Delving into the Latest Updates on Bosutinib Monohydrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

BOSUTINIB, bosutinib (as monohydrate), Bosutinib Hydrate

+ [12]

Target

Bcr-Abl x SRC

Action

inhibitors

Mechanism

Bcr-Abl inhibitors(Bcr-Abl tyrosine kinase inhibitors), SRC inhibitors(Tyrosine-protein kinase SRC inhibitors)

Therapeutic Areas

NeoplasmsCardiovascular DiseasesCongenital Disorders+ [4]

Active Indication

Chronic Myelogenous LeukemiaDuctus Arteriosus, PatentAccelerated phase Philadelphia chromosome positive chronic myeloid leukemia+ [11]

Inactive Indication

Acute Kidney InjuryAdvanced Bile Duct CarcinomaAdvanced breast cancer+ [12]

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Inc.Pfizer Europe MA EEIG

Pfizer Australia Pty Ltd.

+ [3]

Inactive Organization

Wyeth AB

Roche Farma SAPfizer Pharmaceuticals Korea Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (04 Sep 2012),

Philadelphia chromosome positive chronic myelogenous leukemia

RegulationAccelerated Approval (United States), Orphan Drug (United States), Special Review Project (China), Orphan Drug (Japan)

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Structure/Sequence

Molecular FormulaC26H31Cl2N5O4

InChIKeyBXPOSPOKHGNMEP-UHFFFAOYSA-N

CAS Registry918639-08-4

The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice.
This study is seeking for participants who are:
* Adult Patients who are just confirmed to have Chronic Myeloid Leukemia (CML) defined in Local Product Document (LPD). CML is a type of cancer that starts in the blood-forming cells of the bone marrow and invades the blood. LPD explains what a medicine's benefits and problems are. LPD also explains how to use the medicine correctly in Korea.
* willing to take part in the study after being informed about the study. All participants in this study will receive bosulif. All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD. The participants will be treated with bosulif under routine clinical practice in Korea.
The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.
In this study all treatment and checking of the patients will be done as per the study doctor. The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study.

Start Date31 Aug 2024

Sponsor / Collaborator

Pfizer Inc.

NCT06423911

/ RecruitingPhase 3

This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia

A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)

Start Date05 Feb 2024

Sponsor / Collaborator

Ascentage Pharma Group, Inc.

100 Clinical Results associated with Bosutinib Monohydrate

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100 Translational Medicine associated with Bosutinib Monohydrate

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100 Patents (Medical) associated with Bosutinib Monohydrate

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1,459

Literatures (Medical) associated with Bosutinib Monohydrate

31 Dec 2025·Virulence

Ponatinib and other clinically approved inhibitors of Src and Rho-A kinases abrogate dengue virus serotype 2- induced endothelial permeability

Article

Author: Awasthi, Mansi ; Modak, Ayan ; Sobha, Archana ; Sreekumar, Easwaran ; Mishra, Srishti Rajkumar

Severe dengue often presents as shock syndrome with enhanced vascular permeability and plasma leakage into tissue spaces. In vitro studies have documented the role of Src family kinases (SFKs) and RhoA-kinases (ROCK) in dengue virus serotype 2 (DENV2)-induced endothelial permeability. Here, we show that the FDA-approved SFK inhibitors Bosutinib, Vandetanib and Ponatinib, as well as the ROCK inhibitors, Netarsudil and Ripasudil significantly inhibit DENV2-induced endothelial permeability. In cultured telomerase immortalized human microvascular endothelial cells (HMEC-1), treatment with these inhibitors reduced the phosphorylation of VE-Cadherin, Src and myosin light chain 2 (MLC2) proteins that were upregulated during DENV2 infection. It also prevented the loss of VE-Cadherin from the inter-endothelial cell junctions induced by viral infection. In in-vivo studies using DENV2-infected AG129 IFN receptor-α/β/γ deficient mice, ponatinib, when administered 24 h post-infection onwards, demonstrated significant benefits in improving body weight, clinical outcomes, and survival rates. While all virus-infected, untreated mice died by day-10 post-infection, 80% of the ponatinib-treated mice survived, and approximately 60% were still alive at the end of the 15-day observation period. The treatment also significantly reduced disease severity factors such as vascular leakage, thrombocytopenia; mRNA transcript levels of proinflammatory cytokines such as IL-1β and TNF-α; and restored liver function. Comparable effects were observed even when ponatinib treatment was initiated after symptom onset. The results highlight ponatinib as an effective therapeutic option in severe dengue; and also a similar potential for other FDA- approved SFK and ROCK inhibitors.

