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

+ [30]

Target

ABL x Bcr-Abl x PDGFR x c-Kit

Mechanism

ABL inhibitors(Abl family tyrosine kinases inhibitors), Bcr-Abl inhibitors(Bcr-Abl tyrosine kinase inhibitors), PDGFR antagonists(Platelet-derived growth factor receptor antagonists)

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+ [31]

Inactive Indication

Abdominal NeoplasmsAcral Lentiginous Malignant MelanomaAcute Eosinophilic Leukemia+ [171]

Originator Organization

Novartis Pharma AG

Active Organization

Hangzhou Chance Pharmaceuticals Co., Ltd.Novartis Pharmaceuticals Australia Pty Ltd.

National Cancer Institute

+ [9]

Inactive Organization

medac Gesellschaft für klinische Spezialpräparate mbHActavis Group PTC ehf.

Aerovate Therapeutics, Inc.

+ [15]

Drug Highest PhaseApproved

First Approval Date

US (10 May 2001),

Philadelphia chromosome positive chronic myelogenous leukemia

RegulationAccelerated Approval (US), Orphan Drug (US), Priority Review (CN), Orphan Drug (JP)

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Structure/Sequence

Molecular FormulaC30H35N7O4S

InChIKeyYLMAHDNUQAMNNX-UHFFFAOYSA-N

CAS Registry220127-57-1

The treatment landscape for chronic myeloid leukemia (CML) has been revolutionized by the introduction of imatinib, a tyrosine kinase inhibitor, which has transformed the disease from a fatal condition into a manageable chronic illness for a substantial number of patients. Despite this, some individuals do not respond adequately to the treatment, and others may experience disease progression even with continued therapy. This study examined how CYP2C8*3 (G416A; rs11572080) and ABCG2 C421A (rs2231142) single nucleotide polymorphisms (SNPs) affect the plasma trough concentration and therapeutic response of imatinib in Egyptian CML patients.

Methods:

The study included fifty patients with chronic-phase CML, who were categorized into two groups: responders (n = 26) and non-responders (n = 24), according to their BCR-ABL1 transcription levels after 12 months of imatinib treatment. Genotyping of the CYP2C8*3 and ABCG2 C421A polymorphisms was performed using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP), while plasma trough concentrations were determined through high-performance liquid chromatography with ultraviolet-diode array detection (HPLC-UV/DAD).

Results:

Patients with the CA genotype of ABCG2 C421A showed significantly higher mean plasma trough concentrations of imatinib (CA: 1731 ± 424.7 ng/mL; CC: 1294 ± 381.3 ng/mL; p = 0.0132) and demonstrated a better molecular response compared to those with the CC genotype (p = 0.0395).

Conclusion:

The ABCG2 C421A polymorphism significantly influenced imatinib plasma trough concentrations and molecular responses in Egyptian chronic-phase CML patients. Genotyping of this polymorphism in these patients could assist in optimizing imatinib therapy, predicting more favorable treatment outcomes, and enabling the development of more personalized treatment plans.

01 Apr 2025·RESPIRATORY PHYSIOLOGY & NEUROBIOLOGY

Effect of imatinib on lipopolysaccharide‑induced acute lung injury and endothelial dysfunction through the P38 MAPK and NF-κB signaling pathways in vivo and in vitro

Article

Author: Wang, Keruo ; Zhang, Tianyi ; Liu, Yaru ; Zong, Xiaolong ; Liang, Xue ; Yang, Hong ; Li, Zhenyu ; Li, Duanyang

BACKGROUND:

The primary purpose of this study was to demonstrate the preventive effects of imatinib (IMA) on lipopolysaccharide (LPS)-induced inflammation in a mouse model of acute lung injury (ALI) and human umbilical vascular endothelial cells.

METHODS:

LPS stimulation for 24 h induced ALI and cell inflammation. The pathological results of the lungs were evaluated using the wet/dry weight ratio, pulmonary vascular permeability measurements, and myeloperoxidase immunohistochemistry. The expression of pro-inflammatory mediators was analyzed using RT-PCR and enzyme-linked immunosorbent assay. Protein levels were analyzed using western blotting. The structure of cell junctions was detected using immunofluorescence.

