Drug Profile

Venetoclax - AbbVie/Genentech

Alternative Names: A-1195425.0; ABT 0199; ABT 199; GDC-0199; RG-7601; RO-5537382; Venclexta; VENCLYXTO; Venclyxto

Latest Information Update: 18 Jun 2026

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At a glance

Originator Abbott Laboratories; Genentech; Walter and Eliza Hall Institute of Medical Research
Developer AbbVie; Celgene Corporation; Dana-Farber Cancer Institute; Emory University; Genentech; Janssen Research & Development; M. D. Anderson Cancer Center; Merck & Co; Nantes University Hospital; National Cancer Institute (USA); Nordic Lymphoma Group; Pharmacyclics; Roche; Syros Pharmaceuticals; University Health Network
Class Antineoplastics; Benzamides; Heterocyclic bicyclo compounds; Piperazines; Pyrans; Pyridines; Pyrroles; Small molecules; Sulfonamides
Mechanism of Action Apoptosis stimulants; Proto-oncogene protein c-bcl-2 inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Diffuse large B cell lymphoma; Multiple myeloma; Acute myeloid leukaemia; Chronic lymphocytic leukaemia
New Molecular Entity Yes

Marketed Acute myeloid leukaemia; Chronic lymphocytic leukaemia
Phase III Mantle-cell lymphoma
Phase II Breast cancer; Diffuse large B cell lymphoma; Follicular lymphoma; Marginal zone B-cell lymphoma; Multiple myeloma; Non-Hodgkin's lymphoma; T-cell prolymphocytic leukaemia; Waldenstrom's macroglobulinaemia
Phase I/II Chronic myelomonocytic leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma; Prostate cancer
No development reported B-cell lymphoma; Blastic plasmacytoid dendritic cell neoplasm; Cancer; Haematological malignancies; Myelodysplastic syndromes; Non-small cell lung cancer; Small cell lung cancer; Systemic lupus erythematosus

12 Jun 2026 Efficacy and adverse events data from phase III CLL14 trial in Chronic lymphocytic leukaemia (First-line therapy, Combination therapy) released by AbbVie
29 May 2026 EC approves Venetoclax for treatment of Chronic lymphocytic leukemia (First line therapy, Combination therapy) in European Union, Iceland, Norway and Liechtenstein
20 Feb 2026 AbbVie completes a phase III trial in Acute myeloid leukaemia (Combination therapy, Second-line therapy or greater) in Poland, Portugal, USA, Australia, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Puerto Rico, Russia, South Korea, Spain, Taiwan, Turkey, the United Kingdom (PO) (NCT04102020)

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