A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2) Inhibition in Healthy Male Participants

The main purpose of this study is to evaluate the effect of multiple doses of vimseltinib on the pharmacokinetics (PK) of a clinical OCT2 substrate (metformin) in healthy male participants. This study will also assess the safety and tolerability when vimseltinib is co-administered with the clinical OCT2 substrate (metformin) in healthy male participants. This study will last approximately 25 days.

开始日期2025-11-01

申办/合作机构

Deciphera Pharmaceuticals, Inc.

NCT07158398

/ Recruiting临床1期

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Vimseltinib on BCRP and OATP1B1 Inhibition in Healthy Male Participants

The main purpose of this study is to determine the effect of Vimseltinib dosing on breast cancer resistance protein (BCRP) and organic-anion-transporting polypeptide 1 B1 (OAT1PB1) activity by using rosuvastatin in healthy male participants. This study will also evaluate the safety and tolerability when vimseltinib is co-administered with rosuvastatin in healthy male participants. This study will last approximately 26 days.

开始日期2025-10-31

申办/合作机构

Deciphera Pharmaceuticals, Inc.

NCT06619561

/ Recruiting临床2期

A Phase 2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, PK, and Efficacy of Vimseltinib in Adults With Active Chronic GVHD After Failure of Prior Systemic Therapy

The purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD. Participants will be treated with vimseltinib in 28-day treatment cycles for approximately 2 years.

开始日期2024-11-21

申办/合作机构

Deciphera Pharmaceuticals, Inc.

100 项与 Vimseltinib 相关的临床结果

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100 项与 Vimseltinib 相关的转化医学

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100 项与 Vimseltinib 相关的专利（医药）

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项与 Vimseltinib 相关的文献（医药）

2025-08-01·ESMO Open

A phase I study of the CSF1R inhibitor vimseltinib in combination with the PD-L1 inhibitor avelumab in patients with advanced sarcoma

Article

作者: Wong, P ; Antonescu, C R ; Biniakewitz, M ; Chan, J E ; D'Angelo, S P ; Gounder, M M ; Hwang, S ; Movva, S ; Qin, L-X ; Rosenbaum, E ; Avutu, V ; Desir, R ; Chi, P ; Keohan, M L ; Nacev, B A ; Tap, W D ; Seier, K ; Dickson, M A ; Jasnani, S ; Kelly, C M ; Bradic, M ; Erinjeri, J ; Duchemin, M

BACKGROUND:

Sarcomas are frequently infiltrated with immunosuppressive myeloid cells. Vimseltinib is an inhibitor of the colony-stimulating factor 1 receptor kinase and has been shown to decrease tumor-infiltrating myeloid cells in preclinical models. We hypothesized that vimseltinib combined with the Programmed death-ligand 1 (PD-L1) inhibitor avelumab would be safe, tolerable, and clinically effective in patients with advanced sarcoma.

METHODS:

This was a phase I study of vimseltinib plus avelumab in patients with unresectable or metastatic sarcoma. The study used a standard 3 + 3 dose-escalation design, followed by dose expansion in patients with select histological subtypes. Vimseltinib was administered daily by mouth in 28-day cycles; avelumab was administered intravenously every 2 weeks. The primary objectives of the dose-escalation and dose-expansion phases were to determine the recommended phase II dose and to estimate the best objective response rate by RECIST version 1.1.

RESULTS:

Thirteen patients were treated in the dose-escalation phase, and 19 patients were treated in the dose-expansion phase. The most common treatment-related adverse events were asymptomatic increases in serum levels of amylase, lipase, creatine phosphokinase, aspartate aminotransferase, and alanine aminotransferase. One of six patients treated at the highest dose level had a dose-limiting toxicity (grade 4 increase in aspartate aminotransferase). The highest dose level was determined to be the recommended phase II dose. There were no objective responses. The median progression-free survival of patients treated at the recommended phase II dose was 1.55 months (95% confidence interval 1.25-1.78 months). Flow cytometric analysis of peripheral blood mononuclear cells revealed a decrease in myeloid-derived suppressor cells and regulatory T cells after treatment. RNA sequencing of paired tumor samples revealed an increase in tumor-infiltrating T cells and a decrease in macrophages after treatment.

CONCLUSIONS:

Vimseltinib plus avelumab was generally safe and well tolerated. This combination had minimal clinical efficacy in our population of heavily pretreated patients with sarcoma.