31 Dec 2025·ANNALS OF MEDICINE

Construction of a novel prognostic model based on lncRNAs-related to DNA damage repair for predicting the prognosis of clear cell renal cell carcinoma

Article

Author: Chen, Peng ; Li, Jian ; Tian, Renli

BACKGROUND:

CcRCC has the characteristics of high aggression, high metastasis, high mortality, wide tumour heterogeneity and variable clinical course. The purpose of this study was to explore the potential value of lncRNAs-related to DNA damage repair (DDR) in predicting the prognosis of ccRCC by construction and verification a novel prognostic model.

METHODS:

RNA-seq data and clinical data of ccRCC were downloaded from public databases. Subsequently, Pearson correlation analysis and differential expression analysis were performed to identify DElncRNAs-related to DDR. Then, through univariate Cox analysis and LASSO analysis, the DElncRNAs-related to DDR associated with prognosis were screened for the construction of novel risk score prognostic model. In addition, functional annotation, tumour mutation burden, immune correlation and drug sensitivity analyses were performed based on risk score to assess the characteristics of patients in different risk score groups.

RESULTS:

Based on univariate Cox analysis and LASSO analysis, four best DElncRNAs-related to DDR were selected. Subsequently, a novel risk score prognostic model based on these four DElncRNAs was constructed through LASSO. Multivariate Cox analysis showed that risk score and age were independent prognostic factors for ccRCC (p < 0.05). Functional enrichment analysis showed that DDR-related biological processes were mainly enriched in the high risk group. The highly mutated genes in the high and low risk groups were the same (VHL, PBRM1 and TTN), but they also had their own unique mutated genes. Pearson correlation analysis showed that the risk score was significantly (p < 0.05) positively correlated with the infiltration degree of CD8 T cells evaluated by six algorithms. In addition, it was found that the high and low risk groups had different sensitivities to the drugs Etoposide, Imatinib, Sorafenib, Bosutinib and Sunitinib.

CONCLUSION:

A novel prognostic model was constructed based on four DElncRNAs-related to DDR. The model has satisfactory accuracy in predicting survival of ccRCC patients.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Non-optimal treatment with first tyrosine kinase inhibitor and associated economic burden in chronic myeloid leukemia

Article

Author: Guérin, Annie ; Romdhani, Hela ; Jadhav, Kejal ; Yang, Daisy ; Latremouille-Viau, Dominick ; Wei, David ; Kota, Vamsi

AIMS:

Although adenosine triphosphate (ATP)-competitive tyrosine kinase inhibitors (TKI) approved by the Food and Drug Administration have demonstrated effectiveness in treating chronic myeloid leukemia (CML), patients often experience intolerance or resistance, leading to non-optimal treatment (NOPT). This study assessed the treatment patterns, as well as NOPT and its associated economic burden, in newly diagnosed patients with CML receiving first TKI treatment.

METHODS:

This retrospective study identified adult patients with ≥2 CML diagnoses who initiated first TKI treatment (imatinib, dasatinib, nilotinib, or bosutinib) in 2012 or later from United States administrative health claims databases (01 January 2007-30 June 2022). Treatment sequence and time to treatment discontinuation/switch were assessed. NOPT, identified based on treatment modification/adherence criteria, and its associated incremental healthcare resource utilization and medical costs were evaluated.