RESULTS:

IMA improved LPS-induced pulmonary pathological damage and reduced the lung wet/dry weight ratio and myeloperoxidase expression in the lung tissue. IMA decreased bronchoalveolar lavage fluid inflammatory cell count and the release of tumor necrosis factor-α (TNF-α), interleukin (IL)-6, and monocyte chemotactic protein 1 (MCP-1) in the blood. Pretreatment of human umbilical vascular endothelial cells with IMA significantly attenuated LPS-induced actin stress fiber formation and vascular endothelial-cadherin disruption. In addition, IMA downregulated the mRNA abundances of vascular cell adhesion molecule 1, intercellular adhesion molecule 1, IL-1β, IL-6, and tumor necrosis factor-α(TNF-α) expression. The phosphorylation of p65, nuclear factor-kappa B inhibitor alpha (IκBα), p38, extracellular signal-regulated kinase, and Jun N-terminal kinase induced by LPS were attenuated after IMA treatment in vivo and in vitro.

CONCLUSIONS:

IMA modulates the nuclear factor-kappa B and mitogen-activated protein kinase signaling pathways and the production of pro-inflammatory cytokines to prevent cellular damage due to LPS infection. These results indicate that IMA may be a potential modulator of LPS-induced ALI.

01 Mar 2025·JOURNAL OF HAZARDOUS MATERIALS

Exploring the plastic-fed Indian mealworm (Tenebrio molitor) gut bacterial strain (Bacillus subtilis AP-04) – A potential driver of polyethylene degradation

Article

Author: Parthasarathi, Rengasamy ; Bragadeeswaran, Subramanian ; Elango, Rajavel ; Akash, Krishnamoorthi

Plastic biodegradation by microbes is an environmentally friendly and sustainable approach that has no negative consequences. In this study, mealworms were fed with 9 different diets with expanded polystyrene (EPS) and polyethylene foam (PF), after 28 days of incubation mealworm survival rates were highest at 93.3 % when fed wheat bran alone whereas 83.3 % and 80 % when fed EPS and PF exclusively, indicating their adaptability to different plastics and their ability to thrive in various conditions. Histological examination revealed ingestion of EPS and PF found in the intestine confirming through cell wall disruptions. Ten bacterial isolates (AMI-1 to AMI-10) were obtained from EPS and PF-fed mealworms gut. After 30 days in mineral salt media (MSM) with low-density polyethylene (LDPE), AMI-4 showed higher turbidity and biofilm formation. Out of ten isolates seven bacterial isolates produced lipase, six produced proteases and laccases, and all exhibited positive amylase activity, with the highest zone formation in AMI-4. Morphophysical characteristics and 16S rRNA sequencing identified AMI-4 as Bacillus subtilis AP-04 (OR288581). A higher ATP value (783 ± 84.69), LDPE film Weight loss (36.55 %) and CO₂ evolution (15.8 ± 0.99-22.39 ± 1.40 g/l) and the mechanical changes of LDPE film were confirmed through GSM loss 27.24 % and decrease in tensile strength (9.82 ± 0.61-7.98 ± 0.50 Mpa) by Bacillus subtilis AP-04 was recorded at 60 days of incubation. AFM, FTIR, and SEM analyses confirmed degradation in treated LDPE films compared to controls. This study reveals the potential of gut bacterial strain (Bacillus subtilis AP-04) on LDPE film, indicating their potential for bioremediation of plastic waste on a larger scale.

372

News (Medical) associated with Imatinib mesylate

24 Jan 2025

·medcitynews.com

Ascentage Has First U.S. Biotech IPO of 2025, Raising $126M to Bring Its Cancer Meds to the World - MedCity News

