Therapy Areas: Cardiovascular
Esperion partner Otsuka secures Japanese approval to market NEXLETOL for the treatment of hypercholesterolemia
19 September 2025 -

US commercial stage biopharmaceutical company Esperion Therapeutics Inc (NASDAQ:ESPR) announced on Friday that its partner, Japanese pharmaceutical company Otsuka Pharmaceutical Co., Ltd. (TYO:4578), has received approval from the Japanese Ministry of Health, Labour and Welfare to market NEXLETOL (bempedoic acid) for the treatment of hypercholesterolemia and familial hypercholesterolemia.

Japan represents one of the three largest global markets for cardiovascular prevention, positioning NEXLETOL for substantial international growth. With this milestone, the therapy is now approved across the United States, Europe, and Japan, strengthening Esperion's global footprint in non-statin low density lipoprotein cholesterol (LDL-C) lowering treatments.

Esperion's President and CEO Sheldon Koenig stated that the approval reinforces the company's international growth strategy and expands patient access to alternatives for cholesterol management.

Under its collaboration with Otsuka, Esperion is eligible for milestone payments tied to regulatory approval and National Health Insurance Price Listing in Japan. The company may also receive additional sales-based milestones and tiered royalties ranging from 15% to 30% on net sales achieved by Otsuka in the Japanese market.

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