Phase-2 Study of Vedolizumab Plus Post-Transplant Cyclophosphamide and Short Course Tacrolimus for Graft-versus-Host Disease Prevention After Reduced Intensity Conditioning Peripheral Blood Stem Cell Allogeneic Hematopoietic Cell Transplantation

This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.

开始日期2026-01-08

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06362005

/ Not yet recruiting临床4期IIT

The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus (Randomized Clinical Trial)

evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus.

开始日期2025-10-03

申办/合作机构

Al-Azhar University

NCT06859424

/ Not yet recruiting临床2期IIT

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients with Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant. The researchers will compare the new drug combination to a standard drug combination. They will also learn about the safety of each drug combination.
Participants will:
* Receive the standard or new drug combination after transplant
* Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients
* Take surveys about physical and emotional well-being
* Give blood and stool samples.

开始日期2025-06-01

申办/合作机构

Center for International Blood & Marrow Transplant Research

[+2]

100 项与他克莫司相关的临床结果

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100 项与他克莫司相关的转化医学

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100 项与他克莫司相关的专利（医药）

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34,629

项与他克莫司相关的文献（医药）

2025-12-31·RENAL FAILURE

Factors associated with chronic calcineurin inhibitor nephrotoxicity in children with minimal-change disease

Article

作者: Yang, Shicong ; Yue, Zhihui ; Jin, Bei ; Mo, Ying ; Cheng, Cheng ; Lu, Ziji ; Lin, Aihua ; Chen, Lizhi ; Pei, Yuxin ; Jiang, Xiaoyun

BACKGROUND:

Calcineurin inhibitors (CNIs), such as cyclosporine (CsA) and tacrolimus (TAC), are commonly used to treat children with complicated minimal change nephrotic syndrome. However, chronic nephrotoxicity associated with CNIs poses a significant safety concern. This study aimed to identify the risk factors that contribute to chronic nephrotoxicity in these patients.

MATERIAL AND METHODS:

Clinical and pathological data of MCD children treated with CsA or TAC in our center between 1 January 2003 and 31 December 2022, were retrospectively reviewed. Kidney biopsies were performed on 80 patients who received CNI treatment for more than 6 months.

RESULTS:

Chronic CNI nephrotoxicity (striped interstitial fibrosis with tubular atrophy) was observed in 15% (12/80) of patients. Higher CNI culminating amounts were shown in patients who developed nephrotoxicity regardless of CsA or TAC treatment. Risk factors for chronic CNI nephrotoxicity included persistent nephrotic-range proteinuria for more than 30 days during CNI treatment, increased urinary NAG level, and CNI resistance. Multivariate analysis revealed that increased urinary NAG level and CNI resistance were the independent risk factors for chronic CNI nephrotoxicity in children with MCD.

CONCLUSION:

MCD children who developed CNI resistance were susceptible to chronic CNI nephrotoxicity. Urinary NAG might be a valuable biomarker for CNI nephrotoxicity prediction in MCD children.

2025-12-31·RENAL FAILURE

Bibliometric study and visual analysis of postoperative diabetes mellitus in kidney transplant recipients based on WoSCC database

Article

作者: Gao, Hongjun ; Chen, Sheng ; Qiu, Minhua ; Chen, Jibing

BACKGROUND:

In recent years, the increase of the post-transplantation diabetes mellitus (PTDM) after renal transplantation encourages people to do a lot of research on the disease. This paper conducted a bibliometric study on PTDM related literature to explore the risk factors of diabetes after kidney transplantation, as well as the current status, hotspots and development trends of PTDM research, so as to provide reference for researchers in related fields.

METHODS:

We searched the Web of Science Core Collection (WoSCC) database for PTDM literature from January 1, 1990, to August 20, 2023, and used VOSviewer, CiteSpace, and the R package 'bibliometrix' to do bibliometric analysis.

RESULTS:

Obesity, 3 months after transplantation tacrolimus concentration >10 ng/mL, temporary hyperglycemia, delayed graft function, acute rejection is specific risk factors related to PTDM in renal transplant recipients. In addition, 74 countries led by China and the United States published 1546 papers, and the number of PTDM-related publications is increasing every year. Primary institutions included the University of California, Los Angeles, Mayo Clinic, University of Oslo, and University of Toronto. The Journal of Transplantation is the most widely read journal in the subject. The authors with the most published literature are Trond Jenssen and Adnan Sharif, and the most cited author is Kasiske BL. Expectations for continued growth in global PTDM research are increasingly high. Future studies will mainly focus on exploring the risk factors of PTDM and identifying new therapeutic approaches and targets.