Ascentage Pharma, a China-based drug developer with global ambitions, now has $126.4 million from a U.S. IPO that will mainly support late-stage clinical development of two medicines that could offer advantages over some currently available cancer therapies. Ascentage has traded on The Stock Exchange of Hong Kong since 2019. In preliminary financial terms set earlier this week for its U.S. stock market debut, the company planned to offer more than 7.3 million American depositary shares (ADS) priced at $20.34 each. Late Thursday, Ascentage, which is based in Suzhou, China, and maintains U.S. operations in Rockville, Maryland, priced its offering at $17.25 per ADS. Those shares will trade on the Nasdaq under the stock symbol “AAPG.” The only commercialized Ascentage product is olverembatinib, a drug approved in China as a treatment for certain patients with chronic myeloid leukemia (CML). This drug is a small molecule inhibitor of tyrosine kinases, enzymes that drive cancer growth. Tyrosine kinase inhibitors (TKIs) are already available, such as the Novartis drugs Scemblix and Gleevec. But CML can become resistant to these therapies, Ascentage said in its IPO filing. Furthermore, first- and second-generation TKIs have not been able to address CML with T315I mutations, which are associated with rapid disease progression and limited patient survival. Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient Ascentage describes olverembatinib as a next-generation drug for CML that is driven by T315I mutations and is also resistant to first- and second-generation TKIs. The company points to real-world data in China showing benefit in patients whose cancers developed resistance to the Novartis drugs. “In a five-year follow-up of CML [in the chronic phase] patients treated with olverembatinib, 73% had remained on the treatment, response rates continued to increase and the prevalence of treatment-related adverse events, or TRAEs, continued to decrease over such period,” Ascentage said in the IPO filing. “Therefore, we believe that olverembatinib, with its real-world patient data in China, where it is approved, has the potential to be a global therapy for CML.” An ongoing Phase 3 clinical program for olverembatinib is enrolling patients in the U.S., Canada, Australia, and China. One of these pivotal studies is testing the drug as a monotherapy for CML. The design of this study is intended to support an FDA new drug application, which Ascentage plans to file in 2026. Additional Phase 3 tests are evaluating olverembatinib in newly diagnosed Philadelphia chromosome-positive acute lymphocytic leukemia and gastrointestinal stromal tumor. Olverembatinib may achieve Ascentage’s global ambitions in the hands of a big pharmaceutical company. Last June, Ascentage granted Takeda Pharmaceuticals International an exclusive option to license olverembatinib for development and commercialization outside of greater China and Russia. Takeda paid $100 million for that option; the option exercise fee and milestone payments could bring Ascentage up to $1.2 billion more, according to the IPO filing. presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical The next drug in Ascentage’s pipeline is lisaftoclax, a small molecule inhibitor of Bcl-2. Overexpression of this protein can contribute to tumor growth and drug resistance. Ascentage is developing lisaftoclax for various types of blood cancers. A new drug application for the molecule is under regulatory review in China for the treatment of advanced cases of chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). If approved, Ascentage plans to launch the lisaftoclax in China in 2025 and then pursue regulatory approvals in multiple countries, according to the filing. Its main competition would be Venclexta, a Bcl-2 inhibitor marketed by partners AbbVie and Genentech. However. Venclexta is not currently approved in China for CLL or SLL. The Ascentage pipeline includes additional small molecules in earlier stages of development, mainly for cancers. Ascentage co-founder Edward Ming Guo is the company’s largest shareholder with a 17.5% post-IPO stake, according to the prospectus. Takeda owns 7.1% of the company. In the nine months ended Sept. 30, 2024, Ascentage reported 876.8 million Chinese yuan (about $124.9 million) in revenue, most of which came from the Takeda option deal. At the end of the third quarter of 2024, Ascentage reported its cash position was $210.8 million. With the IPO proceeds, Ascentage plans to spend $30 million to $40 million for clinical development of olverembatinib in the U.S. and other countries, and to expand the drug’s label to earlier lines of CML treatment among other indications, according to the prospectus. Another $50 million to $60 million is budgeted for the regulatory approval and potential commercial launch in China of lisaftoclax as a treatment for relapsed or refractory CLL. The company also plans to run clinical trials that could support approvals of this drug in the U.S. and other countries. Between $10 million and $20 is set aside to fund R&D of other drug candidates.