RESULTS:

Nearly a quarter of patients experienced NOPT, as indicated by early treatment modifications or low treatment adherence. NOPT was associated with significant incremental healthcare resource utilization (80% more inpatient admissions; twice as many inpatient days; 30% more outpatient visits) and medical costs (adjusted mean cost difference = $13,551 per-patient-per-year).

LIMITATIONS:

Given the lack of information on reasons of treatment modification in health claims data, NOPT was identified based on indicators of management of intolerance and resistance to TKI.

CONCLUSION:

These findings highlight that unmet clinical needs and significant economic burden still persist in this population and that patients with CML may benefit from using therapeutic options with better efficacy and tolerability profiles as first treatment.

48

News (Medical) associated with Bosutinib Monohydrate

29 Aug 2025

·www.einpresswire.com

April - June 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Adcetris (brentuximab vedotin) Guillain-Barre syndrome FDA determined that no action is necessary at the time based on available information. Arzerra (ofatumumab) Gazyva (obinutuzumab) Riabni (rituximab-arrx) Rituxan (rituximab) Rituxan Hycela (rituximab and hyaluronidase human) Ruxience (rituximab-pvvr) Truxima (rituximab-abbs) Colitis FDA determined that no action is necessary at the time based on available information. Balversa (erdafitinib) Calciphylaxis The "Warnings and Precautions", "Patient Counseling Information", and the "Patient Information" sections of the labeling were updated in April 2022 to include information about soft tissue mineralization, including calciphylaxis. Balversa labeling Bavencio (avelumab) Keytruda (pembrolizumab) Opdivo (nivolumab) Yervoy (ipilimumab) Imfinzi (durvalumab) * Necrotizing fasciitis FDA determined that no action is necessary at this time based on available information. *An administrative error resulted in the omission of Imfinzi (durvalumab) from the list of product names. Imfinzi was added after the initial quarterly report was posted. Beta-blockers Betapace (sotalol hydrochloride) Brevibloc (esmolol hydrochloride) Bystolic (nebivolol) Byvalson (nebivolol and valsartan) Coreg (carvedilol) Coreg CR (carvedilol) Corgard (nadolol) Corzide (nadolol and bendroflumethiazide) Dutoprol (metoprolol succinate and hydrochlorothiazide) Kapspargo Sprinkle (metoprolol succinate) Lopressor HCT (metoprolol tartrate and hydrochlorothiazide) Sectral (acebutolol hydrochloride) Sotylize (sotalol hydrochloride) Tenoretic (atenolol and chlorthalidone) Toprol XL (metoprolol succinate) Trandate (labetalol hydrochloride) Ziac (bisoprolol fumarate and hydrochlorothiazide) Generic products containing beta-blockers Hemangeol (Propranolol Hydrochloride)* Inderal LA (Propranolol Hydrochloride)* Innopran XL (Propranolol hydrochloride)* Lopressor (metoprolol tartrate)* Tenormin (Atenolol)* Hypoglycemia in pediatric patients The "Warnings and Precautions" and "Patient Counseling Information" sections of the labeling were updated between March 2023 and June 2024 to add additional information regarding hypoglycemia. Example: Coreg labeling An administrative error resulted in the inclusion of Betapace AF, Levatol, and Zebeta in the list of product names at the time of the initial quarterly posting. *An administrative error resulted in the omission of Hemangeol, Inderal LA, Innopran XL, Lopressor, and Tenormin from the list of product names and was added after the initial quarterly report was posted. Bosulif (bosutinib monohydrate) Gleevec (imatinib mesylate) Iclusig (ponatinib) Sprycel (dasatinib) Tasigna (nilotinib) Osteonecrosis The "Adverse Reactions" section of the Tasigna labeling was updated in February 2024 to include information about osteonecrosis. Tasigna labeling FDA determined that Gleevec and Sprycel are adequately labeled for osteonecrosis, and that no further regulatory action is needed at this time. FDA determined no action is necessary at this time for Iclusig and Bosulif based on available information. Cablivi (caplacizumab-yhdp) Hemorrhage The "Warnings and Precautions", "Drug Interactions", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about life-threatening and fatal bleeding. Cablivi labeling Cyramza (ramucirumab) Cardiac failure The "Adverse Reactions" section of the labeling was updated in March 2022 to include information about heart failure. Cyramza labeling Doxil (doxorubicin hydrochloride) Acute interstitial pneumonitis FDA determined that no action is necessary at the time based on available information. Gleevec (imatinib mesylate) Tasigna (nilotinib) Myasthenia gravis FDA determined that no action is necessary at the time based on available information. Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (ribociclib; letrozole) Verzenio (abemaciclib) Radiation recall phenomenon FDA determined that no action is necessary at the time based on available information. Lokelma (sodium zirconium cyclosilicate) Gastrointestinal disorders FDA determined that no action is necessary at the time based on available information. Padcev (enfortumab vedotin-ejfv) Pancreatitis FDA determined that no action is necessary at the time based on available information. Padcev (enfortumab vedotin-ejfv) Pneumonitis The "Adverse Reactions", "Warnings and Precautions", and "Patient Counseling Information" sections of the labeling were updated in July 2021 to include information about pneumonitis. Padcev labeling Poteligeo (mogamulizumab-kpkc) Cytomegalovirus viraemia The "Adverse Reactions" section of the labeling was updated in March 2022 to include cytomegalovirus infection. Poteligeo labeling Procysbi (cysteamine bitartrate) Generic products containing cysteamine bitartrate Fibrosing colonopathy The "Warnings and Precautions", "Adverse Reactions", "Patient Information", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about fibrosing colonopathy. Example: Procysbi labeling Sarclisa (isatuximab-irfc) Herpes zoster The "Dosage and Administration", "Adverse Reactions", and "Patient Information" sections of the labeling were updated in July 2022 to include information about herpes zoster. Sarclisa labeling Sprycel (dasatinib) Drug-induced liver injury The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” and “Patient Information” sections of the labeling were updated in February 2023 to include information about hepatotoxicity. Sprycel labeling Taxotere (docetaxel) Rhabdomyolysis FDA determined that no action is necessary at the time based on available information. Veklury (remdesivir) Bradycardia FDA determined that no action is necessary at the time based on available information. Zepzelca (lurbinectedin) Extravasation The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in April 2022 to include information about extravasation. Zepzelca labeling Zepzelca (lurbinectedin) Tumor lysis syndrome The “Adverse Reactions” section of the labeling was updated in April 2022 to include tumor lysis syndrome. Zepzelca labeling Zepzelca (lurbinectedin) Rhabdomyolysis The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in April 2022 to include rhabdomyolysis. Zepzelca labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

