Drugs / Gilteritinib
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Gilteritinib

Small molecule targets ALK, AXL, FLT3, ROS1 via inhibition

Developed for
acute myeloid leukemia · acute myeloid leukemia, FLT3 internal tandem duplication · non-small cell lung carcinoma · myelodysplastic syndrome · acute myeloid leukemia with multilineage dysplasia · acute myeloid leukemia with mutated NPM1 · acute myeloid leukemia, FLT3 tyrosine kinase domain point mutation · acute myeloid leukemia, MLL gene rearrangement
+7 more · childhood acute myeloid leukemia · chronic myelomonocytic leukemia · hematopoietic and lymphoid cell neoplasm · myelodysplastic syndrome with excess blasts-2 · myeloid leukemia · refractory hematologic cancer · therapy related acute myeloid leukemia and myelodysplastic syndrome
Investigated by
Astellas Pharma Global Development, Inc. · Astellas Pharma Inc · M.D. Anderson Cancer Center · National Cancer Institute (NCI) · Institute of Hematology & Blood Diseases Hospital, China · AbbVie
+51 more · Acute Leukemia French Association · GIMEMA Foundation · Astellas Pharma US, Inc. · Ayman H Qasrawi · Beat AML, LLC · Blood and Marrow Transplant Clinical Trials Network · Celgene Corporation · Centre Antoine Lacassagne · Centre Hospitalier Universitaire de Nice · Charite University, Berlin, Germany · Children's Hospital of Soochow University · Children's Oncology Group · City of Hope Medical Center · Cyprus Institute of Neurology and Genetics · Czech Lymphoma Study Group · Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG) · Etan Orgel · European LeukemiaNet · European Organisation for Research and Treatment of Cancer - EORTC · First Affiliated Hospital of Zhejiang University · Fondazione GIMEMA · French Innovative Leukemia Organisation · Fundacion Para La Investigacion Hospital La Fe · Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Genentech, Inc. · German Society for Pediatric Oncology and Hematology GPOH gGmbH · GlaxoSmithKline · H. Lee Moffitt Cancer Center and Research Institute · HOVON Foundation · Hannover Medical School · Hospital Vall d'Hebron · Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Jazz Pharmaceuticals · Kronos Bio · Lithuanian University of Health Sciences · Memorial Sloan Kettering Cancer Center · National Heart, Lung, and Blood Institute (NHLBI) · Oryzon Genomics S.A. · Ospedale Pediatrico Bambin Gesù · Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V. · Pfizer · PrECOG, LLC. · Rigel Pharmaceuticals · Ruijin Hospital · TIMELEX · Technical University Dresden · The First Affiliated Hospital of Soochow University · Toscana Life Sciences Sviluppo s.r.l. · Uma Borate · University of Bologna · University of Michigan Rogel Cancer Center

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Xospata 2019-10-24 europa.eu
Label expansion US (FDA) XOSPATA 2019-05-29 fda.gov
Approved US (FDA) XOSPATA 2018-11-28 fda.gov

