A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Masitinib as add-on Therapy in Patients With Mild Alzheimer's Disease, Treated With Standard of Care

Masitinib is an orally administered tyrosine kinase inhibitor that targets activated cells of the neuroimmune system (mast cells and microglia). Study AB21004 will evaluate masitinib as an adjunct to cholinesterase inhibitor and/or memantine in patients with mild-to-moderate Alzheimer's disease.

开始日期2026-06-01

申办/合作机构

AB Science SA

NCT07174492

/ Not yet recruiting临床3期

A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Groups, Phase 3 Trial to Compare the Efficacy and Safety of Masitinib in Combination With Standard of Care Versus Placebo in Combination With Standard of Care in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).

开始日期2026-01-01

申办/合作机构

AB Science SA

NCT05449444

/ Recruiting临床2期

A 24-week, Multicenter, Randomized, Double Blind, Placebo-controlled, Dose-range Finding Phase II Study to Compare Efficacy and Safety of Oral Masitinib to Placebo in Treatment of Patients With Severe Mast Cell Activation Syndrome (MCAS) With Handicap Unresponsive to Optimal Symptomatic Treatment

To evaluate the efficacy and safety of two dosing schemes of oral masitinib versus matching placebo in the treatment of patients suffering from severe MCAS with handicap unresponsive to optimal symptomatic treatment.

开始日期2022-07-01

申办/合作机构

AB Science SA

100 项与甲磺酸马赛替尼相关的临床结果

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100 项与甲磺酸马赛替尼相关的转化医学

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100 项与甲磺酸马赛替尼相关的专利（医药）

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259

项与甲磺酸马赛替尼相关的文献（医药）

2026-01-22·JOURNAL OF BIOMOLECULAR STRUCTURE & DYNAMICS

An integrated bioinformatics approach to early diagnosis, prognosis and therapeutics of non-small-cell lung cancer

Article

作者: Khanam, Alima ; Singla, Rajeev K. ; Shen, Bairong ; Lin, Yuxin ; Sultana, Adiba ; Alam, Md Shahin ; Sharma, Rohit ; Kuca, Kamil ; Ren, Shumin

Non-small-cell lung cancer (NSCLC) is one of the most deadly tumors characterized by poor survival rates. Advances in therapeutics and precise identification of biomarkers can potentially reduce the mortality rate. Thus, this study aimed to identify a set of common and stable gene biomarkers through integrated bioinformatics approaches that might be effective for NSCLC early diagnosis, prognosis, and therapies. Four gene expression profiles (GSE19804, GSE19188, GSE10072, and GSE32863) downloaded from the Gene Expression Omnibus database to identify common differential expressed genes (DEGs). A total of 213 overlapping DEGs (oDEGs) between NSCLC and healthy samples were identified by using statistical LIMMA method. Then 6 common top-ranked key genes (KGs) (CENPF, CAV1, ASPM, CCNB2, PRC1, and KIAA0101) were selected by using four network-measurer methods in the protein- protein interaction network. The GO functional and KEGG pathway enrichment analysis were performed to reveal some significant functions and pathways associated with NSCLC progression. Transcriptional and post-transcriptional factors of KGs were identified through the regulatory interaction network. The prognostic power and expression level of KGs were validated by using the independent data through the Kaplan-Meier and Box plots, respectively. Finally, 4 KGs-guided repositioning candidate drugs (ZSTK474, GSK2126458, Masitinib, and Trametinib) were proposed. The stability of three top-ranked drug-target interactions (CAV1 vs. ZSTK474, CAV1 vs. GSK2126458, and ASPM vs. Trametinib) were investigated by computing their binding free energies for 140 ns MD-simulation based on MM-PBSA approach. Therefore, the findings of this computational study may be useful for early prognosis, diagnosis and therapies of NSCLC.

2025-12-01·Journal of Gastrointestinal Oncology

Landscape targeted of therapy in advanced pancreatic adenocarcinoma: a network meta-analysis of randomized controlled trials [2010–2024]

Article

作者: Wang, Sheng ; Ma, Huixin ; Jin, Yun ; Deng, Shikang ; Ya, Yunjin

Background:

Advanced pancreatic adenocarcinoma (PA) remains a formidable challenge with limited therapeutic options. Gemcitabine-based regimens, often combined with novel targeted therapies, are widely employed, yet their comparative efficacy is poorly understood. This network meta-analysis (NMA) aimed to systematically evaluate the efficacy of various targeted drug combinations in previously treated patients with advanced or metastatic PA.

Methods:

A systematic search of PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov was conducted to retrieve relevant randomized controlled trials (RCTs) published between 2010 and 2024. Studies comparing targeted drug combinations with chemotherapy or chemotherapy alone in advanced/metastatic PA were included in the NMA. The primary outcomes of the study were overall survival (OS) and progression-free survival (PFS), which were assessed using hazard ratios (HRs) with 95% confidence intervals (CIs) and presented in a Forest plot. Surface under the cumulative ranking (SUCRA) scores were calculated to rank treatment efficacy.

