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: 29 Oct 2025

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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 Chronic lymphocytic leukaemia
Registered Acute myeloid 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

08 Oct 2025 AbbVie completes a phase I trial (In volunteers) in USA (PO, Tablet) (NCT06742086)
28 Aug 2025 No recent reports of development identified for phase-I development in Haematological-malignancies(Combination therapy, Late-stage disease) in USA (PO, Tablet)
21 Aug 2025 AbbVie completes the phase III VIALE-C trial for Acute myeloid leukaemia (Combination therapy, First-line therapy) in Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Ireland, Japan, Mexico, the New Zealand, Norway, Puerto Rico, Russia, South Africa, South Korea, Spain, Taiwan, the USA and the United Kingdom (PO) (NCT03069352) (EudraCT2016-003900-30)

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