Venetoclax is under clinical development by AbbVie and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Venetoclax’s likelihood of approval (LoA) and phase transition for Follicular Lymphoma took place on 15 Aug 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Venetoclax Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Venetoclax overview

Venetoclax (ABT-199, GDC-0199/RG7601, Venclexta, Venclyxto) acts as an antineoplastic agent. It is formulated as film coated tablets and coated tablets for oral route of administration. Venclexta is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venclyxto monotherapy is indicated for the treatment of CLL in the absence of 17p deletion or TP53mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor, and Venclyxto in combination with rituximab is indicated for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy. It is used as monotherapy in adults for the treatment of chronic lymphocytic leukemia (CLL), a 1 7p – deletion or TP53 having mutation and under a treatment with an inhibitor of the B – showed a treatment failure cell receptor signaling pathway, and also indicated in combination with azacitidine, ordecitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy and indicated for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Venclexta is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta is indicated for the treatment of acute myeloid leukemia (AML).  It is under development for the treatment of newly diagnosed Ph-like B cell acute lymphoblastic leukemia, relapsed or refractory light chain amyloidosis, relapsed and refractory mantle cell lymphoma, small cell lung cancer, acute myeloid leukemia, follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), newly diagnosed marginal zone lymphoma, acute myeloid leukemia in first remission after conventional chemotherapy, nom-small cell lung cancer as first line therapy, primary mediastinal B-cell lymphoma, T-cell rich B-cell lymphoma and extranodal MALT lymphoma, multiple myeloma, diffuse large B-cell lymphoma, frontline, relapsed or refractory myelodysplastic syndrome, multiple myeloma, DLBCL, metastatic breast cancer, t-cell acute lymphocytic leukemia  and relapsed and refractory chronic lymphocytic leukemia (CLL), solid tumors, rhabdomyosarcoma, Ewing sarcoma, Wilms' tumor (nephroblastoma). It was also under development for follicular lymphoma as first line therapy. It is a new molecular entity (NME). It was under development for non-small cell lung cancer and angioimmunoblastic T-cell lymphoma (AITL). It was also under development for the treatment of human epidermal growth factor receptor 2 negative breast cancer (her2- breast cancer).

AbbVie overview

AbbVie is a specialty biopharmaceutical company, which discovers, develops, manufactures, and commercializes drugs for the treatment of chronic and complex diseases. Its drugs are indicated for the treatment of metabolic diseases, rheumatological diseases, neurological disorders, viral diseases, skin diseases, complications associated with cystic fibrosis, pain related to endometriosis, diseases of the gastrointestinal tract, various types of cancer, and other serious health conditions. AbbVie is also advancing its pipeline programs for the treatment of cystic fibrosis, women’s health, various cancers, neurological disorders and other autoimmune diseases. The company markets its products directly to wholesalers, distributors, health care facilities, government agencies, specialty pharmacies and independent retailers through its own distribution centers and public warehouses worldwide. AbbVie is headquartered in North Chicago, Illinois, the US.

Quick View Venetoclax LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Venetoclax
Administration Pathway
  • Oral
Therapeutic Areas
  • Immunology
  • Metabolic Disorders
  • Oncology
Key Developers
  • Sponsor Company: AbbVie
  • Originator: Abbott Laboratories, Walter and Eliza Hall Institute of Medical Research and Genentech USA
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.