Results:

In total, 13 RCTs, comprising 4,665 patients and evaluating 13 targeted drug combinations, were included in the NMA. While no statistically significant improvements in OS or PFS were observed for most targeted drug combinations compared with gemcitabine monotherapy, epidermal growth factor receptor (EGFR)-targeted agents, particularly nimotuzumab, demonstrated a significant survival benefit in specific subgroups. Similarly, indirect comparisons among targeted therapies revealed no significant differences. The SUCRA rankings identified gemcitabine plus nimotuzumab (Gem-Nimot; 98%) as having the highest probability of ranking first for OS, followed by gemcitabine plus masitinib (Gem-Masit; 80%), gemcitabine plus erlotinib (Gem-Erlot; 70%), and gemcitabine plus sorafenib (Gem-Soraf; 23%). For PFS, Gem-Nimot (98%) ranked highest, followed by Gem-Erlot (73%), gemcitabine plus rigosertib (Gem-Rigos; 57%), and gemcitabine plus sunitinib (Gem-Sunit; 8%).

Conclusions:

This NMA combining network and forest plot results showed that Gem-Nimot provided significant survival benefits in advanced PA. EGFR-targeted combinations demonstrated a significant advantage in both OS and PFS compared with gemcitabine alone, indicating that EGFR inhibition may provide real clinical benefits.

2025-11-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Structure-activity relationship studies of thiazole-based derivatives leading to the identification of novel and potent SARS-CoV-2 main protease inhibitors

Article

作者: Kong, Wai-Po ; Wong, Kwok-Yin ; Leung, Siu-Lun ; Yin, Weile ; Hung, Cheung-Hin

The COVID-19 pandemic has highlighted the need for effective antiviral agents targeting SARS-CoV-2. This study presents the development of thiazole-based inhibitors against SARS-CoV-2 Main Protease, a key enzyme for viral replication. Using Masitinib and MAC-5576 as leads, we designed 29 compounds featuring a pyridinyl ester for covalent binding to Cys145 and a thiazole core for S2 subsite interaction. Structure-activity relationship (SAR) analysis identified the pyridinyl ester as a critical pharmacophore, with the thiazole core providing superior inhibition compared to oxazole. Compound MC12 (IC₅₀ = 77.7 ± 14.1 nM) demonstrated inhibitory activities comparable to Nirmatrelvir (IC₅₀ = 58.4 ± 8.6 nM). Mass spectrometry and X-ray crystallography confirmed reversible covalent binding of MC compounds to SARS-CoV-2 Main Protease. These compounds also showed low cytotoxicity and dual inhibition of SARS-CoV and SARS-CoV-2 M^pro. Thiazole-based compounds thus emerge as promising leads for developing potent and safe SARS-CoV-2 M^pro inhibitors.

146

项与甲磺酸马赛替尼相关的新闻（医药）

2026-02-25

·BioSpace

AB Science announces the identification of a plasma biomarker that indicates the activity of masitinib in treating ALS

PRESS RELEASE AB SCIENCE ANNOUNCES THE IDENTIFICATION OF A PLASMA BIOMARKER THAT INDICATES THE ACTIVITY OF MASITINIB IN TREATING AMYOTROPHIC LATERAL SCLEROSIS, AND THAT IS CAPABLE OF IDENTIFYING PATIENTS WITH PRO INFLAMATORY MICROGLIA, WHICH ARE TARGETED BY MASITINIB THIS BIOMARKER IS ALSO APPLICABLE TO PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS AND ALZHEIMER DISEASE THIS BIOMARKER CAN BE STRATEGIC TO DETERMINE WHICH PATIENTS RESPOND TO TREATMENT AND POTENTIALLY INCREASE CHANCE OF REGISTRATION IN NEURODEGENERATIVE DISEASES Paris, February 24, 2026, 6pm CET AB Science SA (Euronext - FR0010557264 - AB) announced the identification of a potential biomarker for assessing the activity of masitinib in pathological microglial involvement in Amyotrophic Lateral Sclerosis (ALS). The key characteristics of this newly identified biomarker are as follows: It is a blood-based (plasmatic) biomarker, which has the advantages of being easy to collect and accurately evaluated using ELISA (enzyme-linked immunoassay). It is produced by proinflammatory microglia. It activates microglia and astrocytes and is therefore an activator contributing to a vicious neuroinflammation feedback loop. It is also released by mast cells, establishing a link between mast cells and microglia, which are two major cellular targets of masitinib. It is predictive of survival in ALS, potentially explaining why masitinib could extend survival in some specific patients. In-house experiments showed that this biomarker was reduced by masitinib when mast cells and microglia were activated in vitro , underscoring the specific and potent activity of masitinib on mast cells and microglia. Professor Olivier Hermine, President of AB Science's Scientific Committee, member of the French Academy of Sciences and Head of the Hematology Department at Necker Hospital, commented: “ Interestingly, this biomarker could be used in ALS but also in other neurodegenerative diseases of interest, namely progressive forms of multiple sclerosis (MS) and Alzheimer’s disease. In multiple sclerosis, for instance, this biomarker has normal plasmatic levels in clinically isolated syndrome (CIS), is elevated in RRMS during relapse, and is high in progressive forms, consistent with what we know about the involvement of microglia in MS ”. This biomarker will be introduced in the phase 3 program of masitinib in ALS, as well as in progressive MS and Alzheimer’s disease, to validate the mechanism of action of masitinib in humans and its clinical relevance. Once validated, it could facilitate registration by determining which patients respond best to treatment and serve as a surrogate endpoint of efficacy if necessary. Indeed, FDA Guidance on ALS states that “ FDA encourages sponsors to incorporate exploratory biomarkers in all phases of development of ALS drugs. In the future, greater scientific understanding of ALS may provide opportunities for discussion of surrogate endpoints that are reasonably likely to predict clinical benefit and that might serve as a basis for accelerated approval. ” This biomarker remains undisclosed for patent protection reasons. About AB Science Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development, and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action is key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, which are often lethal with short-term survival or rare or refractory to previous lines of treatment. AB Science has developed a proprietary portfolio of molecules, and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is being developed for human medicine in oncology, neurological diseases, inflammatory diseases, and viral diseases. The company is headquartered in Paris, France and is listed on Euronext Paris (ticker: AB). Further information is available on AB Science’s website: . Forward-looking Statements - AB Science This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions, and expectations regarding financial results, events, operations, future services, product development, and their potential or future performance. These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science, which may imply that results and actual events significantly differ from those expressed, induced, or anticipated in the forward-looking information and statements. These risks and uncertainties include uncertainties related to the product development of the Company, which may not be successful, or to the marketing authorizations granted by competent authorities, or, more generally, any factors that may affect the marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations. For additional information, please contact: AB Science Financial Communication & Media Relations investors@ab-science.com Attachment CP Biomarker VENG VF