Trials 57 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 116 trials
Phase 1 NCT07140016 Sep 2025 → Dec 2029 expected non-small cell lung carcinoma Astellas Pharma Global Development, Inc. Recruiting No outcome recorded
Phase 1 NCT06225427 Jul 2024 → May 2027 expected non-small cell lung carcinoma University of Michigan Rogel Cancer Center Recruiting No outcome recorded
Phase 1 NCT06222580 Feb 2024 → Jan 2027 expected acute myeloid leukemia with mutated NPM1, acute myeloid leukemia, FLT3 internal tandem duplication, acute myeloid leukemia, MLL gene rearrangement Uma Borate Recruiting No outcome recorded
Phase 1 NCT05756777 Oct 2023 → Apr 2027 expected acute myeloid leukemia Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 1 NCT05330377 Mar 2023 → May 2027 acute myeloid leukemia Ayman H Qasrawi Withdrawn No outcome recorded
Phase 1 NCT05546580 Nov 2022 → Nov 2025 overdue acute myeloid leukemia Oryzon Genomics S.A. Recruiting No outcome recorded
Phase 1 NCT04655391 Jun 2022 → Dec 2023 acute myeloid leukemia City of Hope Medical Center Withdrawn No outcome recorded
Phase 1 NCT05024552 Feb 2022 → Feb 2027 expected acute myeloid leukemia, FLT3 internal tandem duplication H. Lee Moffitt Cancer Center and Research Institute Recruiting No outcome recorded
Phase 1 NCT05010772 Oct 2021 → Dec 2026 expected acute myeloid leukemia M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1 NCT04699877 Jan 2021 → Jul 2022 impaired renal function disease, medulloadrenal hyperfunction Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 1/213 trials
Phase 1/2 NCT06561880 Oct 2024 → Sep 2026 expected acute myeloid leukemia Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 1/2 NCT06235801 May 2024 → Oct 2027 expected myeloid leukemia M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 1/2 NCT05520567 Jan 2023 → Jul 2028 expected acute myeloid leukemia Astellas Pharma Global Development, Inc. Active not recruiting No outcome recorded
Phase 1/2 NCT05028751 Aug 2022 → Apr 2024 acute myeloid leukemia Kronos Bio Terminated No outcome recorded
Phase 1/2 NCT05010122 Jul 2021 → Jan 2028 expected acute myeloid leukemia, myelodysplastic syndrome M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT04240002 Sep 2020 → Mar 2025 acute myeloid leukemia, FLT3 internal tandem duplication Astellas Pharma Global Development, Inc. Terminated No outcome recorded
Phase 1/2 NCT04140487 Dec 2019 → Sep 2028 expected acute myeloid leukemia, chronic myelomonocytic leukemia M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT03730012 Jun 2019 → May 2021 acute myeloid leukemia Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 1/2 NCT03013998 Nov 2016 → Dec 2028 expected acute myeloid leukemia Beat AML, LLC Recruiting No outcome recorded
Phase 1/2 NCT02561455 May 2016 → Jul 2020 acute myeloid leukemia Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 212 trials
Phase 2 NCT07548710 May 2026 → May 2027 expected acute myeloid leukemia Ruijin Hospital Recruiting No outcome recorded
Phase 2 NCT07259707 Jan 2026 → Dec 2028 expected acute myeloid leukemia, FLT3 internal tandem duplication First Affiliated Hospital of Zhejiang University Recruiting No outcome recorded
Phase 2 NCT07032727 Sep 2025 → Jun 2027 expected M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT06667973 Jun 2025 → Aug 2028 expected acute myeloid leukemia GIMEMA Foundation Not yet recruiting No outcome recorded
Phase 2 NCT06696183 Apr 2025 → Apr 2029 expected acute myeloid leukemia Technical University Dresden Recruiting No outcome recorded
Phase 2 NCT06317649 Sep 2024 → May 2029 expected acute myeloid leukemia National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 2 NCT05564390 Jun 2024 → May 2029 expected acute myeloid leukemia with multilineage dysplasia, myelodysplastic syndrome, therapy related acute myeloid leukemia and myelodysplastic syndrome National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 2 NCT06022003 Jan 2024 → Oct 2026 expected acute myeloid leukemia, FLT3 internal tandem duplication, acute myeloid leukemia, FLT3 tyrosine kinase domain point mutation French Innovative Leukemia Organisation Recruiting No outcome recorded
Phase 2 NCT06221683 Jan 2024 → Dec 2028 expected childhood acute myeloid leukemia Children's Hospital of Soochow University Recruiting No outcome recorded
Phase 2 NCT05199051 Jun 2023 → Jul 2028 expected acute myeloid leukemia Centre Antoine Lacassagne Active not recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07425808 Dec 2026 → Oct 2028 expected acute myeloid leukemia European Organisation for Research and Treatment of Cancer - EORTC Not yet recruiting No outcome recorded
Phase 39 trials
Phase 3 NCT07463651 May 2026 → May 2028 expected acute myeloid leukemia, FLT3 internal tandem duplication, disease related to hematopoietic stem cell transplant The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
Phase 3 NCT07407140 Apr 2026 → Feb 2029 expected acute myeloid leukemia Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
Phase 3 NCT06713837 Feb 2025 → Jan 2028 expected acute myeloid leukemia Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Recruiting No outcome recorded
Phase 3 NCT04293562 Jul 2020 → Jun 2029 expected acute myeloid leukemia Children's Oncology Group Recruiting No outcome recorded
Phase 3 NCT04027309 Dec 2019 → Oct 2025 overdue acute myeloid leukemia, myelodysplastic syndrome with excess blasts-2 HOVON Foundation Active not recruiting No outcome recorded
Phase 3 NCT03182244 Oct 2017 → Dec 2023 overdue acute myeloid leukemia Astellas Pharma Inc Active not recruiting No outcome recorded
Phase 3 NCT02997202 Aug 2017 → Jan 2023 acute myeloid leukemia Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 3 NCT02752035 Aug 2016 → Mar 2023 acute myeloid leukemia Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 3 NCT02421939 Oct 2015 → Sep 2018 acute myeloid leukemia Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase not applicable3 trials
NCT06992934 Sep 2026 → Aug 2028 expected hematopoietic and lymphoid cell neoplasm Centre Hospitalier Universitaire de Nice Not yet recruiting No outcome recorded
NCT07131059 May 2024 → May 2026 overdue acute myeloid leukemia Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
NCT06265545 Feb 2024 → Jan 2026 overdue acute myeloid leukemia, refractory hematologic cancer Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase not stated3 trials
NCT03409081 acute myeloid leukemia Astellas Pharma Global Development, Inc. No longer available No outcome recorded
NCT03315299 acute myeloid leukemia Etan Orgel No longer available No outcome recorded
NCT03070093 acute myeloid leukemia Astellas Pharma Global Development, Inc. Approved for marketing No outcome recorded
Also used as a comparator or background therapy in 8 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT06001788 Background Feb 2024 → Aug 2026 overdue acute myeloid leukemia with mutated NPM1, acute myeloid leukemia, MLL gene rearrangement Kura Oncology, Inc. Recruiting No outcome recorded
Phase 1 NCT03964038 Comparator May → Jul 2019 Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT05279859 Background Mar 2022 → Mar 2025 acute myeloid leukemia Erasca, Inc. Withdrawn No outcome recorded
Phase 1/2 NCT04988555 Background Feb 2022 → Jun 2027 expected acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, plasma cell myeloma Sumitomo Pharma America, Inc. Recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT05955261 Background Jul 2023 → Dec 2026 acute myeloid leukemia St. Jude Children's Research Hospital Suspended No outcome recorded
Phase 2 NCT02115295 Background May 2014 → May 2030 expected acute biphenotypic leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, myelodysplastic syndrome M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT05177731 Background Mar 2022 → Feb 2024 overdue acute myeloid leukemia, chemotherapy-induced toxicity Chen Suning Active not recruiting No outcome recorded
Phase not applicable1 trial
NCT07117422 Background Jan 2025 → Jan 2026 overdue acute myeloid leukemia The Second Hospital of Hebei Medical University Recruiting No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 68 sources stand behind the page.