2025-12-01·JOURNAL OF CLINICAL IMMUNOLOGY

Successful Allogeneic Hematopoietic Cell Transplantation for Patients with IL10RA Deficiency in Japan

Article

作者: Ishige, Takashi ; Sasahara, Yoji ; Tomomasa, Dan ; Goto, Kimitoshi ; Wada, Taizo ; Ito, Yoshiya ; Matsuda, Yusuke ; Kato, Motohiro ; Kudo, Takahiro ; Hagiwara, Shin-Ichiro ; Kanegane, Hirokazu ; Morio, Tomohiro ; Takeuchi, Ichiro ; Arai, Katsuhiro ; Uhlig, Holm H ; Ishimura, Masataka ; Suzuki, Tasuku ; Keino, Dai ; Saida, Satoshi ; Eguchi, Katsuhide

BACKGROUND:

IL10RA (IL10 receptor subunit alpha) deficiency is an autosomal recessive disease that causes inflammatory bowel disease during early infancy. Its clinical course is often fatal and the only curative treatment is allogeneic hematopoietic cell transplantation (HCT). In Japan, only case reports are available, and there are no comprehensive reports of treatment outcomes.

METHODS:

We retrospectively analyzed patients with IL10RA deficiency in Japan.

RESULTS:

Two newly identified and five previously reported patients were included in this study. Five patients underwent HCT; one untransplanted patient survived to age 14, and one died of influenza encephalopathy before transplantation. All five HCT recipients underwent HCT at the age before 2 years. They all were conditioned with fludarabine/busulfan- or fludarabine /melphalan-based regimens. The donor source was human leukocyte antigen haploidentical donor bone marrow (BM) for two patients and unrelated umbilical cord blood (CB) for two patients. One patient experienced graft failure with unrelated CB and required a second transplant with unrelated BM. All patients who underwent HCT survived and demonstrated an improved performance status.

CONCLUSION:

In cases of IL10RA deficiency, the need for transplantation should be promptly assessed, and early transplantation should be considered. (190/250).