临床3期

2026-01-30

·BioSpace

AB Science receives notice of allowance for US patent covering masitinib in the treatment of metastatic castrate resistant prostate cancer

PRESS RELEASE AB SCIENCE RECEIVES NOTICE OF ALLOWANCE FOR UNITED STATES PATENT COVERING MASITINIB IN THE TREATMENT OF METASTATIC CASTRATE RESISTANT PROSTATE CANCER THIS POSITIVE DECISION FROM THE USA PATENT OFFICE STRENGTHENS THE COMPANY’S INTELLECTUAL PROPERTY POSITION IN THIS INDICATION UNTIL 2042, ADDING TO THE COVERAGE ALREADY GRANTED IN EUROPE Paris, January 29, 2026, 6pm CET AB Science SA (Euronext - FR0010557264 - AB) announced that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance (NOA) for a patent relating to methods of treating metastatic castrate resistant prostate cancer (mCRPC) with its lead compound masitinib (US 18/040884). Delivery of masitinib patent in mCRPC Once granted, this new US secondary medical use patent will provide intellectual property (IP) protection for masitinib in mCRPC until May 2042. A NOA signifies that the USPTO intends to grant the patent application after completing certain formal procedural steps. The US NOA is issued after an examiner confirms that the patent application meets all patentability requirements. This new US patent adds to the IP coverage already granted in Europe (EP4175639) [1]. Counterpart patent applications have also been filed in other major international markets. Masitinib positioning in metastatic prostate cancer after failure to hormone therapy In metastatic prostate cancer, patients take hormone therapies (i.e., androgen-deprivation therapy) in first line and second line. Then when metastatic cancer advances patients have to be treated by chemotherapy. There is only one chemotherapy registered, docetaxel, and no drug in combination with docetaxel or replacement of docetaxel has improved PFS or OS and has been registered for the last 20 years. Masitinib is positioned in combination with docetaxel as a treatment of mCRPC patients who are eligible to chemotherapy. That is to say, it is administered directly following the metastatic hormone-sensitive prostate cancer (mHSPC) treatment space. Masitinib is one of the rare drugs to have generated positive data on progression free survival (PFS) in combination with docetaxel in this population. Masitinib positioning in mCRPC with low metastatic involvement measured by a biomarker More specifically, this patent provides protection for masitinib and related compounds for the treatment of mCRPC in a patient subpopulation with low metastatic involvement (as measured by baseline alkaline phosphatase levels). This patient population is fully consistent with the results of the masitinib study AB12003 [2] and the ongoing clinical development program of masitinib in mCRPC. As a reminder, the key results from study AB12003 include: Masitinib (6.0 mg/kg/day) plus docetaxel conferred a significant progression-free survival (PFS) benefit in mCRPC patients with baseline alkaline phosphatase levels (ALP) less than or equal to 250 IU/L; hazard ratio of 0.79 [0.64,0.97] (p=0.0087), corresponding to a 21% reduction in risk of progression relative to control. Assessment of PFS rates was convergent with this primary outcome, with 12-, 18-, and 24-month PFS rates showing significant improvement in favor of masitinib plus docetaxel relative to the control: 1.6-fold (p=0.0035), 1.9-fold (p=0.0001), and 1.9-fold (p=0.0028), respectively. A progressively greater masitinib treatment effect was observed for lower baseline ALP levels (i.e., less advanced metastatic disease), with a significant 47% reduced risk of progression in patients with ALP less than or equal to 100 IU/L (hazard ratio=0.53, p=0.002). The safety pro masitinib plus docetaxel was acceptable and consistent with the known masitinib profile, with no new safety signals observed. Unmet medical need in mCRPC Although localized disease is associated with high survival rates, metastatic prostate cancer still represents an unmet medical need with a 5-years survival rate of approximately 32% [3]. Practically all patients with metastatic disease become resistant to androgen-deprivation therapy. With 1.5 million new cases and 397,000 deaths worldwide, prostate cancer is the world’s second most frequent cancer and the fifth leading cause of cancer death among men [4]. It is estimated that there are at least 3.5 million men living with prostate cancer in the United States [5] and 2.5 million in Europe [6]. Approximately 2% of all prostate cancer cases are mCRPC [7], and practically all patients with metastatic disease will become resistant to androgen-deprivation therapy. As such, the population with mCRPC eligible to chemotherapy is around 50,000 in the EU and 70,000 in the USA. References [1] AB Science press release dated 26 June, 2023. [2] Pavic, Michel; Hermine, Olivier; Spaeth, Dominique LBA02-11 Masitinib plus docetaxel as first-line treatment of metastatic castrate refractory prostate cancer: results from study AB12003, Journal of Urology: September 2021 - Volume 206 - Issue Supplement 3. doi: 10.1097/JU.0000000000002149.11 [3] American Cancer Society. Cancer Facts & Figures 2023. Atlanta: American Cancer Society; 2023. Accessed June 2023. [4] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians . 2024;74(3):229-263. Published 2024 April 4. doi: 10.3322/caac.21834 [5] SEER Explorer: An interactive website for SEER cancer statistics. Cancer Stat Facts: Prostate Cancer. Available at: (last access 29 Jan 2026) [6] European Association of Urology. White paper on prostate cancer. 2020. (last access 29 Jan 2026) [7] Shore N, Oliver L, Shui I, Gayle A, Wong OY, Kim J, Payne S, Amin S, Ghate S. Systematic Literature Review of the Epidemiology of Advanced Prostate Cancer and Associated Homologous Recombination Repair Gene Alterations. J Urol. 2021 Apr;205(4):977-986. doi: 10.1097/JU.0000000000001570. Epub 2020 Dec 17. PMID: 33332152. About study AB12003 Study AB12003 was a prospective, placebo-controlled, double-blind, randomized, phase 3 trial that evaluated masitinib (6.0 mg/kg/d) in combination with docetaxel (IV 75 mg/m² plus prednisone for up to 10 cycles) as a first-line treatment for metastatic castrate-resistant prostate cancer (mCRPC). Eligible patients were chemotherapy-naïve with confirmed mCRCP, had progressed on previous abiraterone treatment or were indicated for docetaxel treatment, and had an ECOG performance status score of ≤1. Primary analysis was performed on a pre-specified targeted subgroup, defined as patients with baseline alkaline phosphatase (ALP) levels ≤250 IU/L, and on the overall population. The primary endpoint was progression-free survival (PFS) (PCWG2 definition). The study was successful if the improvement in median PFS relative to the control reached a 3.9% level of significance for the target subgroup (alpha split with fallback procedure to conserve the overall type-I error at 5% for the overall study cohort). The primary analysis was based on 450 patients in the targeted subgroup (ALP ≤ 250 IU/L). The overall study cohort comprised 712 patients. About AB Science Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development, and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action is key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, which are often lethal with short-term survival or rare or refractory to previous lines of treatment. AB Science has developed a proprietary portfolio of molecules, and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is being developed for human medicine in oncology, neurological diseases, inflammatory diseases, and viral diseases. The company is headquartered in Paris, France and is listed on Euronext Paris (ticker: AB). Further information is available on AB Science’s website: . Forward-looking Statements - AB Science This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions, and expectations regarding financial results, events, operations, future services, product development, and their potential or future performance. These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science, which may imply that results and actual events significantly differ from those expressed, induced, or anticipated in the forward-looking information and statements. These risks and uncertainties include uncertainties related to the product development of the Company, which may not be successful, or to the marketing authorizations granted by competent authorities, or, more generally, any factors that may affect the marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations. For additional information, please contact: AB Science Financial Communication & Media Relations investors@ab-science.com Attachment mCRPC Patent USPTO VENG VF

