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 17 indications[3], with its most advanced program in Phase 3.[1]

Xospata is one of 381 small molecule programs targeting Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

380

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Lung CancerActive, not recruiting

Kidney DiseaseActive, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmActive, not recruiting

Chronic Myelomonocytic LeukemiaActive, not recruiting

Liver DiseaseActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Myelodysplastic SyndromesActive, not recruiting

Non-Small Cell Lung Cancer (NSCLC)Recruiting

Lung CancerPhase 1/Phase 2

Active, not recruiting

Kidney DiseasePhase 1

Active, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmPreclinical

Active, not recruiting

Chronic Myelomonocytic LeukemiaPhase 1/Phase 2

Active, not recruiting

Liver DiseasePhase 1

Active, not recruiting

Myelodysplastic SyndromePhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 1

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Active, not recruiting

Myelodysplastic SyndromesPhase 3

Active, not recruiting

Non-Small Cell Lung Cancer (NSCLC)Phase 1

Recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Xospata

Astellas

Phase 3

56 2

Yervoy

Bristol-Myers Squibb

Preclinical

31 3

PORTRAZZA

Eli Lilly

Preclinical

8 4

Vizimpro

Pfizer

Preclinical

4 5

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 6

Remeron

OOrganon and Co

Preclinical

1 7

Vidaza

Bristol-Myers Squibb

Preclinical

1 8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

—9

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—10

Huaier Granule

QQidong Gaitianli Medicines Co., Ltd

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Acute Myeloid Leukemia

NCT05010772

Q1 2027

Phase 1Recruiting

Acute Myeloid Leukemia

NCT06222580

Phase 1Recruiting

Relapsed or Refractory

NCT05024552

Q2 2027

Phase 1Recruiting

Acute Myeloid Leukemia (AML)

NCT05756777

Phase 1Recruiting

Lung Non-Small Cell Carcinoma

NCT06225427

Q3 2027

Phase 1Recruiting

Acute Myeloid Leukemia

NCT06001788

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia28 trials

A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation

Active, not recruiting· Astellas logo

Astellas·Phase 3·NCT03182244·276 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 Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia

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

Show 25 more trials

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 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 Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia

Active, not recruiting· Astellas logo

Astellas·Phase 1/2·NCT05520567·70 enrolled

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

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

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

Completed· Astellas logo

Astellas··NCT06734585·114 enrolled

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

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

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

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

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·Phase 1/2·NCT06235801·20 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

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Recruiting·BBeat AML, LLC·Phase 1/2·NCT03013998·3,000 enrolled

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

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 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

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

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 ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy

Completed· Astellas logo

Astellas·Phase 3·NCT02752035·183 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

Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission

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

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

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

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

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

Active, not recruiting·PPrECOG, LLC.·Phase 2·NCT03836209·181 enrolled

Relapsed or Refractory2 trials

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

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

Myelodysplastic Syndrome2 trials

ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT05010122·42 enrolled

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

Infections1 trial

GilteRInf 2022 Study (Gilteritinib Related Infections)

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

22 more indications

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

MRD1 trial

MRD-positive AML Clinical Study

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT07131059·120 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

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

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

Targeted Therapy1 trial

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

R/R AML1 trial

Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)

Recruiting·OOryzon Genomics S.A.·Phase 1·NCT05546580·50 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

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

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

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

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

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

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

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

Acute Myeloid Leukemia (AML)1 trial

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

Regulatory

FDA Approval Timeline[4]

Nov 28, 2018

XOSPATA

NDA NDA211349

Sources

References

[1]
ClinicalTrials.gov — 56 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

Q3 2027

Trials by Indication[1]

Acute Myeloid Leukemia28 trials

Relapsed or Refractory2 trials

Myelodysplastic Syndrome2 trials

Infections1 trial

Acute Leukemia1 trial

Patients With Advanced Solid Tumors1 trial

MRD1 trial

Single Dose1 trial

Trial1 trial

Lung Cancer1 trial

Targeted Therapy1 trial

R/R AML1 trial

Renal Impairment1 trial

Outcome1 trial

Chronic Myelomonocytic Leukemia1 trial

Hematologic Malignancies1 trial

Induction Therapy1 trial

Relapsed/Refractory1 trial

Treatment1 trial

Myelodysplastic Syndromes1 trial

Sorafenib1 trial

Newly Diagnosed1 trial

Induction Chemotherapy1 trial

Lung Non-Small Cell Carcinoma1 trial

Non-small Cell Lung Cancer (NSCLC)1 trial

Hematological Malignancies1 trial

Acute Myeloid Leukemia (AML)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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