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: 11 Feb 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

Highest Development Phases

Marketed Chronic lymphocytic leukaemia
Registered Acute myeloid leukaemia
Phase III Mantle-cell lymphoma; Myelodysplastic syndromes
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
Phase I Haematological malignancies
No development reported B-cell lymphoma; Blastic plasmacytoid dendritic cell neoplasm; Cancer; Non-small cell lung cancer; Small cell lung cancer; Systemic lupus erythematosus

Most Recent Events

11 Feb 2025 Efficacy and adverse events data from phase III CRISTALLO trial in Chronic lymphocytic leukaemia presented at the 66th American Society of Hematology Annual Meeting and Exposition (ASH-Hem 2024)
28 Jan 2025 No recent reports of development identified for phase-I development in Acute-myeloid-leukaemia(Combination therapy, Second-line therapy or greater) in Australia (PO, Tablet)
28 Jan 2025 No recent reports of development identified for phase-I development in Acute-myeloid-leukaemia(Combination therapy, Second-line therapy or greater) in Spain (PO, Tablet)

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