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
NEXLETOL, bempedoic, ESP-2001, and NEXLETOL. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
NEXLETOL FDA Regulatory Timeline and Events
NEXLETOL is a drug developed by Esperion Therapeutics for the following indication: treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease.
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
- Announced Date:
- March 30, 2026
- Indication:
- treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
Announcement
Esperion announced the presentation of two post-hoc analyses from CLEAR Outcomes focused on risk of ischemic stroke and risk of major adverse cardiovascular events (MACE) in patients with autoimmune or inflammatory diseases.
AI Summary
Esperion announced it presented two post-hoc analyses from the CLEAR Outcomes trial at ACC.26. One analysis, presented by Carolina Pires Zingano, MD, looked at stroke in statin-intolerant patients. In the trial there were 293 fatal or non-fatal strokes, 268 (90%) of which were ischemic. Bempedoic acid lowered the risk of ischemic stroke by 22% versus placebo in this analysis.
The second analysis evaluated major adverse cardiovascular events (MACE) in patients with autoimmune or inflammatory diseases (AIID). Results showed bempedoic acid reduced MACE in high‑risk patients with AIID to a degree similar to patients without AIID. Together, these post‑hoc findings suggest bempedoic acid may lower risk of ischemic stroke and provide cardiovascular benefit for people with inflammatory or autoimmune conditions, including those who are statin‑intolerant.Read Announcement
- Drug:
- NEXLETOL
- Announced Date:
- February 17, 2026
- Indication:
- treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
Announcement
Esperion announced that it has entered into a settlement agreement with Alkem Laboratories Ltd. (Alkem).
AI Summary
Esperion announced it has entered into a settlement agreement with Alkem Laboratories Ltd. (Alkem) to resolve Alkem’s patent challenge related to Esperion’s cholesterol-lowering medicines, NEXLETOL and NEXLIZET. The agreement settles the dispute between Esperion and Alkem, clearing that particular legal pathway and removing Alkem as an active patent challenger to those products.
However, patent litigation against other defendants (Aurobindo, MSN Pharmaceuticals, Renata, and Sandoz) is still ongoing. Esperion said there is no guarantee whether the remaining cases will allow a generic version of NEXLETOL and/or NEXLIZET to be marketed in the U.S. before April 19, 2040. In short, the deal with Alkem resolves one dispute but broader legal uncertainty about generic entry remains.
Read Announcement- Drug:
- NEXLETOL
- Announced Date:
- November 21, 2025
- Indication:
- treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
Announcement
Esperion announced that Otsuka Pharmaceutical Co., Ltd. (Otsuka), the Company's partner in Japan for the development and commercialization of NEXLETOL® (bempedoic acid) tablets, received National Health Insurance Price Listing and launched NEXLETOL for the treatment of hypercholesterolemia and familial hypercholesterolemia.
AI Summary
Esperion announced that its partner in Japan, Otsuka Pharmaceutical, received National Health Insurance price listing and launched NEXLETOL (bempedoic acid) tablets for the treatment of hypercholesterolemia and familial hypercholesterolemia in Japan.
Under their collaboration, Esperion will receive a near-term payment of $90 million tied to Otsuka’s product and pricing approvals. Esperion may also earn additional sales milestone payments and tiered royalties on net sales in Japan ranging from 15% to 30%.
Japan is the third-largest global market for cardiovascular prevention, so this launch offers significant growth opportunity for NEXLETOL. The transaction strengthens Esperion’s financial position, highlights the value of the Otsuka partnership, and expands patient access to an additional option for lowering LDL-C and reducing cardiovascular risk in Japan.
Read Announcement- Drug:
- NEXLETOL
- Announced Date:
- November 10, 2025
- Indication:
- treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
Announcement
Esperion announced the presentation of two post hoc analyses from CLEAR Outcomes focused on: 1) risk of major adverse cardiovascular event in ~8200 patients receiving no background lipid lowering therapies (LLT) and 2) risk of venous thromboembolism (VTE) with bempedoic acid compared to placebo.