2025-05-31·Intractable & Rare Diseases Research

Vimseltinib: A novel colony stimulating factor 1 receptor (CSF1R) inhibitor approved for treatment of tenosynovial giant cell tumors (TGCTs)

Letter

作者: Lu, Daoran ; Dou, Fangzhou ; Gao, Jianjun

A tenosynovial giant cell tumor (TGCT) is a rare benign neoplasm arising from the tendon sheaths, bursae, or synovial lining of joints and is characterized by locally aggressive growth and the potential for recurrent disease. Surgery is still the main form of treatment for a TGCT, but these neoplasms, and most notably the diffuse type, exhibit a high proclivity for recurrence, thus highlighting the unmet clinical need for novel therapeutic modalities. At the same time, a subgroup of patients deemed ineligible for surgery are confronted with limited therapeutic alternatives, further underscoring the urgent need for innovative treatment paradigms. On February 14, 2025, the US Food and Drug Administration approved a new colony-stimulating factor 1 receptor (CSF1R) inhibitor, vimseltinib, for the treatment of symptomatic TGCTs in adult patients for whom surgical resection would likely result in severe functional limitations or serious complications. As the second-in-class CSF1R inhibitor approved for TGCTs, vimseltinib exhibits enhanced selectivity for CSF1R over pexidartinib, the first-in-class agent, suggesting potential translational benefits in safety profiles. The clinical utility of vimseltinib is anticipated to be further elucidated by real-world evidence and expanded clinical evaluations.

2025-04-03·Expert Review of Anticancer Therapy

An evaluation of vimseltinib for treatment of tenosynovial giant cell tumors

Review

作者: Rutkowski, Piotr ; Kisielewska, Katarzyna

INTRODUCTION:

Tenosynovial giant cell tumor (TGCT) is a rare soft tissue neoplasm with aggressive local growth. The disease is driven by excessive CSF1 expression in tumor cells, leading to increased recruitment of monocytes and macrophages, cytokine production, and tumor development. Targeted therapy against CSF1R is an effective treatment approach for unresectable, symptomatic TGCT. Vimseltinib, a novel, small-molecule tyrosine kinase inhibitor of CSF1R, has shown clinical efficacy in patients with TGCT.

AREAS COVERED:

This paper outlines the pathogenesis and therapeutic options for TGCT, along with a detailed profile of vimseltinib, including its mechanism of action, pharmacokinetics, efficacy and safety data from clinical studies. The efficacy and tolerability of vimseltinib are indirectly compared with previously known CSF1R inhibitors.

EXPERT OPINION:

In the MOTION study, the use of vimseltinib in patients with advanced TGCT resulted in a high objective response rate, substantial benefit in reducing clinical symptoms (such as pain and stiffness), and a favorable safety profile. Vimseltinib represents a promising new therapeutic option for patients with unresectable TGCT and is currently awaiting regulatory review by the FDA and EMA.

项与 Vimseltinib 相关的新闻（医药）

2025-11-17

·Business Wire

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.

上市批准并购

2025-11-12

·Business Wire

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.