临床结果临床3期

2026-01-29

·阿尔茨海默病研究

2021-2026年全球AD药物研发管线分析

AD_Drug_Development_2021-2026.xlsx 关键词：阿尔茨海默病、药物、临床、研发、Phase 25年的AD药物统计还没看到，AI先做了一个汇总表阿尔茨海默病(AD)药物研发汇总报告 2021-2026年全球AD药物研发管线分析数据摘要已上市药物 3个 (Lecanemab, Donanemab, Aduhelm[退市]) Phase 3在研 18个 Phase 2/3在研 8个 Phase 2在研 22个 Phase 1在研 10个研发失败/终止 19个总计 80个药物说明本报告汇总了2021-2026年间全球阿尔茨海默病药物研发情况，包括已上市药物、在研药物（Phase 1-3）以及研发失败的药物。数据来源于ClinicalTrials.gov、PubMed、FDA等权威机构。涵盖Aβ靶向、tau靶向、神经炎症、老药新用等多种机制。 23/24年大佬整理的药物研发情况汇总：参考文献 ClinicalTrials.gov https://clinicaltrials.gov PubMed https://pubmed.ncbi.nlm.nih.gov FDA https://www.fda.gov Alzheimer's & Dementia (Journal) https://alz-journals.onlinelibrary.wiley.com Nature Reviews Drug Discovery https://www.nature.com/nrd New England Journal of Medicine https://www.nejm.org JAMA Neurology https://jamanetwork.com/journals/jamaneurology Lancet Neurology https://www.thelancet.com/neurology Cummings et al. 2025 Pipeline Report Alzheimer's Dement 2025;11:e70098 Alzforum https://www.alzforum.org Alzheimers Dement (N Y). 2023 May 25;9(2):e12385. Alzheimers Dement (N Y). 2024 Apr 24;10(2):e12465. 本文内容来自公开信息及研究文献，不代表临床建议。如需投稿、转载、商务合作后台留言，回复有一定延迟敬请谅解。辅助编辑：腾讯元宝or（GPT、Gemini、Claude等）扫码加入ima知识库，获取本公众号所有文献全文资料，AI问答了解更多信息，文献实时更新药品名称进展阶段临床试验编号所属公司/机构开发起始时间备注 GV-971 (Sodium Oligomannate) 中国已上市/全球Phase 3终止 NCT04520412 (Green Memory) Green Valley Pharma (China) 2019 中国2019年批准，国际III期2022年终止 Lecanemab (Leqembi) 已上市 (FDA 2023.1加速批准, 2023.7完全批准) NCT03887455 (Clarity AD) Eisai / Biogen / BioArctic 2020 抗Aβ原纤维抗体，减缓认知下降27% Donanemab (Kisunla) 已上市 (FDA 2024.7批准) NCT04437511 (TRAILBLAZER-ALZ 2) Eli Lilly 2020.6 抗Aβ抗体，低/中tau患者减缓下降60% Remternetug Phase 3 (进行中) NCT05463731 (TRAILRUNNER-ALZ1) Eli Lilly 2022.8 第三代抗Aβ抗体，皮下/静脉给药 ALZ-801 (Valiltramiprosate) Phase 3 (进行中) NCT04770220 (APOLLOE4) Alzheon 2021.5 口服Aβ寡聚体抑制剂，针对APOE4/4纯合子 Semaglutide Phase 3 (进行中) NCT04777396 / NCT04777409 (EVOKE/EVOKE+) Novo Nordisk 2021.5 GLP-1受体激动剂，老药新用 Nilotinib Phase 3 (进行中) NCT05143528 Novartis 2022.2 酪氨酸激酶抑制剂，老药新用 Masitinib Phase 3 (进行中) NCT05564169 AB Science 2022 酪氨酸激酶抑制剂，抗炎 KarXT (Xanomeline-Trospium) Phase 3 (进行中) NCT05511363 Karuna Therapeutics / Bristol-Myers Squibb 2022 毒蕈碱受体激动剂组合 Masupirdine (SUVN-502) Phase 3 (进行中) NCT05397639 Suven Pharmaceuticals 2022 5-HT6受体拮抗剂，用于激越症状 Nabilone Phase 3 (进行中) NCT04516057 University of Toronto 2020 大麻素受体激动剂，老药新用，用于激越 Dextromethorphan/Quinidine Phase 3 (进行中) NCT03389922 Otsuka / Avanir 2018 用于AD相关激越 NE3107 Phase 3 (进行中) NCT04669028 BioVie 2021 口服抗炎胰岛素增敏剂 AR1001 Phase 3 (进行中) NCT05531526 AriBio 2022 PDE5抑制剂，老药新用 ATH-1017 (Fosgonimeton) Phase 3 (进行中) NCT04488419 Athira Pharma 2020 肝细胞生长因子增强剂 AXS-05 (Dextromethorphan/Bupropion) Phase 3 (进行中) NCT05526968 Axsome Therapeutics 2022 用于AD相关激越 