592

项与他克莫司相关的新闻（医药）

2025-05-07

·复星医药

利妥昔单抗撬动儿童肾病治疗新纪元！《RTX治疗儿童肾综50问》专家沟通会圆满落幕

金陵春深聚群贤，儿肾杏林谱新篇！2025年4月26日，“领航前行—利妥昔单抗治疗儿童肾病综合征50问专家沟通会”在南京成功召开。本次会议由国家儿童医学中心复旦大学附属儿科医院、中国人民解放军东部战区总医院牵头，联合海南国际医药创新联合基金会共同主办，复星医药全程支持。会议由复旦大学附属儿科医院的徐虹教授和中国人民解放军东部战区总医院的夏正坤教授担任主席，汇聚高春林、沈茜、蒋小云和刘小荣等十余位国内顶尖儿科肾病学专家，围绕利妥昔单抗（RTX）的精准应用展开深度探讨，为儿童肾病综合征的分子靶向治疗开启新纪元。会议背景：从“激素依赖”到“靶向突破”儿童原发性肾病综合征是儿科最常见的肾小球疾病，大多数患儿对糖皮质激素反应良好，但总体复发风险仍然较高，约50%患儿进展为频复发或激素依赖（FRNS/SDNS），反复激素及其他免疫抑制治疗带来的生长发育障碍、感染风险等问题亟待破解。利妥昔单抗作为靶向CD20的单克隆抗体，近年来在肾病综合征的治疗，尤其在FRNS/SDNS患儿中降低复发率、缩短激素疗程，展现出革命性潜力。本次会议以“50问”形式系统梳理RTX应用的临床难点，直击一线医生痛点，推动治疗规范化。大咖云集：共话“RTX撬动”新格局中国人民解放军东部战区总医院的高春林教授首先分享《利妥昔单抗治疗儿童SDNS回顾性研究》报告，详细介绍了利妥昔单抗在儿童肾病综合征中的最新前沿进展，临床实践存在的问题，进一步展示回顾性研究设计，结合多中心实际病例分析了利妥昔单抗的疗效和安全性初步结果，期待论文正式发表。随后，复旦大学附属儿科医院的沈茜教授对《利妥昔单抗治疗儿童肾病综合征50问》进行了深入解读，从RTX的作用机制、适用病种、剂量调整到治疗后的监测、激素撤减等多个方面进行了系统阐述，囊括六个章节（RTX概览篇、激素依赖/复发篇、NS初治篇、NS耐药篇、不良反应篇、注意事项篇），为临床医生提供实用参考。焦点突破：四大共识引领临床实践初治患儿早期RTX干预获强力证据徐虹/沈茜教授团队发布的国内RTXFIRPedINS研究1显示：初治NS患儿在激素诱导缓解后联合RTX治疗，1年无复发生存率提升至74.4%（对照组30.3%），2年无复发率高达62.8%。这一成果被国际权威期刊《Kidney International Reports》收录，标志着RTX从“挽救治疗”迈向“一线预防”时代。剂量优化与个体化撤减方案针对FRNS/SDNS患儿，2025年KDIGO指南2推荐基于体表面积调整RTX剂量（375mg/m²×1-4次）。患儿在病情稳定且尿蛋白转阴后，应用首剂RTX即可启动糖皮质激素撤减，撤减周期可缩短至3个月；部分患儿诱导缓解阶段，除激素外还使用CNI（他克莫司或环孢素）协同，优先减停副作用显著药物。耐药性肾病治疗新希望国际多中心研究3证实：RTX可提高CNI耐药型SRNS患儿的缓解率，推荐尽早使用，为传统难治性患儿提供突破性选择。国内回顾性病例分析4，同步证实RTX可有效降低CNI 抵抗型 SRNS 患儿尿蛋白，提高血清白蛋白，药物总体耐受性良好。高效降复发、长期省费用国内发表的宁夏地区数据5显示：RTX治疗后患儿月均医疗费用下降32%（1863元→1275元），印证其“高效降复发、长期省费用”的双重价值。争议与挑战：精准治疗仍待探索专家们结合自身丰富的临床经验，分享了利妥昔单抗在不同场景下的应用经验和见解，部分议题仍待探索：RTX治疗无效的定义：NS患儿在复发后，再次使用RTX仍可获得缓解，建议明晰RTX治疗无效的定义；患儿维持缓解的策略：定期输注RTX vs 复发后按需治疗，需更多高质量循证验证；生物标志物指导用药：CD19+ B细胞重建与复发无直接关联，如何预测复发仍需探索；RTX破局万象新，靶向治疗启华章利妥昔单抗彻底撬动儿童肾病综合征的治疗逻辑——从激素反复撤减的漫长拉锯，到精准狙击B细胞的靶向突破；从“谈激素色变”的沉重负担，到“免激素、低复发”的自由新生。本次会议以循证为基石，以临床需求为导向，为儿童肾病综合征治疗树立了新标杆。随着RTX应用的不断优化，更多患儿将迎来无复发、免激素的健康未来。参考文献：[1] Liu J, Deng F, Wang X, et al. Early Rituximab as an Add-On Therapy in Children With the Initial Episode of Nephrotic Syndrome. Kidney International Reports. 2024;9(5):1220-1227.[2] Floege J, Gibson KL, Vivarelli M, Liew A, Radhakrishnan J, Rovin BH. KDIGO 2025 Clinical Practice Guideline for the Management of Nephrotic Syndrome in Children. Kidney International. 2025;107(5):S241-S289.[3] Chan E Y, Sinha A, Yu E L M, et al. An international, multi-center study evaluated rituximab therapy in childhood steroid-resistant nephrotic syndrome[J]. Kidney International, 2024, 106(6): 1146–1157.[4] 余思澄, 刘佳璐, 刘娇娇, 等. 利妥昔单抗治疗儿童CNI抵抗型激素耐药型肾病综合征的短期疗效[J]. 中华儿科杂志, 2025, 63(2): 185–189.[5] 杨武, 王小娥, 顾佳乐, 等. 宁夏地区利妥昔单抗治疗儿童原发性肾病综合征的开展及疗效分析. 临床肾脏病杂志. 2024;24(2):103-107.仅供医药学专业人士阅读，材料编码：P-20250429-004本材料的目的在传递前沿信息，不构成对任何药物或诊疗方案的推荐和宣传，非广告用途；本资料所含的信息不能替代医疗卫生专业人士提供的医疗建议，具体疾病诊疗请遵从医疗卫生专业人士的意见或指导

2025-04-29

·Business Wire

CareDx Announces New Data on AlloSure Lung Presented at 2025 International Society for Heart and Lung Transplantation Meeting

