Vanflyta

(Quizartinib)

ApprovedSmall molecule

Vanflyta is a small molecule that works as a Macrophage Colony Stimulating Factor Receptor Inhibitor; Platelet-Derived Growth Factor Receptor Inhibitor; Stem Cell Growth Factor Receptor Inhibitor; Tyrosine-Protein Kinase Receptor FLT3 Inhibitor; Tyrosine-Protein Kinase Receptor FLT3 Inhibitor; Tyrosine-Protein Kinase Receptor RET Inhibitor.[2] It is being used across 7 indications, with its most advanced program in Approved.[1]

Vanflyta is one of 170 small molecule programs targeting Leukemia. It is currently in Approved.

Indications

Total Trials

Active Trials

169

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

LeukemiaActive, not recruiting

Myelodysplastic/myeloproliferative NeoplasmActive, not recruiting

Childhood LeukemiaApproved

Liver DiseaseApproved

Myelodysplastic SyndromeActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Acute Myeloid Leukemia by FAB ClassificationActive, not recruiting

LeukemiaApproved

Active, not recruiting

Myelodysplastic/myeloproliferative NeoplasmPhase 1/Phase 2

Active, not recruiting

Childhood LeukemiaApproved

Approved

Liver DiseaseApproved

Approved

Myelodysplastic SyndromePhase 1/Phase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 3

Active, not recruiting

Acute Myeloid Leukemia by FAB ClassificationApproved

Active, not recruiting

Competition

Competitive Landscape

804 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

62 2

Vanflyta

Daiichi Sankyo

Approved

13 3

Rydapt

Novartis

Phase 3

17 4

Fludara

Sanofi

Phase 3

15 5

Nexavar

Bayer

Phase 3

12 6

Busulfex

Akero Therapeutics

Phase 3

22 7

Clolar

GGenzyme, a Sanofi Company

Phase 3

21 8

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

12 9

Velcade

SShilpa Grover, MD, MPH

Phase 3

11 10

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phase 3

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

Timeline

Expected Milestones

Q2 2027

Phase 1/2Active, not recruiting

Acute Myeloid Leukemia

NCT03793478

Q4 2027

Phase 1/2Recruiting

Myelodysplastic/myeloproliferative Neoplasm

NCT04493138

Phase 1/2Recruiting

Myelodysplastic Syndrome

NCT04128748

Phase 1/2Recruiting

Myelodysplastic Syndrome

NCT04047641

Q1 2028

Phase 1/2Recruiting

Myelodysplastic Syndrome

NCT03661307

Q2 2030

Phase 1Recruiting

ART

NCT05735184

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia13 trials

Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT02834390·7 enrolled

Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT02984995·37 enrolled

Developing and Treating a Mouse Model of Acute Myeloid Leukemia Using Tissue Samples From Younger Patients With Acute Myeloid Leukemia

Completed·CChildren's Oncology Group··NCT01576185·10 enrolled

Show 10 more trials

Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)

Completed·PPETHEMA Foundation·Phase 2·NCT04107727·273 enrolled

Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT03723681·7 enrolled

Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1/2·NCT03793478·65 enrolled

Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT03735875·8 enrolled

Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)

Terminated· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT03552029·10 enrolled

A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia

Terminated·SSCRI Development Innovations, LLC·Phase 2·NCT04209725·1 enrolled

Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06769490·44 enrolled

A Clinical Trial to Assess the Efficacy and Safety of the Combination of a Drug Call Quizartinib With Chemotherapy (FLAG-IDA) in Patients With Acute Myeloid Leukemia That Has Not Responded to the First Treatment or That Has Returned After the First Treatment

Unknown status·PPETHEMA Foundation·Phase 1/2·NCT04112589·63 enrolled

(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT02039726·367 enrolled

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT02668653·539 enrolled

Myelodysplastic Syndrome4 trials

Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT03661307·73 enrolled

Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04128748·52 enrolled

Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04047641·80 enrolled

Show 1 more trial

Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01892371·73 enrolled

Newly Diagnosed3 trials

CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients

Recruiting·PPrincess Maxima Center for Pediatric Oncology·Phase 2·NCT06262438·60 enrolled

Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or Azacitidine Plus Venetoclax and Quizartinib in Newly Diagnosed AML Patients Aged Equal or More Than 60 Years Old

Unknown status·PPETHEMA Foundation·Phase 1/2·NCT04687761·84 enrolled

Daunorubicin or Idarubicin With Cytarabine Plus Quizartinib vs Physician's Choice in Newly Diagnosed FLT3-ITD+ AML

Withdrawn·UUniversity Hospital Heidelberg·Phase 3·NCT04676243

Tics3 trials

Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT06740825·32 enrolled

A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT04459598·32 enrolled

A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT04459585·20 enrolled

ART1 trial

A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML

Recruiting·KKura Oncology, Inc.·Phase 1·NCT05735184·420 enrolled

7 more indications

MACE1 trial

Combination of Quizartinib and Omacetaxine Mepesuccinate for AML Carrying FLT3-ITD

Unknown status·TThe University of Hong Kong·Phase 2·NCT03135054·40 enrolled

Hepatic Impairment1 trial

Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT06740799·12 enrolled

Moderate Hepatic Impairment1 trial

A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT04473664·12 enrolled

Myelodysplastic/Myeloproliferative Neoplasm1 trial

Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04493138·58 enrolled

Azacytidine1 trial

Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (VENP-A-QUI)

Not yet recruiting·PPETHEMA Foundation·Phase 3·NCT07478991·376 enrolled

Heart1 trial

A Study to Evaluate QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT06772246·70 enrolled

Leukemia1 trial

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT06578247·700 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 20, 2023

VANFLYTA

NDA NDA216993

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Quizartinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Quizartinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Quizartinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216993). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vanflyta. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Daiichi Sankyo company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Macrophage Colony Stimulating Factor Receptor Inhibitor; Platelet-Derived Growth Factor Receptor Inhibitor; Stem Cell Growth Factor Receptor Inhibitor; Tyrosine-Protein Kinase Receptor FLT3 Inhibitor; Tyrosine-Protein Kinase Receptor FLT3 Inhibitor; Tyrosine-Protein Kinase Receptor RET Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Daiichi Sankyo

Patent Landscape[5]

Patent Cliff

Mar 16, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8129374Mar 16, 2027

9585892Mar 16, 2027

8557810Mar 16, 2027

8883783Mar 16, 2027

7820657Sep 26, 2028

6 more patents

7968543Aug 15, 2029

8865710Aug 15, 2029

8836218Mar 23, 2030

9555040May 14, 2030

8357690Feb 26, 2031

9675549Sep 30, 2033

Vanflyta

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q1 2028

Q2 2030

Trials by Indication[1]

Acute Myeloid Leukemia13 trials

Myelodysplastic Syndrome4 trials

Newly Diagnosed3 trials

Tics3 trials

ART1 trial

MACE1 trial

Hepatic Impairment1 trial

Moderate Hepatic Impairment1 trial

Myelodysplastic/Myeloproliferative Neoplasm1 trial

Azacytidine1 trial

Heart1 trial

Leukemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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