Trontinemab (RO7126209) Phase 3 (进行中) NCT06385072 Roche / Genentech 2024 Brainshuttle技术抗Aβ抗体，基于gantenerumab ALZ-801 (Long-term Extension) Phase 3扩展 (进行中) NCT06304883 Alzheon 2023 APOLLOE4试验长期扩展 Blarcamesine (ANAVEX 2-73) Phase 2/3 (完成) NCT03790709 Anavex Life Sciences 2019 Sigma-1受体激动剂，已提交欧洲上市申请 Piromelatine Phase 2/3 (进行中) NCT05267535 Neurim Pharmaceuticals 2022.5 褪黑素受体激动剂 Buntanetap Phase 2/3 (进行中) NCT05686044 Annovis Bio 2023 神经毒性聚集蛋白翻译抑制剂 Metformin Phase 2/3 (进行中) NCT04098666 University of Pennsylvania 2021.3 降糖药，老药新用 E2814 (Etalanetug) Phase 2/3 (进行中) NCT05269394 (DIAN-TU Tau NexGen) Eisai / UCL 2022.1 抗tau抗体，靶向MTBR，获FDA快速通道资格 Rotigotine + Rivastigmine Phase 2/3 (进行中) NCT04185099 University of California 2019 多巴胺激动剂+胆碱酯酶抑制剂 Lecanemab + E2814 Phase 2/3 (进行中) NCT05269394 (DIAN-TU-001) Eisai 2022 抗Aβ+抗tau组合疗法 ABBV-916 Phase 2 (进行中) NCT05291234 AbbVie 2022 抗Aβ抗体，靶向N3pG-Aβ CT1812 (Zervimesine) Phase 2 (进行中) NCT03507790 (SHINE) / NCT05531656 (START) Cognition Therapeutics 2018 Sigma-2受体调节剂 Bepranemab (UCB0107) Phase 2 (进行中) NCT04867616 Roche / UCB 2021 抗tau抗体，靶向tau中央区域 JNJ-63733657 Phase 2 (进行中) NCT04619420 (AUTONOMY) Janssen 2020 抗tau抗体，靶向p-tau217 LY3372689 Phase 2 (进行中) NCT05063539 Eli Lilly 2021.9 O-GlcNAcase抑制剂，小分子 BIIB080 (IONIS-MAPTRx) Phase 2 (进行中) NCT05399888 (CELIA) Biogen / Ionis 2022 Tau反义寡核苷酸 ACI-35 Phase 2 (进行中) NCT04445831 AC Immune / Janssen 2020 抗tau疫苗 Hydralazine Hydrochloride Phase 2 (进行中) NCT04842552 University of Colorado 2021 老药新用，激活Nrf2通路 Caffeine Phase 2 (进行中) NCT04570085 University of Miami 2020 腺苷受体拮抗剂，老药新用 Sildenafil Phase 2 (进行中) NCT05403764 Cleveland Clinic 2022 PDE5抑制剂，老药新用 Dasatinib + Quercetin Phase 2 (进行中) NCT04063124 Mayo Clinic 2019 衰老细胞清除剂，老药新用 Liraglutide Phase 2 (进行中) NCT05653675 Novo Nordisk 2023 GLP-1受体激动剂，老药新用 Foralumab Phase 2 (进行中) NCT06382623 Tiziana Life Sciences 2024 抗CD3单抗，鼻内给药，针对神经炎症 PRX005 Phase 2 (进行中) NCT06126686 Prothena 2023 抗tau抗体 Exenatide Phase 2 (进行中) NCT04269349 University of Oxford 2020 GLP-1受体激动剂，老药新用 Lixisenatide Phase 2 (进行中) NCT05837287 Sanofi 2023 GLP-1受体激动剂，老药新用，帕金森病 Tirzepatide Phase 2 (进行中) NCT06556289 Eli Lilly 2024 GLP-1/GIP双受体激动剂，老药新用 Dulaglutide Phase 2 (进行中) NCT05844971 Eli Lilly 2023 GLP-1受体激动剂，老药新用 Tadalafil Phase 2 (进行中) NCT05422885 University of California 2022 PDE5抑制剂，老药新用 Vardenafil Phase 2 (进行中) NCT05575076 University of Pennsylvania 2022 PDE5抑制剂，老药新用 Ibudilast Phase 2 (进行中) NCT05549530 MediciNova 2022 PDE4/PDE3抑制剂，抗炎 Saracatinib Phase 2 (进行中) NCT05256052 AstraZeneca 2022 Src/Fyn激酶抑制剂 AZD0530 Phase 2 (进行中) NCT05256052 AstraZeneca 2022 Src激酶抑制剂 Posdinemab (ACI-35-028) Phase 2 (进行中) NCT06126686 AC Immune / Janssen 2023 抗磷酸化tau抗体 AADvac1 Phase 2完成 (未达主要终点) NCT04170891 (ADAMANT) Axon Neuroscience 2020 抗tau疫苗，未达主要终点 ASN51 Phase 2终止 (2025) NCT05544431 Asceneuron 2022 tau靶向药物，战略调整终止 Lu AF87908 Phase 1 (完成) NCT04149860 Lundbeck 2019 抗磷酸化tau抗体 PNT001 Phase 1 (完成) NCT05059380 Pinteon Therapeutics 2021 抗cis-pT231 tau抗体 MK-2214 Phase 1 (进行中) NCT05544431 Merck 2022 抗tau抗体 APNmAb005 Phase 1 (进行中) NCT05575076 Applied NeuroSolutions 2022 抗tau寡聚体抗体 Denali TVD (Transferrin Receptor) Phase 1 (进行中) NCT05712223 Denali Therapeutics 2023 脑穿梭技术平台，抗体递送 DNL919 Phase 1 (进行中) NCT05544431 Denali Therapeutics 2022 TREM2激活剂，脑穿梭技术 AL101 (GSK4527226) Phase 1 (进行中) NCT05575076 Alector / GSK 2022 Progranulin增强单抗 NI006 Phase 1 (进行中) NCT05575076 University Hospital Zurich 2022 抗Aβ纳米抗体 ATN-101 Phase 1 (进行中) NCT05575076 Aton Pharma 2022 抗Aβ抗体 RG7345 Phase 1终止 (2015) NCT01952637 Roche / Genentech 2015 抗tau抗体 BIIB076 Phase 1终止 (2022) NCT03113815 Biogen / Neurimmune 2017 抗tau抗体 AL002 Phase 2 (失败) NCT04592874 (INVOKE-2) Alector 2020 TREM2激动剂抗体，INVOKE-2试验未达终点 Ponezumab Phase 2失败 NCT00960531 Pfizer 2012 抗Aβ抗体 Gosuranemab (BIIB092) Phase 2失败 (2021终止) NCT03352557 Biogen / Bristol-Myers Squibb 2018 抗tau抗体，未达主要终点 Tilavonemab (ABBV-8E12) Phase 2失败 (2021终止) NCT03413319 Bristol-Myers Squibb / AbbVie 2018 抗tau抗体，未达主要终点 Zagotenemab (LY3303560) Phase 2失败 (2021终止) NCT03518073 Eli Lilly 2018 抗tau抗体，未达主要终点 Varoglutamstat (PQ912) Phase 2失败 (2024终止) NCT03919162 (VIVA-MIND) / NCT04498650 (VIVIAD) Vivoryon Therapeutics 2019 QPCT抑制剂，VIVIAD试验失败，已转向糖尿病肾病 Semorinemab Phase 2失败 (TAURIEL/LAURIET) NCT03289143 (TAURIEL) / NCT03828747 (LAURIET) Genentech / Roche 2018 TAURIEL未达终点，LAURIET部分终点阳性但功能终点阴性 Idalopirdine Phase 3失败 NCT01955143 Lundbeck / Otsuka 2015 5-HT6受体拮抗剂 Intepirdine Phase 3失败 NCT02585934 Axovant 2017 5-HT6受体拮抗剂 Bapineuzumab Phase 3失败 NCT00575055 / NCT00574132 Pfizer / Janssen 2014 抗Aβ抗体，未达临床终点 Verubecestat (MK-8931) Phase 3失败 (2017终止) NCT01739348 Merck 2017 BACE1抑制剂，因无效提前终止 Lanabecestat (AZD3293) Phase 3失败 (2018终止) NCT02245737 AstraZeneca / Eli Lilly 2018 BACE1抑制剂 Atabecestat (JNJ-54861911) Phase 3失败 (2018终止) NCT02569398 Janssen 2018 BACE1抑制剂，肝毒性 Crenezumab Phase 3失败 (2019终止/2022发表) NCT02670083 (CREAD) / NCT03114657 (CREAD2) Roche / Genentech 2019 CREAD/CREAD2试验因无效提前终止 Gantenerumab Phase 3失败 (2022.11) NCT03444870 (GRADUATE I) / NCT03443973 (GRADUATE II) Roche / Genentech 2018 GRADUATE试验未达主要终点，未能减缓认知下降 Solanezumab Phase 3失败 (2023年A4研究失败) NCT02008357 (A4 Study) Eli Lilly 2014 EXPEDITION 1/2及A4研究均未达终点 Simufilam (PTI-125) Phase 3失败 (2024-2025) NCT04994483 (RETHINK-ALZ) / NCT05026177 (REFOCUS-ALZ) Cassava Sciences 2021.11 Filamin A抑制剂，两项Phase 3均未达终点，已停止开发 Aduhelm (Aducanumab) 已退市 (FDA 2021.6加速批准, 2024.1停产) NCT02484547 (EMERGE) Biogen / Neurimmune 2021.6 2024年1月Biogen宣布停产，非安全/疗效原因

