Delving into the Latest Updates on Imatinib mesylate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

imatinib, imatinib mesilate, α-(4-methyl-1-piperazinyl)-3'-((4-(3-pyridyl)-2-pyrimidinyl)amino)-p-toluidide

+ [32]

Target

Bcr-Abl x PDGFRα x c-Kit

Action

inhibitors

Mechanism

Bcr-Abl inhibitors(Bcr-Abl tyrosine kinase inhibitors), PDGFRα inhibitors(Platelet-derived growth factor receptor alpha inhibitors), c-Kit inhibitors(Stem cell growth factor receptor inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [5]

Active Indication

Accelerated phase Philadelphia chromosome positive chronic myeloid leukemiaPhiladelphia chromosome positive chronic myeloid leukemia in blast crisisPhiladelphia chromosome-positive chronic myeloid leukemia in chronic phase+ [32]

Inactive Indication

Abdominal NeoplasmsAcral Lentiginous Malignant MelanomaAcute Eosinophilic Leukemia+ [176]

Originator Organization

Novartis Pharma AG

Active Organization

Teva Pharmaceuticals Europe BV

The Children's Oncology Group Foundation, Inc.

National Cancer Institute

+ [13]

Inactive Organization

Novartis AG

Sanofi

Jade Biosciences, Inc.

+ [36]

License Organization

Hangzhou Chance Pharmaceuticals Co., Ltd.

Vectura Group Ltd.

Novartis AG

+ [3]

Drug Highest PhaseApproved

First Approval Date

United States (10 May 2001),

Philadelphia chromosome positive chronic myelogenous leukemia

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

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Structure/Sequence

Molecular FormulaC30H35N7O4S

InChIKeyYLMAHDNUQAMNNX-UHFFFAOYSA-N

CAS Registry220127-57-1

The goal of this clinical trial is to learn what dose of the drug fampridine can be given safely together with imatinib (Gleevec) in patients with gastrointestinal stromal tumor (GIST) with a DNA mutation in exon 11 of the KIT gene.
The main questions this study aims to answer are:
* What is the maximum dose of fampridine that can be given safely together with imatinib (Gleevec)?
* Is the combination of the two drugs efficacious against the tumor?
Participants will:
* Take the drugs before tumor surgery (neoadjuvant treatment) for at least 2 months with the option to continue for a longer period of time if treatment seems safe and effective.
* Visit the clinic at the scheduled appointments for checkups and tests.

Start Date01 Dec 2025

Sponsor / Collaborator

University of California San Diego

NCT06889168

/ RecruitingPhase 1IIT

A Phase 1, Randomized, Double-blinded, Placebo Controlled, Trial Evaluating the Long-term Safety and Tolerability of Imatinib for the Treatment of Lymphangioleiomyomatosis [LAMP-2 Trial]

Lymphangioleiomyomatosis (LAM) is a rare cystic lung disease that appears to behave like a slowly growing cancer. Since clinical progression is very slow, new blood tests have been used to speed the time required to find safe and effective medications. A large National Institute of Health study called MILES showed that sirolimus (also known as Rapamycin) improved lung function in individuals with LAM. Since most individuals with LAM and impaired lung function are now on sirolimus, future studies may prove more difficult. Laboratory studies suggested that Imatinib mesylate (imatinib), an FDA-approved drug for leukemia, initiates LAM cell death. A pilot trial with imatinib titled "Imatinib Mesylate for the treatment of Lymphangioleiomyomatosis" - (LAMP-1) was funded by the Department of Defense in 2016, and documented (1) the safety of use of tyrosine kinase inhibitors in patients with LAM; (2) the safety of concurrent use of tyrosine kinase and mTOR inhibitors; and, (3) short term variability in vascular endothelial growth factor D (VEGF-D) - a LAM biomarker, as a response to therapies. Due to the short-term LAMP-1 trial, LAMP-2 will be a longer-term 6-month clinical study evaluating the safety and tolerability of imatinib in patients with LAM. Patients that participate in the trial will come in for 5 office visits and check-up phone calls every 2 weeks over the course of 6 months.

