^
    2d
    PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma (clinicaltrials.gov)
    P1, N=12, Terminated, Henan Cancer Hospital | Phase classification: P1/2 --> P1 | Trial completion date: Feb 2025 --> Aug 2025
    Phase classification • Trial completion date
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    ALK (Anaplastic lymphoma kinase)
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    ALK positive • ALK negative
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    Epidaza (chidamide) • parsaclisib (INCB50465)
    3ms
    Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P1, N=50, Active, not recruiting, Mayo Clinic | Trial completion date: May 2027 --> May 2028
    Trial completion date
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • BCL6 (B-cell CLL/lymphoma 6)
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • Truxima (rituximab-abbs) • parsaclisib (INCB50465) • Polivy (polatuzumab vedotin-piiq) • Neulasta (pegfilgrastim) • Mabtas (rituximab biosimilar) • Neupogen (filgrastim)
    5ms
    J-MIND: To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL) (clinicaltrials.gov)
    P1/2, N=72, Active, not recruiting, Incyte Biosciences Japan GK | Recruiting --> Active, not recruiting | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: May 2025 --> Dec 2026
    Enrollment closed • Trial completion date • Trial primary completion date
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    Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
    5ms
    Development and validation of a UPLC-MS/MS method for the quantification of parsaclisib and its application to pharmacokinetics and metabolic stability studies. (PubMed, BMC Chem)
    Parsaclisib was detected by gradient elution on an Acquity UPLC BEH C18 column (2.1 mm × 50 mm, 1.7 μm) using acetonitrile and 0.1% formic acid as mobile phases, and pilaralisib was used as an internal standard (IS). Finally, in vitro results showed that parsaclisib had a slow intrinsic clearance (Clint) value of 2.4 µL/min/mg protein with a half-life (t1/2) value of 571.3 min. These findings theoretically supported the potential metabolism of parsaclisib in vivo.
    PK/PD data • Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
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    parsaclisib (INCB50465) • pilaralisib (SAR245408)
    6ms
    A long-lasting PI3Kδ inhibitor zandelisib forms a water-shielded hydrogen bond with p110δ and demonstrates sustained inhibitory effects. (PubMed, Am J Cancer Res)
    The binding kinetics of zandelisib, parsaclisib, idelalisib, and duvelisib to PI3Kδ were evaluated using surface plasmon resonance (SPR) analysis with the BiacoreTM system, and their binding in living cells was confirmed using the NanoBRETTM TE Intracellular Kinase Assay system. The crystal structure of PI3Kδ in complex with zandelisib was determined at 2.5 Å resolution, revealing the benzimidazole group in zandelisib formed a hydrogen bond to the side chain of Lys779 in p110δ, the catalytic subunit of PI3Kδ. These studies demonstrated a longer duration of action of zandelisib compared to the other compounds, which was attributable to the hydrogen bond between zandelisib and Lys779 in p110δ.
    Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Zydelig (idelalisib) • Copiktra (duvelisib) • parsaclisib (INCB50465) • zandelisib (ME-401)
    7ms
    PI3Kδ Inhibitor Parsaclisib in Japanese Patients With Relapsed or Refractory Follicular Lymphoma. (PubMed, Cancer Sci)
    In conclusion, parsaclisib monotherapy demonstrated durable responses with a manageable safety profile in Japanese patients with R/R FL. Trial Registration: ClinicalTrials.gov, NCT04434937.
    Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    parsaclisib (INCB50465)
    8ms
    PI3Kδ Inhibitor Parsaclisib Combined with Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=12, Terminated, Henan Cancer Hospital | N=28 --> 12 | Trial completion date: Jan 2027 --> Feb 2025 | Recruiting --> Terminated; The clinical development of parsaclisib was stopped by it's manufacturer.
    Enrollment change • Trial completion date • Trial termination
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK negative
    |
    Epidaza (chidamide) • parsaclisib (INCB50465)
    9ms
    CITADEL-205: A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor (clinicaltrials.gov)
    P2, N=162, Completed, Incyte Corporation | Trial primary completion date: Mar 2021 --> Apr 2024
    Trial primary completion date
    |
    parsaclisib (INCB50465)
    11ms
    Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas (clinicaltrials.gov)
    P1, N=5, Completed, Walter Hanel | Active, not recruiting --> Completed
    Trial completion
    |
    TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    TNFRSF8 positive
    |
    Istodax (romidepsin) • parsaclisib (INCB50465)
    12ms
    To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313) (clinicaltrials.gov)
    P3, N=252, Terminated, Incyte Corporation | Active, not recruiting --> Terminated; The study was terminated due to futility.
    Trial termination
    |
    Jakafi (ruxolitinib) • parsaclisib (INCB50465)
    1year
    topMIND: A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
    P1/2, N=54, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Pan tumor
    |
    BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
    |
    Chr t(11;14) • CCND1 overexpression • BCL6 rearrangement • BCL2 rearrangement
    |
    parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
    1year
    Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) (clinicaltrials.gov)
    P2, N=112, Active, not recruiting, Incyte Corporation | Recruiting --> Active, not recruiting | N=200 --> 112
    Enrollment closed • Enrollment change
    |
    Imbruvica (ibrutinib) • Jakafi (ruxolitinib) • parsaclisib (INCB50465) • itacitinib (INCB039110)