An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Bosutinib Tablets 100 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with Bosulif (bosutinib) 100 mg, Manufactured and Packed by: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee, Freiburg, Germany, Imported by: Pfizer Brasil Ltda. Rodovia Presidente Castelo Branco, nº32501, km 32.5 CEP 06696-000 – Itapevi – SP, in healthy adult, human subjects under fed condition.

Start Date31 Jan 2025

Sponsor / Collaborator

Sun Pharmaceutical Industries Ltd.

NCT06297161

/ RecruitingNot Applicable

Post Marketing Surveillance Study to Observe Safety and Effectiveness of BOSULIF

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:
1. Patients who are being treated* or will be treated with Bosulif according to it's local product document under routine clinical practice (*Patients who initiated Bosulif treatment within one year before consent)
2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of 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 Date20 Jan 2025

Sponsor / Collaborator

Pfizer Inc.

CTIS2024-516511-24-00

/ CompletedPhase 4

A Patient guided dose reduction strategy of tyrosine kinase inhibitors in chronic myeloid leukaemia: RODEO study

Start Date14 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Bosutinib Monohydrate

100 Translational Medicine associated with Bosutinib Monohydrate

100 Patents (Medical) associated with Bosutinib Monohydrate

1,290

Literatures (Medical) associated with Bosutinib Monohydrate

01 May 2027·Value in Health Regional Issues

Cost-Effectiveness Analysis of Asciminib in Patients With Chronic Phase Chronic Myeloid Leukemia Previously Treated With 2 or More Tyrosine Kinase Inhibitors in Colombia

Article

Author: Ospina, Juan Alejandro ; Prieto, Natalia ; Lasalvia, Pieralessandro ; Jaramillo, Paola ; Ceballos, Mateo ; Abello, Virginia ; Arias, Sara

OBJECTIVES:

To assess the cost-effectiveness of asciminib in adult patients with chronic-phase chronic myeloid leukemia who have been treated with 2 or more tyrosine kinase inhibitors, from a third-party payer perspective in Colombia.

METHODS:

A nonhomogeneous partitioned survival model was developed using ASCEMBL trial and matching-adjusted indirect comparisons. Outcomes included overall survival, progression-free survival, and safety. Overall survival was modeled using exponential functions based on 6-month major molecular response rates. Quality-adjusted life-years (QALYs) were estimated using phase-specific utilities. Direct medical costs were obtained from national public databases (2024-2025) and expressed in 2025 USD (USD 1 = COP 4053). A 30-year time horizon was applied. Base case compared asciminib with bosutinib and ponatinib. Scenario analyses included nilotinib and dasatinib because they are rarely used in third line in Colombia. Sensitivity analyses explored ponatinib dose deescalation, generic drug pricing, asciminib price thresholds, relative dose intensity, and alternative overall survival assumptions. Probabilistic sensitivity analyses were performed.

RESULTS:

Asciminib was dominant compared with bosutinib and ponatinib, yielding more QALYs (0.41 and 0.20) and lower costs (-USD 47 334 and -USD 88 554). Scenario analyses including nilotinib and dasatinib favored asciminib, with higher QALYs (0.32 and 0.25) and lower costs (-USD 43 785 and -USD 6400). Results remained robust across analyses, including ponatinib dose deescalation, generic pricing, relative dose intensity, and alternative overall survival assumptions.

CONCLUSIONS:

Asciminib was a dominant treatment option for patients with chronic-phase chronic myeloid leukemia who have been treated with 2 or more tyrosine kinase inhibitors, offering clinical and economic advantages over other pharmacological treatments.

