VANFLYTA

Growth

quizartinib

NDAORALTABLETPriority Review
Approved
Jul 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
25

Mechanism of Action

FLT3. Quizartinib and its major active metabolite AC886 bind to the adenosine triphosphate (ATP) binding domain of FLT3 with comparable affinity, and both had 10-fold lower affinity towards FLT3-ITD mutation compared to FLT3 in a binding assay. Quizartinib and AC886 inhibited FLT3 kinase activity,…

Clinical Trials (5)

NCT06824168Phase 2Recruiting

Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission

Started Jul 2025
130 enrolled
Acute Myeloid LeukemiaLeukemia
NCT06578247Phase 3Recruiting

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

Started Nov 2024
700 enrolled
Leukemia
NCT06740825Phase 1Completed

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

Started Oct 2024
32 enrolled
Healthy Subjects
NCT06772246Phase 1Completed

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

Started Oct 2024
70 enrolled
Healthy Subjects
NCT06740799Phase 1Recruiting

Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

Started Sep 2024
12 enrolled
Hepatic Impairment

Loss of Exclusivity

LOE Date
Sep 30, 2033
92 months away
Patent Expiry
Sep 30, 2033
Exclusivity Expiry
Jul 20, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
9585892
Mar 16, 2027
U-3661
8129374
Mar 16, 2027
U-3661
8883783
Mar 16, 2027
Substance
8557810
Mar 16, 2027
Product
7820657
Sep 26, 2028
Substance