BRISBANE, Calif.--(BUSINESS WIRE)--CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that CareDx, together with study collaborators, presented new scientific evidence on the use of AlloSure® Lung in clinical practice at the International Society for Heart and Lung Transplantation (ISHLT) 45th Annual Meeting & Scientific Sessions, held from April 27-30 in Boston, Massachusetts. AlloSure Lung and AlloHome™ were featured in 8 abstracts including 2 oral presentations and key findings were: Surveillance monitoring using AlloSure Lung effectively identified rising dd-cfDNA levels signaling onset of acute cellular rejection and decline in levels after treatment for rejection ( Abstract 1627 ). AlloSure Lung was used to monitor safety and graft function of Tacrolimus (TAC) inhalation powder as a replacement to oral TAC in lung transplant patients with renal insufficiency ( Abstract 143, oral session). AlloSure Lung was used to investigate the impact of TAC drug levels on the outcomes of DSA-positive lung transplant recipients over a one-year follow-up ( Abstract 403 , mini oral). AlloHome remote patient monitoring system in lung transplant enables real-time treatment adjustments and improved triage, easing workload on transplant center staff ( Abstract 1204 ). “We are very pleased with the new data presented at ISHLT indicating that surveillance monitoring using AlloSure effectively detected rejection and could be used to monitor patient treatment responses,” said Robert Woodward, CareDx Chief Scientific Officer. Additionally, during a CareDx sponsored symposium, an interim analysis of the ALAMO (AlloSure Lung Assessment and Metagenomics Outcomes) prospective, multi-center study showed that AlloSure Lung may be prognostic of Chronic Allograft Lung Dysfunction (CLAD), a leading cause of death after lung transplantation. Elevated levels of AlloSure dd-cfDNA in patients early post-transplant were associated with future occurrence of restrictive allograft syndrome (RAS), a severe form of CLAD. "We have observed the advantages of using AlloSure Lung for monitoring patients for early signs of graft injury and rejection. The early findings from the ALAMO study are promising as it indicates that increased levels of AlloSure Lung dd-cfDNA may identify patients at higher risk of developing CLAD, which is a major cause of mortality among lung transplant patients," said Ciara Shaver, MD, PhD, Principal Investigator for ALAMO at Vanderbilt University Medical Center. "Furthermore, the ALAMO data show that AlloSure Lung may identify subclinical lung injury during CMV viremia. In these ways, AlloSure Lung may help clinicians to identify the patients with the greatest chance to respond to therapy to enhance long-term outcomes.” For a complete listing of abstracts, oral presentations and posters featuring CareDx’s heart and lung transplant portfolio, please follow this link. About CareDx – The Transplant Company CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com. Forward Looking Statements This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that have been or may be achieved with AlloSure Lung, AlloHome, and other CareDx products, and statements regarding the interim study results of CareDx’s ALAMO registry at the 2025 International Society for Heart and Lung Transplantation Meeting (the “ISHLT Presentation”). These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloSure Lung, AlloHome, or other CareDx products or its ISHLT Presentation; risks that the ISHLT Presentation and the data to be presented may not follow the agenda as stated in this press release; risks that the findings in the studies supporting the data may be inaccurate, general economic and market factors, and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by CareDx with the SEC on February 28, 2025, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