01 Dec 2026·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Synthesis and in silico evaluation of novel hybrid 1,4-benzothiazine-1,1-dioxide–bis(1,2,3-triazole) derivatives as potential SRC kinase inhibitors via 1,3-dipolar cycloaddition

Article

Author: Altharawi, Ali ; Riadi, Yassine ; Madkhali, Hassan A ; Taha, Mohamed Labd ; Elmachkouri, Younesse Ait ; Irrou, Ezaddine ; Kumar, Chagaleti Bharath ; Azzallou, Rachid ; Aldakhil, Taibah ; Altamimi, Abdulmalik A S

Herein, we report the synthesis of new 1,4-benzothiazine-1,1-dioxide derivatives bearing bis(1,2,3-triazole) moieties via click chemistry in good to high yields and fully characterized by ¹H NMR, ¹³C NMR and HRMS. The compounds were evaluated using a combined in silico approach, including physicochemical, pharmacokinetic and toxicity analysis, molecular docking and molecular dynamics studies. Drug-like properties of all compounds were favourable. Molecular docking against SRC kinase suggested binding affinities ranging from -7.14 to -8.13 kcal/mol. Compound 11 displayed the most favorable docking score (-8.13 kcal/mol), comparable to that of bosutinib (-8.54 kcal/mol), and formed key interactions within the active site. This finding was consistent with the 100 ns molecular dynamics simulations, which indicated that the SRC-compound 11 complex remained structurally stable and maintained key interactions with residues such as Met341, Tyr340 and Lys295. Despite showing conformational flexibility than bosutinib, compound 11 maintained stable binding throughout the simulation. Overall, compound 11 showed favorable predicted binding toward SRC kinase, suggesting that these bis-triazole derivatives may represent potential leads for future anticancer investigation.

01 Dec 2026·BIOCHEMICAL PHARMACOLOGY

Allosteric kinase inhibition in hematological malignancies: from asciminib to emerging regulatory sites

Review

Author: Marx, Ailie ; Cohen, Maor ; Mahajna, Jamal ; Ruthardt, Martin

ATP-site resistance mutations, exemplified by T315I in BCR::ABL1, limit the durability of kinase inhibitor therapy in hematological malignancies. Allosteric sites outside the catalytic cleft offer an alternative: ligands that bind regulatory pockets can stabilize inactive conformations and retain activity against mutations that defeat ATP-site drugs. Several reviews have addressed this principle across the kinome, but none has applied a hematology-focused druggability appraisal anchored in the BCR::ABL1/asciminib precedent. This review fills that gap with two contributions: mechanistic evidence that crizotinib engages BCR::ABL1 through a putative dual ATP-site/myristoyl-pocket mechanism, supported by indirect evidence and pending direct structural confirmation; and a hypothesis linking recurrent synonymous mutations in non-receptor tyrosine kinases to transiently structured regulatory regions, as a strategy for identifying latent allosteric sites. Asciminib is the proof of concept. It binds the MBP of ABL1, locking the kinase in an autoinhibited-like state without competing for ATP. In the ASCEMBL trial, it achieved a major molecular response rate of 25.5% at 24 weeks versus 13.2% for bosutinib in heavily pretreated CML, with better tolerability-the first regulatory-site inhibitor approved for a hematological malignancy. The question is whether this can extends further. Dual-site strategies may raise the barrier to resistance, but the structural and biochemical validation remains incomplete for FLT3, JAK2, and BTK. Asciminib resistance is already real: A337V and P465S mutations reduce binding, and bypass signaling adds another layer. Each approved allosteric agent-asciminib, trametinib, and ivosidenib-required extensive structural and functional validation before reaching the clinic; structural prediction alone is not enough.

News (Medical) associated with Bosutinib Monohydrate

06 Oct 2026

·www.prnewswire.com

Enliven Therapeutics Announces FDA Alignment on ENABLE-2 Phase 3 Trial Design for Relcobatinib (ELVN-001) in Previously Treated Chronic Myeloid Leukemia