Start Date01 Oct 2025

Sponsor / Collaborator

Columbia University

[+1]

ChiCTR2500109043

/ Not yet recruitingNot ApplicableIIT

Clinical Study of Adebrelimab Combined with Chemotherapy and Adebrelimab as Neoadjuvant Therapy for NSCLC

Start Date26 Aug 2025

Sponsor / Collaborator

Peking University People's Hospital

[+2]

100 Clinical Results associated with Imatinib mesylate

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100 Translational Medicine associated with Imatinib mesylate

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100 Patents (Medical) associated with Imatinib mesylate

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20,091

Literatures (Medical) associated with Imatinib mesylate

01 Feb 2026·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Molecular docking and dynamics simulations of 4-heteroarylidenamino-4,5-dihydro-1H-1,2,4-triazol-5-one derivatives as potential anticancer agents

Article

Author: Baykara, Haci ; Siguenza, Jose

The search for anticancer therapies remains imperative, as many existing treatments are hindered by drug resistance, limited efficacy, and undesirable side effects. This study explores the anticancer potential of four 4-heteroarylidenamino-4,5-dihydro-1H-1,2,4-triazol-5-one derivatives using molecular docking and molecular dynamics simulations. These compounds were evaluated against crucial cancer-related proteins, including kinases, histone demethylases, and metabolic regulators. Binding affinity analysis revealed that some derivatives exhibited comparable or superior docking scores to commercial inhibitors such as Imatinib. Compound 1d showed high binding affinities, -7.882 kcal/mol, -9.107 kcal/mol, and -8.474 kcal/mol, for human histone deacetylase 6 catalytic domain 2, A2A adenosine receptor, and human tyrosinase-related protein one mutant (TYRP1), respectively, suggesting strong interactions with key cancer targets. Molecular dynamics simulations confirmed the stability of ligand-protein complexes, with root mean square deviation values below 2.5 Å, indicating minimal conformational fluctuations. Additionally, root mean square fluctuation values ranged from 0.8 to 1.5 Å, supporting stable binding interactions, and the radius of gyration values between 20.2 and 22.5 Å highlighted the compact structural integrity of the complexes. Among the tested ligands, compound 1d demonstrated exceptional binding affinity and stability across multiple targets, particularly the A2A adenosine receptor and TYRP1, which are highly related to epigenetic regulation and cancer progression. These findings suggest that triazole derivatives could serve as promising anticancer agents, warranting further experimental validation to assess their therapeutic potential.

31 Dec 2025·ANNALS OF MEDICINE

Distinguishing very high-risk patients among high-risk gastrointestinal stromal tumor cases: development and validation of a nomogram based on a multicenter population-based retrospective cohort study

Article

Author: Jiang, Qi ; Zhao, Xuefeng ; Zhang, Bo ; Qiu, Haibo ; Zhang, Zilong ; Gao, Zhidong ; Fu, Yang ; Fu, Yingfeng ; Yang, Zhenhua ; Zhang, Xinhua ; Tao, Kaixiong ; Gao, Xiaodong ; Zhang, Peng ; Zhang, Jun ; Liu, Jian

BACKGROUND:

High-risk gastrointestinal stromal tumors (GISTs) are highly heterogeneous. This study aimed to developa nomogram for predicting recurrence in patients with high-risk GISTand to provide guidance for adjuvant therapy.

METHODS:

Data were retrospectively collected from 971 patients with high-risk GIST who underwent genetic testingat 13 centers in China. A nomogram was constructed in the training cohort and validated in the validation cohort.

