BOSULIF

GrowthSM

bosutinib

NDAORALCAPSULEPriority Review
Approved
Sep 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

TKI. Bosutinib inhibits the BCR-ABL kinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck. Bosutinib inhibited 16 of 18 imatinib-resistant forms of BCR-ABL kinase expressed in murine myeloid cell lines. Bosutinib did not inhibit the T315I and V299L…

Clinical Trials (5)

NCT06297161N/AActive Not Recruiting

A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML).

Started Jan 2025
600 enrolled
Chronic Leukemia Myelogenous
NCT05032690Phase 1Completed

Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule

Started Jan 2022
32 enrolled
Healthy Participants
NCT05363488N/ACompleted

Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland

Started Oct 2021
17 enrolled
Myeloid Leukemia
NCT05743465N/ACompleted

A Study to Evaluate Available Treatment Information of Ponatinib, Bosutinib, Imatinib, Dasatinib and Nilotinib in Adults With Chronic Myeloid Leukemia

Started Oct 2021
1,769 enrolled
Leukemia
NCT04916769Phase 1Completed

Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition

Started Aug 2021
18 enrolled
Healthy Participants

Loss of Exclusivity

LOE Date
Aug 28, 2034
103 months away
Patent Expiry
Aug 28, 2034
Exclusivity Expiry
Mar 26, 2031

Patent Records (5)

Patent #ExpiryTypeUse Code
7919625
Dec 11, 2025Expired
Product
7417148
Dec 11, 2025Expired
U-3708
7919625*PED
Jun 11, 2026
7417148*PED
Jun 11, 2026
7767678
Nov 23, 2026
SubstanceProduct