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    DRUG CLASS:

    PI3Kγ inhibitor

    Related drugs:
    3d
    Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=40, Recruiting, Rhizen Pharmaceuticals SA | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Oct 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    tenalisib (RP6530)
    1m
    Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC (clinicaltrials.gov)
    P2, N=26, Completed, Glenn J. Hanna | Active, not recruiting --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    docetaxel • Copiktra (duvelisib)
    2ms
    Combination of HDAC inhibitor and PI3K inhibitor suppresses autophagy and induces apoptosis via cytoplasmic IκBα stabilization in p53-mutant diffuse large B-cell lymphoma. (PubMed, Cell Death Discov)
    In this study, we systematically validated the synergistic therapeutic potential of HDAC inhibitor chidamide and PI3K inhibitor duvelisib in p53+ DLBCL through cellular models, in vivo experiments, and clinical samples. This acetylation promoted histone H1.5-IκBα interactions, further stabilizing IκBα and attenuating p65 nuclear trafficking. Our findings identify a novel and potent therapeutic strategy for p53+ DLBCL, warranting clinical translation.
    Journal • P53mut
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    TP53 (Tumor protein P53) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta) • HDAC2 (Histone deacetylase 2) • NFKBIA (NFKB Inhibitor Alpha 2)
    |
    TP53 mutation • TP53 wild-type
    |
    Copiktra (duvelisib) • Epidaza (chidamide)
    3ms
    A Study of Bosmolisib (BR101801) in Participants With R/R PTCL. (clinicaltrials.gov)
    P2, N=44, Not yet recruiting, Boryung Pharmaceutical Co., Ltd
    New P2 trial
    |
    bosmolisib (BR101801)
    3ms
    A051902: Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma (clinicaltrials.gov)
    P2, N=170, Suspended, Alliance for Clinical Trials in Oncology | Recruiting --> Suspended
    Trial suspension
    |
    PD-1 (Programmed cell death 1) • TNFRSF8 (TNF Receptor Superfamily Member 8) • BCL6 (B-cell CLL/lymphoma 6) • CXCL13 (Chemokine (C-X-C motif) ligand 13) • ICOS (Inducible T Cell Costimulator) • MME (Membrane Metalloendopeptidase)
    |
    TNFRSF8 expression
    |
    doxorubicin hydrochloride • cyclophosphamide • etoposide IV • Copiktra (duvelisib) • vincristine • prednisone • Onureg (azacitidine oral)
    3ms
    BR-101801-CT-101: BR101801 in Adult Patients With Advanced Hematologic Malignancies(Phase I) (clinicaltrials.gov)
    P1, N=26, Completed, Boryung Pharmaceutical Co., Ltd | Active, not recruiting --> Completed
    Trial completion
    |
    bosmolisib (BR101801)
    3ms
    Immunomodulatory microbubbles targeting integrin αvβ3 in combination with immunotherapy for the theranostic of anaplastic thyroid cancer in mice. (PubMed, J Control Release)
    UTMD mediated delivery using IPI549@αIMBs combined with anti-PD1 therapy markedly inhibited subcutaneous ATC tumor growth in mice, effectively reduced the proportion of M2-like tumor associated macrophage, and increased CD8+ T cell infiltration, which alleviated the tumor immunosuppressive state. In summary, this study explored a novel therapeutic strategy for ATC, demonstrating the efficacy of the IPI549@αIMB-based UTMD approach combined with anti-PD1 therapy and validating the underlying immunomodulatory mechanisms.
    Preclinical • Journal
    |
    CD8 (cluster of differentiation 8) • PIK3CG (Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Gamma)
    |
    eganelisib (IPI-549)
    3ms
    A Phase 1b/2 Study of IPI-145 Plus FCR in Previously Untreated, Younger Patients With CLL (clinicaltrials.gov)
    P1/2, N=32, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Jul 2025 --> Jul 2026
    Trial completion date
    |
    Rituxan (rituximab) • cyclophosphamide • Copiktra (duvelisib) • fludarabine IV
    4ms
    A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL) (clinicaltrials.gov)
    P1, N=30, Recruiting, Memorial Sloan Kettering Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Alecensa (alectinib) • Copiktra (duvelisib)
    4ms
    A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects (clinicaltrials.gov)
    P1, N=56, Completed, Kither Biotech Srl | Recruiting --> Completed
    Trial completion
    4ms
    Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jun 2025 --> Nov 2025
    Trial completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    Chr t(11;14)
    |
    Copiktra (duvelisib) • ETP-47187
    4ms
    A Phosphatidylinositol 3-Kinase Gamma Inhibitor Enhances Anti-Programmed Death-1/Programmed Death Ligand-1 Antitumor Effects by Remodeling the Tumor Immune Microenvironment of Ovarian Cancer. (PubMed, MedComm (2020))
    OC is an immunosuppressed tumor with predominant infiltration of M2 throughout the entire disease course. We also found that a PI3Kγ inhibitor combined with anti-PD-1 therapy can enhance the antitumor effects of anti-PD-1 agents by modulating the PI3Kγ-AKT-NF-κB pathway, reprogramming TAMs, decreasing the number of myeloid-derived suppressor cells, increasing the number of CD8+ T cells, and increasing the levels of proinflammatory factors; consequently, this approach transforms the tumor immune microenvironment of OC into a more active state.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PIK3CG (Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Gamma)