Enliven remains on track to initiate ENABLE-2 before year-end 2026 BURLINGAME, Calif., Oct. 6, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced that it has reached alignment with the U.S. Food and Drug Administration (FDA) on the final design of the ENABLE-2 pivotal trial, a Phase 3 trial of relcobatinib (ELVN-001) in patients with previously treated chronic myeloid leukemia (CML). United States Adopted Names (USAN) Council has adopted relcobatinib as the nonproprietary name for ELVN-001. Relcobatinib is an investigational, potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver of CML. "We are pleased to have reached alignment with the FDA on the design of the ENABLE-2 pivotal Phase 3 trial, providing a clear path to initiate the trial before year-end," said Helen Collins, M.D., Chief Medical Officer of Enliven. "ENABLE-2 is designed to directly compare relcobatinib to the second-generation TKIs and evaluate its potential to be the best-in-class ATP-competitive inhibitor for patients with CML. We are encouraged by the enthusiasm from physicians and the broader CML community as we prepare to initiate the trial." ENABLE-2 Phase 3 Trial Design: A 2L+ Pivotal Trial for Patients with CML ENABLE-2 is a planned randomized 2L+ phase 3 trial expected to enroll approximately 450 adults with CML previously treated with one or more tyrosine kinase inhibitors (TKIs). Participants will be randomized 1:1 to receive either relcobatinib 80 mg once daily or an investigator-selected second-generation TKI (dasatinib, nilotinib, or bosutinib). The primary endpoint is major molecular response (MMR) at Week 24, with the key secondary endpoint of MMR at Week 96. With approximately 450 patients, the trial is designed such that an improvement in MMR rate of at least 10 percentage points over the control arm would be sufficient to demonstrate statistical superiority. We believe this difference would represent a clinically meaningful improvement over currently available second-generation TKIs. The Company remains on track to initiate ENABLE-2 before year-end 2026. About Enliven Therapeutics Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Burlingame, California. To learn more, visit and connect with us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of Enliven's management, as well as assumptions made by, and information currently available to, Enliven's management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to: statements regarding the potential of, and plans regarding, market opportunities, and expectations regarding relcobatinib (ELVN-001); statements regarding the potential profile, activity, selectivity, safety, tolerability, efficacy, differentiated attributes, therapeutic benefit and potential best-in-class or complementary profile of relcobatinib to allosteric inhibitors; the interpretation of data from the ongoing ENABLE trial, including MMR rate, safety and tolerability data; comparisons to historical or precedent clinical trial results; the timing, content and availability of additional clinical data and presentation materials; the continued conduct, design, objectives, endpoints, dose selection and future clinical evaluation of relcobatinib, including the planned ENABLE-2 Phase 3 trial, the statistical power, sample size assumptions and expected treatment effect sizes for ENABLE-2 and the belief that such treatment benefit would be clinically meaningful, the potential timing of initiation of ENABLE-2, the potential timing and outcome of further FDA discussions and the finalization of additional Phase 3 trial design details; and statements by Enliven's Chief Medical Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation the limited operating history of Enliven; the potential for interim, topline and preliminary results from Enliven's clinical trials to materially change as additional patient data become available or following more comprehensive review; the potential for results from the ongoing or any future clinical trial of relcobatinib to differ from the results of earlier trials of relcobatinib; relcobatinib failing to demonstrate sufficient safety, efficacy, tolerability, durability, differentiated attributes or therapeutic benefit in current or future clinical trials; risks associated with unexpected events during the remainder of the ENABLE trial including serious adverse events, toxicities, dose reductions, discontinuations or other undesirable side effects; delays or difficulties in recruiting, enrolling or maintaining patients in relcobatinib clinical trials; the risks of delays in completing the ongoing ENABLE trial or initiating ENABLE-2; Enliven failing to complete the ongoing ENABLE trial, to present additional data, to initiate ENABLE-2 or to advance relcobatinib through clinical development; regulatory authorities disagreeing with Enliven's clinical trial design, dose selection, endpoints or interpretation of data, or requiring additional studies or diagnostics; the risk that statistical assumptions underlying the ENABLE-2 trial design may not hold, including assumptions regarding treatment effect sizes, comparator arm performance and statistical power; lack of reliability of cross-trial comparisons because the referenced data are derived from different clinical trials at different points in time, with differences in trial design and patient populations, and results may differ in head-to-head studies; developments relating to Enliven's competitors and industry which may affect the development or potential market opportunity for relcobatinib; and the potential inability of Enliven to obtain regulatory approval for, or ultimately commercialize or license, relcobatinib or other product candidates; Enliven's limited resources; Enliven's limited experience as a company in designing and conducting clinical trials; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geopolitical developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and Form 10-Q filed with the SEC and in Enliven's future SEC filings. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. SOURCE Enliven Therapeutics, Inc. 21% more press release views with Request a Demo

