[{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astellas Announces Acceptance of XOSPATA\u00ae (gilteritinib) for Regulatory Review in China","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilteritinib Becomes First NICE-Approved Oral Therapy for Relapsed or Refractory Acute Myeloid Leukaemia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"July 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FLT3 Mutation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Kronos Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kronos Gets FDA Clearance Investigational NDA for Lanraplenib for Treatment of Patient with Leukemia AML","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Oryzon Genomics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ORYZON Announces FDA Approval of IND for FRIDA, a Phase Ib Trial With Iadademstat in R\/R AML FLT3mut+ Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"SPAIN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Kura Oncology","sponsor":"BofA Securities","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"Undisclosed","newsHeadline":"Kura Oncology Announces Pricing of $100 Million Public Offering of Common Stock and Pre-funded Warrants","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Kura Oncology","sponsor":"BofA Securities","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"Undisclosed","newsHeadline":"Kura Oncology Announces Commencement of Public 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Trials Network","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astellas and BMT CTN Announce Topline Results from Phase 3 MORPHO Trial of Gilteritinib","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Oryzon Genomics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ORYZON Announces First Patient In in FRIDA, a Phase Ib Trial With Iadademstat in Relapsed\/Refractory FLT3-mutant Acute Myeloid Leukemia Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"SPAIN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Kotobuki Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astellas Launches XOSPATA (Gilteritinib) in Singapore to Treat Adult Leukaemia Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Kotobuki Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Health Canada Approves Astellas' XOSPATA\u00ae (gilteritinib) for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Erasca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Erasca Presents Compelling Preclinical Data Supporting Clinical Development of Potentially Best-in-Class Programs ERAS-007, ERAS-601, and ERAS-3490 at 2022 AACR Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Kura Oncology","sponsor":"AstraZeneca","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kura Oncology Doses First Patient in KOMET-008 Trial of Ziftomenib in Combination with Standards of Care, Including FLT3 Inhibitor, in Acute Myeloid Leukemia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Clinical Trial Evaluates Triple-Drug Regimen for Patients Newly Diagnosed with FLT3-Mutated AML","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for Gilteritinib Fumarate
KO-539 (ziftomenib) is a potent and selective a menin-MLL(KMT2A) inhibitor, which is being evaluated in phase 1 clinical trials in patients with NPM1-mutant & KMT2A-rearranged acute myeloid leukemia.
Clinical Trial Evaluates Triple-Drug Regimen for Patients Newly Diagnosed with FLT3-Mutated AML
Details:
Xospata (gilteritinib) is a small molecule that inhibits multiple receptor tyrosine kinases, including FLT3. It is being evaluated in combination with venetoclax & azacitidine for the treatment of relapsed/refractory acute myeloid leukaemia with a FLT3 mutation.
The net proceeds will be used for the development of KO-539 (ziftomenib), a potent and selective inhibitor, being developed in combination with Xospata (gilteritinib), an inhibitor of FLT3, for the treatment of NPM1-mutated acute myeloid leukemia.
The net proceeds will be used for the development of KO-539 (ziftomenib), a potent and selective inhibitor, being developed in combination with Xospata (gilteritinib), an inhibitor of FLT3, for the treatment of NPM1-mutated acute myeloid leukemia.
ORY-1001 (iadademstat) is a highly selective inhibitor of the epigenetic enzyme LSD1 with powerful differentiating effect in hematologic cancer. It is being investigated in with gilteritinib for relapsed/refractory AML harboring a FMS-like tyrosine kinase mutation.
Xospata (gilteritinib) is a FLT3 inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high disease burden and poor prognosis, and FLT3-tyrosine kinase domain mutations.
Lanraplenib (Lanra) has demonstrated favorable pharmacokinetic (PK), pharmacodynamic (PD) and safety in more than 250 trial participants, including healthy volunteers and patients with autoimmune diseases.
Lanra (lanraplenib) is the company’s next-generation spleen tyrosine kinase (SYK) inhibitor. In addition to lanraplenib, Kronos Bio is also evaluating its lead investigational SYK inhibitor, entospletinib, in the Phase 3 patients with NPM1-mutated AML.
The net proceeds will be used to evaluate efficacy and optimal dose of ORY-1001 (iadademstat), a novel, highly potent, and selective inhibitor of LSD1, plus Xospata (gilteritinib), an inhibitor of FLT3, in patients with relapsed/refractory AML with FLT3 mutations.
ERAS-007 is a highly potent and selective small molecule ERK1/2 inhibitor. It is being evaluated in phase 1/2 clinical trials in combination with gilteritinib for the treatment of acute myeloid leukemia.
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