Venetoclax is a Small Molecule owned by AbbVie, and is involved in 219 clinical trials, of which 65 were completed, 134 are ongoing, and 20 are planned.

ABT-199 (GDC-0199/RG7601) is a BH3-mimetic drug, designed to block the function of the protein Bcl-2 which allowed leukemia cells to become long-lived. It is a small molecule that is designed to restore apoptosis, also known as programmed cell death, by blocking the function of pro-survival Bcl-2 family proteins. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance to treatment. The Bcl-2 protein is a suppressor of programmed cell death that homodimerizes with itself and forms heterodimers with a homologous protein Bax, a promoter of cell death. Thus, the Bcl-2 family of proteins acts as a critical life-death decision point within the common pathway of apoptosis.

The revenue for Venetoclax is expected to reach a total of $45.3bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Venetoclax NPV Report.

Venetoclax was originated by Abbott Laboratories, Walter and Eliza Hall Institute of Medical Research and Genentech USA and is currently owned by AbbVie.

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.

The company reported revenues of (US Dollars) US$56,197 million for the fiscal year ended December 2021 (FY2021), an increase of 22.7% over FY2020. In FY2021, the company’s operating margin was 31.9%, compared to an operating margin of 24.8% in FY2020. In FY2021, the company recorded a net margin of 20.5%, compared to a net margin of 10.1% in FY2020. The company reported revenues of US$14,812 million for the third quarter ended September 2022, an increase of 1.6% over the previous quarter.

Quick View – Venetoclax

Report Segments
  • Innovator (NME)
Drug Name
  • Venetoclax
Administration Pathway
  • Oral
Therapeutic Areas
  • Immunology
  • Metabolic Disorders
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

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

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.