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.
Treats Alzheimer's disease. Sold as Kisunla. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Donanemab-Azbt (sold as Kisunla), first approved Jul 2, 2024, with 1 new use approved and 1 published complete response letter.
First approved: Jul 2, 2024
Applications: 1
New uses approved: 1
Complete response letters: 1
Medicare spending, 2025: $126M
First approved in the EU: Sep 24, 2025
First approved in Japan: Sep 24, 2024
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 3 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
KisunlaA drug with a new dosage indicated for slowing the progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease. · Eli Lilly Japan K.K. · Aug 25, 2025
Kisunla, new ingredientA drug with a new active ingredient indicated for slowing the progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease. · Eli Lilly Japan K.K. · Sep 24, 2024 · Review report
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Approved
Application
Sponsor
Supplements
Marketing
Jul 2, 2024
KisunlaBLA 761248 · New molecular entity, new combination
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