临床2期临床1期临床3期上市批准

2025-11-07

·安徽药监

9月份中美欧批准上市新药盘点

9月份，中美欧批准上市的新药中，中国批准4款新药上市，美国和欧盟各批准5款。中国批准四款新药上市 9月份，我国共批准4款新药上市。根据Pharmadigger数据库，其中莫米司特片为我国企业自主研发的全球范围内首次批准上市的新药（详见表1）。莫米司特片是和美药业研发的一款磷酸二酯酶4（PDE4）小分子抑制剂，具备磷酸二酯酶4B（PDE4B）蛋白表达阻断剂和PDE4抑制剂双重机制。该药本次获批是基于一项在我国开展的针对中度至重度慢性斑块状银屑病成人患者的Ⅲ期临床研究。研究结果显示，莫米司特组在治疗16周时，银屑病面积与严重程度指数改善至少75%的患者比例高于安慰剂组（53.6%vs.16.0%）。盐酸菲优拉生片（商品名：菲速乐）是扬子江药业和韩国大熊制药合作开发的一款新型钾离子竞争性酸阻滞剂（P-CAB），能够可逆性阻断分泌胃酸的质子泵，用于治疗反流性食管炎。与传统质子泵抑制剂相比，P-CAB在用药便捷性、夜间酸突破控制等方面具有优势。2021年3月，扬子江药业旗下海尼药业与大熊制药达成协议，获得盐酸菲优拉生片在中国的研发和商业化权益。替利珠单抗注射液（商品名：特瑞可）是赛诺菲通过收购美国生物制药公司Provention Bio获得的一款靶向CD3的单克隆抗体，其通过与效应T细胞表面的CD3结合，抑制T细胞对胰岛β细胞的攻击，从而保护胰岛β细胞不受破坏。该药已于2022年11月在美国获批上市。泽卢克布仑钠注射液（商品名：卓倍可）是优时比研发的首个经皮下注射、可自行给药并拥有双重抑制作用的新一代C5补体抑制剂。该药可特异性结合C5，并阻止C5裂解为C5a和C5b，从而防止末端补体复合物C5b-9的生成；同时，该药还可与C5b结构域结合，阻止新生的C5b与C6结合，通过双重作用防止末端攻膜复合物的形成，有效阻止补体级联反应。该药已于2023年10月在美国获批上市。美国批准五款新药上市 9月份，美国共批准5款新药上市。根据Pharmadigger数据库，5款新药均为全球范围内首次获批（详见表2）。 Elamipretide hydrochloride（商品名：Forzinity）是Stealth生物制药公司研发的肽类化合物，能够穿透细胞膜、靶向线粒体内膜，并可逆性地与心磷脂结合。巴思综合征（Barth Syndrome）是一种极罕见的X连锁遗传性线粒体疾病，患者因参与线粒体心磷脂最终重塑步骤的酰基转移酶发生突变，出现心脏异常、运动不耐受、肌无力、严重疲劳及心力衰竭等症状。该药本次获批基于一项Ⅱ/Ⅲ期临床研究。研究人员将接受168周Elamipretide hydrochloride治疗的巴思综合征患者与自然病程患者进行了对照研究。结果显示，与对照组相比，治疗组患者心功能明显改善，左心室搏出量提升超过40%；同时，患者多项诊断性生物标志物得到改善，6分钟步行测试和肌力较基线均有提升。 Pembrolizumab and berahyaluronidase alfa（商品名：Keytruda Qlex）是默沙东研发的一款皮下注射剂，该药将Pembrolizumab与Alteogen公司开发的透明质酸酶变体Berahyaluronidase alfa结合，旨在提升给药便捷性。自2014年首次获美国食品药品管理局（FDA）批准治疗晚期黑色素瘤以来，Pembrolizumab已被批准用于至少16种癌种及不限癌种的适应证。Pembrolizumab and berahyaluronidase alfa本次获批主要基于一项代号为MK-3475A-D77的Ⅲ期临床研究。研究结果显示，在晚期非小细胞肺癌患者中，与静脉输注Pembrolizumab相比，Pembrolizumab and berahyaluronidase alfa在无进展生存期与总生存期方面未见显著差异。 Paltusotine hydrochloride（商品名：Paltusotine）是Crinetics制药公司研发的一种每日1次口服的非肽类、偏向性生长抑素受体2型（SST2）激动剂。相较其他SST受体亚型，Paltusotine hydrochloride对SST2的选择性超过4000倍，或可降低脱靶风险。该药本次获批主要基于PATHFNDR-1与PATHFNDR-2两项Ⅲ期临床试验。此两项试验分别评估了该药在既往接受过治疗与未接受药物治疗的成人肢端肥大症患者中的安全性与有效性。结果显示，Paltusotine hydrochloride起效迅速，能实现稳定的生化控制并具有持久疗效，患者的相关体征与症状亦获得改善。 Imlunestrant tosylate（商品名：Inluriyo）是礼来研发的一款口服雌激素受体拮抗剂，可持续抑制雌激素受体活性，包括存在ESR1突变的肿瘤。该药本次获批基于一项Ⅲ期EMBER-3研究。研究结果显示，Imlunestrant tosylate组患者的中位无进展生存期为5.5个月，优于标准内分泌治疗组的3.8个月，且疾病进展或死亡风险降低了38%。 Remibrutinib（商品名：Rhapsido）是诺华研发的一款高选择性口服布鲁顿酪氨酸激酶（BTK）抑制剂，其可阻断BTK信号通路，抑制导致瘙痒性风团和肿胀的组胺释放。该药本次获批主要基于REMIX-1和REMIX-2两项Ⅲ期临床试验。试验结果显示，与安慰剂相比，Remibrutinib在第12周时于瘙痒严重程度等关键评分的基线变化方面显示出优势。欧盟批准五款新药上市 9月份，欧盟批准5款新药上市。根据Pharmadigger数据库，均非全球范围内首次批准上市（详见表3）。 Donanemab（商品名：Kisunla）是礼来研发的一种每月输注1次的靶向β淀粉样蛋白的单克隆抗体，能特异性地结合淀粉样斑块，并通过小胶质细胞介导的吞噬作用帮助清除这些斑块，从而延缓阿尔茨海默病（AD）进展。该药已于2024年7月在美国获批上市。 Sebetralstat（商品名：Ekterly）是KalVista制药公司研发的新型口服血浆激肽释放酶抑制剂，用于治疗遗传性血管性水肿（HAE）。该药主要通过抑制因C1INH突变导致的PKK-激肽系统过度激活，来减少全身组织肿胀的发生。该药已于2025年7月在美国获批上市。 Vimseltinib（商品名：Romvimza）是Deciphera制药公司研发的一种口服酪氨酸激酶抑制剂，可选择性和强效抑制集落刺激因子1受体，用于治疗腱鞘巨细胞瘤（TGCT）成人患者。该药已于2025年2月在美国获批上市。 Olezarsen（商品名：Tryngolza）是Ionis制药公司研发的一种RNA靶向药物，通过降低肝脏产生的载脂蛋白C-Ⅲ来调节甘油三酯代谢。该药已于2024年12月在美国获批上市。 Zuranolone（商品名：Zurzuvae）是渤健研发的一种神经活性类固醇γ-氨基丁酸(GABA) A受体正调节剂，可以作为一种类固醇与大脑内的GABA受体结合，重置抑郁症患者释放的神经递质。该药最早于2023年8月在美国获批上市。（注：本文中的新药分别按中国、美国、欧盟三地新分子实体或生物药首次NDA/BLA来统计，一些药物首先在美国上市后首次在中国或欧盟上市时也会纳入统计）来源：中国医药报