Phase 3Phase 2

24 Aug 2026

·www.prnewswire.com

BRC Therapeutics Appoints Biopharma Veteran Chandra Ramanathan as Executive Vice President of Commercialization and Strategy

Seasoned Executive Brings Track Record of Drug Launches, External Innovation, and Portfolio Growth at Bristol Myers Squibb, Wyeth, Bayer, and Danaher to BRC's Next Phase of Growth MONTEREY, Calif., Aug. 24, 2026 /PRNewswire/ -- BRC Therapeutics (BRC), a clinical-stage pharmaceutical company developing multimodal cannabinoid therapeutics for neurological and inflammatory conditions, today announced the appointment of Chandra Ramanathan, Ph.D., M.B.A., as Executive Vice President of Commercialization and Strategy. Ramanathan brings more than 30 years of biopharmaceutical leadership spanning drug development, global product launches, commercialization, and external innovation to BRC as the company advances its pipeline and prepares for its next phase of growth. Ramanathan joins BRC from Danaher Corporation, where he served as Vice President and Global Head of Innovation Hubs and Head of External Innovation, Life Sciences Innovation Group (LSIG) building a funnel of product-oriented partnerships across genomic medicine, diagnostics, LSIG, and biomanufacturing. Prior to Danaher, he spent more than 12 years at Bayer, most recently as Global Head of Pharma R&D Open Innovation, where he chaired the Open Innovation Committee overseeing an annual investment budget of more than $90 million across more than 50 academic and biotech partnerships. While leading Bayer's East Coast Innovation Center in Cambridge, MA, Ramanathan built major partnerships with the Broad Institute, MassGeneral Brigham, and Johns Hopkins University. Earlier in his career, Ramanathan led global launch teams behind two approved therapies (Bosulif®, Aliqopa®) and contributed to the launches of Orencia®, and Sprycel® across roles at Wyeth (now Pfizer), Bristol Myers Squibb, and Bayer. As the Head of oncology strategic marketing, he grew Bayer's oncology clinical portfolio from two assets to fifteen over five years. His experience spans the full spectrum of drug development and commercialization: external innovation, product development, companion diagnostics strategy, portfolio and launch planning, and building cross-functional global teams across the U.S., Europe, and Asia. "Chandra has spent his career doing precisely what BRC needs next: progressing promising science into the next phase of clinical development and ultimately into approved medicines that reach patients, based on proven growth strategies and commercial infrastructure to get there," said George Hodgin, Founder and CEO of BRC Therapeutics. "He has led launches at some of the most respected companies in our industry, built innovation engines from the ground up, and has a rare ability to move fluidly between science, innovation strategy, and commercial strategy. As we advance our pipeline in CRPS, AIIA, RLS and additional indications and prepare for our next phase of growth, Chandra's judgment, expertise and experience will be invaluable." "BRC is pursuing something genuinely novel: FDA-regulated cannabinoid medicines for patients with too few good options. The company's foundation is innovative science, a strong intellectual property estate, unique and evolving regulatory approach, and an unwavering drive to make a difference for patients," said Chandra Ramanathan. "I've spent my entire career helping companies bridge early science and commercial reality, and I see that same opportunity here. I'm excited to work alongside George and the BRC team as the company moves toward pivotal trials, new opportunities, and ultimately helping patients." Ramanathan currently serves as Chairperson of the Board of Directors of Nucleate, a nonprofit developing the next generation of biotech entrepreneurs, and holds board and advisory roles with the McLean Hospital, the Johns Hopkins University Innovation, Development & Entrepreneurial Advisory Board and Harvard Business School Blavatnik Fellowship Council. He was also a board member with MassBIO and Chair of the Innovation Committee where he recently finished his 9-year term. He is also an Adjunct Assistant Professor at Tufts University School of Medicine. Ramanathan holds an M.B.A. from Columbia Business School and a Ph.D. in Genomics and Bioinformatics from the University of Georgia. BRC Therapeutics (BRC) is a pharmaceutical company focused on developing innovative therapeutics to deliver relief from pain and other symptoms in chronic conditions. BRC's medicines are multimodal and contain cannabinoids at defined ratios. BRC has developed a pipeline of investigational prescription medicines addressing neurological and inflammatory conditions. Investigational products are currently being tested in clinical trials for Complex Regional Pain Syndrome (CRPS), Restless Legs Syndrome (RLS), and Aromatase Inhibitor-Induced Arthralgia (AIIA) and an additional confidential indication. BRC is registered with the Drug Enforcement Administration and is based in Monterey, CA. To learn more about BRC, visit . Forward-Looking Statements This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks, uncertainties and assumptions, including without limitation statements about the development, use, benefits and effects of BRC Therapeutics' (BRC) therapeutic product candidates and related technology, future plans for BRC's business and growth, and expected plans with respect to clinical trials, including the number of patients enrolled and timing of patient enrollment. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "design," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements. The forward-looking statements made herein speak only as of the date of this press release and, unless otherwise required by law, BRC does not undertake any obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. SOURCE BRC Therapeutics 21% more press release views with Request a Demo