15 May 2025

·www.fiercebiotech.com

Kinase inhibitor biotech Enliven calls time on phase 1 HER2 solid tumor program

Enliven “plans to explore strategic alternatives for the ELVN-002 program and does not intend to pursue its development beyond 2025,\" the company said in a press release.\n Enliven Therapeutics has decided against taking its phase 1-stage solid tumor drug into further development next year in order to keep resources flowing toward its leukemia candidate.The Colorado-based biotech is currently evaluating ELVN-002, which is designed to inhibit the HER2 pathway in solid tumors, in a pair of phase 1 trials. One of these studies is looking at ELVN-002 in combination with AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu as a treatment for HER2-positive breast cancer. The other study is looking at ELVN-002 in combination with Roche’s Herceptin for patients with HER2-positive colorectal cancer.However, Enliven said in its first-quarter earnings release that it now “plans to explore strategic alternatives for the ELVN-002 program and does not intend to pursue its development beyond 2025.”Mothballing work on ELVN-002 means Enliven can prioritize the upcoming pivotal trial of ELVN-001. The small-molecule kinase inhibitor is designed to inhibit BCR-ABL gene fusion, which is the oncogenic driver of chronic myeloid leukemia (CML).In an ongoing phase 1 trial, 44% of 36 evaluable patients with previously treated CML have experienced a major molecular response—meaning the level of the BCR-ABL1 gene is reduced to 0.1% or less—by 24 weeks, the biotech reported in the same May 14 release.Multiple BCR-ABL tyrosine kinase inhibitors are marketed to treat CML in Novartis’ Gleevec and Tasigna, Bristol Myers Squibb’s Sprycel and Pfizer’s Bosulif. But Enliven said its latest data “compare favorably to precedent phase 1 trials of the approved BCR::ABL1 tyrosine kinase inhibitors, particularly given the more heavily pre-treated patient population in the ELVN-001 clinical trial.”“We continue to gain confidence and momentum in the program as the efficacy, safety and tolerability data consistently compare favorably to the approved BCR::ABL inhibitors,” Enliven’s CEO Sam Kintz added in yesterday’s release. “Looking towards the rest of the year, we remain focused on clinical execution as we prepare for the potential start of a pivotal trial for ELVN-001 in 2026,” Kintz added.Having called time on further development of ELVN-002, Enliven now expects the $289.6 million it ended March with to last into late 2027.

