Drugs / Gilteritinib
Gilteritinib
also known as
ASP2215 · XOSPATA · ASP-2215 HEMIFUMARATE · GILT · Gilteritinib fumarate · Gilteritinib hemifumarate
Small molecule targets ALK, AXL, FLT3, ROS1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute megakaryoblastic leukemia in adult 1 milestone | |||||
| Filed | China (NMPA) | XOSPATA | acute megakaryoblastic leukemia in adult | 2020-04-10 | “Astellas Announces Acceptance of XOSPATA ® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration” astellas.com ↗ |
| Approved Indication not stated 6 milestones | |||||
| Approved | EU (EMA) | Xospata | — | 2019-10-24 | europa.eu ↗ |
| Label expansion | US (FDA) | XOSPATA | — | 2019-05-29 | fda.gov ↗ |
| Filed | EU (EMA) | XOSPATA | FLT3 mutation-positive relapsed or refractory acute myeloid leukemia | 2019-02-28 | “submission for a marketing authorisation application (MAA) for the oral once-daily therapy XOSPATA (gilteritinib) for the treatment of adult patients who have relapsed or...” astellas.com ↗ |
| Approved | US (FDA) | XOSPATA | — | 2018-11-28 | fda.gov ↗ |
| Filed | US (FDA) | — | FLT3 mutation-positive relapsed or refractory acute myeloid leukemia | 2018-03-29 | “submitted a NDA for approval of gilteritinib in the same patient population to the U.S. Food and Drug Administration (FDA) on March 29, 2018” astellas.com ↗ |
| Filed | Japan (PMDA) | — | FLT3 mutation-positive relapsed or refractory acute myeloid leukemia | 2018-03-23 | “submitted on March 23, 2018, a new drug application (NDA) for marketing approval of gilteritinib (generic name) in Japan” astellas.com ↗ |
Trials 58
News releases announcing trial results or a regulatory action · 31
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Oryzon Genomics S.A. | Results ORYZON Presents Updated Positive Clinical Data for Iadademstat in Acute Myeloid Leukemia (AML) at European Hematology Association (EHA) 2026 Annual Congress oryzon.com ↗
In FLT3-mutated refractory-relapsed patients (FRIDA trial), iadademstat with gilteritinib continued to show a favorable safety profile and a high CRc rate of 67% |
| 2026-06-02 | Oryzon Genomics S.A. | Results ORYZON initiates patient enrollment in IDEAL Phase II trial of iadademstat in essential thrombocythemia oryzon.com ↗
In addition, updated data from the FRIDA study evaluating iadademstat in combination with gilteritinib in relapsed/refractory FLT3-mutated AML demonstrated a favorable safety profile and a CRc rate of 67% in a heavily pre-treated patient population. |
| 2026-05-14 | Oryzon Genomics S.A. | Results ORYZON reports financial results and corporate update for quarter ended March 31st, 2026 oryzon.com ↗
Updated data from the expansion cohort showed a favorable safety profile and a CRc rate of 67% (12/18 patients evaluable for response harboring canonical FLT3 mutations) in a heavily pre-treated patient population. |
| 2026-05-13 | Oryzon Genomics S.A. | Results ORYZON to Present Updated Positive Clinical Data for Iadademstat in Acute Myeloid Leukemia at EHA 2026 oryzon.com ↗
In FLT3‑mutated refractory-relapsed setting, iadademstat with gilteritinib has shown favorable safety profile and a high CRc rate (67%) |
| 2026-03-09 | Astellas Pharma Inc | Results Astellas and Hovon Confirm Phase 3 Study Did not Meet its Primary Endpoint of Overall Survival in Patients with Newly Diagnosed FLT3 m+ AML astellas.com ↗
While the study did not meet its primary endpoint of OS, gilteritinib showed a comparable OS benefit to midostaurin-based treatment in newly diagnosed FLT3 m+ AML. |
| 2025-12-09 | Oryzon Genomics S.A. | Results ORYZON presents data for iadademstat combinations in AML at the American Society of Hematology (ASH) 67th Annual Meeting oryzon.com ↗
67% CCR at the expansion dose in study evaluating iadademstat plus gilterinib in FLT3-mutated relapsed/refractory AML patients; 47% CR+CRh |
| 2025-11-04 | Oryzon Genomics S.A. | Results ORYZON announces positive clinical data of iadademstat at ASH-2025 oryzon.com ↗
Updated preliminary data from the ongoing Phase Ib FRIDA trial evaluating iadademstat in combination with gilteritinib in FLT3-mutated relapsed/refractory AML showed a 67% response rate in the expanded dose, superior to both historical and real-world gilteritinib monotherapy |