Drug ApprovalPhase 3IPOLicense out/inAcquisition

23 Jan 2025

·www.biopharmadive.com

Ascentage prices first biotech IPO of 2025, raising $126M

Dive Brief:Ascentage Pharma, a cancer drug developer based in Suzhou, China, on Thursday raised just over $126 million in the first U.S. initial public offering by a biotechnology company this year.The company, which is already publicly traded in Hong Kong, sold 7,325,000 American depositary shares at $17.25 apiece, a lower price than it had projected earlier this week. Shares will begin trading on the Nasdaq Stock Exchange Friday under the ticker symbol AAPG.Ascentage will use the proceeds to develop treatments for cancer, among them a leukemia drug called olverembatinib thats approved in China. Its IPO comes amid increased dealmaking involving drugs from China, a trend industry watchers expect to continue this year. Ascentage is one such beneficiary, having licensed olverembatinib to Takeda last year.Dive Insight:Ascentages Wall Street debut is a test of U.S. investors interest in the progress Chinas biotech sector has made.Efforts by the Chinese government to boost the countrys capabilities have produced a burgeoning ecosystem of drug companies, many of which are trying to improve on medicines either on the market or in development. That, combined with tight funding in biotech, has led to a flurry of licensing deals.Though relatively few China-based biotechs have reached public markets in the U.S., some, like oncology-focused drug developers Legend Biotech and BeiGene, have prospered.Ascentage is developing small molecule drugs that block or degrade protein targets implicated in cancer. Its most advanced prospect is olverembatinib, which is cleared in China for certain people with chronic myeloid leukemia. Its in multi-country Phase 3 trials in CML, as well as for two other forms of cancer.Though similar drugs, such as Novartis Gleevec and Scemblix, are available, there is room for improvement, as CML can be stubbornly resistant to approved therapies, Ascentage said in its IPO prospectus.A second Ascentage drug, lisaftoclax, is in late-stage testing for blood cancers including chronic lymphocytic leukemia and acute myeloid leukemia and is under regulatory review in China. Ascentage claims it has the potential to become a backbone molecule for combination regimens.Three additional drugs are in clinical testing for a variety of other tumors.Ascentage was formed in Hong Kong in 2009, and has headquarters in Suzhou as well as in Rockville, Maryland. The company generated 877 million yuan in revenue, or about $125 million, over the first nine months of 2024, according to its IPO filing. Most came from the $100 million Takeda paid to license olverembatinib.The IPO could be the first of several to price in the coming weeks. Five companies Maze Therapeutics, Metsera, Aardvark Therapeutics, Sionna Therapeutics and Odyssey Therapeutics outlined IPO plans in January.Overall, however, biotech IPOs have remained stagnant since 2022, with only around two dozen companies going public in each of the past three years, according to BioPharma Dive data. Most trade below their debut price. '

Drug ApprovalIPOPhase 3AcquisitionBiosimilar

13 Jan 2025

·pipelinereview.com

GSK Enters Agreement to Acquire IDRx, Inc.