临床3期上市批准抗体药物偶联物加速审批申请上市

100 项与甲磺酸马赛替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲磺酸马赛替尼	L01XE22	DB11526

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肌萎缩侧索硬化	申请上市	加拿大	AB Science SA	2022-05-26
肥大细胞增多症	申请上市	欧盟	AB Science SA	2017-09-14
胃肠道间质瘤	申请上市	欧盟	AB Science SA	-
多发性硬化症	临床3期	美国	AB Science SA	2022-12-29
系统性肥大细胞增多症	临床3期	意大利	AB Science SA	2021-02-23
哮喘	临床3期	阿根廷	AB Science SA	2016-12-01
哮喘	临床3期	马来西亚	AB Science SA	2016-12-01
哮喘	临床3期	秘鲁	AB Science SA	2016-12-01
哮喘	临床3期	菲律宾	AB Science SA	2016-12-01
哮喘	临床3期	乌克兰	AB Science SA	2016-12-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05441488 (MAXIMS, GlobeNewswire) 人工标引	临床3期	原发性进行性多发性硬化 \| 继发进展型多发性硬化 Expanded Disability Status Scale (EDSS)	-	Masitinib	醖繭構鏇選築艱繭襯夢(膚蓋蓋夢顧選鑰構製簾) = 襯鏇壓鑰膚顧觸淵夢餘製獵獵窪壓蓋鏇願艱積 (餘獵鬱願衊鬱襯構製廠 ) 更多	积极	2024-09-23
				Placebo	-
NCT04622865 (Biospace) 人工标引	临床2期	新型冠状病毒感染	95	masitinib + Isoquercetin + Best Supportive Care	築鏇鹹積鏇鬱廠廠鹹構(壓鹽鬱簾積積膚積顧淵) = odds ratio of 2.4 in favor of the treatment arm after 15 days of treatment, superior to the odds ratio of 2.2 initially hypothesized, with p=0.038 simulated with 200 patients and p=0.072 detected with 95 patients recruited. 鏇築積遞獵獵鹹壓鑰網 (鏇網衊構構鑰膚餘遞獵 ) 更多	积极	2024-07-08
				Best Supportive Care
NCT02588677 (AB10015, AAN2023)	临床2/3期	肌萎缩侧索硬化追加	-	Masitinib 4.5 mg/kg/d	築膚膚選製鏇艱齋製壓(淵構獵窪範餘遞網觸構) = 積鬱獵糧獵鬱製鑰願顧艱餘夢鬱夢艱製衊膚願 (醖範艱蓋淵網簾構憲構 )	-	2023-04-25
				Riluzole alone	築膚膚選製鏇艱齋製壓(淵構獵窪範餘遞網觸構) = 鹹蓋願願製夢獵積積夢艱餘夢鬱夢艱製衊膚願 (醖範艱蓋淵網簾構憲構 )
NCT01433497 (Pubmed \| Neurol Neuroimmunol Neuroinflamm) 人工标引	临床3期	多发性硬化症	611	masitinib	構糧獵襯願願蓋淵獵簾(衊簾選壓鏇簾顧淵壓積) = 範窪夢顧鬱憲繭範選網願憲選觸壓衊壓膚範膚 (窪衊壓襯膚壓淵憲齋鏇 )	积极	2022-02-21