RSEULTS:

The training and validation cohorts included 696 and 275 patients, respectively. The nomogram incorporated blood plateletlevels, total protein, tumor location, tumor size, mitotic count, tumor rupture, Ki-67 index, and gene mutations. The C-index and AUC were 0.758 and 0.781 in the training cohort and 0.841 and 0.755, respectively, in the validation cohort. Calibration and DCA curves confirmed favorable discrimination, calibration accuracy, and clinical benefits. Using the nomogram, patients were categorized into a general high-risk groupand a very high-risk group. Among the general high-risk group, no significant difference in RFS was observed between patients who received adjuvant imatinib for 2.5 years or longer. Conversely, in the very high-risk group, patients receiving adjuvant imatinib for five or more years had markedly improved RFS.

CONCLUSIONS:

Based on the largest nomogram-related multicenter study in high-risk GIST, the nomogram accurately predicted RFS in patients with high-risk GIST and provided guidance on adjuvant therapy for the first time. For general high-risk patients, 3 years of adjuvant imatinib is adequate, whereas very high-risk patients benefit significantly from more than 5 years of adjuvant imatinib.

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 ; Jadhav, Kejal ; Romdhani, Hela ; 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.

432

News (Medical) associated with Imatinib mesylate

21 Nov 2025

·www.globenewswire.com

Inhibikase Therapeutics Announces Pricing of $100 Million Public Offering of Common Stock and Pre-Funded Warrants

WILMINGTON, Del., Nov. 20, 2025 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (NASDAQ: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of pulmonary arterial hypertension (“PAH”), today announced the pricing of its underwritten public offering of 46,091,739 shares of common stock and pre-funded warrants to purchase 22,873,779 shares of common stock. The shares of common stock are being sold at an offering price of $1.45 per share, and the pre-funded warrants are being sold at an offering price of $1.449 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. In addition, Inhibikase has granted the underwriters a 30-day option to purchase up to an additional 10,344,827 shares of its common stock at the public offering price, less underwriting discounts and commissions. The aggregate gross proceeds to Inhibikase from this offering are expected to be approximately $100.0 million, before deducting underwriting discounts and commissions and other offering expenses, excluding the exercise of any pre-funded warrants. All of the securities being sold in the offering are being offered by Inhibikase. The offering is expected to close on November 24, 2025, subject to the satisfaction of customary closing conditions. Jefferies, BofA Securities and Cantor are acting as joint book-running managers for the offering. LifeSci Capital and Oppenheimer & Co. are acting as co-lead managers for the offering. H.C. Wainwright & Co. and Ladenburg Thalmann & Co. Inc. are acting as co-managers for the offering. The securities described above are being offered by Inhibikase pursuant to a shelf registration statement on Form S-3 (No. 333-288213) that was previously filed with the Securities and Exchange Commission (“SEC”) and declared effective on June 27, 2025. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com; BofA Securities, Inc., Attention: Prospectus Department, 201 North Tryon Street, NC1-022-02-25 Charlotte, NC 28255- 0001, or by email at dg.prospectus_requests@bofa.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com. This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. About Inhibikase Therapeutics Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), that arise from aberrant signaling through the Abelson Tyrosine Kinase, and type III receptor tyrosine kinases including platelet derived growth factor receptors and c-KIT. Our lead product candidate is IKT-001, a prodrug of imatinib mesylate, for PAH which is an orphan indication. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” “anticipates,” “plans,” or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, uncertainties related to market conditions and statements regarding the timing, size and expected proceeds of the offering, the satisfaction of customary closing conditions related to the offering and sale of securities, and Inhibikase's ability to complete the offering. These forward-looking statements are based on Inhibikase’s current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase’s actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to execute clinical trials, including to evaluate IKT-001 as a treatment for PAH, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the SEC. Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. Contacts:Investor Relations:Michael MoyerLifeSci Advisorsmmoyer@lifesciadvisors.com

