Asciminib as Single Agent or in Combination With Nilotinib in the 1st-line Treatment of BCR-ABL1+ Chronic Myeloid Leukemia: a Randomized GIMEMA-GELMC Phase II Study PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML

A phase 2, interventional, randomized unblinded study will be conducted in newly diagnosed CP CML patients, to investigate the efficacy and the safety of asciminib at a dose of 80 mg QD as single agent (arm A) or 40 mg BID in combination with nilotinib 300 mg BID (arm B).
All patients in both arm A and arm B will be treated for a minimum of 2 years (core phase). If they will have achieved a DMR (MR4), or if it will be in the interest of the patient, the treatment will be continued.
During the consolidation phase (2 years) asciminib will be continued at the same dose in both arms; in the combination arm the nilotinib dose will be reduced to 300 mg daily.
The patients maintaining a stable MR4 up to the end of the fourth year will discontinue the treatment (TFR phase). The rate of TFR at 5 year (1 year after discontinuation) will be evaluated.

开始日期2025-06-01

申办/合作机构

Gruppo Italiano Malattie EMatologiche dell'Adulto

CTR20243911

/ CompletedN/A

尼洛替尼胶囊在中国健康成年受试者中空腹条件下口服给药的单中心、随机、开放、两制剂、两周期的交叉设计的生物等效性试验

主要研究目的：本研究以仁合熙德隆药业有限公司研发的尼洛替尼胶囊为受试制剂，按生物等效性研究的有关规定，以持证商Novartis Pharma Schweiz AG 生产的尼洛替尼胶囊(规格：200mg，商品名：达希纳)为参比制剂，评估受试制剂和参比制剂在空腹条件下给药后的生物等效性。次要研究目的：观察健康受试者在服用受试制剂尼洛替尼胶囊或参比制剂尼洛替尼胶囊(商品名：达希纳)后的安全性。

开始日期2024-12-09

申办/合作机构

仁合熙德隆药业有限公司

IRCT20200623047902N17

/ SuspendedN/A

Bioequivalence study of Nilotinib 200mg capsule manufactured by Rooyan darou versus Tasigna 200 mg in healthy volunteers in the fasted condition

开始日期2024-10-22

申办/合作机构-

100 项与尼洛替尼相关的临床结果

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100 项与尼洛替尼相关的转化医学

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100 项与尼洛替尼相关的专利（医药）

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4,622

项与尼洛替尼相关的文献（医药）

2025-12-31·Hematology

Second-line use of dasatinib and nilotinib in a real-world patient population with chronic phase chronic myeloid leukemia

Article

作者: Toptas, Tayfur ; Yilmaz, Asu Fergun ; Kaygusuz Atagunduz, Isik ; Menguc, Meral ; Demirtas, Derya ; Yanik, Ahmet Mert ; Candan, Ozlem ; Salim, Secil ; Tuglular, Tulin ; Arikan, Fatma

BACKGROUND:

While there has been no direct head-to-head comparison, it is assumed that second-line treatment with dasatinib and nilotinib has comparable efficacy but distinct safety profiles in the treatment of patients with chronic phase chronic myeloid leukemia (CML-CP). Our aim was to conduct a real-world analysis to compare the efficacy and safety profiles of these two agents.

METHODS:

Data from 73 CML-CP patients, who received either dasatinib or nilotinib in second-line treatment, were analyzed. The primary interest of the efficacy assessment was a major molecular response (MMR) at the 12-month, 5-year cumulative incidence of treatment failure, and overall survival.

RESULTS:

A total of 73.5% of 34 patients in the dasatinib and 76.9% of 39 patients in the nilotinib group achieved MMR at 12 months. Five-year cumulative probability of treatment failure in patients, who previously achieved MMR was 0 and 7.6% for patients receiving dasatinib and nilotinib, respectively (p = 0.25). Eight-year OS was 82.7 and 86.3% for dasatinib and nilotinib groups, respectively (p = 0.90). Pleural effusions were more common in the dasatinib group, leading to treatment discontinuation, while cardiovascular events and thrombotic incidents were more prevalent in the nilotinib group.

CONCLUSION:

Dasatinib and nilotinib exhibit similar efficacy in the CML-CP treatment. Individualized patient management should consider patient comorbidities and safety profiles.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Non-optimal treatment with first tyrosine kinase inhibitor and associated economic burden in chronic myeloid leukemia

Article

作者: Guérin, Annie ; Romdhani, Hela ; Jadhav, Kejal ; Yang, Daisy ; Latremouille-Viau, Dominick ; Wei, David ; Kota, Vamsi

AIMS:

Although adenosine triphosphate (ATP)-competitive tyrosine kinase inhibitors (TKI) approved by the Food and Drug Administration have demonstrated effectiveness in treating chronic myeloid leukemia (CML), patients often experience intolerance or resistance, leading to non-optimal treatment (NOPT). This study assessed the treatment patterns, as well as NOPT and its associated economic burden, in newly diagnosed patients with CML receiving first TKI treatment.

METHODS:

This retrospective study identified adult patients with ≥2 CML diagnoses who initiated first TKI treatment (imatinib, dasatinib, nilotinib, or bosutinib) in 2012 or later from United States administrative health claims databases (01 January 2007-30 June 2022). Treatment sequence and time to treatment discontinuation/switch were assessed. NOPT, identified based on treatment modification/adherence criteria, and its associated incremental healthcare resource utilization and medical costs were evaluated.

RESULTS:

Nearly a quarter of patients experienced NOPT, as indicated by early treatment modifications or low treatment adherence. NOPT was associated with significant incremental healthcare resource utilization (80% more inpatient admissions; twice as many inpatient days; 30% more outpatient visits) and medical costs (adjusted mean cost difference = $13,551 per-patient-per-year).

LIMITATIONS:

Given the lack of information on reasons of treatment modification in health claims data, NOPT was identified based on indicators of management of intolerance and resistance to TKI.