临床研究

2025-04-25

·E药经理人

一地方医保局局长被查；医药千亿巨头疑年报造假；GSK中国新设COO；云顶新耀“摘B”丨E周药闻

本周，血制品、医药流通及疫苗行业多家企业相继披露了2024年财报。默沙东、罗氏、BMS、赛诺菲等同期公布2025年Q1表现。其中，默沙东中国区收入同比下滑62%，HPV疫苗在中国地区需求明显下降。罗氏中国区制药业务实现了14%的增长。另一边，中国创新药行业悄然于本周迎来几大代表性的事件：一是中国药企掀起大胆变革。康方双沃西，“头对头”胜K药后，再赢“头对头”之战，挑战对象为百济替雷利珠单抗联合疗法。二是创新药出海格局生变。第一个由中国公司全过程独立主导且成功获FDA批准上市的创新生物药诞生。三是中国Biopharma阵营再添一员大将，云顶新耀成功“摘B”。一起看看本周还有什么大事发生？财报季科伦药业：2024年实现营收218.1亿元，同比上升1.7%；归母净利润为29.4亿元，同比增长19.5%；扣非归母净利润为29.0亿元，同比上升22.7%。经营业绩创自上市以来最高水平。乐普医疗：2024年收入61.03亿元，同比下滑23.52%；净利润2.46亿元，同比下滑80.37%。恒瑞医药：2025年Q1营收为72.06亿元，同比增长20.14%；归母净利润为18.74亿元，同比增长36.9%。主要原因是报告期公司收到IDEAYA 7500万美元的对外许可首付款，确认为收入，利润增加较多。万泰生物：2025年Q1营收为4.01亿元，同比下降46.76%；亏损额为5277.69万元，去年同期净利润1.26亿元，业绩下滑主要由于公司疫苗板块受市场调整、政府集采及九价HPV疫苗扩龄等影响，销售不及预期，疫苗板块收入较同期回落。罗欣药业：2024年实现营收26.47亿元，同比增长11.99%，实现归母净利润-9.65亿元，亏损原因主要系创新药推广长期且复杂，需要不断加大投入，同时公司基于谨慎性原则对部分资产计提了减值准备。同日，公司发布了2025年Q1财报，成功扭亏为盈。甘李药业：2025年Q1营收为9.85亿元，同比增长75.76%；归属于上市公司股东的净利润为3.12亿元，同比增长224.90%。政策动态新版市场准入负面清单发布：近日，国家发展改革委会同商务部、市场监管总局发布《市场准入负面清单（2025年版）》。全国版市场准入负面清单事项数量由2018年版的151项缩减至2025年版的106项，准入门槛降低。一批全国性措施部分放开，涉及药品批发和零售单位筹建、药品和医疗器械互联网信息服务等领域。国家医保局关于开展智能监管改革试点：通过智能监管改革试点赋能定点医药机构、赋能医保基金监管工作。推动国家局公布公开的“两库”在定点医药机构自建事前提醒系统中落地应用，将参加试点的定点医药机构建设成为国家医保局“两库”开发建设、公布公开的“试验田”，以及自查自纠的“标杆”。广东省茂名市医保局局长被查：据南粤清风网消息，广东省茂名市医疗保障局党组书记、局长黄东明涉嫌严重违纪违法，目前正接受茂名市纪委监委纪律审查和监察调查。2021年11月，黄东明出任广东省茂名市医保局局长。海南省医保局发出《关于做好第十批国家组织药品集中带量采购等批次中选结果执行工作的通知》：包括第十批国采62个品种、广东联盟易短缺及急抢救药的9个药品、第七批直接接续的51个药品、第九批直接接续的41个药品、全国中成药(第二批)直接接续的16个品种、广东联盟他克莫司及血塞通注射液直接接续的2个药品。执行周期均为2025年4月30日0时至2026年4月29日24时。七部门开展“人工智能赋能医药全产业链”应用试点：工信部等七部门印发《医药工业数智化转型实施方案（2025-2030年）》提出，深化人工智能赋能应用。支持相关单位建立医药大模型创新平台，协同开展医药大模型技术产品研发、监管科学研究等，强化标准规范、科技伦理、应用安全和风险管理等规则建设。大型制药罗氏未来5年将在美国投资500亿美元：这是迄今为止跨国药企为应对特朗普关税政策而宣布的在美国的最大的投资举措之一。这项投资将创造超过12000个新工作岗位，其中包括近6500个建筑工作岗位，以及1000个新建和扩建设施的工作岗位。目前，罗氏在美国拥有13个生产基地和15个研发基地，涵盖制药和诊默沙东2025Q1业绩表现断业务。GSK中国新设首席运营官：4 月 21 日，GSK大中华和洲际区域高级副总裁柯瑞康（Mike Crichton）向员工宣布一项重大人事任命，在中国市场设立首席运营官（COO）职位，并任命现任葛兰素史克副总裁、韩国总经理 Maurizio Borgatta 担任这一职务，长驻上海并加入葛兰素史克中国公司领导团队。礼来口服GLP-1药物III期临床研究成功：礼来宣布首个小分子口服GLP-1RA药物Orforglipron III期临床研究成功。III期临床研究ACHIEVE-1评估了Orforglipron对比安慰剂，在饮食控制和运动基础上血糖控制仍不佳的2型糖尿病患者中的安全性和有效性，最终取得积极顶线结果。吉利德Trop2 ADC一线治疗三阴乳腺癌III期临床成功：吉利德宣布Trop2 ADC新药Trodelvy+PD-1抗体K药联合一线治疗转移性三阴乳腺癌的关键III期临床获得成功，主要终点mPFS相比于化疗+PD-1对照组显著延长，这也是mTNBC首个达到PFS终点的PD-1+Trop2 ADC联合治疗的III期临床试验。诺和诺德与京东健康携手：诺和诺德与京东健康在北京正式签署战略合作协议，标志着双方在糖尿病和体重管理领域的合作进入新阶段。依托诺和诺德百年深耕慢病领域的专业经验和创新治疗方案，并借助京东健康的全场景医疗服务能力，双方将携手打造肥胖症公众科普专区，助力糖尿病一站式诊疗，全面赋能慢病管理数字化转型升级。正大天晴康方PD-1美国获批上市：正大天晴宣布，安尼可（派安普利单抗注射液）已获得美国FDA批准上市，用于治疗复发或转移性鼻咽癌（NPC）的一线治疗和以铂类为基础的至少一线化疗治疗进展后治疗的2项适应证。该药是正大天晴/康方生物第一个获美国FDA批准上市的创新生物药，也是第一个由中国公司全过程独立主导且成功获得FDA批准上市的创新生物药。生物科技云顶新耀成功“摘B”：云顶新耀本周宣布已获得香港联交所批准，将“B”标记从股票代码中移除。“摘B”是一家Biotech成长壮大为一家Biopharma的重要参考。2024年，公司总营收超额完成7亿元既定目标，大幅增长461%，现金储备达16亿元，首次实现年度商业化层面盈利，全球首个对因治疗IgA肾病药物耐赋康自在中国首张处方成功落地起的7个月，销售收入达3.534亿元（+1581%）。依沃西“头对头”战胜PD-1联合化疗：康方生物宣布，全球首创双抗新药依沃西单抗注射液联合化疗对比替雷利珠单抗联合化疗一线治疗晚期鳞状非小细胞肺癌（sq-NSCLC）的注册性III期临床研究，经独立数据监察委员会（IDMC）评估的预先设定的期中分析显示强阳性结果：达到无进展生存期（PFS）的主要研究终点，研究结果具有统计学显著获益和重大临床获益。荃信生物与Caldera就QX030N达成授权合作：作为回报，荃信生物或其指定联属公司（集团）将获得1000万美元一次性、不可退还及不可抵扣的预付款及Caldera约24.88%的股权；在达成特定临床开发、监管及商业里程碑的前提下，集团可获得最多5.45亿美元的额外付款；此外，集团有权在QX030N首次商业销售后的一段特定时间内收取销售净额的分级特许权使用费。诺诚健华宜诺凯（奥布替尼）在中国获批一线治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤：今日，公司自主研发的新型BTK（布鲁顿酪氨酸激酶）抑制剂奥布替尼获批新适应证。奥布替尼已在中国获批用于治疗既往至少接受过一次治疗的CLL/SLL、套细胞淋巴瘤（R/R MCL）和边缘区淋巴瘤（R/R MZL），三项适应证均已纳入国家医保。资本市场三博脑科董事长涉案被留置：三博脑科发布公告，称公司收到内蒙古自治区监察委员会签发的关于公司控股股东、实际控制人之一、董事长张阳的《留置通知书》和《立案通知书》。不过，该公告并未透露董事长被留置、立案调查的具体原因。康哲药业建议分拆德镁医药于联交所主板独立上市：康哲药业近期宣布，为使皮肤健康业务子公司德镁医药更好地释放增长潜力，建议将德镁医药股份分拆，并于联交所主板独立上市，建议分拆（倘进行）预计将透过由本公司以实物方式向股东分派其持有的所有德镁医药股份的方式实施，分派比例将按截至董事会为确定股东权利而厘定的记录日期当日彼等各自于本公司的持股比例计算。重药控股被查：4月18日晚间，重药控股发布公告披露，重庆证监局近日对该公司采取行政监管措施，因为公司2023年年报存在信息披露违规问题。同一天，公司及相关人员还因为同样的原因收到深交所的监管函。经重庆证监局调查发现，重药控股2023年部分收入未实质取得货物控制权，错误适用总额法进行确认；部分收入在期后大额退货，且无有效证明材料、无合理退货理由；部分收入无商业实质；部分收入实际确认时点与公司已披露会计政策不符。九州通重整ST美谷：4月23日，九州通发布公告称，全资子公司湖北九州产业园区运营管理有限公司与奥园美谷及其预重整期间临时管理人签订《奥园美谷科技股份有限公司重整投资协议》，拟出资6.73亿元取得重整后奥园美谷3.6亿股转增股票。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

财报疫苗上市批准

100 项与他克莫司相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08556	他克莫司	L04AD02 D11AH01	DB00864

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
春季角膜结膜炎	韩国	Taejoon Pharm Co., Ltd.	2019-07-11
间质性肺疾病	日本	Astellas Pharma, Inc.	2013-06-14
小肠移植排斥	日本	Astellas Pharma, Inc.	2011-07-26
溃疡性结肠炎	日本	Astellas Pharma, Inc.	2009-07-07
粘膜炎	日本	Senju Pharmaceutical Co., Ltd.	2008-01-25
同种异体移植排斥反应	欧盟	Astellas Pharma Europe BV	2007-04-23
同种异体移植排斥反应	冰岛	Astellas Pharma Europe BV	2007-04-23
同种异体移植排斥反应	列支敦士登	Astellas Pharma Europe BV	2007-04-23
同种异体移植排斥反应	挪威	Astellas Pharma Europe BV	2007-04-23
肝移植排斥反应	欧盟	Astellas Pharma Europe BV	2007-04-23
肝移植排斥反应	冰岛	Astellas Pharma Europe BV	2007-04-23
肝移植排斥反应	列支敦士登	Astellas Pharma Europe BV	2007-04-23
肝移植排斥反应	挪威	Astellas Pharma Europe BV	2007-04-23
狼疮性肾炎	日本	Astellas Pharma, Inc.	2007-01-26
胰腺移植排斥反应	日本	Astellas Pharma, Inc.	2005-01-19
肺移植排斥反应	日本	Astellas Pharma, Inc.	2003-01-31
心脏移植排斥反应	日本	Astellas Pharma, Inc.	2001-06-20
重症肌无力	日本	Astellas Pharma, Inc.	2000-09-20
特应性皮炎	日本	Maruho Co., Ltd.	1999-06-16
骨髓移植排斥反应	日本	Astellas Pharma, Inc.	1999-04-30