Executive Change

13 Jun 2026

·www.businesswire.com

Dr. Reddy’s Announces the First-to-Market Launch of Bosutinib Tablets 400mg, a Generic Equivalent of Bosulif ® , in the United States

HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the first-to-market launch of Bosutinib Tablets 400mg, a generic equivalent of Bosulif®, in the United States, expanding its oncology portfolio and reinforcing its commitment to improving patient access to affordable, high-quality medicines. Dr. Reddy’s has collaborated with MSN Laboratories Private Limited (“MSN”), a leading pharmaceutical company in India, on this product. Dr. Reddy’s holds the exclusive marketing rights for the product in the United States. MSN is responsible for the development and manufacturing of the product. Bosutinib Tablets (400mg) was a first-to-file product and is eligible for 180-days of generic drug exclusivity for this strength, in the U.S. Milan Kalawadia, CEO- North America, Dr. Reddy’s Laboratories, Inc. said: “This launch highlights our commitment to leading with timely market entry for high-priority therapies while broadening access for both patients and healthcare providers. With this launch, we remain focused on strengthening our oncology portfolio and partnering across the healthcare system to ensure that critical treatments are both accessible and affordable.” Bharat Reddy, Executive Director, MSN Laboratories added: “The successful development and commercialization of Bosutinib Tablets demonstrates MSN’s strong scientific, regulatory, and manufacturing capabilities in complex oncology products. We remain committed to delivering high-quality, affordable medicines globally through efficient development and reliable manufacturing excellence.” The Bosulif® brand (400mg) had U.S. sales of approximately $253.8 million for the latest 12-month period ended April 2026, according to IQVIA National Sales Perspectives data. Bosulif® is a registered trademark of Wyeth LLC. RDY-0626-887 ………………………………………………………………………………………………………………………………………………………………………………………………………… About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com. About MSN Laboratories: MSN Laboratories is a research-driven pharmaceutical company with integrated capabilities across APIs and finished dosage formulations. The company is recognized for its strong expertise in product development, regulatory execution, and world-class manufacturing infrastructure with USFDA approved facilities in Hyderabad, India and in New Jersey, USA. MSN serves global markets with a focus on quality, affordability, and operational excellence across multiple therapeutic segments, including oncology. ……………………………………………………………………………………………………………………………………………………… Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2025. The company assumes no obligation to update any information contained herein.

