NDAORALCAPSULEPriority Review
Approved
Sep 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
BOSULIF (bosutinib) by Pfizer is tki. First approved in 2023.
Drug data last refreshed 2d ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BOSULIF (bosutinib) is an oral tyrosine kinase inhibitor (TKI) that targets BCR-ABL kinase and Src-family kinases to treat chronic myeloid leukemia (CML). It is indicated for patients with CML who are resistant or intolerant to imatinib and other BCR-ABL inhibitors. Bosutinib demonstrates activity against 16 of 18 imatinib-resistant BCR-ABL mutations, though not against T315I and V299L variants.
$0.199BPart D
Growth8.2 years to LOERecent 2023 approval in growth phase with $199M in Part D spending suggests expanding market penetration and active commercial team building.
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…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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
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
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
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
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.