[{"orgOrder":0,"company":"Kyowa Kirin","sponsor":"MEI Pharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyowa Kirin and MEI Pharma Dosed First Patient in Japanese Pivotal Phase 2 Study of Zandelisib for Indolent B-cell non-Hodgkin's Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma and Kyowa Kirin to Present Clinical Data from Phase 1b Study of Zandelisib and Zanubrutinib Combo at EHA 2021","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma and Kyowa Kirin to Present Clinical Data from Ongoing Studies Evaluating Zandelisib for Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma and Kyowa Kirin Receive Orphan Drug Designation for Zandelisib for the Treatment of Follicular Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma and Kyowa Kirin Announce Data From the Ongoing Global Phase 2 TIDAL Study Evaluating Zandelisib as a Single Agent in Patients with Relapsed or Refractory Follicular Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma Announces Acceptance of Two Abstracts for Presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma and Kyowa Kirin Provide Regulatory Update on Zandelisib Following Meeting with the FDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma Announces Two Presentations at the American Association for Cancer Research Annual Meeting 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma and Kyowa Kirin Announce Acceptance of Two Abstracts for Presentation at the European Hematology Association 2022 Hybrid Congress","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma and Kyowa Kirin Announce Acceptance of Abstract for Presentation at the American Society of Clinical Oncology Annual Meeting 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma and Kyowa Kirin Report New Clinical Data on Zandelisib at American Society of Clinical Oncology Annual Meeting 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma and Kyowa Kirin Report Clinical Data on Zandelisib at European Hematology Association 2022 Hybrid Congress","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma and Kyowa Kirin Announce Publication in The Lancet Oncology of Data from Phase 1b Clinical Study of Zandelisib in Patients with Relapsed or Refractory B-cell Malignancy","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Kyowa Kirin","sponsor":"MEI Pharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyowa Kirin and MEI Pharma Announce Topline Data from the Phase 2 MIRAGE Study Evaluating Zandelisib in Patients with Indolent B-cell non-Hodgkin\u2019s Lymphoma in Japan","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"MEI Pharma","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MEI Pharma and Kyowa Kirin Announce Discontinuation of Zandelisib Development Outside of Japan Following Recent FDA Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for Zandelisib
ME-401 (zandelisib), a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies.
ME-401 (zandelisib), a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies.
ME-401 (zandelisib), a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, potential therapeutic option for patients with B-cell malignancies.
ME-401 (zandelisib), an orally administered investigational phosphatidylinositol 3- kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies
Clinical trials are investigating the efficacy and safety of ME-401 (zandelisib) as a single agent and in combination with other modalities while administered on an Intermittent Dosing Regimen (ID) and in a time-limited manner when dosed in combination.
ME-401 (Zandelisib), an oral and selective inhibitor of PI3Kδ, is being evaluated in multiple clinical studies, including COASTAL, a Phase 3 study, and TIDAL, a Phase 2 study, in patients with relapsed and refractory follicular and marginal zone lymphomas.
Clinical and preclinical data suggest that ME-401 (zandelisib) distinct characteristics include prolonged target binding, preferential cellular accumulation, high volume of distribution throughout body tissues, and an approx, 28-hour half-life suitable for oral administration.
Data from preclinical studies with ME-401 (zandelisib), a selective PI3Kδ inhibitor, ex vivo in normal human T cells and in vivo in a murine CLL model suggest that zandelisib has immunomodulatory properties on human T cells.
ME-401 (zandelisib), a selective phosphatidylinositol-3-kinase inhibitor, an investigational cancer treatment for patients with B-cell malignancies, demonstrated a 70.3% objective response rate in Phase 2 TIDAL study.
ME-401 (zandelisib), an oral and selective inhibitor of PI3K delta, is being evaluated in multiple clinical studies, including COASTAL and TIDAL study, in patients with follicular and marginal zone lymphomas and other B-cell malignancies.
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