Drug Approval

100 Deals associated with Bosutinib Monohydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D09728	Bosutinib Monohydrate	L01EA04	DB06616

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03888222 (CTgov)	Phase 2	Lewy Body Disease	26	Placebo Oral Tablet (Placebo)	ezpoulaweu = cpfgezaqzo qwyxoqkmxq (slthzaonju, gtrfekzrci - evgkaicogc) View more	-	10 Jul 2026
				Bosutinib Oral Tablet (100 mg of Bosutinib)	ezpoulaweu = rtennfgjvh qwyxoqkmxq (slthzaonju, rbklrnpjrc - pxgjgwzbjy) View more
ASCO_Breakthrough2026	Not Applicable	Chronic phase chronic myeloid leukemia	118	Dasatinib	kjlffiuatw(wvvubtwwsm) = caxzwkcihj evkxoamzzc (ojajuhvsfo ) View more	Positive	25 Jun 2026
				Nilotinib	kjlffiuatw(wvvubtwwsm) = jzjjmivcrp evkxoamzzc (ojajuhvsfo ) View more
AACR2026	Not Applicable	Chronic Myelogenous Leukemia	291	Ponatinib	kapkfyyxpb(clokjplatt) = irjcnorgun infmufgfks (dkudnqntyi )	Positive	21 Apr 2026
				Bosutinib	wywsgvunft(djovekbpwo) = rkwmxfvcpx gaaihgnbuy (xnfpwdzohj ) View more
NCT04258943 (ITCC-054/COG-AAML1921, EHA2025)	Phase 2	Norrie Disease BCR::ABL1	30	Bosutinib 300 mg/m2 QD	icxfydeibt(zyhnoxrgfl) = ghpvwjegwz rhdeufnqtt (rcltppatfu, 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	kacydjgkps(lwvmjcgpvd) = All pts had ≥1 any grade treatment emergent adverse event (TEAE), occuring a median of 15 days after starting bosutinib (range: 1 - 225 days) sghbczxfpr (cscjwkxydi ) View more	Positive	07 Dec 2024
				Nilotinib
NCT04916769 (CTgov)	Phase 1	-	18	Bosutinib (Bosutinib 500 mg Capsule Contents + Applesauce 45 mL)	kbzdujxnti(embhipyckz) = tsxqqevfpb atpvizhvms (bxveqknbph, 28) View more	-	07 Nov 2024
				Bosutinib (Bosutinib 500 mg Capsule Contents + Yogurt 45 mL)	kbzdujxnti(embhipyckz) = kbgfnvqmec atpvizhvms (bxveqknbph, 23) View more
NCT02228382 (BYOND, Pubmed \| Leukemia) Manual	Phase 4	Chronic Myelogenous Leukemia Philadelphia Chromosome	163	Bosutinib 500 mg QD	bsvupuihvz(xkcinmtdds) = oksvthjitj kxdvxzdmpj (jeeaqgqeog, 63.9 - 78.9) View more	Positive	01 Oct 2024
NCT05032690 (CTgov)	Phase 1	-	32	Bosutinib (Treatment A: Bosutinib 1*100 mg Capsule Fed)	zkeqmhidme(iynovwrtnj) = gwdyuqzcds shwhehhgpo (ezhmmfvaze, 32) View more	-	20 Sep 2024
				Bosutinib (Treatment B: Bosutinib 4*25 mg Capsule Fed)	zkeqmhidme(iynovwrtnj) = vptdoqzorl shwhehhgpo (ezhmmfvaze, 39) View more
NCT02228382 (BYOND, Pubmed) Manual	Phase 4	Philadelphia chromosome positive chronic myelogenous leukemia Philadelphia chromosome-positive	156	Bosutinib500mg once daily	hhkifefvol(rmqgfycrbr) = fawblsdlni vxzuqtiorm (hdwghzghzt ) View more	Positive	01 Apr 2024
				Bosutinib 500mg once daily (dasatinib/nilotinib-resistant)	hhkifefvol(rmqgfycrbr) = whmxzxanvp vxzuqtiorm (hdwghzghzt ) View more
NCT04793399 (CTgov)	Phase 1/2	Chronic phase chronic myeloid leukemia \| Chronic leukemia \| Philadelphia chromosome positive chronic myelogenous leukemia	9	Atezolizumab+Bosutinib	fggnvbhtzw = vsgnjmcnoz qyhlmwhvut (aztumeamun, cbcosejbby - dmhhpyunef) View more	-	12 Mar 2024

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