上市批准临床3期并购

100 项与 Vimseltinib 相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
腱鞘巨细胞瘤	美国	Deciphera Pharmaceuticals, Inc.	2025-02-14

未上市

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
慢性移植物抗宿主病	临床2期	美国	Deciphera Pharmaceuticals, Inc.	2024-11-21
晚期癌症	临床2期	美国	Deciphera Pharmaceuticals, Inc.	2017-02-16
晚期癌症	临床2期	澳大利亚	Deciphera Pharmaceuticals, Inc.	2017-02-16
晚期癌症	临床2期	加拿大	Deciphera Pharmaceuticals, Inc.	2017-02-16
晚期癌症	临床2期	法国	Deciphera Pharmaceuticals, Inc.	2017-02-16
晚期癌症	临床2期	意大利	Deciphera Pharmaceuticals, Inc.	2017-02-16
晚期癌症	临床2期	荷兰	Deciphera Pharmaceuticals, Inc.	2017-02-16
晚期癌症	临床2期	波兰	Deciphera Pharmaceuticals, Inc.	2017-02-16
晚期癌症	临床2期	西班牙	Deciphera Pharmaceuticals, Inc.	2017-02-16
晚期癌症	临床2期	英国	Deciphera Pharmaceuticals, Inc.	2017-02-16

