risk of experiencing major adverse limb events compared to those taking a placebo. These events include worsening PAD symptoms, the need for revascularization, chronic limb-threatening ischemia, and acute limb ischemia. Researchers emphasized that lowering LDL cholesterol is key to reducing these limb risks, and patients with PAD may benefit from combination therapy. The findings suggest that bempedoic acid is a safe and well-tolerated oral option for statin-intolerant patients. This research was shared at the American Heart Association Scientific Sessions, supporting new treatment strategies and offering hope for improved patient outcomes in managing their cardiovascular risk.
Read Announcement- Drug:
- NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin
- Announced Date:
- May 22, 2024
- Indication:
- Hypercholesterolemia
Announcement
Daiichi Sankyo Europe GmbH and Esperion Therapeutics, Inc. jointly announced today that the European Commission (EC) has approved the label update of both NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events.
AI Summary
Daiichi Sankyo Europe GmbH and Esperion Therapeutics, Inc. announced that the European Commission has approved a label update for NILEMDO® (bempedoic acid) and NUSTENDI® (a fixed-dose combination of bempedoic acid and ezetimibe). The update confirms these medications as treatments for hypercholesterolemia and for reducing the risk of adverse cardiovascular events. This decision is based on positive results from the CLEAR Outcomes trial, making bempedoic acid the first and only therapy indicated for both primary and secondary cardiovascular event prevention by effectively lowering low-density lipoprotein cholesterol (LDL-C) levels.
The approval highlights the potential of these treatments to help patients who have high cholesterol levels, especially those who do not reach guideline-recommended LDL-C targets with existing therapies like statins. This milestone supports healthcare professionals across Europe in managing patients' cardiovascular risks more robustly.
Read Announcement- Drug:
- NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin
- Announced Date:
- May 14, 2024
- Indication:
- Hypercholesterolemia
Announcement
Esperion announced that the U.S. Patent and Trademark Office (USPTO) issued a U.S. Patent Term Extension (PTE) certificate for bempedoic acid, which is contained in NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets.
Read Announcement- Drug:
- NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin
- Announced Date:
- April 7, 2024
- Indication:
- Hypercholesterolemia
Announcement
Esperion 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.
AI Summary
Esperion announced at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24) that they presented results from three pre-specified subgroups in the CLEAR Outcomes trial. The analyses focused on women, Hispanic/Latinx patients, and patients with obesity. In the obesity subgroup, patients taking NEXLETOL were 23% less likely to suffer a major adverse cardiovascular event compared to placebo. The findings also showed that NEXLETOL provided clear clinical benefits for women and Hispanic/Latinx patients—groups that have been historically underrepresented in cardiovascular studies. Researchers noted improvements in LDL-cholesterol and inflammatory markers without worsening glucose or weight. These results underscore the importance of early and aggressive LDL-C lowering and support efforts to include diverse patient backgrounds in cardiovascular research, highlighting how tailored therapies can help reduce cardiovascular risks across various populations.
Read Announcement
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