PLYMOUTH, MA, USA I January 13, 2025 I GSK plc (LSE/NYSE: GSK) and IDRx, Inc. (IDRx) today announced that they have entered into an agreement under which GSK will acquire IDRx, a Boston-based, clinical-stage biopharmaceutical company dedicated to developing precision therapeutics for the treatment of GIST. Under the agreement, GSK will pay $1 billion upfront, with potential for an additional $150 million success-based regulatory approval milestone payment. The acquisition includes lead molecule, IDRX-42, a highly selective KIT TKI being developed as a first- and second-line therapy for the treatment of GIST. GIST typically presents in the GI tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation, and survival of tumour cells (primary or activating mutations). 1 90% of patients treated in the first-line develop new KIT mutations (secondary or resistance mutations) that typically lead to relapse with limited therapeutic options. 2 Currently, there are no approved TKIs that inhibit the full spectrum of clinically relevant primary and secondary mutations in KIT. IDRX-42 has demonstrated activity against all key primary and secondary KIT mutations, designed to improve outcomes for patients with GIST. This breadth of mutational coverage, in addition to high selectivity which could improve tolerability, provides potential for a best-in-class profile. Luke Miels, Chief Commercial Officer, GSK, said: “IDRX-42 complements our growing portfolio in gastrointestinal cancers. This acquisition is consistent with our approach of acquiring assets that address validated targets and where there is clear unmet medical need, despite existing approved products.” Tony Wood, Chief Scientific Officer, GSK, said: “We are excited by the early data from IDRX-42 and its unique ability to target all clinically relevant KIT mutations present in GIST, a major gap in the current standard of care. We look forward to accelerating its development in 2025 to redefine treatment.” Updated clinical data from StrateGIST 1, an ongoing phase I/Ib trial of IDRX-42 in patients with advanced GIST, were presented in an oral presentation at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting. These data show promising anti-tumour activity of IDRX-42 in patients with advanced GIST with a manageable safety profile. Across patients with second-line or greater GIST, and amongst all KIT mutation subsets, the objective response rate (ORR) by modified RECIST v1.1 in the total efficacy evaluable population was 29% (n=87), including one complete response (CR) and 24 partial responses (PRs). Amongst patients who have had one prior line of therapy, the ORR was 53% (n=15) including one CR and 7 PRs. 3 Across all patients, two of the PRs were awaiting confirmation at the time of the data cut, both of which were subsequently confirmed. The emerging durability data from StrateGIST 1 was also favourable. IDRX-42 was generally well-tolerated and treatment-related adverse events (TRAEs) were mainly low grade at the recommended phase Ib dose. 4 Tim Clackson, CEO, IDRx, said: “We are looking forward to working with GSK to advance IDRX-42 for patients with GIST given there have been no major advances to the standard of care for almost 20 years. Combining our experience to date with GSK’s expertise in GI cancers, global clinical development capability, and strong commercial presence in oncology will help to accelerate the development of this novel medicine for patients.” GSK has a growing portfolio in development targeting the significant medical need in GI cancers, including ongoing trials with dostarlimab and GSK5764227 (GSK’227), a B7-H3-targeted antibody-drug conjugate. This agreement reflects GSK’s portfolio approach of identifying potentially best-in-class molecules with targeted mechanisms of action. The transaction supports GSK’s ambitions for growth through 2031 and beyond. IDRx was founded in 2021 with a mission to address the limitations of today’s precision cancer medicines with highly potent and selective targeted therapies to stop key tumor escape mechanisms and prolong patients’ response to therapy. IDRx investors include Andreessen Horowitz (a16z), Casdin Capital, Nextech Invest, Forge Life Science Partners, RA Capital Management, Commodore Capital, Blackstone Multi-Asset Investing and Rock Springs Capital. IDRx co-founders include George Demetri, M.D., FACP, FASCO, FAACR, Nicholas Lydon, Ph.D., Alexis Borisy, Robert Forrester and Ben Auspitz. Financial considerations Under the terms of the agreement, GSK will acquire one hundred percent (100%) of the outstanding equity interests (including all options and other incentive equity) in IDRx for up to $1.15 billion of total cash consideration, comprising an upfront payment of $1 billion with potential for an additional $150 million success-based regulatory approval milestone payment. GSK will also be responsible for success-based milestone payments as well as tiered royalties for IDRX-42 owed to Merck KGaA, Darmstadt, Germany. This transaction is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US. For IDRx, Centerview Partners LLC is acting as exclusive financial advisor and Goodwin Procter LLP as legal counsel. For GSK, Leerink Partners LLC is acting as the exclusive financial advisor. About GIST Gastrointestinal stromal tumours (GIST) are the most common subtype of soft tissue sarcoma, with about 80,000 to 120,000 patients diagnosed with GIST per year worldwide. 5 GIST typically presents in the GI tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation, and survival of tumour cells (primary or activating mutations in exons 9 and 11). 6 Additionally, about 90% of patients treated in the first-line develop new KIT mutations (secondary or resistance mutations in exons 13 and 17) that typically lead to relapse with limited therapeutic options. 7 There are no approved TKIs that inhibit the full spectrum of clinically relevant primary and secondary mutations in KIT. About IDRX-42 IDRX-42 is a highly selective, investigational small molecule tyrosine kinase inhibitor (TKI) designed to target all key KIT mutations in GIST. The U.S. Food and Drug Administration (FDA) has granted IDRX-42 Fast Track designation for the treatment of patients with GIST after disease progression on or intolerance to imatinib, and Orphan Drug designations for the treatment of GIST. About IDRx IDRx is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. IDRx aims to address the limitations of today’s precision cancer medicines with highly potent and selective targeted therapies to stop key tumour escape mechanisms and prolong response to therapy. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References 1 Bauer S, George S, von Mehren M, Heinrich MC. Early and Next-Generation KIT/PDGFRA Kinase Inhibitors and the Future of Treatment for Advanced Gastrointestinal Stromal Tumor. Front Oncol. 2021 Jul 12;11:672500. 2 Zhou S, Abdihamid O, Tan F, Zhou H, Liu H, Li Z, Xiao S, Li B. KIT mutations and expression: current knowledge and new insights for overcoming IM resistance in GIST. Cell Commun Signal. 2024 Feb 27;22(1):153. 3 George et al CTOS 2024 4 George et al CTOS 2024 5 Søreide K, Sandvik OM, Søreide JA, Giljaca V, Jureckova A, Bulusu VR. Global epidemiology of gastrointestinal stromal tumours (GIST): A systematic review of population-based cohort studies. Cancer Epidemiol. 2016 Feb;40:39-46. 6 Bauer S, George S, von Mehren M, Heinrich MC. Early and Next-Generation KIT/PDGFRA Kinase Inhibitors and the Future of Treatment for Advanced Gastrointestinal Stromal Tumor. Front Oncol. 2021 Jul 12;11:672500. 7 Zhou S, Abdihamid O, Tan F, Zhou H, Liu H, Li Z, Xiao S, Li B. KIT mutations and expression: current knowledge and new insights for overcoming IM resistance in GIST. Cell Commun Signal. 2024 Feb 27;22(1):153. SOURCE: GlaxoSmithKline