17 Nov 2025

·www.businesswire.com

Deciphera Announces the Opening of a New Office in Zug, Switzerland

OSAKA, Japan & WALTHAM, Mass.--(BUSINESS WIRE)--Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced the opening of a new 733-square-meter office in Zug, Switzerland, to accommodate the company’s growth in Europe and partner markets. The occasion will be commemorated with a ceremony attended by company management, including the CEO of Ono, Gyo Sagara, President and CEO of Deciphera, Ryota Udagawa, and regional government officials, including Director of Economic Affairs of Kanton Zug, Silvia Thalmann-Gut. “The opening of our new Zug office marks a key milestone in Deciphera’s journey. Following the Ono acquisition, we have significantly broadened our pipeline with several promising clinical candidates that have the potential to expand our commercial portfolio in the coming years. This office positions us for growth in international markets as we advance these candidates toward commercialization,” said Ryota Udagawa, President and Chief Executive Officer of Deciphera. “The Zug office plays a pivotal role as our hub in Europe, reinforcing our global footprint and enhancing our ability to better serve communities worldwide. Furthermore, our Zug office was recognized as the Best Workplace™ in Switzerland in its category in 2025 by Great Place to Work and we believe this new office will further contribute to attract and retain top talent as well as foster teamwork and collaboration.” “I am always very pleased to see companies like Deciphera choose Zug as their International Hub and seeing the current expansion of office is a true testament to the incredible biotech and pharma eco-system that was developed over the years and that we will continue to support in the future," said Silvia Thalmann-Gut, Director of Economic Affairs of Kanton Zug. Deciphera’s international office was founded in Zug in early 2021 and has since expanded across Europe. About Deciphera Pharmaceuticals Inc. Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. Deciphera is leveraging its proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from Deciphera’s platform in clinical studies, QINLOCK® (ripretinib) is Deciphera’s switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ROMVIMZA™ (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. For more information, visit www.deciphera.com and follow us on LinkedIn and X (@Deciphera). About Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co., Ltd. delivers innovative therapies for patients worldwide. Upholding its philosophy of “Dedicated to the Fight against Disease and Pain,” Ono targets areas with unmet medical needs including oncology, immunology, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery. Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care. For more information, please visit the company's website at https://www.ono-pharma.com/en. Cautionary Note Regarding Forward-Looking Statements In this press release, statements made with respect to current plans, estimates, strategies and beliefs, and other statements that are not historical facts are forward-looking statements about the future performance of the company. These statements are based on current assumptions and beliefs in light of the information currently available and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in the business environment in the pharmaceutical market and amendments to relevant laws and regulations, (ii) disruptions to product supply due to stagnation or delays in production caused by natural disasters, fires, etc., (iii) the possibility that sales activities for new and existing products may not achieve the expected results, (iv) the emergence of new side effects in post-marketing drugs, and (v) infringements of intellectual property rights by third parties. Information about pharmaceutical products included in this press release is not intended to constitute an advertisement or medical advice.

Drug ApprovalAcquisition

12 Nov 2025

·www.businesswire.com

Deciphera Announces Multiple Data Presentations at the Connective Tissue Oncology Society (CTOS) Annual Meeting 2025

