Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Lowers the risk of major adverse cardiovascular events (cardiovascular death, myocardial…. Sold as Nexletol. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Bempedoic Acid (sold as Nexletol), first approved Feb 21, 2020, with 3 new uses approved and 0 published complete response letters.
First approved: Feb 21, 2020
Applications: 1
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $108M
First approved in the EU: Apr 1, 2020
First approved in Japan: Sep 19, 2025
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 67 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Nexletol, new ingredientA drug with a new active ingredient indicated for the treatment of hypercholesterolemia and familial hypercholesterolemia. · Otsuka Pharmaceutical Co., Ltd. · Sep 19, 2025
Clinical Trials
21 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