Read Announcement- Drug:
- NEXLETOL
- Announced Date:
- October 3, 2025
- Indication:
- treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
Announcement
Esperion announced that it has entered into a settlement agreement with Dr. Reddy's Laboratories, Inc. and its affiliate Dr. Reddy's Laboratories Ltd. (together, Dr. Reddy's Laboratories).
AI Summary
Esperion today announced it reached a settlement with Dr. Reddy’s Laboratories and its affiliate to end patent litigation over Dr. Reddy’s Abbreviated New Drug Application for generic versions of NEXLETOL and NEXLIZET.
Under the agreement, Dr. Reddy’s agreed not to market generic NEXLETOL or NEXLIZET in the United States before April 19, 2040, except in limited situations usually allowed in such deals.
The dispute concerned U.S. Patent No. 7,335,799 for bempedoic acid, which expires in December 2030. With this settlement, there are no pending challenges to that patent’s validity or infringement.
Other Esperion patents tied to NEXLETOL and NEXLIZET expire in March 2036 and June 2040. Litigation with other generic makers is still ongoing, and it’s unclear if or when they may enter the market early.
This settlement gives Esperion more certainty about its product timetable and market exclusivity as it continues to defend its patents against other challengers.
Read Announcement
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:
- November 18, 2025
- Indication:
- For the Treatment for Hypercholesterolemia
Announcement
Esperion has received approval from Health Canada to market NILEMDO for the reduction of LDL-Cholesterol in Canadians at risk of cardiovascular disease.
AI Summary
Esperion announced that its Canadian partner, HLS Therapeutics, has received Health Canada approval to market NILEMDO (bempedoic acid) to reduce LDL‑cholesterol in Canadians at risk of cardiovascular disease. The company expects a commercial launch in Q2 2026. The approval allows HLS to begin promoting NILEMDO as an oral treatment option for patients who need additional LDL‑C lowering beyond current therapies.
NILEMDO is an oral medicine taken once daily that targets elevated low‑density lipoprotein cholesterol (LDL‑C), a major risk factor for heart disease. Esperion and HLS aim to make the drug available to patients who remain at risk despite other treatments, offering another tool for doctors to manage cholesterol and reduce cardiovascular events.
Heart disease affects about 1 in 12 Canadian adults (roughly 2.6 million people) and is the second leading cause of death in Canada. Esperion says this approval is a key step in expanding access to bempedoic acid products for patients in need.
Read Announcement- 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
ESP-2001 FDA Regulatory Events
ESP-2001 is a drug developed by Esperion Therapeutics for the following indication: Treatment of Primary Sclerosing Cholangitis.
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:
- ESP-2001
- Announced Date:
- October 16, 2025
- Indication:
- Treatment of Primary Sclerosing Cholangitis
Announcement
Esperion announced the nomination of ESP-2001, the Company's highly-specific allosteric ATP citrate lyase (ACLY) inhibitor, as preclinical development candidate for the treatment of primary sclerosing cholangitis (PSC).
AI Summary
Esperion announced the nomination of ESP-2001, a highly-specific allosteric ATP citrate lyase (ACLY) inhibitor, as a preclinical development candidate for primary sclerosing cholangitis (PSC). Designed to target liver and bile duct injury, inflammation, and fibrosis, ESP-2001 addresses a rare disease with no approved treatments. With its selection, Esperion will begin IND-enabling studies and aims to file an IND with the FDA to launch first-in-human trials in 2026.
In multiple preclinical models, ESP-2001 consistently reduced markers of liver damage, duct inflammation, and fibrosis. Esperion discovered the compound using advanced high-throughput and structure-based screening, then optimized it through a partnership with Evotec. Esperion retains exclusive global rights and views ESP-2001 as a potential blockbuster with over $1 billion in annual market opportunity. It may also qualify for Orphan Drug, Fast Track, and PRIME designations, highlighting its promise for patients with PSC.
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