OSAKA, Japan & WALTHAM, Mass.--(BUSINESS WIRE)--Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced that data from multiple pipeline programs, including long-term and safety results from its MOTION Phase 3 study of vimseltinib in patients with TGCT in cases where surgical removal of the tumor is not an option, will be presented during the CTOS Annual Meeting 2025, taking place November 12-15 in Boca Raton, Florida. “We are excited about the breadth of data we’re presenting at CTOS this year, which underscore the strong progress we continue to sustain across our pipeline,” said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. “We look forward to sharing encore data from our Phase 3 MOTION study of vimseltinib and providing updates on our DCC-3009 Phase 1 program, which demonstrate how we can expand our GIST treatment capabilities by targeting known primary and secondary drug-resistant mutations spanning multiple KIT exons.” Oral and Poster presentation details are as follows: Title: Long-Term Efficacy and Safety of Vimseltinib in Patients (Pts) with Tenosynovial Giant Cell Tumor (TGCT): Results from the MOTION Phase 3 Trial Presenter: Silvia Stacchiotti, M.D., Fondazione IRCCS Istituto Nazionale Dei Tumori Session Title: Session 8: TGCT & Desmoid Tumor Session Date: Friday, November 14, 2025 Session Time: 2:30 – 3:30 PM ET Title: Impact of Expert-Led Education Programs on Health Care Provider (HCP) Knowledge of Gastrointestinal Stromal Tumor (GIST) Presenter: Mark Agulnik, M.D., USC Norris Comprehensive Cancer Center, University of Southern California Poster Reception: Thursday, November 13, 2025 Session Time: 5:30 – 6:30 PM ET Title: Efficacy with Vimseltinib in Patients (Pts) with Tenosynovial Giant Cell Tumor (TGCT) and Prior Colony-Stimulating Factor 1 (CSF1) Inhibitor Therapy: A Phase 2 Case Series Presenter: Andrew J. Wagner, M.D., Ph.D., Harvard Medical School, Dana-Farber Cancer Institute Poster Reception: Thursday, November 13, 2025 Session Time: 5:30 – 6:30 PM ET Title: Effect of a High-Fat Meal on the Pharmacokinetics (PK) of Vimseltinib, an Oral Inhibitor of the Colony-Stimulating Factor 1 Receptor (CSF1), in Healthy Participants Presenter: Chengyue Zhang, Ph.D., Deciphera Pharmaceuticals, LLC Poster Reception: Thursday, November 13, 2025 Session Time: 5:30 – 6:30 PM ET Title: Effect of Itraconazole (ITX) and Rabeprazole (RBP) on the Pharmacokinetics (PK) of Vimseltinib, an Oral Inhibitor of the Colony-Stimulating Factor 1 Receptor (CSF1), in Healthy Participants Presenter: Chengyue Zhang, Ph.D., Deciphera Pharmaceuticals, LLC Poster Reception: Thursday, November 13, 2025 Session Time: 5:30 – 6:30 PM ET Title: An Open-Label Phase 1/2 Study of DCC-3009 Monotherapy in Patients (Pts) with Advanced Gastrointestinal Stromal Tumor (GIST) Presenter: Suzanne George, M.D., Division of Sarcoma, Dana-Farber Cancer Institute - Sarcoma Center Poster Reception: Thursday, November 13, 2025 Session Time: 5:30 – 6:30 PM ET About Deciphera Pharmaceuticals Inc. Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. Deciphera is leveraging its proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from Deciphera’s platform in clinical studies, QINLOCK® (ripretinib) is Deciphera’s switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ROMVIMZA™ (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. For more information, visit www.deciphera.com and follow us on LinkedIn and X (@Deciphera). About Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co., Ltd. delivers innovative therapies for patients worldwide. Upholding its philosophy of “Dedicated to the Fight against Disease and Pain,” Ono targets areas with unmet medical needs including oncology, immunology, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery. Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care. For more information, please visit the company's website at https://www.ono-pharma.com/en . Cautionary Note Regarding Forward-Looking Statements In this press release, statements made with respect to current plans, estimates, strategies and beliefs, and other statements that are not historical facts are forward-looking statements about the future performance of the company. These statements are based on current assumptions and beliefs in light of the information currently available and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in the business environment in the pharmaceutical market and amendments to relevant laws and regulations, (ii) disruptions to product supply due to stagnation or delays in production caused by natural disasters, fires, etc., (iii) the possibility that sales activities for new and existing products may not achieve the expected results, (iv) the emergence of new side effects in post-marketing drugs, and (v) infringements of intellectual property rights by third parties. Information about pharmaceutical products included in this press release is not intended to constitute an advertisement or medical advice.

