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: 28 Aug 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; Acute myeloid leukaemia; Chronic lymphocytic leukaemia; Multiple myeloma
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

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)
30 Jul 2025 AbbVie files sNDA for treatment of patients with Chronic lymphocytic leukemia in USA
24 Jul 2025 Discontinued - Phase-III for Myelodysplastic syndromes (Combination therapy, First-line therapy, Newly diagnosed) in Turkey, Spain, Puerto Rico, Netherlands, Japan, Czech Republic, Belgium, Italy, Australia, France, USA (PO)

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