FieldValueCited text
Known as gilteritinib Gilteritinib alone or in combination with low dose hypomethylating agent or low dose cytarabine” NCT06713837
62

Gilteritinib 120 mg/day, PO by 28 days-cycle” NCT06022003

“Sorafenib or Gilteritinib, Day 8-14” NCT07117422

NCT03409081

NCT06221683

NCT03625505

NCT07407140

NCT04336982

NCT04140487

NCT07140016

NCT02115295

NCT03182244

NCT07259707

NCT06235801

NCT05177731

NCT05756777

NCT07425808

NCT02927262

NCT05955261

NCT02014558

NCT05028751

NCT04027309

NCT05279859

NCT05546580

NCT06696183

NCT03730012

NCT06667973

NCT06992934

NCT02561455

NCT05199051

NCT05330377

NCT06225427

NCT02181660

NCT07548710

NCT06317649

NCT03836209

NCT07032727

NCT05520567

NCT06561880

NCT03013998

NCT03964038

NCT04655391

NCT06265545

NCT05010772

NCT04699877

NCT02310321

NCT03070093

NCT02236013

NCT07463651

NCT02997202

NCT02421939

NCT04240002

NCT04293562

NCT02456883

NCT06222580

NCT05010122

NCT05024552

NCT05564390

NCT04988555

NCT07131059

NCT02495233

NCT06001788

NCT02752035

Known as ASP-2215 HEMIFUMARATE ChEMBL registry synonym — accepted as the source's own label CHEMBL3301622
Known as ASP2215 “A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute...” NCT02927262
3

ASP2215NCT03070093

NCT03315299

NCT02571816

Known as GILT Gilteritinib (GILT)” NCT06696183
Known as Gilteritinib fumarate Gilteritinib fumarate is an oral, selective FLT3 and AXL inhibitor.” NCT06667973
Known as Gilteritinib hemifumarate ChEMBL registry synonym — accepted as the source's own label CHEMBL3301622
Known as XOSPATA “The United States Food and Drug Administration (FDA), the Japanese Ministry of Health, Labour and Welfare (MHLW) and Health Canada have approved ASP2215/Gilteritinib (XOSPATA®)...” NCT03070093
1

“Gilteritinib (XOSPATA®, Astellas) is a type I oral FLT3 inhibitor, a tyrosine kinase AXL inhibitor, involved in both c-Kit and FMS-like tyrosine kinase 3 (FLT3) resistance.” PMID 37180209 May 2023

Action Inhibit “Selective inhibition of FLT3 by gilteritinib” PMID 28645776 Jun 2017
Modality Small molecule “In this line, crenolanib and Gilteritinib are two potent and more specific TKI” NCT06992934
Route Oral “Participants received gilteritinib oral tablets (10 mg, 40 mg or 100 mg, depending on the dose) once daily without food allowed for at least 2 hours before and 1 hour after...” NCT02014558
Target FLT3 “Selective inhibition of FLT3 by gilteritinib” PMID 28645776 Jun 2017