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Venetoclax · Venclexta, ABT-199

Small molecule · Inhibitor of BCL-2 · developed by Abbvie

Approved FDA, Apr 2016

ABBV Developer

1 Registered trials

What is Venetoclax?

Venetoclax is a selective oral BCL-2 inhibitor that binds directly to BCL-2, displacing pro-apoptotic proteins and triggering mitochondrial outer membrane permeabilization and caspase activation. It restores apoptosis in tumor cells that overexpress BCL-2.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Venclexta, ABT-199, GDC-0199
Drug type: Small molecule
Targets: BCL-2
Mechanism: Inhibitor of BCL-2
Pathways: apoptosis, mitochondrial outer membrane permeabilization
Therapy area: Oncology
Developer: Abbvie (ABBV)
FDA status: Approved as Venclexta (April 11, 2016), NDA208573 · FDA label
UNII: N54AIC43PW

✅ FDA-approved uses

Chronic lymphocytic leukemia
Small lymphocytic lymphoma
Acute myeloid leukemia

From the indications section of the FDA label (version of May 20, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07581002	Phase 2/3	Acute Myeloid Leukemia	Recruiting	ABBV

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Acute Myeloid Leukemia

Other drugs acting on BCL2

Lisaftoclax Phase 3 Pelcitoclax Phase 1/2

More from Abbvie

Adalimumab FDA approved Atogepant FDA approved Pivekimab Sunirine FDA approved Risankizumab FDA approved Telisotuzumab Vedotin FDA approved Upadacitinib FDA approved ABBV-1042 Phase 1 ABBV-291 Phase 1 ABBV-295 Phase 2 ABBV-313 Phase 1 ABBV-324 Phase 1 ABBV-438 Phase 1

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the ABBV page.

Follow ABBV, the company behind Venetoclax

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z