| 2024-06-14 | Oryzon Genomics S.A. | Results ORYZON presents preliminary data from ongoing Phase Ib FRIDA trial with iadademstat plus gilteritinib in relapsed/refractory FLT3-mut AML patients at EHA-2024 oryzon.com ↗
Data from the first two cohorts demonstrated that combination of iadademstat plus gilteritinib was safe and showed strong antileukemic activity |
| 2023-06-09 | Astellas Pharma Inc | Results Gilteritinib as Maintenance Therapy Demonstrated Benefit in Subgroups of FLT3-ITD Acute Myeloid Leukemia Patients astellas.com ↗
In exploratory analysis, gilteritinib showed favorable RFS for the approximate 50% of patients with detectable MRD pre- or post-HSCT, compared to those without detectable MRD. |
| 2023-03-09 | Astellas Pharma Inc | Results Astellas and BMT CTN Announce Topline Results from Phase 3 MORPHO Trial of Gilteritinib astellas.com ↗
Based on the data, the study did not meet its pre-defined primary endpoint of relapse-free survival (RFS) for patients treated with gilteritinib compared to placebo. |
| 2022-11-22 | AbbVie | Results AbbVie Highlights Blood Cancer Data From Its Growing Oncology Pipeline at the 64th ASH Annual Meeting abbvie.com ↗
Multi-Omic Single-Cell Sequencing Reveals Genetic and Immunophenotypic Clonal Selection in Patients With FLT3-mutated AML Treated With Gilteritinib/Venetoclax |
| 2021-03-30 | Astellas Pharma Inc | Results Astellas’ XOSPATA® (gilteritinib) Meets Overall Survival Endpoint in COMMODORE Trial of Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation astellas.com ↗
“In COMMODORE, patients receiving gilteritinib lived longer than those receiving salvage chemotherapy, confirming the overall survival benefit seen in the Phase 3 ADMIRAL trial,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development. |
| 2021-02-04 | Astellas Pharma Inc | Regulatory Astellas’ XOSPATA® (gilteritinib) Receives Conditional Approval by China’s National Medical Products Administration for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation astellas.com ↗
Gilteritinib has been approved under an expedited pathway, following NMPA’s acceptance of gilteritinib for priority review in July 20201 and its inclusion in the third batch of overseas new drugs urgently needed in clinical settings in November 2020.2 |
| 2020-12-21 | Astellas Pharma Inc | Results Astellas Reports XOSPATA® (gilteritinib) in Combination with Azacitidine Did Not Meet Endpoint of Overall Survival in Newly Diagnosed FLT3 Mutation-Positive Acute Myeloid Leukemia Patients Ineligible for Intensive Induction Chemotherapy astellas.com ↗
An independent Data Monitoring Committee recommended terminating the study for futility, concluding results are unlikely to show a statistically significant increase in overall survival. |
| 2020-04-10 | Astellas Pharma Inc | Regulatory Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration astellas.com ↗ |
| 2019-10-31 | Astellas Pharma Inc | Results New England Journal of Medicine Publishes Results from Astellas’ Phase 3 ADMIRAL Trial of XOSPATA® (gilteritinib) in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia1 astellas.com ↗
The results appear in the October 31 print edition of the Journal and are currently available online. |
| 2019-10-25 | Astellas Pharma Inc | Regulatory European Commission Approves Astellas’ XOSPATA™ (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation astellas.com ↗
European Commission Approves Astellas’ XOSPATA™ (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation |
| 2019-09-24 | Astellas Pharma Inc | Regulatory Astellas Receives Positive CHMP Opinion for XOSPATA® (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation astellas.com ↗
Astellas Receives Positive CHMP Opinion for XOSPATA® (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation |
| 2019-05-30 | Astellas Pharma Inc | Regulatory U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA® (gilteritinib) astellas.com ↗
U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA® (gilteritinib) |
| 2019-04-01 | Astellas Pharma Inc | Results Phase 3 ADMIRAL Trial Data Show XOSPATA® (gilteritinib) Significantly Prolongs Overall Survival in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia -Study results will be presented at AACR2019- astellas.com ↗
The results show that patients treated with XOSPATA had significantly longer Overall Survival (OS) than those who received standard salvage chemotherapy. |
| 2019-02-28 | Astellas Pharma Inc | Regulatory Astellas Announces Acceptance of XOSPATATM (gilteritinib) for Regulatory Review by the European Medicines Agency astellas.com ↗
Astellas Announces Acceptance of XOSPATATM (gilteritinib) for Regulatory Review by the European Medicines Agency |
| 2018-12-03 | Astellas Pharma Inc | Results Astellas Presents Updated Results from Phase 1 Study of Gilteritinib Plus Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) astellas.com ↗ |
| 2018-11-29 | Astellas Pharma Inc | Regulatory XOSPATA® (gilteritinib) Approved by U.S. FDA for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) approved XOSPATA® (generic name: gilteritinib) for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. |
| 2018-09-21 | Astellas Pharma Inc | Regulatory Astellas Announces Approval in Japan for XOSPATA® 40 mg Tablets for the Treatment of FLT3mut+ Relapsed or Refractory AML astellas.com ↗
Astellas Announces Approval in Japan for XOSPATA® 40 mg Tablets for the Treatment of FLT3mut+ Relapsed or Refractory AML |
| 2018-05-29 | Astellas Pharma Inc | Regulatory U.S. FDA Grants Priority Review to Astellas’ New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) astellas.com ↗
The FDA’s acceptance of this NDA, with Priority Review, represents a significant milestone for gilteritinib and Astellas in our mission to help AML patients and the physicians who treat them. |
| 2018-04-24 | Astellas Pharma Inc | Regulatory Astellas Submits New Drug Applications for Approval of Gilteritinib for the Treatment of FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia astellas.com ↗
Astellas also submitted a NDA for approval of gilteritinib in the same patient population to the U.S. Food and Drug Administration (FDA) on March 29, 2018 (U.S. time) following the submission in Japan. |
| 2018-03-22 | Astellas Pharma Inc | Regulatory Astellas Receives Orphan Drug Designation from the Japanese MHLW for Gilteritinib astellas.com ↗
Astellas Receives Orphan Drug Designation from the Japanese MHLW for Gilteritinib |
| 2018-01-23 | Astellas Pharma Inc | Regulatory Astellas Receives Orphan Designation from the European Commission for Gilteritinib for the Treatment of Acute Myeloid Leukaemia astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that the European Commission (EC) has issued Orphan Designation to gilteritinib for the treatment of patients with acute myeloid leukaemia (AML). |
| 2017-12-11 | Astellas Pharma Inc | Results Astellas Announces First Clinical Data from Phase I Study of Gilteritinib in Combination with Intensive Chemotherapy in Patients Newly Diagnosed with Acute Myeloid Leukemia astellas.com ↗
In addition, while evaluating antitumor effects is an exploratory goal, the response rates in FLT3mut+ patients are promising and warrant expanded investigation of gilteritinib in this upfront treatment setting. |
| 2017-10-11 | Astellas Pharma Inc | Regulatory U.S. FDA Grants Fast Track Designation to Astellas for Development of Gilteritinib in Relapsed or Refractory Acute Myeloid Leukemia astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of gilteritinib for adult patients with FLT3 mutation-positive (FLT3+) relapsed or refractory acute myeloid leukemia (AML). |
| 2017-07-21 | Astellas Pharma Inc | Regulatory U.S. FDA Grants Orphan-Drug Designation to Astellas for Development of FLT3 Inhibitor Gilteritinib in Acute Myeloid Leukemia astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) granted orphan-drug designation to gilteritinib in patients with acute myeloid leukemia (AML). |
All press releases naming this drug 40 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 69 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gilteritinib | “Gilteritinib alone or in combination with low dose hypomethylating agent or low dose cytarabine” NCT06713837 ↗63“Gilteritinib 120 mg/day, PO by 28 days-cycle” NCT06022003 ↗ “Sorafenib or Gilteritinib, Day 8-14” NCT07117422 ↗ |
| 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 ↗ |
| 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 |