A pilot study to explore safety, tolerability and efficacy of ORal IrON supplementation with ferric maltol in treating iron deficiency and anaemia in patients with Heart Failure (ORION-HF) - ORION-HF

开始日期2022-12-23

申办/合作机构

Hannover Medical School

NCT05456932 / Recruiting临床4期

Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease

Iron deficiency anemia is the most common systemic manifestation of Inflammatory Bowel Diseases (IBD)-Crohn's disease and ulcerative colitis. Iron deficiency with or without anemia poses a diagnostic and therapeutic challenge due to chronic gastrointestinal blood loss and the inflammatory nature of IBD. Recent illumination of iron metabolism has brought attention to the systemic iron regulator-hepcidin, a peptide hormone that regulates intestinal iron absorption and systemic iron availability. Elevated hepcidin is associated with oral iron malabsorption in IBD. This study aims to evaluate whether hepcidin concentration at baseline can predict response to oral and intravenous iron therapy in patients with IBD and concomitant iron deficiency with or without anemia.

开始日期2022-08-19

申办/合作机构

Academisch Ziekenhuis Leiden

[+3]

NCT05177484 / Recruiting临床3期

An Open Label Randomised Trial to Assess the Efficacy of Post-Operative Ferric Maltol Vs Standard Care for Anaemia Following Colorectal Cancer Surgery

The PICoC study aims to investigate whether oral ferric maltol given postoperatively offers an improvement in patient and clinician reported outcomes compared to standard care.

开始日期2022-05-30

申办/合作机构

The Royal Wolverhampton Hospital NHS Trust

[+1]

100 项与麦芽醇铁相关的临床结果

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100 项与麦芽醇铁相关的转化医学

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100 项与麦芽醇铁相关的专利（医药）

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项与麦芽醇铁相关的文献（医药）

2024-02-01·Ecotoxicology and environmental safety

miR-128-3p is involved in aluminum-induced cognitive impairment by regulating the Sirt1-Keap1/Nrf2 pathway

Article

作者: Li, Huan ; Zhang, Xiaoyu ; Wang, Xiangmeng ; Niu, Qiao ; Xu, Chaoqun ; Zhang, Jing ; Lin, Li ; Liu, Yan

Aluminum (Al) is a common neurotoxicant in the environment, but the molecular mechanism of its toxic effects is still unclear. Studies have shown that aluminum exposure causes an increase in neuronal apoptosis. The aim of this study was to investigate the mechanism and signaling pathway of neuronal apoptosis induced by aluminum exposure. The rat model was established by intraperitoneal injection of maltol aluminum for 90 days. The results showed that the escape latency of the three groups exposed to maltol aluminum was higher than that of the control group on the 3rd, 4th and 5th days of the positioning cruise experiment (P < 0.05). On the 6th day of the space exploration experiment, compared with the control group(6.00 ± 0.71,15.33 ± 1.08) and the low-dose group(5.08 ± 1.69,13.67 ± 1.09), the number of times that the high-dose group crossed the platform(2.25 ± 0.76) and the platform quadrant(7.58 ± 1.43) was significantly reduced (P < 0.01). The relative expression levels of Sirt1 and Nrf2 in hippocampal tissues of all groups decreased gradually with increasing maltol aluminum exposure dose the relative expression levels of Sirt1 and Nrf2 in high-dose group (0.261 ± 0.094,0.325 ± 0.108) were significantly lower than those in control group (1.018 ± 0.222,1.009 ± 0.156)(P < 0.05). The relative expression level of Keap1 increased gradually with increasing maltol aluminum exposure dose (P < 0.05). The relative expression level of miR-128-3p in the high-dose group(1.520 ± 0.280) was significantly higher than that in the control group(1.000 ± 0.420) (P < 0.05). The content of GSH-Px in the hippocampus of rats decreased with increasing dose. ROS levels gradually increased. We speculated that subchronic aluminum exposure may lead to the activation of miR-128-3p in rat hippocampus of rats, thereby inhibiting the Sirt1-Keap1/Nrf2 pathway so that the Sirt1-Keap1/Nrf2 pathway could not be activated to exert antioxidant capacity, resulting in an imbalance in the antioxidant system of rats and the apoptosis of neurons, which caused reduced cognitive impairment in rats.