Phase 1ADCPROTACs

06 Feb 2025

·www.echemi.com

Pfizer Reports 2024 Earnings with $63.6 Billion Revenue and Concerns Over Innovation

On February 4, Pfizer announced its financial results for the fourth quarter and the entire year of 2024, revealing a total revenue of $63.6 billion, a 7% increase year-on-year. The fourth quarter alone saw revenues of $17.8 billion, reflecting a substantial 22% growth compared to the same period last year. However, the net profit for the year was $8.031 billion, with only $410 million generated in the fourth quarter, raising concerns among investors. Pfizer operates through three main business segments: Generic Medicines, Specialty Medicines, and Oncology. The Generic Medicines division reported annual revenues of $30.135 billion, a 2% decline from the previous year. In contrast, the Specialty Medicines segment achieved $16.652 billion in revenue, marking an 11% increase, while the Oncology division saw a 25% rise in revenue, totaling $15.612 billion. In the Generic Medicines segment, sales of the COVID-19 vaccine reached $5.353 billion, down 52% year-on-year. Despite this significant drop, there is no indication that the vaccine has fallen out of favor. Sales of apixaban totaled $7.366 billion, up 9%, although this product is nearing the end of its lifecycle. The pneumonia vaccine family generated $6.411 billion, a slight 1% decline. Notably, sales of Rimegepant, an oral CGRP inhibitor, surged to $1.263 billion, a 36% increase from 2022. The RSV bivalent vaccine Abrysvo brought in $755 million, down approximately $150 million from the previous year. Other pipeline products primarily consist of Pfizer's mature offerings, which generally experienced declines. In the Specialty Medicines sector, the drug Vyndaqel for transthyretin amyloidosis proved to be a significant revenue generator, contributing $5.411 billion in sales, a remarkable 64% increase. However, sales of tofacitinib fell 31% to $1.168 billion due to patent cliffs affecting the immediate-release formulation. The older drug ilaprazole saw sales of $690 million, down 17% year-on-year. Surprisingly, the antibiotic sufentanil still managed to generate $637 million in sales, despite a 4% decline, with a significant portion likely coming from China. The injectable ceftazidime-avibactam (Sivextro) achieved $586 million in sales, a 16% decline, marking it as the first cephalosporin antibiotic to surpass $500 million in sales since 2010. In the Oncology division, palbociclib generated $4.367 billion, down 8% year-on-year. Enzalutamide saw revenues of $2.039 billion, a 23% increase. The new drug padcev (enfortumab vedotin) performed exceptionally well, achieving $1.588 billion in sales during its first full fiscal year. Adcetris (brentuximab vedotin) also showed strong performance, with sales soaring to $1.089 billion. Axitinib generated $978 million, down 6%, while bosutinib remained stable at $645 million. Despite maintaining its position as the world's largest pharmaceutical company, Pfizer faces significant challenges regarding innovation and pipeline development. As of December 2024, the company's market capitalization stood at $150 billion, significantly lower than competitors such as Eli Lilly ($750 billion), Johnson & Johnson ($350 billion), AbbVie ($320 billion), Novo Nordisk ($300 billion), Merck ($250 billion), Roche ($220 billion), Novartis ($210 billion), and AstraZeneca ($200 billion). The pressure to innovate and expand its product pipeline remains a critical concern for Pfizer moving forward.