Phase 2Phase 1Phase 3Drug Approval

100 Deals associated with Imatinib mesylate

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External Link

KEGG	Wiki	ATC	Drug Bank
D01441	Imatinib mesylate	L01XE01	DB00619

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Accelerated phase Philadelphia chromosome positive chronic myeloid leukemia	United States	Shorla Pharma Ltd.	22 Nov 2024
Philadelphia chromosome positive chronic myeloid leukemia in blast crisis	United States	Shorla Pharma Ltd.	22 Nov 2024
Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase	United States	Shorla Pharma Ltd.	22 Nov 2024
Metastatic Gastrointestinal Stromal Tumor	European Union	Accord Healthcare SLU	30 Jun 2013
Metastatic Gastrointestinal Stromal Tumor	Iceland	Accord Healthcare SLU	30 Jun 2013
Metastatic Gastrointestinal Stromal Tumor	Liechtenstein	Accord Healthcare SLU	30 Jun 2013
Metastatic Gastrointestinal Stromal Tumor	Norway	Accord Healthcare SLU	30 Jun 2013
Myeloproliferative Disorders	European Union	Teva Pharmaceuticals Europe BV	07 Jan 2013
Myeloproliferative Disorders	Iceland	Teva Pharmaceuticals Europe BV	07 Jan 2013
Myeloproliferative Disorders	Liechtenstein	Teva Pharmaceuticals Europe BV	07 Jan 2013
Myeloproliferative Disorders	Norway	Teva Pharmaceuticals Europe BV	07 Jan 2013
Ph-Like Acute Lymphoblastic Leukemia	European Union	Teva Pharmaceuticals Europe BV	07 Jan 2013
Ph-Like Acute Lymphoblastic Leukemia	Iceland	Teva Pharmaceuticals Europe BV	07 Jan 2013
Ph-Like Acute Lymphoblastic Leukemia	Liechtenstein	Teva Pharmaceuticals Europe BV	07 Jan 2013
Ph-Like Acute Lymphoblastic Leukemia	Norway	Teva Pharmaceuticals Europe BV	07 Jan 2013
Philadelphia Chromosome Positive Leukemia	European Union	Teva Pharmaceuticals Europe BV	07 Jan 2013
Philadelphia Chromosome Positive Leukemia	Iceland	Teva Pharmaceuticals Europe BV	07 Jan 2013
Philadelphia Chromosome Positive Leukemia	Liechtenstein	Teva Pharmaceuticals Europe BV	07 Jan 2013
Philadelphia Chromosome Positive Leukemia	Norway	Teva Pharmaceuticals Europe BV	07 Jan 2013
Acute Lymphoblastic Leukemia	United States	Novartis Pharmaceuticals Corp.	19 Oct 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mixed phenotype acute leukemia	Phase 3	United States	The Children's Oncology Group Foundation, Inc.	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	Australia	The Children's Oncology Group Foundation, Inc.	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	Austria	The Children's Oncology Group Foundation, Inc.	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	Belgium	The Children's Oncology Group Foundation, Inc.	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	Canada	The Children's Oncology Group Foundation, Inc.	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	Chile	The Children's Oncology Group Foundation, Inc.	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	Czechia	The Children's Oncology Group Foundation, Inc.	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	Finland	The Children's Oncology Group Foundation, Inc.	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	France	The Children's Oncology Group Foundation, Inc.	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	Germany	The Children's Oncology Group Foundation, Inc.	08 Aug 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2025	Not Applicable	Gastrointestinal Stromal Tumors First line	1,060	imatinib (KIT exon 13 or 17 mutations)	btlgebyloy(aneihsjfdm) = cfaufuyyot enxdeuymjx (mubtcbjxjl ) View more	Positive	17 Oct 2025
