Data updated: Jun 28, 2026
BOSUTINIB (bosutinib monohydrate)
Trial Activity: Declining 6 active trials
Oncology
Approved 2026-06-12
Development Insights
Pfizer conducting 17 trials (43%)
65 indications explored (Broad Platform)
→ chronic myeloid leukemia (4 trials)
→ healthy (4 trials)
→ renal disease, end-stage (4 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2026-06-12
- Routes
- FILM COATED
- Dosage Forms
- TABLET
BOSUTINIB Approval History
Original
New Indication
New Form
Label Update
2 FDA actions from 2026 to 2026
What BOSUTINIB Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2026) NewLetter
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Clinical Trial Registry
34 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04877522 | CABL001A2001B 2021-000602-17, 2023-507557-16-00 | Ph 4 | recruiting | Asciminib Roll-over Study |
| NCT04971226 results posted | CABL001J12301 2023-508838-33-00 | Ph 3 | active not recruiting | A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP |
| NCT03297606 CAPTUR | PM1 ESR-17-12831, CA209-9DL | Ph 2 | recruiting | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) |
| NCT03654768 results posted | S1712 NCI-2017-02066, S1712 | Ph 2 | active not recruiting | Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia |
| NCT04258943 | AAML1921 ITCC-054, 2015-002916-34 | Ph 1, Ph 2 | active not recruiting | Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia |
| NCT03831776 BosuPeg | BosuPeg TRIAL 2018-001044-54 | Ph 2 | completed | Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis |
| NCT06423911 POLARIS-2 | HQP1351CG301 | Ph 3 | recruiting | Study of Olverembatinib (HQP1351) in Patients With CP-CML |
| NCT03106779 results posted | CABL001A2301 2016-002461-66 | Ph 3 | completed | Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs |
| NCT03854903 | STUDY00000057 | Ph 1 | completed | WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor |
| NCT05032690 results posted | B1871062 2021-004911-24 | Ph 1 | completed | Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule |
| NCT02311998 results posted | 2014-0435 NCI-2014-02606, 2014-0435 | Ph 1, Ph 2 | completed | Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML |
| NCT02810990 BEST | CML1516 2016-002216-40 | Ph 2 | completed | Bosutinib in Elderly Chronic Myeloid Leukemia |
| NCT03023319 | EXP-16-01 | Ph 1 | completed | Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors |
| 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 |
| NCT03128411 results posted | B1871048 | Ph 2 | completed | Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia |
| NCT02228382 results posted | B1871039 2013-003250-25, BYOND | Ph 4 | terminated | Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors |
| NCT00880009 results posted | 3160A6-2207 B1871010, 2008-006252-21 | Ph 2 | terminated | Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer |
| NCT02130557 results posted | AV001 2013-005101-31, B1871053 | Ph 3 | completed | A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia |
| NCT02782403 | 2015-0787 NCI-2016-01188, 2015-0787 | Ph 1 | terminated | Axitinib and Bosutinib in Treating Patients With Chronic, Accelerated, or Blastic Phase Chronic Myeloid Leukemia |
| NCT02638467 | alloCML | Ph 2 | completed | Allogeneic Stem Cell Transplantation in Chronic Myeloid Leukemia Failing TKIs Therapy |
| NCT02906696 results posted | 2016-0081 NCI-2016-01954, 2016-0081 | Ph 2 | terminated | Bosutinib in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase After Frontline TKI Failure |
| NCT02445742 BOSTRO | BOS-IIG-01 | Ph 2 | completed | CML Treated With Bosutinib After Relapse |
| NCT00574873 results posted | 3160A4-3000 B1871008, 2007-003780-50 | Ph 3 | completed | Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML |
| NCT01331291 results posted | 10-190 | Ph 2 | completed | Bosutinib in Adult Patients With Recurrent Glioblastoma |
| NCT01233869 results posted | B1871019 3160A7-2211, 2010-023017-65 | Ph 2 | completed | Bosutinib For Autosomal Dominant Polycystic Kidney Disease |
| NCT02102633 | B1871043 | Ph 1 | completed | Drug Interaction Study Between Bosutinib And Dabigatran |
| NCT00959946 results posted | 3160A6-2208 B1871011 | Ph 1, Ph 2 | terminated | Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer |
| NCT00793546 results posted | 3160A6-2206 B1871009 | Ph 2 | terminated | Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer |
| NCT01233882 | B1871020 | Ph 1 | completed | Bosutinib In Subjects With Renal Impairment |
| NCT01374139 | B1871035 | Ph 1 | completed | Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects |
| NCT00952913 | 3160A4-1108 B1871002 | Ph 1 | completed | Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects |
| NCT00759837 | 3160A4-1111 | Ph 1 | completed | Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects |
| NCT00725426 | 3160A4-1106 | Ph 1 | completed | Effect of Rifampin on Bosutinib When Both Are Given to Healthy People |
| NCT00721474 | 3160A4-1110 | Ph 1 | completed | Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
BOSUTINIB FDA Label Details
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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