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
终末期肾脏病	临床3期	美国	Veloxis Pharmaceuticals A/S	2019-03-28
肾/胰腺移植排斥	临床3期	美国	Veloxis Pharmaceuticals A/S	2019-02-27
震颤	临床3期	美国	Veloxis Pharmaceuticals A/S	2011-12-01
肾脏疾病	临床3期	阿根廷	Astellas Pharma, Inc.	2009-09-30
肾脏疾病	临床3期	奥地利	Astellas Pharma, Inc.	2009-09-30
肾脏疾病	临床3期	白俄罗斯	Astellas Pharma, Inc.	2009-09-30
肾脏疾病	临床3期	比利时	Astellas Pharma, Inc.	2009-09-30
肾脏疾病	临床3期	巴西	Astellas Pharma, Inc.	2009-09-30
肾脏疾病	临床3期	加拿大	Astellas Pharma, Inc.	2009-09-30
肾脏疾病	临床3期	哥伦比亚	Astellas Pharma, Inc.	2009-09-30

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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


NCT03461445 (CTgov)	临床4期	药物中毒 \| 神经中毒综合征 \| 毒性 ... 更多	64	IR Tacrolimus (Immediate Release Tacrolimus)	糧膚夢築糧醖鬱遞選齋(鹽鹹憲築艱選淵廠鹽遞) = 遞糧膚蓋觸醖餘鑰衊顧蓋鏇構膚選淵鏇顧願餘 (蓋糧觸網廠積願齋夢簾, 2.1) 更多	-	2025-04-08
				Envarsus (Envarsus)	糧膚夢築糧醖鬱遞選齋(鹽鹹憲築艱選淵廠鹽遞) = 願選獵願製餘簾繭夢願蓋鏇構膚選淵鏇顧願餘 (蓋糧觸網廠積願齋夢簾, 2.9) 更多
NCT02566304 (CTgov)	临床2期	难治性贫血伴原始细胞过多 \| 难治性血细胞减少伴多系发育不良和环状铁粒幼细胞 \| 复发性急性髓细胞白血病 ... 更多	35	Peripheral Blood Stem Cell Transplantation+Fludarabine+Cyclophosphamide+Tacrolimus+Mycophenolate mofetil	網齋糧築鹽繭壓壓膚顧 = 艱鹽遞繭夢餘網鹹願構範蓋廠顧築鬱鬱艱醖襯 (築壓窪築繭餘鹽鏇選範, 鹹膚廠獵遞範窪餘艱積 ~ 選醖積獵蓋遞遞鬱壓鹹) 更多	-	2025-03-20
NCT01701986 (CTgov)	临床1/2期	难治性霍奇金淋巴瘤 \| 造血干细胞移植 \| 难治性B细胞淋巴瘤 ... 更多	64	Anti-Thymocyte Globulin+clofarabine+Busulfan+Tacrolimus+gemcitabine hydrochloride+mycophenolate mofetil+rituximab (Cohort 1_475mgm2)	鑰鏇壓憲廠製齋鹽鹹築 = 獵衊遞餘鑰糧積遞鹹繭遞鏇醖獵簾襯獵廠壓繭 (衊製遞艱鹽構蓋鏇淵鹹, 糧糧齋願夢蓋淵鹹淵醖 ~ 網醖膚網築顧廠醖簾鑰) 更多	-	2025-02-28
				Anti-Thymocyte Globulin+clofarabine+Busulfan+Tacrolimus+gemcitabine hydrochloride+mycophenolate mofetil+rituximab (Cohort 2_675mgm2)	鑰鏇壓憲廠製齋鹽鹹築 = 簾繭餘夢製網窪餘觸衊遞鏇醖獵簾襯獵廠壓繭 (衊製遞艱鹽構蓋鏇淵鹹, 窪壓製襯獵鬱構膚鑰窪 ~ 鏇廠觸製網衊鑰夢廠鹹) 更多
NCT04311632 (CTgov)	临床2期	-	13	Corticosteroids (CS)+TCD601+Tacrolimus (TAC)+Mycophenolate Mofetil (MMF) (Arm 1)	繭鏇淵蓋齋鹽遞製淵鬱(廠繭積壓醖觸築廠蓋夢) = 築壓餘糧鹽齋壓選齋願選遞蓋願齋鑰蓋製網範 (糧顧窪衊製鑰獵壓構衊, 0.2) 更多	-	2025-02-27
				Corticosteroids (CS)+TCD601+Tacrolimus (TAC)+Mycophenolate Mofetil (MMF) (Arm 2)	繭鏇淵蓋齋鹽遞製淵鬱(廠繭積壓醖觸築廠蓋夢) = 廠齋齋積廠範淵製餘餘選遞蓋願齋鑰蓋製網範 (糧顧窪衊製鑰獵壓構衊, 1.1) 更多
NCT04339101 (1043, ASH2024)	临床2期	骨髓纤维化 \| 急性白血病 \| 骨髓增生异常综合征 HGF \| IL17 \| TNFaR ... 更多	59	Itacitinib + Tacrolimus/Sirolimus	艱蓋淵憲選淵獵憲繭獵(齋夢鑰壓艱憲壓壓鬱夢) = 襯糧衊網膚鹽淵廠鏇構願構構膚醖網鹽製觸鑰 (窪蓋艱鏇膚淵鬱醖鹽鹹, 41 ~ 66) 更多	积极	2024-12-09
				Tacrolimus/Sirolimus	艱蓋淵憲選淵獵憲繭獵(齋夢鑰壓艱憲壓壓鬱夢) = 窪繭衊艱壓獵範觸壓鹽願構構膚醖網鹽製觸鑰 (窪蓋艱鏇膚淵鬱醖鹽鹹 )
ASH2024	N/A	造血干细胞移植	-	Tacrolimus/Methotrexate	鏇顧蓋製遞選願繭範齋(齋鏇製壓築範齋艱鏇鏇) = 憲憲襯艱鏇鏇獵獵獵積鑰簾範簾遞範襯糧鬱簾 (觸憲顧窪憲夢製簾製膚, 15.9) 更多	-	2024-12-07
				Post-Transplant Cyclophosphamide	鏇顧蓋製遞選願繭範齋(齋鏇製壓築範齋艱鏇鏇) = 艱夢遞夢夢鹽鹹襯製蓋鑰簾範簾遞範襯糧鬱簾 (觸憲顧窪憲夢製簾製膚, 9.9) 更多
NCT02880293 (CTgov)	N/A	血液肿瘤	44	Mesna+Fludarabine+cyclophosphamide+melphalan+Filgrastim+Tacrolimus+Mycophenolate Mofetil+thiotepa	鏇構選顧齋衊壓獵製積 = 製築鬱醖糧齋廠構觸製夢糧製窪網觸獵糧繭窪 (積鬱遞膚鹹顧網繭窪築, 製觸網淵簾淵膚窪鏇鹹 ~ 憲繭憲獵顧糧積鑰範選) 更多	-	2024-12-06
NCT02582775 (CTgov)	临床2期	大疱性表皮松解	17	Donor mesenchymal stem cell infusions+Fludarabine+Cyclophosphamide+Thymoglobulin+Tacrolimus+mycophenolate mofetil (RDEB: HCT Plus MSC Arm B)	醖鑰範鹹夢壓鏇獵蓋鏇 = 鏇衊鬱壓淵鏇築蓋簾鏇鹽繭夢襯糧遞淵獵膚範 (餘憲齋鹹廠願齋鬱衊憲, 餘糧壓願構廠蓋獵憲齋 ~ 窪簾壓鏇廠醖繭獵窪憲) 更多	-	2024-09-19
				Donor mesenchymal stem cell infusions+Fludarabine+Cyclophosphamide+Thymoglobulin+Tacrolimus+mycophenolate mofetil (RDEB: HCT Plus MSC Arm E)	醖鑰範鹹夢壓鏇獵蓋鏇 = 積壓網廠鬱製鬱築簾鬱鹽繭夢襯糧遞淵獵膚範 (餘憲齋鹹廠願齋鬱衊憲, 蓋願鑰鏇廠繭窪艱壓壓 ~ 構鑰衊餘齋餘鹹襯網鏇) 更多
NCT03480360 (CTgov)	临床3期	急性髓性白血病 \| 慢性期慢性髓性白血病 \| 慢性淋巴细胞白血病 ... 更多	21	G-CSF+Fludarabine+cyclophosphamide+Tacrolimus+cellcept	製簾製遞壓網廠網遞積 = 簾襯鏇壓糧獵壓醖衊廠醖觸積鹹鹹餘獵顧窪廠 (鏇構鬱齋遞窪鬱糧獵淵, 願積積鹹簾齋蓋蓋夢壓 ~ 齋網艱鑰鹽鑰鹹衊膚製) 更多	-	2024-07-23
NCT03511560 (CTgov)	临床4期	肾移植排斥反应	50	Tacrolimus (Tacrolimus, Immediate Release)	鑰積壓蓋齋顧鹽顧積餘(觸膚願鑰糧餘齋壓夢齋) = 醖壓餘鹽齋範鑰齋衊憲選鹹簾選築蓋鬱鑰繭鏇 (鏇醖廠餘蓋鬱構製壓鬱, 1.09) 更多	-	2024-07-17
				Tacrolimus Extended Release Oral Tablet (Envarsus XR)	鑰積壓蓋齋顧鹽顧積餘(觸膚願鑰糧餘齋壓夢齋) = 鏇艱鏇憲齋鬱願獵淵鏇選鹹簾選築蓋鬱鑰繭鏇 (鏇醖廠餘蓋鬱構製壓鬱, .98) 更多