				imatinib (KIT exon 11 mutations)	btlgebyloy(aneihsjfdm) = mnbbxrhnaw enxdeuymjx (mubtcbjxjl ) View more
ESMO2025	Not Applicable	Gastrointestinal Stromal Tumors Adjuvant	175	Adjuvant imatinib	jloukrmdnf(rxgjuzqyhp) = iibnbfjmul dnegmxpiac (asjgbxvyzy ) View more	Positive	17 Oct 2025
NCT00476190 (CTgov)	Phase 2	Adult Acute Lymphocytic Leukemia	112	Radiation Therapy+PEG-Asparaginase+Etoposide+doxorubicin+Hydrocortisone Sodium Succinate+6-MP+Methotrexate+Cytarabine+Methylprednisone+Cyclophosphamide+Imatinib+Dexamethasone+E. coli Asparaginase+Vincristine (Pre-amendment Cohort, 2500 IU/m2 q2 Weeks)	woideodhau = slmxhgxlbz kmitwwwyzn (mvpjsfbbss, nvkwdizmzx - nvcpsyrgmv) View more	-	12 Jun 2025
				Radiation Therapy+PEG-Asparaginase+Etoposide+Doxorubicin+Hydrocortisone Sodium Succinate+6-MP+Methotrexate+Cytarabine+Methylprednisone+Cyclophosphamide+Imatinib+Dexamethasone+E. coli Asparaginase+Vincristine (Post-amendment Cohort, 2000 IU/m2 q3 Weeks)	woideodhau = uxdcqqcnwm kmitwwwyzn (mvpjsfbbss, kxfbiyaebx - zitmllreez) View more
ASCO2025	Not Applicable	Chronic phase chronic myeloid leukemia	100	Imatinib	pqmrugrwmk(zhesdmssba) = pofrxyrpvi egdlzfdcnu (wjagrhodtd ) View more	-	30 May 2025
The Max Foundation (ASCO2025)	Not Applicable	Gastrointestinal Stromal Tumors Adjuvant KIT-positive	721	Metastatic/unresectable GIST patients receiving imatinibimatinib or imatinib+sunitinib	xqufwrurlb(smabkatdng) = nbpjadaykg dkxsausmfv (igjygllebe, 28.4% - 44.2) View more	Positive	30 May 2025
				Adjuvant treatment GIST patients receiving imatinib	xqufwrurlb(smabkatdng) = cbdqiiifhq dkxsausmfv (igjygllebe, 48.6% - 69.5) View more
IRIS trial (ASCO2025)	Not Applicable	Chronic Myelogenous Leukemia BCR::ABL1 fusion gene	-	Imatinib	oksrbffjxb(csqyiprydj) = ymvbjppyxc rgelotgpsi (xrlebcgsya ) View more	Positive	30 May 2025
NCT01991379 (GIST Trial 13-162, ASCO2025)	Phase 2	Gastrointestinal Stromal Tumors ETV1 \| KIT	42	Imatinib 400mg daily + Binimetinib 30mg twice daily	rvicnpgfdx(ovniulmdqo) = mlxqolholr zeaifxynyy (jbbxgorsqc, 52.9% - 82.4%) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Chronic phase chronic myeloid leukemia First line BCR-ABL1	118	Imatinib	opxzgluftx(vfeboqjnqe) = pqwfgymgrn dciftnwrfv (bqhhyrasic ) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Metastatic Gastrointestinal Stromal Tumor	234	Imatinib only	ilcohlhiiy(anrgwjqsdn) = rhmoytwjvr vxtkqiljom (cwmrlpckph )	Positive	30 May 2025
				imatinib (IM and surgery before IM)	ilcohlhiiy(anrgwjqsdn) = paabpkqujp vxtkqiljom (cwmrlpckph )
NCT04147533 (HALF, EHA2025)	Phase 2	Chronic phase chronic myeloid leukemia First line rs460089	287	Imatinib (GC genotype)	hzaxuvthhy(kmyvlrlzhw) = xdaxxtqsco oasmzjfexx (hzitegrsje ) View more	Positive	14 May 2025
				Imatinib (GG genotype)	hzaxuvthhy(kmyvlrlzhw) = ipibemgkqs oasmzjfexx (hzitegrsje ) View more