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05059262 (MOTION, ESMO2025)	临床3期	腱鞘巨细胞瘤	83	Vimseltinib 30 mg	衊鏇範襯鑰襯壓淵鑰夢(糧蓋餘繭繭襯夢積願衊) = 鹹願壓襯鹹選憲鏇鏇齋製鑰製遞廠鏇繭壓齋構 (襯衊壓蓋遞齋網膚蓋鏇, 37 ~ 59) 更多	积极	2025-10-17
NCT05059262 (MOTION, ASCO2025)	临床3期	腱鞘巨细胞瘤 CSF1	83	Vimseltinib 30 mg twice weekly	鏇顧鹽繭鏇艱鹹鏇遞襯(糧憲艱鹽蓋鏇壓醖艱艱) = 蓋獵壓蓋願簾淵鏇鏇餘糧糧醖夢範淵構築餘壓 (鏇觸餘積繭願壓鏇鹹鹽, 29 ~ 51) 更多	积极	2025-05-30
NCT05059262 (MOTION, CTgov)	临床3期	腱鞘巨细胞瘤	123	Vimseltinib (Vimseltinib)	網顧夢構鹽顧衊醖齋窪 = 範淵夢鏇製醖蓋遞願鏇積鏇蓋襯範夢壓積鑰遞 (艱觸窪壓糧窪範願範糧, 遞艱顧繭齋獵壓壓窪顧 ~ 遞廠衊壓獵窪衊製鹽鏇) 更多	-	2025-02-24
				placebo (Placebo)	網顧夢構鹽顧衊醖齋窪 = 觸壓遞鹹鬱構蓋範網廠積鏇蓋襯範夢壓積鑰遞 (艱觸窪壓糧窪範願範糧, 淵膚襯簾襯齋窪鑰壓網 ~ 範簾窪獵廠衊構鬱餘觸) 更多
NCT03069469 (ESMO2024)	临床1/2期	腱鞘巨细胞瘤	-	Vimseltinib 30 mg	蓋顧積構積觸顧顧繭夢(選鑰鹹齋艱鏇顧鏇膚簾) = 積糧膚壓顧顧襯鬱繭獵築膚製膚鬱憲艱窪衊積 (鬱獵鹽淵網製醖鑰齋餘 ) 更多	-	2024-09-14
NCT03069469 (ESMO2024)	临床1/2期	腱鞘巨细胞瘤	-	Vimseltinib 30 mg	鑰廠簾壓鹹衊獵選觸鹹(廠鑰觸構憲襯壓艱壓膚) = Grade 3/4 TEAEs (>5% of pts) were increased creatine phosphokinase, hypertension, and eczema. 憲醖築窪願網艱築獵膚 (淵廠鑰襯鏇夢遞鏇積製 ) 更多	-	2024-09-14
				Placebo
NCT05059262 (MOTION, ASCO2024) 人工标引	临床3期	腱鞘巨细胞瘤	123	Vimseltinib 30 mg	遞構簾製鏇範鏇選鏇鑰(積選築鬱齋鑰餘艱構醖) = 憲壓糧膚衊繭壓醖獵鏇糧蓋衊選顧糧遞壓壓鑰 (簾獵簾鏇壓觸衊構願範 ) 更多	积极	2024-05-24
				Placebo	遞構簾製鏇範鏇選鏇鑰(積選築鬱齋鑰餘艱構醖) = 膚簾衊願觸網鏇衊築觸糧蓋衊選顧糧遞壓壓鑰 (簾獵簾鏇壓觸衊構願範 ) 更多
NCT05059262 (MOTION, Biospace \| FDA) 人工标引	临床3期	腱鞘巨细胞瘤	123	vimseltinib	窪醖遞觸願醖廠窪齋範(壓鹹鹽構糧獵廠淵襯衊) = 糧鏇糧夢醖繭廠廠獵築鬱憲襯觸鹹窪襯齋顧衊 (選糧壓衊鏇淵繭觸網艱, 29 ~ 51) 达到更多	积极	2023-10-30
				Placebo	窪醖遞觸願醖廠窪齋範(壓鹹鹽構糧獵廠淵襯衊) = 鬱鏇夢壓壓艱餘醖膚餘鬱憲襯觸鹹窪襯齋顧衊 (選糧壓衊鏇淵繭觸網艱, 0 ~ 9) 达到更多
NCT03069469 (Biospace) 人工标引	临床1/2期	腱鞘巨细胞瘤 CSF1R	97	vimseltinib (Phase 1)	淵範壓遞願積壓鹽糧鏇(憲醖簾鬱願憲顧繭鏇齋) = 範鏇夢齋鑰糧願夢膚鹹鹽蓋願壓襯製觸築顧繭 (顧鹹選窪範醖範鹹鑰鬱 ) 更多	积极	2023-10-30
				vimseltinib (Phase 2 Cohort A)	淵範壓遞願積壓鹽糧鏇(憲醖簾鬱願憲顧繭鏇齋) = 鏇衊獵願壓衊襯壓襯窪鹽蓋願壓襯製觸築顧繭 (顧鹹選窪範醖範鹹鑰鬱 ) 更多
NCT03069469 (ESMO2022) 人工标引	临床2期	腱鞘巨细胞瘤	57	Vimseltinib	-	积极	2022-09-10
				Vimseltinib (no prior anti-CSF1/CSF1R therapy except imatinib and/or nilotinib)	淵淵襯艱願觸觸鹽觸選(鬱積願夢蓋觸網鬱製淵) = 築淵築齋簾遞衊製膚鑰壓製糧廠鑰築淵蓋糧網 (齋選壓蓋觸簾窪膚鹽淵 ) 更多
NCT03069469 (ESMO2022)	临床1期	腱鞘巨细胞瘤	32	Vimseltinib	鹹窪選鑰壓艱繭顧遞壓(襯憲製築網觸糧醖鏇窪) = 3 pts discontinued treatment due to an adverse event (AE) 築積積築選願淵廠淵衊 (鏇糧膚選願願範夢鹽鹹 )	-	2022-09-10