NDAORALTABLETPriority Review
Approved
Apr 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
P-Glycoprotein Inhibitors
Pharmacologic Class:
BCL-2 Inhibitor
Clinical Trials (5)
HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Started Oct 2026
42 enrolled
Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) RecurrentLymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory+2 more
Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
Started May 2026
25 enrolled
IDH1 MutationRelapsed / Refractory AML
Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy
Started May 2026
16 enrolled
Acute Myeloid LeukemiaIDH1 Mutation
Study to Assess Change in Disease Activity of Oral Venetoclax in Adult Participants With Recurring Relapsed or Refractory (R/R) Waldenström Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
Started Mar 2026
14 enrolled
Waldenstrom MacroglobulinemiaLymphoplasmacytic Lymphoma
Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma
Started Feb 2026
33 enrolled
LymphomaMarginal Zone LymphomaMZL
Loss of Exclusivity
LOE Date
Sep 6, 2033
91 months away
Patent Expiry
Sep 6, 2033
Exclusivity Expiry
May 15, 2026