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Treats chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Sold as Venclexta. Every FDA application for this active ingredient: 1 branded and 2 generic.
As of Nov 15, 2026, FDA lists 3 applications for Venetoclax (sold as Venclexta), first approved Apr 11, 2016, with 11 new uses approved and 0 published complete response letters.
First approved: Apr 11, 2016
Applications: 3
New uses approved: 11
Complete response letters: 0
Medicare spending, 2025: $1.15B
First approved in the EU: Dec 4, 2016
First approved in Japan: Sep 20, 2019
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 41 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
VenclextaDrugs with a new indication and a new dosage for the treatment of chronic lymphocytic leukemia (including small lymphocytic lymphoma). · AbbVie GK · Nov 20, 2025
VenclextaDrugs with a new indication and a new dosage for the treatment of relapsed or refractory mantle cell lymphoma. · AbbVie GK · Mar 27, 2025
VenclextaDrugs with a new indication and a new dosage for the treatment of acute myeloid leukemia. · AbbVie GK · Mar 23, 2021
Venclexta, new ingredientDrugs with a new active ingredient indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. · AbbVie GK · Sep 20, 2019
Clinical Trials
537 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
Abbvie
Alembic