VaccineFinancial StatementDrug ApprovalClinical ResultBiosimilar

100 Deals associated with Bosutinib Monohydrate

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External Link

KEGG	Wiki	ATC	Drug Bank
D09728	Bosutinib Monohydrate	L01XE14	DB06616

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Myelogenous Leukemia	Japan	Pfizer Japan, Inc.	26 Sep 2014
Ductus Arteriosus, Patent	Australia	Pfizer Australia Pty Ltd.	29 Apr 2014
Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia	European Union	Pfizer Europe MA EEIG	27 Mar 2013
Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia	Iceland	Pfizer Europe MA EEIG	27 Mar 2013
Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia	Liechtenstein	Pfizer Europe MA EEIG	27 Mar 2013
Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia	Norway	Pfizer Europe MA EEIG	27 Mar 2013
Philadelphia chromosome positive chronic myeloid leukemia in blast crisis	European Union	Pfizer Europe MA EEIG	27 Mar 2013
Philadelphia chromosome positive chronic myeloid leukemia in blast crisis	Iceland	Pfizer Europe MA EEIG	27 Mar 2013
Philadelphia chromosome positive chronic myeloid leukemia in blast crisis	Liechtenstein	Pfizer Europe MA EEIG	27 Mar 2013
Philadelphia chromosome positive chronic myeloid leukemia in blast crisis	Norway	Pfizer Europe MA EEIG	27 Mar 2013
Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase	European Union	Pfizer Europe MA EEIG	27 Mar 2013
Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase	Iceland	Pfizer Europe MA EEIG	27 Mar 2013
Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase	Liechtenstein	Pfizer Europe MA EEIG	27 Mar 2013
Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase	Norway	Pfizer Europe MA EEIG	27 Mar 2013
Philadelphia chromosome positive chronic myelogenous leukemia	United States	PF Prism CV	04 Sep 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic phase chronic myeloid leukemia	Phase 3	United States	Pfizer Inc.	15 Jul 2014
Chronic phase chronic myeloid leukemia	Phase 3	Australia	Pfizer Inc.	15 Jul 2014
Chronic phase chronic myeloid leukemia	Phase 3	Belgium	Pfizer Inc.	15 Jul 2014
Chronic phase chronic myeloid leukemia	Phase 3	Canada	Pfizer Inc.	15 Jul 2014
Chronic phase chronic myeloid leukemia	Phase 3	Czechia	Pfizer Inc.	15 Jul 2014
Chronic phase chronic myeloid leukemia	Phase 3	Denmark	Pfizer Inc.	15 Jul 2014
Chronic phase chronic myeloid leukemia	Phase 3	Finland	Pfizer Inc.	15 Jul 2014
Chronic phase chronic myeloid leukemia	Phase 3	France	Pfizer Inc.	15 Jul 2014
Chronic phase chronic myeloid leukemia	Phase 3	Germany	Pfizer Inc.	15 Jul 2014
Chronic phase chronic myeloid leukemia	Phase 3	Hungary	Pfizer Inc.	15 Jul 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04258943 (ITCC-054/COG-AAML1921, EHA2025)	Phase 2	Norrie Disease BCR::ABL1	30	Bosutinib 300 mg/m2 QD	oscxcudart(botspohaod) = yjflrmarrp zuqcbdlehl (fukkimuraf, 90 - 100%) View more	Positive	14 May 2025
