^
    14d
    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)
    24d
    Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) (clinicaltrials.gov)
    P2, N=200, Recruiting, Incyte Corporation | Trial completion date: Sep 2024 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Sep 2027
    Trial completion date • Trial primary completion date
    |
    Imbruvica (ibrutinib) • Jakafi (ruxolitinib) • parsaclisib (INCB50465) • itacitinib (INCB039110)
    1m
    To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313) (clinicaltrials.gov)
    P3, N=252, Active, not recruiting, Incyte Corporation | Trial completion date: Jul 2024 --> Nov 2024
    Trial completion date
    |
    Jakafi (ruxolitinib) • parsaclisib (INCB50465)
    3ms
    To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304) (clinicaltrials.gov)
    P3, N=177, Terminated, Incyte Corporation | Active, not recruiting --> Terminated; The study was terminated due to futility.
    Trial termination
    |
    Jakafi (ruxolitinib) • parsaclisib (INCB50465)
    4ms
    A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204) (clinicaltrials.gov)
    P2, N=110, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    parsaclisib (INCB50465)
    4ms
    CITADEL-203: A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov)
    P2, N=126, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    parsaclisib (INCB50465)
    5ms
    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 | Active, not recruiting --> Completed
    Trial completion
    |
    parsaclisib (INCB50465)
    5ms
    CIBI376A201: IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma (clinicaltrials.gov)
    P2, N=81, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Nov 2023
    Trial completion • Trial completion date
    |
    parsaclisib (INCB50465)
    5ms
    Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia (clinicaltrials.gov)
    P3, N=13, Terminated, Incyte Corporation | Active, not recruiting --> Terminated; A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
    Trial termination
    |
    parsaclisib (INCB50465)
    6ms
    To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313) (clinicaltrials.gov)
    P3, N=252, Active, not recruiting, Incyte Corporation | Trial completion date: Apr 2024 --> Jul 2024
    Trial completion date
    |
    Jakafi (ruxolitinib) • parsaclisib (INCB50465)
    6ms
    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=65, Recruiting, Incyte Biosciences Japan GK | Phase classification: P1 --> P1/2
    Phase classification • Combination therapy
    |
    Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
    6ms
    PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=28, Recruiting, Henan Cancer Hospital | Trial primary completion date: Feb 2024 --> Jun 2024
    Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK negative
    |
    Epidaza (chidamide) • parsaclisib (INCB50465)
    7ms
    INCB 50465-201: A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis (clinicaltrials.gov)
    P2, N=74, Terminated, Incyte Corporation | Completed --> Terminated; A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
    Trial termination • Combination therapy
    |
    Jakafi (ruxolitinib) • parsaclisib (INCB50465)
    7ms
    Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas (clinicaltrials.gov)
    P1, N=5, Active, not recruiting, Walter Hanel | Recruiting --> Active, not recruiting | N=20 --> 5 | Trial primary completion date: Dec 2023 --> Dec 2024
    Enrollment closed • Enrollment change • Trial primary completion date • Combination therapy
    |
    TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    TNFRSF8 positive
    |
    Istodax (romidepsin) • parsaclisib (INCB50465)
    7ms
    AIHA: A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (clinicaltrials.gov)
    P2, N=25, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    parsaclisib (INCB50465)
    7ms
    Crystal structure of (S)-5-(3-acetyl-5-chloro-2-ethoxy-6-fluorophenyl)-2-oxazolidinone. (PubMed, Acta Crystallogr E Crystallogr Commun)
    The compound has a polymeric structure propagated by a screw axis parallel to the b axis with N-H⋯O hydrogen bonding. It is of inter-est with respect to efforts in the synthesis of a candidate anti-cancer drug, parsaclisib.
    Journal
    |
    CDKN1A (Cyclin-dependent kinase inhibitor 1A)
    |
    parsaclisib (INCB50465)
    9ms
    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, N=65, Recruiting, Incyte Biosciences Japan GK | Phase classification: P1b/2 --> P1
    Phase classification
    |
    Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
    9ms
    Evaluation of the cardiac safety of parsaclisib, a selective PI3Kδ inhibitor, in patients with previously treated B-cell malignancies: Results from the CITADEL-101 study. (PubMed, Pharmacol Res Perspect)
    From the concentration-ΔQTcF analyses, the predicted ΔQTcF (90% CI) for all dose levels was between 0.365 (-1.75 to 2.48) and 7.87 ms (0.921-14.8), with the highest upper limit of CIs well below 20 ms, and therefore, a large QT/QTc effect was ruled out up to the highest dose level (45 mg) investigated. Overall, parsaclisib at the dose ranges studied did not reveal concentration-dependent effects on change in QTcF and did not have a significant effect on HR or cardiac conduction.
    Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    parsaclisib (INCB50465)
    9ms
    A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204) (clinicaltrials.gov)
    P2, N=110, Active, not recruiting, Incyte Corporation | Trial completion date: Dec 2023 --> May 2024
    Trial completion date
    |
    parsaclisib (INCB50465)
    10ms
    Phase 2 study of add-on parsaclisib in myelofibrosis patients with suboptimal response to ruxolitinib: Final results. (PubMed, Blood Adv)
    Hemoglobin levels remained steady. The addition of parsaclisib to stable dose ruxolitinib can reduce splenomegaly and improve symptoms, with manageable toxicity in patients with myelofibrosis with suboptimal response to ruxolitinib.
    P2 data • Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Jakafi (ruxolitinib) • parsaclisib (INCB50465)
    11ms
    Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study. (PubMed, Cancer Res Commun)
    In this phase I study, patients with advanced solid tumors treated with pembrolizumab (PD-1 inhibitor) and either itacitinib (JAK1 inhibitor) or parsaclisib (PI3Kδ inhibitor) experienced limited clinical activity beyond that expected with checkpoint inhibition alone and showed little effect on T-cell infiltration in the tumor. These results do not support continued development of these combinations.
    P1 data • Clinical Trial,Phase I • Journal • Metastases
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Keytruda (pembrolizumab) • parsaclisib (INCB50465) • itacitinib (INCB039110)
    11ms
    A phase 2 study of the PI3Kδ inhibitor parsaclisib in relapsed and refractory marginal zone lymphoma (CITADEL-204). (PubMed, Blood Adv)
    TEAEs led to dose interruptions, reductions, and discontinuations in 56.0%, 16.0%, and 29.0% of all patients, respectively. Durable responses and overall manageable safety profile were demonstrated in patients with R/R MZL treated with parsaclisib monotherapy.
    P2 data • Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    parsaclisib (INCB50465)
    11ms
    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, Active, not recruiting, Incyte Corporation | Phase classification: P1b/2a --> P1/2 | Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Dec 2024
    Phase classification • Trial completion date • Trial primary completion date • 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)
    11ms
    PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=28, Recruiting, Henan Cancer Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK negative
    |
    Epidaza (chidamide) • parsaclisib (INCB50465)
    12ms
    Safety and Efficacy of Parsaclisib in Combination with Rituximab in Patients with Previously Untreated Indolent B-Cell Lymphoma: Primary Analysis from a Phase 2 Study (REPLY) (ASH 2023)
    The combination of parsaclisib with rituximab showed a deep and durable response, with a favorable safety profile and generally good tolerability in patients with previously untreated indolent B-Cell Lymphoma.
    Clinical • P2 data • Combination therapy • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2)
    |
    BCL2 expression • MYC expression
    |
    Rituxan (rituximab) • parsaclisib (INCB50465)
    12ms
    Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213) (clinicaltrials.gov)
    P2, N=42, Completed, Incyte Biosciences Japan GK | Active, not recruiting --> Completed
    Trial completion
    |
    parsaclisib (INCB50465)
    1year
    Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia (clinicaltrials.gov)
    P3, N=13, Active, not recruiting, Incyte Corporation | Trial primary completion date: Apr 2023 --> Oct 2023
    Trial primary completion date
    |
    parsaclisib (INCB50465)
    1year
    AIHA: A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, Incyte Corporation | Trial completion date: Sep 2023 --> Mar 2024
    Trial completion date
    |
    parsaclisib (INCB50465)
    1year
    Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov)
    P1, N=0, Withdrawn, Innovent Biologics (Suzhou) Co. Ltd. | N=560 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy
    |
    Rituxan (rituximab) • lenalidomide • parsaclisib (INCB50465)
    1year
    To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313) (clinicaltrials.gov)
    P3, N=252, Active, not recruiting, Incyte Corporation | N=440 --> 252 | Trial completion date: May 2026 --> Apr 2024 | Trial primary completion date: Nov 2023 --> Aug 2023
    Enrollment change • Trial completion date • Trial primary completion date
    |
    Jakafi (ruxolitinib) • parsaclisib (INCB50465)
    1year
    Metabolic and toxicological considerations for phosphoinositide 3-kinase delta inhibitors in the treatment of chronic lymphocytic leukemia. (PubMed, Expert Opin Drug Metab Toxicol)
    Idelalisib is a first-in-class PI3Kδ inhibitor effective in patients with B-cell lymphoid malignancies...Newer drugs are in development to reduce toxicity with novel schedules and/or combinations. The development of novel PI3Kδ inhibitors might help to reduce toxicity and improve efficacy in patients with CLL and other B-cell lymphoid malignancies.
    Review • Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Aliqopa (copanlisib) • Zydelig (idelalisib) • Copiktra (duvelisib) • Ukoniq (umbralisib) • parsaclisib (INCB50465) • zandelisib (ME-401)
    1year
    Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory follicular lymphoma (CITADEL-203): a phase 2 study. (PubMed, EClinicalMedicine)
    Treatment with parsaclisib demonstrated rapid and durable responses, and a manageable safety profile in patients with R/R FL. Incyte Corporation.
    P2 data • Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    parsaclisib (INCB50465)
    1year
    Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory mantle cell lymphoma (CITADEL-205): a phase 2 study. (PubMed, EClinicalMedicine)
    Future development of PI3K inhibitors for NHL will require further investigation of dose optimisation to improve safety and long-term survival. Incyte Corporation.
    P2 data • Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    parsaclisib (INCB50465)
    over1year
    A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111) (clinicaltrials.gov)
    P1b, N=17, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    IL10 (Interleukin 10)
    |
    parsaclisib (INCB50465)
    over1year
    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)
    P1b/2a, N=54, Active, not recruiting, Incyte Corporation | N=100 --> 54
    Enrollment change • 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)
    over1year
    Safety and efficacy of parsaclisib in combination with obinutuzumab and bendamustine in patients with relapsed or refractory follicular lymphoma (CITADEL-102): A phase 1 study. (PubMed, Hematol Oncol)
    Seventeen patients (65.4%) had a complete response and 3 patients (11.5%) had a partial response, for an objective response rate of 76.9%. Overall, results from CITADEL-102 suggest that the combination of parsaclisib with obinutuzumab and bendamustine did not result in unexpected safety events, with little evidence of synergistic toxicity, and demonstrated preliminary efficacy in patients with R/R FL who progressed following prior rituximab-containing regimens.
    Clinical • P1 data • Journal • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    CD20 positive
    |
    Rituxan (rituximab) • Gazyva (obinutuzumab) • bendamustine • parsaclisib (INCB50465)
    over1year
    Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213) (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, Incyte Biosciences Japan GK | Trial completion date: Feb 2024 --> Oct 2023 | Trial primary completion date: Feb 2024 --> Feb 2023
    Trial completion date • Trial primary completion date
    |
    parsaclisib (INCB50465)
    over1year
    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, Active, not recruiting, Incyte Corporation | Trial completion date: Mar 2023 --> Apr 2024
    Trial completion date
    |
    parsaclisib (INCB50465)
    over1year
    A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204) (clinicaltrials.gov)
    P2, N=110, Active, not recruiting, Incyte Corporation | Trial completion date: Mar 2023 --> Dec 2023
    Trial completion date
    |
    parsaclisib (INCB50465)
    over1year
    Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov)
    P1, N=560, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P1 trial • Combination therapy
    |
    Rituxan (rituximab) • lenalidomide • parsaclisib (INCB50465)
    over1year
    Parsaclisib With or Without Polatuzumab Vedotin 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 | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    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)
    |
    BCL2 expression • MYC expression • CD20 expression • MYC rearrangement • BCL6 rearrangement • BCL2 rearrangement
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • parsaclisib (INCB50465) • Polivy (polatuzumab vedotin-piiq) • Neulasta (pegfilgrastim) • Neupogen (filgrastim)
    over1year
    A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF PARSACLISIB, A PI3KΔ INHIBITOR, IN RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA IN CHINA: UPDATED RESULTS FROM THE STUDY (EHA 2023)
    With longer follow-up, parsaclisib demonstrated a high rate of complete response and durable responses, and had an acceptable safety profile. These results demonstrate that parsaclisib has a favorable benefit-risk profile in patients with line 3 or higher Chinese follicular lymphoma. Clinical trial information: NCT04298879 Targeted therapy, Follicular lymphoma, Phase II
    Clinical • P2 data
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    parsaclisib (INCB50465)