Product Description
Venetoclax is used alone or in combination with obinutuzumab (Gazyva) or rituximab (Rituxan) to treat certain types of chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) or certain types of small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes). It is also used in combination with either azacitidine (Vidaza), decitabine (Dacogen), or cytarabine as a first treatment for acute myeloid leukemia (AML; a type of cancer that begins in the white blood cells) in people 75 years of age or older, or in adults who have medical conditions that prevents them from being treated with other chemotherapy medications. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It works by blocking the action of a certain protein in the body that helps cancer cells survive. This helps to kill cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a616028.html)
Mechanisms of Action: BCL2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Breakthrough Therapy - Myelodysplastic Syndrome *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: None
Known Adverse Events: None
Company: AbbVie
Company Location: NORTH CHICAGO IL 60064
Company CEO: Richard A. Gonzalez
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
- Clinical Outcomes Reported - AbbVie presented P3 Myelodysplastic Syndrome results on 2025-12-06 for Venetoclax
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Myelodysplastic Syndrome results on 2025-06-16 for Venetoclax
- Clinical Outcomes Reported - Aptose Biosciences presented P1 Acute Myeloid Leukemia results on 2025-02-12 for Venetoclax
Highest Development Phases
Phase 3: Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|Leukemia|Lymphocytic Chronic B-Cell Leukemia|Lymphoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Mantle-Cell Lymphoma|Multiple Myeloma|Myelodysplastic Syndrome|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Preleukemia
Phase 2: Acquired Immunodeficiency Syndrome|Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Acute Respiratory Distress Syndrome|Allogeneic Stem Cell Transplant|Amyloidosis|B-Cell Leukemia|B-Cell Marginal Zone Lymphoma|Biphenotypic Acute Leukemia|Burkitt Lymphoma|Chronic Myelomonocytic Leukemia|Diffuse Large B-Cell Lymphoma|Follicular Lymphoma|HIV Infections|Juvenile Myelomonocytic Leukemia,|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Oncology Unspecified|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Sarcoma, Myeloid|T-Cell Leukemia|T-Cell Peripheral Lymphoma|Tic Disorders|Waldenstrom Macroglobulinemia
Phase 1: Healthy Volunteers|Leukemia, Plasma Cell|Myelofibrosis|Myeloproliferative Disorders|Neuroblastoma|T-Cell Lymphoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT02992522 |
OSU-16187 | P1 |
Active, not recruiting |
B-Cell Marginal Zone Lymphoma|Lymphoma, Non-Hodgkin|Burkitt Lymphoma|Follicular Lymphoma|Diffuse Large B-Cell Lymphoma |
2026-08-15 |
12% |
2025-09-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06177067 |
RAVAML | P1 |
Recruiting |
Biphenotypic Acute Leukemia|Acute Myeloid Leukemia |
2026-07-01 |
12% |
2025-11-04 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT03113643 |
BPDCN | P1 |
Recruiting |
Myelodysplastic Syndrome|Acute Myeloid Leukemia|Leukemia, Plasma Cell|Preleukemia |
2026-05-31 |
50% |
2025-06-21 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05455294 |
NCT05455294 | P1 |
Active, not recruiting |
Myeloproliferative Disorders|Acute Myeloid Leukemia|Myelofibrosis|Myelodysplastic Syndrome|Preleukemia |
2025-12-31 |
12% |
2025-01-30 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT05016947 |
NCT05016947 | P1 |
Recruiting |
Lymphoma, B-Cell|Precursor Cell Lymphoblastic Leukemia-Lymphoma|B-Cell Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia |
2025-12-23 |
50% |
2025-01-24 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT03844815 |
