BOSULIF (bosutinib monohydrate)
Bosulif is a medication used for adults and children at least one year old who have chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia. It helps patients who are newly diagnosed as well as those who have become resistant or intolerant to previous therapies. For adult patients, it also treats more advanced stages of the disease, including the accelerated and blast phases, when prior treatments are no longer effective or tolerated.
How BOSULIF Works
This drug works by inhibiting the BCR-ABL kinase, a protein that promotes the growth of chronic myelogenous leukemia. It also targets Src-family kinases, such as Src, Lyn, and Hck, and is effective against many forms of the disease that have developed resistance to other treatments. However, it does not inhibit specific mutant cells known as T315I and V299L.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-09-04
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
BOSULIF Approval History
What BOSULIF Treats
1 indicationsBOSULIF is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Myelogenous Leukemia
BOSULIF Target & Pathway
ProTarget
An abnormal fusion protein created by a chromosomal translocation, found in chronic myeloid leukemia (CML). BCR-ABL has constitutive kinase activity that drives leukemic cell proliferation. Targeting BCR-ABL transformed CML from a fatal disease to a manageable condition.
BOSULIF Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BOSULIF's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BOSULIF treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BOSULIF
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04655391 | 20456 NCI-2020-10595, 20456 | Ph 1 | withdrawn | Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BOSULIF FDA Label Details
Indications & Usage
FDA Label (PDF)BOSULIF is indicated for the treatment of Chronic Myelogenous Leukemia.
BOSULIF Patents & Exclusivity
Patents (8 active)
Exclusivity
Pro Intelligence Preview
Deep insights for BOSULIF
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 139 active patents
Trial Analysis
- • 40 total trials
- • Stage: Declining
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment