Bosulif

(Bosutinib)

ApprovedProtein / enzyme

Bosutinib is used to treat a type of blood cancer called chronic myeloid leukemia (CML) by blocking proteins that help cancer cells grow and divide.[2] Bosulif is currently approved and in use across 8 indications[4].[1]

Bosulif is one of 247 small molecule programs targeting Lewy body dementia. It is currently in Approved.

Indications

Total Trials

Active Trials

246

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Lewy Body DementiaApproved

Glioblastoma MultiformeApproved

Breast CarcinomaApproved

Pancreatic CancerApproved

TrialRecruiting

Amyotrophic Lateral SclerosisCompleted

Chronic Myelogenous LeukemiaCompleted

Myeloid LeukemiaTerminated

Lewy Body DementiaApproved

Approved

Glioblastoma MultiformeApproved

Approved

Breast CarcinomaApproved

Approved

Pancreatic CancerApproved

Approved

TrialPhase 2

Recruiting

Amyotrophic Lateral SclerosisApproved

Completed

Chronic Myelogenous LeukemiaApproved

Completed

Myeloid LeukemiaApproved

Terminated

Competition

Competitive Landscape

335 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Bosulif

PPrism Pharmaceuticals

Approved

52 2

Medrol

Pfizer

Preclinical

1 3

Byetta

AstraZeneca

Preclinical

1 4

Ayvakit Sprinkle

MMemorial Sloan Kettering Cancer Center

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 6

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 7

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 8

Sulfonylureas

Eli Lilly

Preclinical

1 9

Active Comparator

Moderna

Preclinical

1 10

HS-20093

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Trial

NCT03297606

Q3 2028

Phase 2Active, not recruiting

Myeloid Leukemia

NCT03654768

Phase 1/2Active, not recruiting

Myeloid Leukemia

NCT04258943

Phase 3Recruiting

Chronic Myeloid Leukemia

NCT06423911

Q3 2030

ApprovedRecruiting

Chronic Myelogenous Leukemia

NCT04877522

Q1 2031

Phase 3Active, not recruiting

Chronic Myeloid Leukemia (CML)

NCT04971226

Clinical

Trials by Indication[1]

Myeloid Leukemia11 trials

Axitinib and Bosutinib in Treating Patients With Chronic, Accelerated, or Blastic Phase Chronic Myeloid Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT02782403·4 enrolled

Bosutinib in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase After Frontline TKI Failure

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT02906696·8 enrolled

Bosutinib in Elderly Chronic Myeloid Leukemia

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT02810990·65 enrolled

Show 8 more trials

Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors

Terminated· Pfizer logo

Pfizer·Phase 4·NCT02228382·163 enrolled

Allogeneic Stem Cell Transplantation in Chronic Myeloid Leukemia Failing TKIs Therapy

Completed·UUniversity of Milano Bicocca·Phase 2·NCT02638467·2 enrolled

Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis

Completed·SSt. Olavs Hospital·Phase 2·NCT03831776·212 enrolled

Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia

Active, not recruiting·SSWOG Cancer Research Network·Phase 2·NCT03654768·81 enrolled

Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database

Completed· Pfizer logo

Pfizer··NCT05286528·1,484 enrolled

Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia

Active, not recruiting·CChildren's Oncology Group·Phase 1/2·NCT04258943·60 enrolled

Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008

Completed· Pfizer logo

Pfizer·N/A·NCT01903733·281 enrolled

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

Completed· Pfizer logo

Pfizer··NCT05363488·17 enrolled

BOS7 trials

Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00777530·48 enrolled

Absolute Bioavailability Of Bosutinib

Completed· Pfizer logo

Pfizer·Phase 1·NCT02192294·14 enrolled

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

Completed· Pfizer logo

Pfizer·Phase 1·NCT04916769·18 enrolled

Show 4 more trials

Effect of Rifampin on Bosutinib When Both Are Given to Healthy People

Completed· Pfizer logo

Pfizer·Phase 1·NCT00725426·24 enrolled

A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands

Completed· Pfizer logo

Pfizer··NCT02546375·87 enrolled

Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01374139·88 enrolled

Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT02311998·22 enrolled

Chronic Myelogenous Leukemia5 trials

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Completed· Pfizer logo

Pfizer·Phase 3·NCT02130557·536 enrolled

Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Completed· Pfizer logo

Pfizer·Phase 2·NCT03128411·64 enrolled

A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors

Completed· Novartis logo

Novartis·Phase 3·NCT03106779·233 enrolled

Show 2 more trials

DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)

Completed· Pfizer logo

Pfizer··NCT02501330·702 enrolled

An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

Recruiting· Novartis logo

Novartis·Approved·NCT04877522·347 enrolled

Breast Cancer4 trials

Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00880009·16 enrolled

WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor

Completed·GGeorgetown University·Phase 1·NCT03854903·19 enrolled

Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer

Terminated· Pfizer logo

Pfizer·Phase 1/2·NCT00959946·32 enrolled

Show 1 more trial

Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00793546·42 enrolled

Tyrosine Kinase Inhibitors2 trials

The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)

