How many clinical trials are studying Venetoclax?

3 recruiting trials in our tracked data involve Venetoclax.

What conditions is Venetoclax being studied for?

In our tracked recruiting trials, Venetoclax is being studied in trials for HIV, Colorectal cancer, HIV-1.

Venetoclax: clinical trials recruiting now

Q: Is Venetoclax FDA-approved?

Yes. According to the FDA drug label available through openFDA, Venetoclax is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Venetoclax appears in the FDA drug-label database. Marketed as Venclexta.
Drug class: BCL-2 Inhibitor (FDA established pharmacologic class)
Mechanism of action: P-Glycoprotein Inhibitors (as stated on the FDA label)

FDA-approved use

VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) 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. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 1.2 Acute Myeloid Leukemia 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.

FDA label via openFDA

Phase breakdown

Phase 1 2 Phase 2 2

Conditions being studied

Condition	Trials
HIV	2
Colorectal cancer	1
HIV-1	1
HIV-1-infection	1
Metastatic Colorectal Cancer	1

Recruiting trials involving Venetoclax

Administration of Venetoclax to Promote Apoptosis of HIV-infected Cells and Reduce the Size of the HIV Reservoir Among People Living With HIV on ART
NCT05668026 · Phase: Phase 1, Phase 2 · Ages: 18 Years to 65 Years · Sex: All (male and female) · 1 location
Inhibiting the Anti-apoptotic Factor, BCL-2, at the Time of ART Initiation to Promote Apoptosis of HIV-infected Cells and Restrict the Seeding of the HIV Reservoir (The INITIATE Study)
NCT07481175 · Phase: Phase 1 · Ages: 18 Years to 70 Years · Sex: All (male and female) · 2 locations
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
NCT05725200 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Venetoclax FDA-approved?

Yes, marketed as Venclexta.

How many recruiting trials involve Venetoclax?

3 recruiting trials across 5 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.