Drug Profile


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

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Abbott Laboratories; Genentech; Walter and Eliza Hall Institute of Medical Research
  • Developer AbbVie; Dana-Farber Cancer Institute; Genentech; Janssen Research & Development; Nantes University Hospital; Pharmacyclics; Roche
  • 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 - Acute myeloid leukaemia; Diffuse large B cell lymphoma; Chronic lymphocytic leukaemia; Multiple myeloma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic lymphocytic leukaemia
  • Phase III Acute myeloid leukaemia; Mantle-cell lymphoma; Multiple myeloma
  • Phase II Diffuse large B cell lymphoma; Myelodysplastic syndromes; Non-Hodgkin's lymphoma; Waldenstrom's macroglobulinaemia
  • Phase I/II Follicular lymphoma
  • Phase I Breast cancer; Systemic lupus erythematosus

Most Recent Events

  • 24 Aug 2017 Roche initiates enrolment in a phase I trial in Diffuse large B-cell lymphoma (Refractory metastatic disease, Second-line therapy or greater, Combination therapy) in USA (NCT03255096)
  • 07 Aug 2017 AbbVie plans a phase I trial for Cancer (Refractory metastatic disease, In neonates, In infants, In children, In adolescents, In adults) in USA (NCT03236857)
  • 31 Jul 2017 Venetoclax receives Breakthrough Therapy status for Acute myeloid leukaemia (Combination therapy, First-line therapy, In the elderly, In adults) in USA
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