Completed·MMedical College of Wisconsin·Phase 2·NCT02269267·173 enrolled

Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients

Completed·UUNC Lineberger Comprehensive Cancer Center··NCT03885830·45 enrolled

21 more indications

Oral2 trials

Palatability (Taste) of Oral Formulations of Bosutinib

Completed· Pfizer logo

Pfizer·Phase 1·NCT03747679·8 enrolled

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

Completed· Pfizer logo

Pfizer·Phase 1·NCT05032690·32 enrolled

Interaction2 trials

A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT02058277·20 enrolled

Drug Interaction Study Between Bosutinib And Dabigatran

Completed· Pfizer logo

Pfizer·Phase 1·NCT02102633·27 enrolled

Renal Impairment1 trial

Bosutinib In Subjects With Renal Impairment

Completed· Pfizer logo

Pfizer·Phase 1·NCT01233882·34 enrolled

Pediatric1 trial

Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition

Completed· Pfizer logo

Pfizer·Phase 1·NCT04549480·66 enrolled

Autosomal Dominant Polycystic Kidney Disease1 trial

Bosutinib For Autosomal Dominant Polycystic Kidney Disease

Completed· Pfizer logo

Pfizer·Phase 2·NCT01233869·172 enrolled

Single Dose1 trial

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

Completed· Pfizer logo

Pfizer·Phase 1·NCT00721474·24 enrolled

Dementia1 trial

Study for the Use of TKIs for Treatment of Cognitive Decline Due to Degenerative Dementias

Unknown status·NNeurological Associates of West Los Angeles·Phase 1·NCT02921477·150 enrolled

Advanced Malignant Solid Tumors1 trial

Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT00195260·151 enrolled

Trial1 trial

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT03297606·720 enrolled

Tics1 trial

Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00952913·24 enrolled

Philadelphia Chromosome Positive CML1 trial

Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

Completed· Pfizer logo

Pfizer·Phase 3·NCT00574873·502 enrolled

Leukemia1 trial

Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias

Completed· Pfizer logo

Pfizer·Phase 2·NCT00261846·571 enrolled

Treatment1 trial

A Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib)

Unknown status·NNational Research Center for Hematology, Russia·Phase 2·NCT04578847·100 enrolled

Metastatic Solid Tumors1 trial

Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

Completed·NNagla Abdel Karim·Phase 1·NCT03023319·6 enrolled

Glioblastoma1 trial

Bosutinib in Adult Patients With Recurrent Glioblastoma

Completed·MMassachusetts General Hospital·Phase 2·NCT01331291·36 enrolled

Liver Disease1 trial

Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00759837·27 enrolled

Relapse1 trial

CML Treated With Bosutinib After Relapse

Completed·PPETHEMA Foundation·Phase 2·NCT02445742·30 enrolled

Chronic Myeloid Leukemia1 trial

A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 3·NCT06423911·333 enrolled

Chronic Myeloid Leukemia (CML)1 trial

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Active, not recruiting· Day One Biopharmaceuticals logo

Day One Biopharmaceuticals·Phase 3·NCT04971226·405 enrolled

Amyotrophic Lateral Sclerosis1 trial

Phase 1/2 Study of Bosutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)

Completed·KKyoto University·Preclinical·NCT04744532·46 enrolled

Dementia With Lewy Bodies1 trial

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Bosutinib on Safety, Tolerability, Biomarkers and Clinical Outcomes in Dementia With Lewy Bodies (DLB)

Completed·GGeorgetown University·Phase 2·NCT03888222·26 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 4, 2012

BOSULIF

NDA NDA203341

Sep 26, 2023

BOSULIF

NDA NDA217729

Sources

References

[1]
ClinicalTrials.gov — 52 trial records for Bosutinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Bosulif drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bosutinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bosutinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217729). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Bosulif. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Prism Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bcr/abl Fusion Protein Inhibitor; Tyrosine-Protein Kinase HCK Inhibitor; Tyrosine-Protein Kinase Lyn Inhibitor; Tyrosine-Protein Kinase SRC Inhibitor; Tyrosine-Protein Kinase ABL Inhibitor[3]
Modality: Protein / enzyme[3]
Highest Phase: Approved[1]
Company: PPrism Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Nov 23, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7919625Dec 11, 2025

7417148Dec 11, 2025

7417148*PEDJun 11, 2026

7919625*PEDJun 11, 2026

7767678Nov 23, 2026

3 more patents

7767678*PEDMay 23, 2027

11103497Feb 28, 2034

11103497*PEDAug 28, 2034

Bosulif

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2028

Q3 2030

Q1 2031

Trials by Indication[1]

Myeloid Leukemia11 trials

BOS7 trials

Chronic Myelogenous Leukemia5 trials

Breast Cancer4 trials

Tyrosine Kinase Inhibitors2 trials

Oral2 trials

Interaction2 trials

Renal Impairment1 trial

Pediatric1 trial

Autosomal Dominant Polycystic Kidney Disease1 trial

Single Dose1 trial

Dementia1 trial

Advanced Malignant Solid Tumors1 trial

Trial1 trial

Tics1 trial

Philadelphia Chromosome Positive CML1 trial

Leukemia1 trial

Treatment1 trial

Metastatic Solid Tumors1 trial

Glioblastoma1 trial

Liver Disease1 trial

Relapse1 trial

Chronic Myeloid Leukemia1 trial

Chronic Myeloid Leukemia (CML)1 trial

Amyotrophic Lateral Sclerosis1 trial

Dementia With Lewy Bodies1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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