				Placebo	構糧獵襯願願蓋淵獵簾(衊簾選壓鏇簾顧淵壓積) = 夢夢網積鹹鏇蓋餘鏇鏇願憲選觸壓衊壓膚範膚 (窪衊壓襯膚壓淵憲齋鏇 )
AUA2021	临床3期	转移性去势抵抗性前列腺癌一线 alkaline phosphatase levels (ALP)	714	Masitinib 6.0 mg/kg/d plus Docetaxel	積壓積鑰鏇積衊構遞艱(鏇醖鬱憲廠淵願窪壓範) = 鏇夢顧糧鑰願顧簾糧鹽鹽餘襯構顧餘顧範淵鏇 (構製顧鹹顧製築窪夢簾 ) 更多	积极	2021-09-01
				Placebo plus Docetaxel	積壓積鑰鏇積衊構遞艱(鏇醖鬱憲廠淵願窪壓範) = 襯築蓋觸衊構鬱鏇築繭鹽餘襯構顧餘顧範淵鏇 (構製顧鹹顧製築窪夢簾 ) 更多
NCT01872598 (AB09004, GlobeNewswire) 人工标引	临床3期	阿尔茨海默症	358	Masitinib mesylate	衊積醖廠構鑰選襯顧憲(鑰範蓋窪積襯網鬱鑰積) = 選積淵觸壓繭淵廠願觸襯簾遞鹽艱製觸夢窪網 (遞衊鬱鹹壓觸醖網繭艱 ) 更多	积极	2021-07-29
				Placebo	衊積醖廠構鑰選襯顧憲(鑰範蓋窪積襯網鬱鑰積) = 壓築憲顧鏇簾願餘鹹壓襯簾遞鹽艱製觸夢窪網 (遞衊鬱鹹壓觸醖網繭艱 ) 更多
NCT03766295 (AB12005, ASCO2021)	临床3期	胰腺癌一线	384	Masitinib plus gemcitabine	築鬱製衊鏇選鹹選壓淵(願選鏇製鏇獵醖遞鬱衊) = 鹽憲鹽憲蓋遞顧憲醖蓋鹽網構獵顧憲範製觸鏇 (獵簾醖衊觸選窪築廠遞 )	积极	2021-05-28
				Placebo plus gemcitabine	築鬱製衊鏇選鹹選壓淵(願選鏇製鏇獵醖遞鬱衊) = 鹹積鬱夢鹹襯獵壓鏇餘鹽網構獵顧憲範製觸鏇 (獵簾醖衊觸選窪築廠遞 )
NCT03761225 (AB12003, Corporate Publications) 人工标引	临床3期	去势抵抗性前列腺癌一线	714	Docetaxel+Masitinib	鑰壓鹹壓醖獵糧築顧鹹(製餘糧網衊簾網鑰遞夢) = 醖齋鏇鏇築醖膚憲夢遞製艱遞蓋顧衊夢淵顧鑰 (糧簾醖製艱壓醖膚襯齋, 4.9 ~ 6.3) 更多	不佳	2021-05-25
				Docetaxel+Placebo	鑰壓鹹壓醖獵糧築顧鹹(製餘糧網衊簾網鑰遞夢) = 憲積餘齋艱醖築範觸膚製艱遞蓋顧衊夢淵顧鑰 (糧簾醖製艱壓醖膚襯齋, 4.9 ~ 5.9) 更多
NCT01433497 (AB07002, ECTRIMS2020)	临床3期	慢性进行性多发性硬化	-	Masitinib 4.5 mg/kg/d	鏇鬱襯糧襯艱簾衊顧願(範糧糧願鬱鬱鑰範鏇簾): ΔLSM = -0.097 (95% CI, -0.192 ~ -0.002), P-Value = 0.0256 更多	积极	2020-12-07
				Placebo
NCT03771040 (AB14001, GlobeNewswire) 人工标引	临床3期	重度哮喘	-	masitinib	壓繭簾鹽窪繭築糧顧糧(衊糧簾鬱餘觸繭憲鹹齋) = 糧繭鬱鹹窪襯鏇鑰壓窪餘遞鹹觸淵願觸網膚襯 (簾獵夢範鹽繭鬱鹽鹽鏇 ) 更多	积极	2020-10-20
				Placebo	壓繭簾鹽窪繭築糧顧糧(衊糧簾鬱餘觸繭憲鹹齋) = 鑰觸鏇繭憲製蓋簾築積餘遞鹹觸淵願觸網膚襯 (簾獵夢範鹽繭鬱鹽鹽鏇 ) 更多