NCT03205267 (Bodo Trial (CML-VII-study of the German CML Study Group), ASH2024)	Phase 2	Chronic phase chronic myeloid leukemia Second line	45	Bosutinib	cgnwcnvgjk(hiipuufbat) = All pts had ≥1 any grade treatment emergent adverse event (TEAE), occuring a median of 15 days after starting bosutinib (range: 1 - 225 days) uzdwgbbktb (mqutvfeelo ) View more	Positive	07 Dec 2024
				Nilotinib
NCT02228382 (BYOND, Pubmed \| Leukemia) Manual	Phase 4	Chronic Myelogenous Leukemia Philadelphia Chromosome	163	Bosutinib 500 mg QD	sqitsdgbbd(casidqwfww) = dqeycefrlg judwfxsuli (oqcgujeznc, 63.9 - 78.9) View more	Positive	01 Oct 2024
NCT05032690 (CTgov)	Phase 1	-	32	Bosutinib (Treatment A: Bosutinib 1*100 mg Capsule Fed)	eiwlyksxeg(zqqlamsews) = pybiylwudl qzvjnbndne (ocxifxtblc, 32) View more	-	20 Sep 2024
				Bosutinib (Treatment B: Bosutinib 4*25 mg Capsule Fed)	eiwlyksxeg(zqqlamsews) = ckjamfarfx qzvjnbndne (ocxifxtblc, 39) View more
JPRN-jRCTs071180012 (EHA 12024 \| EHA 22024) Manual	Phase 2	Philadelphia chromosome positive chronic myelogenous leukemia	35	Bosutinib	otcpfekqek(lpbdityskr) = xfxyufbgxq ctjezvqiza (gmfutkenus, 5.2 - 23.2) Met View more	Positive	14 May 2024
NCT02228382 (BYOND, Pubmed) Manual	Phase 4	Philadelphia chromosome positive chronic myelogenous leukemia Philadelphia chromosome-positive	156	Bosutinib500mg once daily	gisyznhdvx(tejlyhuypr) = pixnnazdhu ajdtznfpcb (yvrlozowzb ) View more	Positive	01 Apr 2024
				Bosutinib 500mg once daily (dasatinib/nilotinib-resistant)	gisyznhdvx(tejlyhuypr) = ysnjuobuve ajdtznfpcb (yvrlozowzb ) View more
NCT04793399 (CTgov)	Phase 1/2	Chronic phase chronic myeloid leukemia \| Chronic leukemia \| Philadelphia chromosome positive chronic myelogenous leukemia	9	Atezolizumab+Bosutinib	igyuyzrfcm = bselurslni xekwbdkrcg (qzykcmtduw, wxwgczoqiy - dngfdkuurx) View more	-	12 Mar 2024
NCT04258943 (ITCC054 \| COG AAML1921, Pubmed) Manual	Phase 1	Chronic phase chronic myeloid leukemia EGFR T790M	27	Bosutinib 300-400 mg/m2 once daily	bucaywawyb(edrfhjkjza) = ramlohugta umstygqain (boeaoawsxc )	Positive	01 Mar 2024
				Bosutinib 300 mg/m2 once daily	rezuvcitgm(ejueyvzggo) = lvwhhbvovf mmdzywfxiw (ralmciggou ) View more
BOGI trial (ASH2023)	Phase 2	Philadelphia chromosome positive chronic myelogenous leukemia	35	Bosutinib 200 mg	pmngjckiaf(pbvsvteoyk) = ugsdhanwzp tyawcndnkz (bhhaqqlypn ) View more	-	10 Dec 2023
NCT02130557 (BFORE, FDA) Manual	Phase 3	Philadelphia chromosome positive chronic myelogenous leukemia First line	487	Bosutinib (mITT)	dyhwtnfjmb(cidwhwmqow) = jlavmxbnzi grcvllobsb (eejdqeemfx, 41 - 53) View more	Positive	26 Sep 2023
				Imatinib (mITT)	dyhwtnfjmb(cidwhwmqow) = dcgevpdpku grcvllobsb (eejdqeemfx, 31 - 43) View more