CONCLUSION:

These findings highlight that unmet clinical needs and significant economic burden still persist in this population and that patients with CML may benefit from using therapeutic options with better efficacy and tolerability profiles as first treatment.

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Pharmacokinetic profile of novel reduced-dose Danziten™ (nilotinib tablets) versus Tasigna® (nilotinib capsules): in vivo bioequivalence and population pharmacokinetic analysis

Article

作者: Mauro, Michael ; Sequeira, David ; Jain, Paras ; Douer, Dan ; Radich, Jerald ; Bellanti, Francesco

PURPOSE:

To evaluate single dose pharmacokinetics (PK) of novel reduced-dose film coated Danziten^™ (nilotinib tablets) using a population PK approach, establish bioequivalence vs. Tasigna^® (nilotinib capsules) and investigate food effects on PK of both formulations.

METHODS:

A population PK model evaluating nilotinib capsules (300 or 400 mg) or tablets (142 or 190 mg) was developed using data from 14 single dose studies and > 30,000 plasma samples from healthy men and women. Steady-state nilotinib concentration-time profiles following twice daily dosing with various treatment and food conditions were simulated using a randomly sampled dataset of 50 subjects.

RESULTS:

PK was characterized by a 2-compartment model with linear elimination and zero-order absorption with lag time. Bioequivalence was met for all steady state exposure metrics for both doses under fasted conditions. A milligram strength for nilotinib tablets ~ 50% lower than that for capsules resulted in bioequivalent nilotinib exposures. Administration with a low-fat meal under modified fasting conditions increased the bioavailability (BA) of 142 mg and 190 mg nilotinib tablets by 26.0% and 29.3%, respectively, vs. fasting; values for 300 mg and 400 mg capsules were 56.8% and 60.7%. Administration with a high-fat meal under modified fasting conditions increased the BA of 142 and 190 mg nilotinib tablets by 48.6% and 52.2%, respectively; values for 300 and 400 mg capsules were 180.6% and 183.3%.

CONCLUSION:

Nilotinib tablets 142 and 190 mg provide bioequivalent exposures to 300 mg and 400 mg capsules under fasted conditions and substantially smaller effects of food on exposure.

221

项与尼洛替尼相关的新闻（医药）

2025-06-25

·EINPresswire

Journal of Clinical Medicine Publishes Results of Phase 2 Trial of Nilotinib in Treatment of Dementia with Lewy Bodies

Dementia with lewy bodies (“DLB”) patients, treated with 200mg of nilotinib had statistically significant improvement in cognitive function compared to placebo. MCLEAN, VA, UNITED STATES, June 25, 2025 / EINPresswire.com / -- Nilotinib demonstrated a statistically significant improvement in cognitive function compared to placebo as measured by ADAS-COG14 with a compelling safety profile KeifeRx announced this week that the full results of a phase 2 trial of nilotinib for the treatment of patients with Lewy Body Dementia conducted in collaboration with Georgetown University Medical Center and MedStar Health have been published in the Journal of Clinical Medicine . The results showed that in patients with dementia with Lewy bodies (“DLB”), treatment with 200mg of nilotinib resulted in a statistically significant improvement in cognitive function and a 73% reduction in falls compared to placebo. About the Trial: The phase 2 randomized, double-blind study (NCT04002674) evaluated the safety and tolerability of nilotinib in individuals with DLB. The trial included 43 adults who were randomized to either receive nilotinib (200 mg/day) or placebo over a 6-month period. The clinical endpoint was the change in ADAS-Cog14 total score. Patients receiving nilotinib showed a greater improvement in cognitive decline as measured by ADAS-Cog14 with a 2.8-point improvement over 3 months (95% CI, p=0.037) and 3.2 points over 6 months (95% CI, p=0.08) Safety measures showed more adverse events in the placebo group (74) versus nilotinib (37) groups (p=.0054) and the number of falls was reduced in the nilotinib group (6) versus placebo (21) group (p=.006) by 73%. The study documented an improvement in homovanillic acid (HVA), a biomarker of dopamine levels, (p=.004) for those taking nilotinib and a reduction in the ratio of pTau181/AB42 (p=.0034), which the authors say suggest a reduced CNS amyloid burden. There was also a positive effect on CSF markers of inflammation. The study showed that Nilotinib demonstrated favorable safety, biomarkers and efficacy outcomes in patients with dementia with Lewy bodies. The study authors further noted that the favorable effects of nilotinib (200 mg) on cognition, without worsening motor and/or behavioral symptoms, may help overcome the dilemma of currently approved symptomatic drugs that improve motor but worsen cognitive symptoms, or vice versa. “These ground-breaking clinical trial results demonstrate the potential of nilotinib to provide the first effective treatment addressing dementia in LBD patients without negatively impacting movement or other symptoms,” said KeifeRx CEO Chris Hoyt. “We are encouraged by the results and believe that nilotinib may be an effective treatment for the hundreds of thousands of DLB patients suffering from dementia in the United States.” KeifeRx, a biopharmaceutical company located in McLean, Va. holds an exclusive license from Georgetown University for a patent associated with the use of nilotinib in neurodegenerative diseases, including DLB, Alzheimer’s disease, and Parkinson’s disease dementia. The study’s senior author, Charbel Moussa, PhD, MBBS, is a named inventor on the patent. “As a scientist, the opportunity to use an existing, well-studied drug like nilotinib as a baseline for development of the next generation of therapies for neurodegenerative dementias is a dream. This study provided further evidence that nilotinib can make a meaningful contribution to slowing the progression of dementia and the associated complications like falls,” said Moussa, associate professor of neurology at Georgetown University Medical Center and Director of the Translational Neurotherapeutics Program. “The findings from this Phase II trial suggest that Nilotinib could become a vital treatment for patients with Dementia with Lewy Bodies and other forms of dementia including Parkinson’s Disease Dementia,” said the study’s first author Fernando Pagan, MD, associate professor of neurology at Georgetown University Medical Center, vice chairman of neurology at MedStar Georgetown University Hospital and medical director of the Translational Neurotherapeutics Program. “As a neurologist specializing in neurodegenerative disease, I look forward to offering hope to patients where current therapies fall short. I am optimistic that nilotinib could have a positive impact on the standard of care for these patients.” About KeifeRx KeifeRx is an emerging clinical-stage biopharmaceutical company developing a portfolio of novel and optimized, low-dose kinase inhibitors for the treatment of multiple, high-need neurodegenerative and immune diseases, including Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and dementia with Lewy bodies. KeifeRx’s diverse pipeline of early- and late-stage products leverages mechanisms of action inherent to kinase inhibitors which thus far have been underexplored. This includes the ability to penetrate the brain, induce autophagy, and enable the bulk disposal of disease-causing toxic proteins to treat neurodegenerative diseases. Georgetown University owns several issued patents and pending patent applications on the underlying technology related to the use of kinase inhibitors for the treatment of neurodegenerative diseases with KeifeRx co-founder Dr. Charbel Moussa, MBBS, Ph.D., named as one of three inventors. Dr. Charbel Moussa is a co-founder, shareholder and paid consultant to KeifeRx. Dr. Fernando Pagan is a co-founder, shareholder and board member of KeifeRx. KeifeRx has an exclusive license to intellectual property from Georgetown University. For more information on KeifeRx, please visit https://www.keiferx.com . For more information, contact: Chris Hoyt, CEO KeifeRx, c.hoyt@keiferx.com Chris Hoyt KeifeRx +1 703-989-0386 email us here Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床结果临床2期引进/卖出