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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	US	Shorla Pharma Ltd.Startup	22 Nov 2024
Philadelphia chromosome positive chronic myeloid leukemia in blast crisis	US	Shorla Pharma Ltd.Startup	22 Nov 2024
Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase	US	Shorla Pharma Ltd.Startup	22 Nov 2024
Metastatic Gastrointestinal Stromal Tumor	EU	Accord Healthcare SLU	30 Jun 2013
Metastatic Gastrointestinal Stromal Tumor	IS	Accord Healthcare SLU	30 Jun 2013
Metastatic Gastrointestinal Stromal Tumor	LI	Accord Healthcare SLU	30 Jun 2013
Metastatic Gastrointestinal Stromal Tumor	NO	Accord Healthcare SLU	30 Jun 2013
Myeloproliferative Disorders	EU	Teva Pharmaceuticals Europe BV	07 Jan 2013
Myeloproliferative Disorders	IS	Teva Pharmaceuticals Europe BV	07 Jan 2013
Myeloproliferative Disorders	LI	Teva Pharmaceuticals Europe BV	07 Jan 2013
Myeloproliferative Disorders	NO	Teva Pharmaceuticals Europe BV	07 Jan 2013
Ph-Like Acute Lymphoblastic Leukemia	EU	Teva Pharmaceuticals Europe BV	07 Jan 2013
Ph-Like Acute Lymphoblastic Leukemia	IS	Teva Pharmaceuticals Europe BV	07 Jan 2013
Ph-Like Acute Lymphoblastic Leukemia	LI	Teva Pharmaceuticals Europe BV	07 Jan 2013
Ph-Like Acute Lymphoblastic Leukemia	NO	Teva Pharmaceuticals Europe BV	07 Jan 2013
Philadelphia Chromosome Positive Leukemia	EU	Teva Pharmaceuticals Europe BV	07 Jan 2013
Philadelphia Chromosome Positive Leukemia	IS	Teva Pharmaceuticals Europe BV	07 Jan 2013
Philadelphia Chromosome Positive Leukemia	LI	Teva Pharmaceuticals Europe BV	07 Jan 2013
Philadelphia Chromosome Positive Leukemia	NO	Teva Pharmaceuticals Europe BV	07 Jan 2013
Acute Lymphoblastic Leukemia	US	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	US	National Cancer Institute	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	AU	National Cancer Institute	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	AT	National Cancer Institute	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	BE	National Cancer Institute	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	CA	National Cancer Institute	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	CL	National Cancer Institute	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	CZ	National Cancer Institute	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	FI	National Cancer Institute	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	FR	National Cancer Institute	08 Aug 2017
Mixed phenotype acute leukemia	Phase 3	DE	National Cancer Institute	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


