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.
For hypercholesterolemia. Sold as Leqvio. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Inclisiran Sodium (sold as Leqvio), first approved Dec 22, 2021, with 3 new uses approved and 1 published complete response letter.
First approved: Dec 22, 2021
Applications: 1
New uses approved: 3
Complete response letters: 1
Medicare spending, 2025: $475M
Orphan exclusivity until: Feb 12, 2033
First approved in the EU: Dec 9, 2020
First approved in Japan: Sep 25, 2023
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 21 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Leqvio, new ingredientA drug with a new active ingredient indicated for the treatment of familial hypercholesterolemia and hypercholesterolemia (for use only in patients who met… · Novartis Pharma K.K. · Sep 25, 2023
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
Novartis