IRB18-1498 | P1 |
Active, not recruiting |
Acute Myeloid Leukemia |
2025-12-10 |
50% |
2025-10-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05665530 |
PRT2527-02 | P1 |
Active, not recruiting |
Acute Myeloid Leukemia|Chronic Myeloid Leukemia|Acute Lymphoid Leukemia|B-Cell Marginal Zone Lymphoma|T-Cell Lymphoma|Chronic Lymphoid Leukemia|Mantle-Cell Lymphoma|Chronic Myelomonocytic Leukemia|Lymphocytic Chronic B-Cell Leukemia|Diffuse Large B-Cell Lymphoma|Myelodysplastic Syndrome|Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Lymphoma, Non-Hodgkin|T-Cell Leukemia |
2025-06-12 |
12% |
2025-09-25 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT04062266 |
NCI-2019-04987 | P2 |
Active, not recruiting |
Tic Disorders|Acute Myeloid Leukemia|Acute Lymphoid Leukemia |
2030-10-31 |
12% |
2025-02-05 |
Primary Endpoints|Treatments|Trial Status |
NCT05099471 |
VIWA-1 | P2 |
Recruiting |
Waldenstrom Macroglobulinemia |
2028-03-01 |
12% |
2025-04-09 |
|
NCT06390319 |
SJALL23T | P2 |
Recruiting |
Acute Lymphoid Leukemia|T-Cell Peripheral Lymphoma|T-Cell Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
2027-12-01 |
2% |
2025-02-04 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT04797767 |
RG1121403 | P2 |
Recruiting |
Sarcoma, Myeloid|Acute Myeloid Leukemia|Biphenotypic Acute Leukemia |
2026-12-31 |
12% |
2025-05-06 |
Primary Endpoints |
NCT05451771 |
AAAT8639 | P2 |
Recruiting |
Amyloidosis |
2026-09-01 |
12% |
2024-06-28 |
Primary Endpoints|Treatments |
NCT04416451 |
NCT04416451 | P2 |
Active, not recruiting |
B-Cell Marginal Zone Lymphoma |
2026-06-01 |
12% |
2025-07-03 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT03319901 |
NCT03319901 | P2 |
Recruiting |
Leukemia |
2026-04-30 |
12% |
2024-05-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04450173 |
UCDCC#275 | P2 |
Recruiting |
Follicular Lymphoma |
2026-04-01 |
12% |
2025-04-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT03824483 |
NCT03824483 | P2 |
Recruiting |
Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia |
2026-02-01 |
2% |
2025-03-14 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05768711 |
AVENHIR | P2 |
Recruiting |
Myelogenous, Chronic, BCR-ABL Positive Leukemia|Juvenile Myelomonocytic Leukemia,|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia |
2026-02-01 |
12% |
2023-10-18 |
|
NCT07007052 |
TAGVEN | P2 |
Not yet recruiting |
Oncology Unspecified |
2026-01-31 |
12% |
2025-06-06 |
Primary Endpoints|Treatments |
NCT05701215 |
VARIANT | P2 |
Active, not recruiting |
Myelogenous, Chronic, BCR-ABL Positive Leukemia|Chronic Myeloid Leukemia |
2026-01-31 |
12% |
2025-03-11 |
Primary Endpoints |
NCT04855695 |
NCT04855695 | P2 |
Recruiting |
Mantle-Cell Lymphoma |
2025-12-31 |
12% |
2025-01-30 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT04550442 |
NCI-2020-06538 | P2 |
Active, not recruiting |
Chronic Myelomonocytic Leukemia|Myelodysplastic Syndrome |
2025-12-30 |
50% |
2025-10-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
jRCT2080225346 |
jRCT2080225346 | P2 |
Completed |
Lymphoma |
2025-10-04 |
|||
NCT04572763 |
NCT04572763 | P2 |
Active, not recruiting |
Diffuse Large B-Cell Lymphoma |
2025-10-01 |
12% |
2025-07-16 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
NCT02401503 |
CLL2-BAG | P2 |
Completed |
Chronic Lymphoid Leukemia|Acute Respiratory Distress Syndrome |
2024-12-10 |
12% |
2025-06-11 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT03844048 |
M19-388 | P3 |
Active, not recruiting |
Lymphocytic Chronic B-Cell Leukemia|Lymphoma, Non-Hodgkin|Chronic Myeloid Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Lymphoma, B-Cell|Acute Myeloid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Multiple Myeloma|Chronic Lymphoid Leukemia |
2026-02-01 |
46% |
2024-12-04 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |