Xospata

(Gilteritinib)

Phase 3Small molecule

Gilteritinib is used to treat a type of blood cancer called acute myeloid leukemia (AML) in adult patients, particularly those with a specific genetic mutation called FLT3.[1] Xospata is currently being investigated across 24 indications[3], with its most advanced program in Phase 3.[1]

Xospata is one of 369 small molecule programs targeting Childhood Acute Myeloid Leukemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

368

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Childhood Acute Myeloid LeukemiaUnknown

Acute Myeloid Leukemia by FAB ClassificationUnknown

Hematopoietic and Lymphoid Cell NeoplasmActive, not recruiting

Hematological MalignanciesNot yet recruiting

Non-Small Cell Lung Cancer (NSCLC)Recruiting

Lung Non-Small Cell CarcinomaRecruiting

Acute Myeloid Leukemia (AML)Completed

AML With FLT3 MutationActive, not recruiting

AML, AdultRecruiting

AMLRecruiting

Childhood Acute Myeloid LeukemiaPreclinical

Unknown

Acute Myeloid Leukemia by FAB ClassificationPreclinical

Unknown

Hematopoietic and Lymphoid Cell NeoplasmPreclinical

Active, not recruiting

Hematological MalignanciesPreclinical

Not yet recruiting

Non-Small Cell Lung Cancer (NSCLC)Phase 1

Recruiting

Lung Non-Small Cell CarcinomaPhase 1

Recruiting

Acute Myeloid Leukemia (AML)Phase 3

Completed

AML With FLT3 MutationPhase 3

Active, not recruiting

AML, AdultPreclinical

Recruiting

AMLPhase 1

Recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Xospata

Astellas

Phase 3

1 2

Dexilant

Takeda

Preclinical

2 3

Niclocide

Bayer

Preclinical

1 4

Alfenta

Jazz Pharmaceuticals

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Lotemax

PPharmos

Preclinical

1 8

Norpramin

VValidus Pharmaceuticals

Preclinical

1 9

Clomid

Ferring

Preclinical

1 10

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Acute Myeloid Leukemia, in Relapse

NCT05546580

Phase 1Recruiting

Acute Myeloid Leukemia

NCT05010772

Q1 2027

Phase 1Recruiting

Acute Myeloid Leukemia

NCT06222580

Phase 1Recruiting

Relapsed or Refractory

NCT05024552

Phase 3Active, not recruiting

AML With FLT3 Mutation

NCT03182244

Q2 2027

Phase 1Recruiting

Acute Myeloid Leukemia (AML)

NCT05756777

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia24 trials

Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed· Astellas logo

Astellas·Phase 1·NCT02181660·24 enrolled

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

Recruiting·UUma Borate·Phase 1·NCT06222580·30 enrolled

A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04336982·22 enrolled

Show 21 more trials

Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or With FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

No longer available· Astellas logo

Astellas··NCT03409081

Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed· Astellas logo

Astellas·Phase 1/2·NCT02014558·265 enrolled

A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation

Completed· Astellas logo

Astellas·Phase 3·NCT02421939·371 enrolled

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.

Completed· Astellas logo

Astellas·Phase 1/2·NCT02310321·97 enrolled

Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

Not yet recruiting·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT06667973·80 enrolled

A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)

Terminated·KKronos Bio·Phase 1/2·NCT05028751·24 enrolled

A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

Completed· Astellas logo

Astellas·Phase 3·NCT02997202·356 enrolled

A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission

Completed· Astellas logo

Astellas·Phase 2·NCT02927262·98 enrolled

A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia

Completed· AbbVie logo

AbbVie·Phase 1·NCT03625505·61 enrolled

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed· Astellas logo

Astellas·Phase 1·NCT02236013·80 enrolled

Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

Approved for marketing· Astellas logo

Astellas··NCT03070093

A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)

Completed· Astellas logo

Astellas·Phase 1/2·NCT03730012·11 enrolled

A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Terminated· Astellas logo

Astellas·Phase 1/2·NCT04240002·9 enrolled

Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant

Completed· Astellas logo

Astellas··NCT06734585·114 enrolled

A Randomized Phase II Study of Venetoclax and HMA-Based Therapies for the Treatment of Older and Unfit Adults With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Substudy

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06317649·147 enrolled

Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564390·2,000 enrolled

A Collaboration Phase 2 Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT05955261·70 enrolled

A Phase I/II Study of ASTX727, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT05010122·42 enrolled

Clinical Study of Sonrotoclax Combined With Azacitidine Plus Individualized Targeted Drugs in the Treatment of Newly Diagnosed Adult Acute Myeloid Leukemia

Recruiting·RRuijin Hospital·Phase 2·NCT07548710·205 enrolled

Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML)

Completed·PPrECOG, LLC.·Phase 2·NCT03836209·181 enrolled

Oral Decitabine-Based Maintenance Therapy in Patients With AML in Remission

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05010772·125 enrolled

Acute Myeloid Leukemia (AML)3 trials

A Phase 1/2, Multicenter, Open-Label, Randomized Dose Ranging and Expansion Study of the Combination of Gilteritinib, Venetoclax and Azacitidine in Patients With Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) Not Eligible for Intensive Induction Chemotherapy

Active, not recruiting· Astellas logo

Astellas·Preclinical·NCT05520567·70 enrolled

A Phase 3 Multicenter, Open-label, Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

Completed· Astellas logo

Astellas·Phase 3·NCT02752035·183 enrolled

A Phase 1b Multi-center Study of the FLT3 Inhibitor Gilteritinib in Combination With the IDH1 Inhibitor Ivosidenib or the IDH2 Inhibitor Enasidenib for Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Have Co-occurring FLT3/IDH1 or FLT3/IDH2 Mutations

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT05756777·18 enrolled

Targeted Therapy2 trials

FLT3-ITD Targeted Therapy in Fit AML Patients

Not yet recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2/3·NCT07425808·230 enrolled

Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07032727·68 enrolled

AML2 trials

Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

Recruiting·KKura Oncology, Inc.·Phase 1·NCT06001788·171 enrolled

Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT06265545·458 enrolled

Lung Cancer1 trial

A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)

Terminated· Astellas logo

Astellas·Phase 1/2·NCT02495233·10 enrolled

26 more indications

Relapsed/Refractory1 trial

GM-CLAG in Relapsed/Refractory FLT3-mutated AML

Withdrawn·AAyman H Qasrawi·Phase 1·NCT05330377

Treatment1 trial

Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

Recruiting·TTechnische Universität Dresden·Phase 2·NCT06696183·60 enrolled

Induction Chemotherapy1 trial

Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML

Active, not recruiting·CChen Suning·Phase 3·NCT05177731·188 enrolled

Infections1 trial

GilteRInf 2022 Study (Gilteritinib Related Infections)

Unknown status·UUniversity of Rome Tor Vergata··NCT05791890·78 enrolled

Single Dose1 trial

A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT03964038·48 enrolled

Newly Diagnosed1 trial

The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1/2·NCT06561880·36 enrolled

Trial1 trial

Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial

Completed· Astellas logo

Astellas·Phase 1/2·NCT02561455·9 enrolled

Renal Impairment1 trial

A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function

Completed· Astellas logo

Astellas·Phase 1·NCT04699877·17 enrolled

Outcome1 trial

Real World Outcomes Using Novel Agents for AML in the UK

Unknown status·GGuy's and St Thomas' NHS Foundation Trust··NCT05312112·1,000 enrolled

Myelodysplastic Syndrome1 trial

Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02115295·508 enrolled

Chronic Myelomonocytic Leukemia1 trial

Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04140487·97 enrolled

Hematologic Malignancies1 trial

A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies

Withdrawn·EErasca, Inc.·Phase 1/2·NCT05279859

Relapsed or Refractory1 trial

Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT05024552·22 enrolled

Patients With Advanced Solid Tumors1 trial

Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors

Completed· Astellas logo

Astellas·Phase 1·NCT02456883·6 enrolled

Sorafenib1 trial

MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 3·NCT07463651·594 enrolled

Induction Therapy1 trial

Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML

Recruiting·—·Phase 2·NCT06221683·500 enrolled

Acute Leukemia1 trial

A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)

Recruiting· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1/2·NCT04988555·606 enrolled

Myelodysplastic Syndromes1 trial

A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy

Active, not recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 3·NCT04027309·777 enrolled

Myeloid Leukemia1 trial

A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06235801·40 enrolled

Refractory Acute Myeloid Leukemia1 trial

A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)

Recruiting·BBeat AML, LLC·Preclinical·NCT03013998·3,000 enrolled

Acute Myeloid Leukemia, in Relapse1 trial

An Escalation/Expansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study

Active, not recruiting·OOryzon Genomics S.A.·Phase 1·NCT05546580·50 enrolled

Non-small Cell Lung Cancer (NSCLC)1 trial

A Phase 1b Study of Gilteritinib in Participants With Locally Advanced or Metastatic NSCLC With ALK Rearrangement After Prior Treatment With an ALK Inhibitor

Recruiting· Astellas logo

Astellas·Phase 1·NCT07140016·40 enrolled

AML, Adult1 trial

MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT07131059·537 enrolled

AML With FLT3 Mutation1 trial

Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

Active, not recruiting· Astellas logo

Astellas·Phase 3·NCT03182244·276 enrolled

Lung Non-Small Cell Carcinoma1 trial

Phase I Study of Gilteritinib for ALK Positive Non-Small Cell Lung Cancer

Recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 1·NCT06225427·30 enrolled

Hematological Malignancies1 trial

Non Interventional Study Aiming to Assess the Immunological Impact of a Post Cell Therapy Treatment With FLT3 Inhibitors on the Phenotype, the Metabolism, the Function of T-cells and Monocytes and Macrophages

Not yet recruiting·CCentre Hospitalier Universitaire de Nice·Preclinical·NCT06992934·10 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 28, 2018

XOSPATA

NDA NDA211349

Sources

References

[1]
ClinicalTrials.gov — 58 trial records for Gilteritinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Gilteritinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Gilteritinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211349). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Xospata. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tyrosine-Protein Kinase Receptor FLT3 Inhibitor; Tyrosine-Protein Kinase Receptor UFO Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Astellas

Patent Landscape[5]

Patent Cliff

Jul 28, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9487491Jul 28, 2030

8969336Nov 28, 2032

11944620Jul 1, 2036

11938130Jul 1, 2036

10786500Jul 1, 2036

3 more patents

11938131Jul 1, 2036

11938132Jul 1, 2036

11938133Jul 1, 2036

Xospata

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Acute Myeloid Leukemia24 trials

Acute Myeloid Leukemia (AML)3 trials

Targeted Therapy2 trials

AML2 trials

Lung Cancer1 trial

Relapsed/Refractory1 trial

Treatment1 trial

Induction Chemotherapy1 trial

Infections1 trial

Single Dose1 trial

Newly Diagnosed1 trial

Trial1 trial

Renal Impairment1 trial

Outcome1 trial

Myelodysplastic Syndrome1 trial

Chronic Myelomonocytic Leukemia1 trial

Hematologic Malignancies1 trial

Relapsed or Refractory1 trial

Patients With Advanced Solid Tumors1 trial

Sorafenib1 trial

Induction Therapy1 trial

Acute Leukemia1 trial

Myelodysplastic Syndromes1 trial

Myeloid Leukemia1 trial

Refractory Acute Myeloid Leukemia1 trial

Acute Myeloid Leukemia, in Relapse1 trial

Non-small Cell Lung Cancer (NSCLC)1 trial

AML, Adult1 trial

AML With FLT3 Mutation1 trial

Lung Non-Small Cell Carcinoma1 trial

Hematological Malignancies1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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