NCT03578367 (ASC4MORE, Pubmed \| J Hematol Oncol)	Phase 2	Chronic phase chronic myeloid leukemia Add-on	84	Asciminib 40 mg QD add-on to Imatinib 400 mg QD	xebokiypyx(skorbegeiw) = qtooybojnp vbnapylkiz (zcmawlgeyh ) View more	Positive	18 Dec 2024
				Asciminib 60 mg QD add-on to Imatinib 400 mg QD	xebokiypyx(skorbegeiw) = ofzmmoqcbr vbnapylkiz (zcmawlgeyh ) View more
ASH2024	Not Applicable	Philadelphia chromosome positive chronic myelogenous leukemia	-	Imatinib	gwycmsqlrt(jtdxxctxnv): HR = 3.11 (95% CI, 1.25 - 7.77), P-Value = 0.015	-	09 Dec 2024
				Nilotinib
ASH2024	Not Applicable	Philadelphia positive acute lymphocytic leukaemia	-	Imatinib + low intensity chemotherapy	dvavgpspmt(zlpdcliyqp) = ewbrdahoiq tiztbgzsop (iloshoukzo )	-	09 Dec 2024
				Imatinib (Allogeneic SCT)	dvavgpspmt(zlpdcliyqp) = ypqullddiv tiztbgzsop (iloshoukzo )
ASH2024	Not Applicable	Myeloid Leukemia	-	Imatinib (TKI-Sensitive (TKI-S) patients)	extubviwun(hviqbdyaan) = rknbxsegrj cootshmlki (hdmyxwaxgo ) View more	-	08 Dec 2024
				Imatinib (TKI-Resistant (TKI-R) patients)	extubviwun(hviqbdyaan) = xuecztsqfq cootshmlki (hdmyxwaxgo ) View more
NCT04070443 (TIPI, ASH2024)	Phase 2	Philadelphia chromosome positive chronic myelogenous leukemia	-	Ponatinib 30 mg QD	aqyqxzsjoc(iakvxdegsn) = 2 hematologic (grade 4 neutropenia at M6) ypvjfdfmoy (rrcmpyrcjd )	Positive	08 Dec 2024
				Imatinib 400 mg QD
FDA_CDER Manual	Phase 2	Aggressive Systemic Mastocytosis	28	Imatinib	wolqiepgaf(bkjtbatqkk) = uemwquzttc vgaypjhrhd (insqgkxgbx ) View more	Positive	22 Nov 2024
				Imatinib (FIP1L1-PDGFRα fusion kinase (or CHIC2 deletion))	wolqiepgaf(bkjtbatqkk) = wimrqkzaio vgaypjhrhd (insqgkxgbx ) View more
FDA_CDER Manual	Phase 2	Unresectable Gastrointestinal Stromal Tumor KIT Positive	147	Imatinib 400 mg	krzdzffzmt(ufxpflkjcq) = jvckcdfruf erswutbjdv (dyswtigmjf )	Positive	22 Nov 2024
				Imatinib 600 mg	krzdzffzmt(ufxpflkjcq) = nlxngatbwj erswutbjdv (dyswtigmjf )
FDA_CDER Manual	Not Applicable	Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase First line	846	Imatinib 400 mg once daily	suotsjhkxh(gbkkbnyhhr) = hthjykwfra ysljvetrtj (nrsenogpta, 17.6 - 27.6) View more	Positive	22 Nov 2024
				Nilotinib 300 mg twice daily	suotsjhkxh(gbkkbnyhhr) = fzfrptvagv ysljvetrtj (nrsenogpta, 38.4 - 50.3) View more
FDA_CDER Manual	Phase 3	Unresectable Gastrointestinal Stromal Tumor	1,640	Imatinib 400mg	xemakvrzbr(mqufcfqrxw) = hicwfuapnx beprcgbiqc (erxzlntdeo, 17.4 - 21.2) View more	Positive	22 Nov 2024
				Imatinib 800mg	xemakvrzbr(mqufcfqrxw) = ejzasnjtln beprcgbiqc (erxzlntdeo, 20.8 - 24.9) View more
FDA_CDER Manual	Not Applicable	Philadelphia chromosome positive chronic myelogenous leukemia	14	Imkeldi	kvvekftslp(jymrvpqrqf) = wwqwdidvud qcsxwxiunt (mwitivlqqt ) View more	Positive	22 Nov 2024