2025-06-18

·医脉通

2025 EHA前沿 | 江倩教授：阿思尼布破局耐药与安全困境，CML靶向治疗的突破与展望

导读慢性髓性白血病（CML）是骨髓造血干细胞克隆性增殖形成的恶性肿瘤，占成人白血病的15%1。酪氨酸激酶抑制剂（TKIs）的出现极大地改善了患者的预后，使CML成为一种可治可控的慢性疾病。然而，传统TKIs由于选择性较差，容易导致脱靶，引发多种不良反应，从而导致治疗中断，影响患者的长期生存和生活质量。阿思尼布作为特异性靶向ABL1肉豆蔻酰口袋（STAMP）的BCR-ABL1抑制剂，因其结合位点的特异性在实现疗效提升的同时，脱靶效应更少2，为CML患者带来全新的治疗选择。2025年6月12-15日，第30届欧洲血液学会（EHA）年会在意大利米兰圆满落幕，来自全球多个国家的血液专家和专业人士汇聚一堂，共同探讨血液学领域的最新进展，本次会议公布了多项阿思尼布的最新研究成果。基于此，医脉通特邀北京大学人民医院江倩教授聚焦CML前沿进展与阿思尼布的临床突破，就未来CML的发展方向发表独到见解！医脉通：CML是一种由BCR-ABL融合蛋白驱动的恶性血液病，近年来，随着靶向治疗药物的迭代升级与诊疗理念的革新，CML领域取得突破性进展。本届EHA大会公布了众多关于CML的研究。能否请您结合前沿进展，谈谈近年来CML领域取得了哪些重大突破？江倩教授近年来，随着靶向治疗药物TKIs的出现和不断迭代，CML患者的临床结局已发生重大转变。第一代TKI的出现，使慢性期CML（CML-CP）患者的生存期延长并接近正常人群水平2。然而，CML临床实践中仍存在未被满足的需求，部分患者对一代TKI产生耐药，且存在诸多不良反应。为克服一代TKI的耐药问题，第二代TKI应运而生，尽管在疗效上有所提升，但其脱靶效应导致的不良事件更多，患者常需调整剂量2。在此基础上，第三代TKI进一步解决了二代TKI的耐药难题，但仍需优化安全性。由此可见，CML的药物研发均围绕未满足的临床需求展开，推动CML治疗向更高安全性、更优耐受性的方向持续探索。当前，研究者开发了新型STAMP药物——阿思尼布，与传统的TKIs不同，阿思尼布由于结合位点的特异性在实现疗效提升的同时，减少了脱靶效应，从而改善了治疗安全性和耐受性，为CML治疗带来全新选择。医脉通：在CML靶向治疗版图中，阿思尼布作为首个靶向ABL肉豆蔻酰口袋的BCR-ABL1抑制剂，是CML领域继现有TKI后取得的又一重大进展。本届EHA大会公布了阿思尼布在CML患者中的多维度研究数据，能否请您为我们介绍一下其中的亮点内容？江倩教授本届EHA会议公布了ASC4START研究的主要终点结果3，旨在头对头比较阿思尼布和第二代TKI尼洛替尼在新诊断CML-CP患者中的耐受性。结果显示，阿思尼布组与既往报道一致，未出现新的不良事件（AE），降低55%因AE停药风险（P=0.004）。阿思尼布组因AE或死亡导致的停药（5.6%和12.1%）、≥3级AE（25.0%和31.9%）和因AE导致剂量调整/中断（24.3%和30.1%）的发生率均低于尼洛替尼组。在疗效方面，阿思尼布组第12周的分子学反应率更高，包括BCR-ABL1IS≤10%（89.8%和82.0%）、BCR-ABL1IS≤1%（69.0%和52.5%）、主要分子学反应（MMR）（22.9%和10.2%）、分子学反应4（MR4）（4.6%和1.1%）和分子学反应4.5（MR4.5）（2.5%和0.4%）。此外，EHA会议还公布了ASC4FIRST研究48周时的分析结果4，比较新诊断CML-CP患者接受阿思尼布与研究者选择的一代或二代TKIs治疗后患者报告结局（PROs）的差异。结果显示，阿思尼布组在疲劳、疼痛、健康相关生活质量（HRQoL）、认知、社会功能、症状负担、对日常生活影响、担忧/情绪、身体形象以及对护理和信息的满意度方面均较TKIs组获益更多，发生疼痛和胃肠道相关不良事件（AE）的患者更少且症状更轻，这意味着接受阿思尼布治疗可获得更好的生活质量。综上，阿思尼布的耐受性及分子学反应更佳，在长期管理中，对患者的生活质量及症状改善更优，为新诊断CML-CP患者提供了兼具安全性与有效性的治疗选择。医脉通：基于坚实的循证医学证据，近期阿思尼布在我国正式获批CML一线治疗，这无疑是CML治疗领域的重大里程碑。您认为这一获批对于CML的整体治疗格局有着怎样深远的意义？江倩教授作为一种需长期用药的慢性病，CML的治疗亟需兼顾疗效与安全性的药物。尽管现有TKIs极大地改善了患者的预后，但从“活下来”到“活得好”的跨越，仍是当前临床治疗的核心诉求。近期，阿思尼布获得中国国家药品监督管理局（NMPA）批准，用于治疗新诊断的费城染色体阳性的慢性髓细胞白血病（Ph+CML）慢性期（CP）成人患者。阿思尼布的获批，不仅为CML患者提供了兼具疗效与安全性的一线治疗方案，并且打破了传统TKIs“疗效与毒性权衡”的困境，为追求高质量生活与长期治疗安全的患者提供了新选择，推动CML治疗理念从“生存延长”向“品质生存”升级，填补了临床未满足的需求。医脉通：作为该领域的权威专家，能否请您谈谈未来CML领域会朝着哪些方向进一步发展，以更好地满足患者的需求，提高患者的生活质量和长期生存率？江倩教授在新药研发方面，未来CML的药物研发需兼顾疗效和安全性，避免高毒性影响长期治疗，同时还需探索新型药物靶点或联合用药方案，为耐药的CML患者提供新的治疗选择。在个体化治疗方面，对于疗效良好但无法停药的CML患者，未来剂量优化将成为研究重点，临床需进一步探索合适的药物剂量，确保在维持疗效的同时减轻药物不良反应，为患者制定个体化给药方案。在精准医疗方面，精准检测技术将成为重要驱动力。例如，临床可通过应用数字PCR监测CML患者的深层分子学反应，为CML患者的治疗和停药决策提供更科学的依据。针对难治性耐药患者，临床可整合基因组、转录组等多组学数据，识别预后不良的分子特征，指导初始治疗方案选择与动态剂量调整。在以患者为中心的全生命周期管理方面，未来还需强化“以患者为中心”的医患沟通，中国CML患者更为年轻，对生活质量（如升学、就业、生育需求）改善和追求无治疗缓解（TFR）的愿望更强烈，临床医生需主动与患者进行充分沟通，深入了解患者的核心诉求与顾虑，共同决策治疗目标，并提供全程心理社会支持。此外，对于老年CML患者，临床则应关注合并症处理，实现CML治疗与基础疾病管理的协同优化。江倩教授医学博士，主任医师，二级教授，博士生导师北京大学人民医院血液科副主任北京大学人民医院青岛医院副院长国际CML基金会国家代表委员会成员国际白血病及相关疾病比较研究协会委员中华医学会血液学分会委员，白血病-淋巴瘤学组副组长北京医学会血液学分会主任委员中国抗癌协会中西整合白血病专业委员会主任委员中国医药教育协会白血病分会主任委员「参考文献」1.中华医学会血液学分会. 中华血液学杂志, 2020, 41（5） : 353-364.2.Hochhaus A, et al. N Engl J Med. 2024 Sep 12;391（10）:885-898.3.Andreas Hochhaus, et al. 2025 EHA. Abstract S166.4.Andreas Hochhaus, et al. 2025 EHA. Abstract PS1588.审批码ASC0048768-103321，有效期为2025-06-18至2026-06-17，资料过期，视同作废小调研撰写：Julia审校：Vera排版：Atai执行：Atai本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

临床研究ASCO会议临床结果

2025-06-15

·信狐药迅

五个国产仿制上市申请品规获得通知件| 新获批(6.9-6.15）

每周药品注册获批数据，分门别类呈现，一目了然。(6.9-6.15）新药上市申请无新药临床申请药品名称企业注册分类受理号IGP-14068-TM片杭州英创医药科技有限公司1CXHL2500361IGP-14068-TM片杭州英创医药科技有限公司1CXHL2500360JMKX005425片上海济煜医药科技有限公司1CXHL2500352SHR2554片江苏恒瑞医药股份有限公司1CXHL2500347SNH-119014片赛诺哈勃药业(成都)有限公司1CXHL2500346SNH-119014片赛诺哈勃药业(成都)有限公司1CXHL2500345SNH-119014片赛诺哈勃药业(成都)有限公司1CXHL2500344VVN432鼻喷雾剂维眸生物科技(浙江)有限公司1CXHL2500335VVN432鼻喷雾剂维眸生物科技(浙江)有限公司1CXHL2500334CPI-818片嘉兴和剂药业有限公司1CXHL2500332CPI-818片嘉兴和剂药业有限公司1CXHL2500331BW-40202注射液上海舶望制药有限公司1CXHL2500338JZ-14胶囊云白药征武科技(上海)有限公司1CXHL2500320JZ-14胶囊云白药征武科技(上海)有限公司1CXHL2500319AP303片礼邦药业(上海)有限公司1CXHL2500306AP303片礼邦药业(上海)有限公司1CXHL2500305AP303片礼邦药业(上海)有限公司1CXHL2500304AP303片礼邦药业(上海)有限公司1CXHL2500303AP303片礼邦药业(上海)有限公司1CXHL2500302ZL-0018山东则正医药技术有限公司2.2CXHL2500328硫酸镁无菌溶液广东迈恒医药研发有限公司2.2CXHL2500326注射用甲苯磺酸瑞马唑仑江苏恒瑞医药股份有限公司2.4CXHL2500317吸附组分无细胞百白破(减剂量)联合疫苗中国医学科学院医学生物学研究所2.5CXSL2500229吸附组分无细胞百白破(减剂量)联合疫苗中国医学科学院医学生物学研究所2.5CXSL2500228注射用SKB315四川科伦博泰生物医药股份有限公司1CXSL2500270注射用SSGJ-612沈阳三生制药有限责任公司1CXSL2500269SSGJ-707注射液沈阳三生制药有限责任公司1CXSL2500268重组抗IL-1β人源化单克隆抗体注射液三生国健药业(上海)股份有限公司1CXSL2500267注射用TQB6411正大天晴药业集团南京顺欣制药有限公司1CXSL2500266Cizutamig注射液上海坦蒂生物医药科技有限公司1CXSL2500265LM-168注射液礼新医药科技(上海)有限公司1CXSL2500260MRG007乐普生物科技股份有限公司1CXSL2500262重组抗CD19m-CD3抗体注射液天劢源和生物医药(上海)有限公司1CXSL2500255SHR-1701注射液苏州盛迪亚生物医药有限公司1CXSL2500253注射用SHR-A1904苏州盛迪亚生物医药有限公司1CXSL2500258注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2500256注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2500254注射用人白介素-2(高亲和型复合物)北京良远生物医药研究有限公司1CXSL2500248Cizutamig注射液上海坦蒂生物医药科技有限公司1CXSL2500249GenSci134注射液长春金赛药业有限责任公司1CXSL2500238GenSci134注射液长春金赛药业有限责任公司1CXSL2500237VPD/FC01002 注射液微能生命科技集团有限公司1CXSL2500234塔戈利单抗注射液四川科伦博泰生物医药股份有限公司2.2CXSL2500271阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500257注射用重组A型肉毒毒素北京博特维克生物技术有限公司2.4CXSL2500246溴莫尼定凝胶深圳珐玛易药品科技有限公司3CYHL2500072仿制药申请药品名称企业注册分类受理号肾上腺素注射液武汉久安药物研究院有限公司3CYHS2401310盐酸溴己新注射液安徽新世纪药业有限公司3CYHS2400788去氧胆酸注射液南京迈诺威医药科技有限公司3CYHS2400661碳酸氢钠注射液广州合和医药有限公司3CYHS2400568吡拉西坦注射液四川新斯顿制药股份有限公司3CYHS2400580吸入用盐酸丙卡特罗溶液北京柏雅联合药物研究所有限公司3CYHS2400570氯化钾注射液广州瑞尔医药科技有限公司3CYHS2400563二羟丙茶碱注射液成都欣捷高新技术开发股份有限公司3CYHS2400476硝苯地平缓释片(II)浙江京新药业股份有限公司3CYHS2400208吸入用盐酸氨溴索溶液山西阳和医药技术有限公司3CYHS2400176氯化钾口服溶液湖南科伦制药有限公司3CYHS2400166环丝氨酸胶囊湖南埃威格林医药科技有限公司3CYHS2400170硫酸阿米卡星注射液济南辰欣医药科技有限公司3CYHS2400146卡络磺钠片成都倍特药业股份有限公司3CYHS2400086马来酸噻吗洛尔滴眼液石家庄四药有限公司3CYHS2400075氨甲环酸氯化钠注射液石家庄四药有限公司3CYHS2400076注射用青霉素钠昆明南疆制药有限公司3CYHS2303653注射用青霉素钠昆明南疆制药有限公司3CYHS2303652注射用青霉素钠昆明南疆制药有限公司3CYHS2303651注射用青霉素钠昆明南疆制药有限公司3CYHS2303650左羟丙哌嗪口服溶液安徽茂康药业有限公司3CYHS2303634左羟丙哌嗪口服溶液安徽茂康药业有限公司3CYHS2303633盐酸溴己新口服溶液浙江赛默制药有限公司3CYHS2303594法莫替丁注射液福建天泉药业股份有限公司3CYHS2303505盐酸右美托咪定注射液广州一品红制药有限公司3CYHS2303464注射用头孢唑林钠/氯化钠注射液湖南科伦制药有限公司3CYHS2303443盐酸多巴胺注射液湖南恒生制药股份有限公司3CYHS2303382盐酸多巴胺注射液湖南恒生制药股份有限公司3CYHS2303381盐酸曲唑酮片深圳市泛谷药业股份有限公司3CYHS2303360盐酸曲唑酮片深圳市泛谷药业股份有限公司3CYHS2303359盐酸溴己新口服溶液成都诺和晟鸿生物制药有限公司3CYHS2303287氨磺必利注射液齐鲁制药(海南)有限公司3CYHS2303269盐酸非索非那定口服混悬液浙江普利药业有限公司3CYHS2303171布美他尼注射液成都米子生物医药科技有限公司3CYHS2303128法莫替丁注射液湖南赛隆药业(长沙)有限公司3CYHS2303140法莫替丁注射液湖南赛隆药业(长沙)有限公司3CYHS2303139氯化钾颗粒赤峰固得药业有限公司3CYHS2303118氯化钾颗粒赤峰固得药业有限公司3CYHS2303117氯化钾颗粒河北三禾实创生物科技有限公司3CYHS2303127氯化钾颗粒河北三禾实创生物科技有限公司3CYHS2303126卡络磺钠注射液河北创健药业有限公司3CYHS2303002氯化钾注射液重庆万霖生物医药科技有限公司3CYHS2302986盐酸丙卡特罗口服溶液仁合益康集团有限公司3CYHS2302911艾司奥美拉唑镁肠溶干混悬剂瑞阳制药股份有限公司3CYHS2302896铝碳酸镁混悬液重庆中创科医药有限公司3CYHS2302845马来酸噻吗洛尔滴眼液石家庄四药有限公司3CYHS2302790盐酸去氧肾上腺素注射液德全药品(江苏)股份有限公司3CYHS2302683注射用苯唑西林钠重庆士立德医药科技有限公司3CYHS2302452注射用苯唑西林钠重庆士立德医药科技有限公司3CYHS2302451氯化钾颗粒重庆鑫禾生物科技有限责任公司3CYHS2302422盐酸去氧肾上腺素注射液安徽恒星制药有限公司3CYHS2302376注射用尼可地尔山东新时代药业有限公司3CYHS2302298注射用尼可地尔山东新时代药业有限公司3CYHS2302297注射用硫酸多黏菌素B海南倍特药业有限公司3CYHS2302289氟[18F]洛贝平注射液北京欣翮医药科技有限公司3CYHS2302261地氯雷他定口服溶液浙江高跖医药科技股份有限公司3CYHS2302256盐酸拉贝洛尔注射液南京斯泰尔医药科技有限公司3CYHS2302203复方匹可硫酸钠口服溶液杭州沐源生物医药科技有限公司3CYHS2302197盐酸美金刚口服溶液吉林长白山药业集团股份有限公司3CYHS2302016多种维生素注射液(13)山东鲁盛制药有限公司3CYHS2301923注射用苯唑西林钠山东道齐生物医药科技有限公司3CYHS2301889注射用苯唑西林钠山东道齐生物医药科技有限公司3CYHS2301888注射用苯唑西林钠杭州沐源生物医药科技有限公司3CYHS2301534注射用苯唑西林钠杭州沐源生物医药科技有限公司3CYHS2301533注射用苯唑西林钠福安药业集团庆余堂制药有限公司3CYHS2301488注射用苯唑西林钠福安药业集团庆余堂制药有限公司3CYHS2301487盐酸多巴胺注射液吉林省辉南长龙生化药业股份有限公司3CYHS2301439头孢丙烯干混悬剂广东恒健制药有限公司3CYHS2301198米诺地尔外用溶液江右制药(常德)有限公司3CYHS2300091米诺地尔外用溶液江右制药(常德)有限公司3CYHS2300090二甲硅油乳剂浙江众延医药科技有限公司4CYHS2402219二甲硅油乳剂浙江众延医药科技有限公司4CYHS2402221二甲硅油乳剂山东齐都药业有限公司4CYHS2402161二甲硅油乳剂山东齐都药业有限公司4CYHS2402160二甲硅油乳剂山东齐都药业有限公司4CYHS2402159氧(液态)荆州华尔文气体有限公司4CYHS2401250注射用头孢唑肟钠山东鲁抗医药股份有限公司4CYHS2401188注射用头孢唑肟钠山东鲁抗医药股份有限公司4CYHS2401187孟鲁司特钠片浙江诺得药业有限公司4CYHS2401155利丙双卡因乳膏深圳市泰力生物医药有限公司4CYHS2401080硫酸氨基葡萄糖胶囊天津天士力圣特制药有限公司4CYHS2401047依非米替片(I)安徽贝克生物制药有限公司4CYHS2401026阿昔莫司胶囊北京福元医药股份有限公司4CYHS2401004玻璃酸钠滴眼液江西马应龙美康药业有限公司4CYHS2400952硫酸氨基葡萄糖胶囊广州江正医药科技有限公司4CYHS2400911甲氨蝶呤注射液胜思(广州)制药科技有限公司4CYHS2400816氟哌噻吨美利曲辛片成都倍特药业股份有限公司4CYHS2400787硫酸氨基葡萄糖胶囊成都恒瑞制药有限公司4CYHS2400771布洛芬混悬液湖北亨迪药业股份有限公司4CYHS2400680布洛芬混悬液湖北亨迪药业股份有限公司4CYHS2400679氟马西尼注射液河南润弘制药股份有限公司4CYHS2400573沙库巴曲缬沙坦钠片青岛黄海制药有限责任公司4CYHS2400534沙库巴曲缬沙坦钠片青岛黄海制药有限责任公司4CYHS2400533沙库巴曲缬沙坦钠片青岛黄海制药有限责任公司4CYHS2400532盐酸乌拉地尔注射液安徽长江药业有限公司4CYHS2400471盐酸乌拉地尔注射液安徽长江药业有限公司4CYHS2400470布洛芬混悬液青岛黄海制药有限责任公司4CYHS2400439盐酸贝尼地平片浙江赛默制药有限公司4CYHS2400387盐酸贝尼地平片浙江赛默制药有限公司4CYHS2400386磷酸特地唑胺片海南通用三洋药业有限公司4CYHS2400360乳酸环丙沙星氯化钠注射液海南爱科制药有限公司4CYHS2400307硫酸特布他林雾化吸入用溶液海南斯达制药有限公司4CYHS2400300沙库巴曲缬沙坦钠片宁波美诺华天康药业有限公司4CYHS2400276沙库巴曲缬沙坦钠片宁波美诺华天康药业有限公司4CYHS2400275富马酸伏诺拉生片华东医药(西安)博华制药有限公司4CYHS2400240富马酸伏诺拉生片华东医药(西安)博华制药有限公司4CYHS2400239注射用头孢唑肟钠圣嘉(滨海)生物医药科技有限公司4CYHS2400190注射用头孢唑肟钠圣嘉(滨海)生物医药科技有限公司4CYHS2400189甲钴胺片四川成都同道堂制药有限责任公司4CYHS2400161替米沙坦氨氯地平片(II)晖致(海南)投资有限公司4CYHS2400119培哚普利氨氯地平片(I)山西同达药业有限公司4CYHS2400136注射用头孢他啶阿维巴坦钠华北制药河北华民药业有限责任公司4CYHS2400114注射用氯诺昔康重庆万霖生物医药科技有限公司4CYHS2400079富马酸伏诺拉生片湖南先施制药有限公司4CYHS2400040富马酸伏诺拉生片湖南先施制药有限公司4CYHS2400041双氯芬酸二乙胺乳胶剂浙江赛默制药有限公司4CYHS2303687左氧氟沙星片浙江东亚药业股份有限公司4CYHS2303685非洛地平缓释片辰欣药业股份有限公司4CYHS2303670阿加曲班注射液陕西天宇制药有限公司4CYHS2303629左卡尼汀口服溶液石家庄四药有限公司4CYHS2303380硝酸异山梨酯注射液平光制药股份有限公司4CYHS2303322富马酸福莫特罗吸入溶液山东禾琦制药有限公司4CYHS2303267盐酸阿莫罗芬搽剂浙江赛默制药有限公司4CYHS2303230多巴丝肼片重庆药友制药有限责任公司4CYHS2303197富马酸喹硫平缓释片浙江华海药业股份有限公司4CYHS2303129左卡尼汀口服溶液安徽四环科宝制药有限公司4CYHS2302923西甲硅油乳剂呋欧医药科技(湖州)有限公司4CYHS2302881夫西地酸乳膏浙江高跖医药科技股份有限公司4CYHS2302822注射用头孢唑肟钠湖北多瑞药业有限公司4CYHS2302639注射用头孢唑肟钠湖北多瑞药业有限公司4CYHS2302638拉考沙胺片上海理想制药有限公司4CYHS2302634拉考沙胺片上海理想制药有限公司4CYHS2302633盐酸乌拉地尔注射液海南爱科制药有限公司4CYHS2302144美沙拉秦肠溶片辰欣药业股份有限公司4CYHS2301886枸橼酸西地那非片江苏万邦生化医药集团有限责任公司4CYHS2301509枸橼酸西地那非片江苏万邦生化医药集团有限责任公司4CYHS2301508利斯的明透皮贴剂江苏康倍得药业股份有限公司4CYHS2200355国;CYHS2200355利斯的明透皮贴剂江苏康倍得药业股份有限公司4CYHS2200354国;CYHS2200354硫酸多黏菌素B华北制药股份有限公司CYHS2360714沙库巴曲缬沙坦钠山东新华制药股份有限公司CYHS2360783进口申请药品名称企业注册分类受理号雷芬那辛吸入溶液Mylan Ireland Limited5.1JXHS2400048帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSS2400071尼洛替尼胶囊Dr. Reddy′s Laboratories Limited5.2JYHS2300084尼洛替尼胶囊Dr. Reddy′s Laboratories Limited5.2JYHS2300083吸入用七氟烷Baxter Healthcare Limited5.2JYHS2300043兰索拉唑肠溶胶囊Hetero Labs Limited5.2JYHS2200099国;JYHS2200099Lartesertib片剂Merck Healthcare KGaA1JXHL2500071Tuvusertib片剂Merck Healthcare KGaA1JXHL2500070Tuvusertib片剂Merck Healthcare KGaA1JXHL2500069Tuvusertib胶囊Merck Healthcare KGaA1JXHL2500068Tuvusertib胶囊Merck Healthcare KGaA1JXHL2500067PF-07985045片Pfizer Inc.1JXHL2500066PF-07985045片Pfizer Inc.1JXHL2500065TPST-1120片Tempest Therapeutics, Inc.1JXHL2500058醋酸甲地孕酮口服混悬液TWi Pharmaceuticals, Inc.2.4JXHL2500056罗氟司特泡沫Arcutis Biotherapeutics INC5.1JXHL2500057DS-1062aASTRAZENECA AB1JXSL2500054Bimagrumab注射液Eli Lilly and Company1JXSL2500049Empasiprubart注射用浓溶液argenx BV1JXSL2500047ADI-001Adicet Therapeutics, Inc.1JXSL2500038仑卡奈单抗注射液(皮下注射)Eisai Co., Ltd.2.1JXSL2500046注射用佐妥昔单抗Astellas Pharma Global Development,Inc.2.2JXSL2500048中药相关申请药品名称企业注册分类受理号天苓止眩片湖南中医药大学1.1CXZL2500019肺热咳喘颗粒海南葫芦娃药业集团股份有限公司2.3CXZL2500020松龄血脉康胶囊成都康弘制药有限公司2.3CXZL2500018养血祛风止痛颗粒广东方盛健盟药业有限公司1.1CXZS2400030注：橙色字体部分结论为不批准或收到通知件；

疫苗申请上市

100 项与尼洛替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06413	尼洛替尼	L01XE08	DB04868

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
加速期慢性骨髄性白血病	美国	Novartis Pharmaceuticals Corp.	2014-01-22
加速期费城染色体阳性慢性粒细胞白血病	美国	Novartis Pharmaceuticals Corp.	2007-10-29
慢性期费城染色体阳性慢性粒细胞白血病	美国	Novartis Pharmaceuticals Corp.	2007-10-29
费城染色体阳性慢性粒细胞白血病	瑞士	Novartis Pharma Schweiz AG	2007-07-24

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
慢性期慢性髓性白血病	申请上市	欧盟	Novartis Europharm Ltd.	2024-06-27
阿尔茨海默症	临床3期	-	KeifeRx LLC	2022-02-01
慢性粒细胞性白血病	临床3期	中国	Novartis Pharmaceuticals Corp.	2011-04-01
急性转化期慢性粒细胞性白血病	临床3期	哥伦比亚	Novartis Pharmaceuticals Corp.	2009-01-01
急性转化期慢性粒细胞性白血病	临床3期	委内瑞拉	Novartis Pharmaceuticals Corp.	2009-01-01
脑瘫	临床3期	美国	Novartis AG	2009-01-01
转移性胃肠道间质瘤	临床3期	德国	Novartis Pharmaceuticals Corp.	2008-11-01
转移性胃肠道间质瘤	临床3期	意大利	Novartis Pharmaceuticals Corp.	2008-11-01
胃肠道间质瘤	临床3期	美国	Novartis Pharmaceuticals Corp.	2007-03-01
胃肠道间质瘤	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2007-03-01

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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


NCT04449549 (RARE CANCER 1, ASCO2025)	临床2期	实体瘤	31	Nilotinib 300 mg	壓鬱糧構範艱夢獵憲夢(餘醖醖窪選積構鑰獵齋) = 網製膚構壓齋夢鹽淵憲淵鏇餘壓鹽膚壓構遞獵 (醖壓選窪顧糧選衊壓糧 ) 更多	积极	2025-05-30
S23.008 (AAN2025)	临床2期	路易体病 CSF HVA \| CSF ratio of pTau181/Aβ42	43	Nilotinib 200mg	範壓獵蓋衊觸範淵積範(製醖簾鬱醖願淵壓膚艱) = 製蓋襯網繭範淵鹽餘構醖餘構鬱蓋築艱製鹹憲 (鹽網願醖獵繭餘醖夢觸, 0 ~ 6.34) 更多	积极	2025-04-07
				Placebo	鬱獵願顧選網襯鬱窪製(窪獵鑰鬱製窪繭範窪鹽) = 製鑰襯艱願簾範構範積齋夢淵廠獵餘淵憲窪鹹 (構壓選範觸鏇餘範壓膚 )
ASH2024	N/A	费城染色体阳性慢性粒细胞白血病	-	Nilotinib	簾繭願鏇鹽網夢夢餘鏇(構築憲遞衊顧構淵獵繭) = increased creatinine and thyroid disease in flumatinib group 齋齋鬱餘鏇願顧鹹壓獵 (夢願網築簾觸獵餘構襯 ) 更多	-	2024-12-09
				Dasatinib
ASH2024	N/A	费城染色体阳性慢性粒细胞白血病	-	Imatinib	鹹鏇範蓋膚鑰鑰鑰選衊(夢鹹壓蓋夢餘蓋艱觸網): HR = 3.11 (95% CI, 1.25 ~ 7.77), P-Value = 0.015	-	2024-12-09
				Nilotinib
NCT01784068 (ENESTfreedom, FDA_CDER) 人工标引	临床2期	慢性期费城染色体阳性慢性粒细胞白血病一线	190	Nilotinib	網膚願網鑰膚憲糧製鑰(製衊構齋糧獵築糧範膚) = 築壓窪艱繭製鹹獵鹽齋鹹膚餘壓醖衊齋繭繭願 (鹹鹹艱艱窪齋鑰顧網顧, 54.8 ~ 69.0) 更多	积极	2024-11-07
				Nilotinib (Loss of MMR)	網膚願網鑰膚憲糧製鑰(製衊構齋糧獵築糧範膚) = 淵觸選廠網鹹蓋廠齋糧鹹膚餘壓醖衊齋繭繭願 (鹹鹹艱艱窪齋鑰顧網顧 ) 更多
NCT01698905 (ENESTop, FDA_CDER) 人工标引	临床2期	慢性期费城染色体阳性慢性粒细胞白血病	126	Nilotinib (without loss of MMR or confirmed loss of MR4)	醖鏇簾築膚憲窪鬱艱鏇(夢鑰願網壓齋窪餘構窪) = 鹽蓋簾艱鹹觸構淵觸淵糧淵餘簾鬱憲積鹽鏇積 (齋淵糧鏇鏇遞艱範淵構, 51.2 ~ 68.9) 更多	积极	2024-11-07
				Nilotinib (Loss of MMR or confirmed loss of MR4)	醖鏇簾築膚憲窪鬱艱鏇(夢鑰願網壓齋窪餘構窪) = 齋網簾餘簾窪餘製鬱蓋糧淵餘簾鬱憲積鹽鏇積 (齋淵糧鏇鏇遞艱範淵構 ) 更多
NCT00471497 (ENESTnd, FDA_CDER) 人工标引	临床3期	慢性期费城染色体阳性慢性粒细胞白血病一线	-	Nilotinib 300 mg Twice Daily	築鏇襯醖蓋築壓製遞夢(壓襯繭齋糧鏇齋壓簾襯) = 構夢窪壓襯遞繭鏇鹹糧構膚齋鹽鬱願鑰齋衊築 (鏇選廠簾鏇鏇鏇獵鏇鏇, 38.4 ~ 50.3) 更多	积极	2024-11-07
				Imatinib 400 mg Once Daily	築鏇襯醖蓋築壓製遞夢(壓襯繭齋糧鏇齋壓簾襯) = 簾淵觸鏇憲淵餘衊遞鑰構膚齋鹽鬱願鑰齋衊築 (鏇選廠簾鏇鏇鏇獵鏇鏇, 17.6 ~ 27.6) 更多
NCT00109707 (CAMN107A2101, FDA_CDER) 人工标引	临床1/2期	慢性期费城染色体阳性慢性粒细胞白血病 \| 加速期费城染色体阳性慢性粒细胞白血病	458	Nilotinib (Ph+ CML-CP)	壓齋餘網蓋築觸襯壓齋(簾艱壓艱顧築襯鬱鏇蓋) = 選齋選憲願範鏇糧夢遞夢簾積齋願鏇鏇醖積衊 (製鹽窪廠襯簾蓋鏇窪膚, 46 ~ 57) 更多	积极	2024-11-07
				Nilotinib (Ph+ CML-AP)	襯積醖膚膚糧襯簾蓋範(餘構窪醖簾選鏇淵製鬱) = 築衊鹽壓積餘壓鹽獵夢範夢憲齋網願蓋窪製膚 (遞簾範獵憲鹹網夢廠鬱, 31 ~ 48) 更多
ESC2024	N/A	费城染色体阳性慢性粒细胞白血病	-	Nilotinib	膚觸鬱顧繭壓遞鹹顧鹹(壓願遞膚鏇憲膚獵築遞) = 鏇糧鑰鏇鏇夢艱簾觸鹹獵鑰選築願淵襯範糧餘 (窪觸願遞範範蓋膚築夢, 15.7 ~ 26.2) 更多	-	2024-08-30
NCT01863745 (CTgov)	临床2期	胃肠道间质瘤	15	nilotinib	遞壓構淵獵範鹽齋餘積 = 繭獵餘鏇壓餘鏇鹹餘選顧製餘範窪網艱窪醖衊 (選糧獵繭鏇淵鏇襯願膚, 繭鏇餘鑰廠鹽襯餘範網 ~ 廠膚膚鹹簾糧醖鏇選壓) 更多	-	2024-08-19