2024-01-01·BMJ open

Predicting response to iron supplementation in patients with active inflammatory bowel disease (PRIme): a randomised trial protocol

Article

作者: van der Meulen-de Jong, Andrea E ; Duijvestein, Marjolijn ; Goetgebuer, Rogier L ; Loveikyte, Roberta ; Mujagic, Zlatan ; Dijkstra, Gerard

Introduction:

Iron deficiency anaemia (IDA) is the most common systemic manifestation of inflammatory bowel disease (IBD) that has detrimental effects on quality of life (QoL) and disease outcomes. Iron deficiency (ID), with or without anaemia, poses a diagnostic and therapeutic challenge in patients with IBD due to the multifactorial nature of ID(A) and its frequent recurrence. Elevated hepcidin—a systemic iron regulator that modulates systemic iron availability and intestinal iron absorption—has been associated with oral iron malabsorption in IBD. Therefore, hepcidin could assist in therapeutic decision-making. In this study, we investigate whether hepcidin can predict response to oral and intravenous iron supplementation in patients with active IBD undergoing anti-inflammatory treatment.

Methods and analysis:

PRIme is an exploratory, multicentre, open-label and randomised trial. All adult patients with active IBD and ID(A) will be assessed for eligibility. The participants (n=90) will be recruited at five academic hospitals within the Netherlands and randomised into three groups (1:1:1): oral ferrous fumarate, oral ferric maltol or intravenous iron. Clinical and biochemical data will be collected at the baseline and after 6, 14 and 24 weeks. Blood samples will be collected to measure hepcidin and other biomarkers related to iron status. In addition, patient-reported outcomes regarding QoL and disease burden will be evaluated. The primary outcome is the utility of hepcidin as a predictive biomarker for response to iron therapy, which will be assessed using receiver operating curve analysis.

Ethics and dissemination:

The study has been approved by the Institutional Review Board at the Leiden University Medical Center (IRB No. P21.109) and other study sites. All participants will provide written informed consent to enrol in the study. The findings will be published in a peer-reviewed journal and disseminated at scientific conferences; the dataset will be available on reasonable request.

Trial registration:

Prospectively registered in thehttps://clinicaltrials.gov/and the Eudra registries. First submitted on 10 May 2022 to the ClinicalTrials.gov (ID:NCT05456932) and on 3 March 2022 to the European Union Drug Regulating Authorities Clinical Trials Database (ID: 2022-000894-16).

2024-01-01·Ecotoxicology and environmental safety

Aluminum-maltol induced oxidative stress and reduced AMPK activity via BCK-related energy supply failure in C6 cell

Article

作者: Yu, Qianqian ; Liu, Sijia ; Cheng, Dai ; Ju, Yaojun ; Song, Qi ; Liu, Chunxu ; Wang, Yingjie

Aluminum (Al) exposure significantly interferes with the energy supply in astrocytes, which may be a potential mechanism of Al-induced neurotoxicity. This study was designed to explore the mechanisms of Al-induced energy supply impairment in rat C6 astroglioma cell line. Aluminum-maltolate (Al(mal)₃) (0.1 mM, 24 h) exposure significantly decreased brain-type creatine kinase (BCK) co-localization with the endoplasmic reticulum (ER) and resulted in mitochondrial dysfunctions, accompanied by a decrease in AMPK phosphorylation. The results of molecular docking showed that Al(mal)₃ increased BCK's hydrophobicity and hindered the localization movement of BCK between subcells·H₂O₂ co-administration was found to exacerbate mitochondrial dysfunction, Ca²⁺ dyshomeostasis, and apoptosis. After treated with Al(mal)₃, additional oxidative stress contributed to BCK activity inhibition but did not promote a further decrease in AMPK phosphorylation. The activation of p-AMPK by its agonist can partially restore mitochondrial function, BCK activity, and ER-localized-BCK levels in Al(mal)₃-treated astrocytes. In summary, Al exposure resulted in a sustained depletion of the mitochondrial and antioxidant systems, which was associated with reduced p-AMPK activity and decreased ER-localized-BCK levels in astrocytes. This study provides a theoretical basis for exploring the mechanisms of neurotoxicity induced by Al exposure.

项与麦芽醇铁相关的新闻（医药）

2024-03-15

·米内网

奥赛康厚积薄发！首款改良新药获批，新品大涨4277%，8款1类新药、3个首仿药在路上

精彩内容2024年开局不久，奥赛康迎来了多个好消息：公司首款改良新药注射用右兰索拉唑获批，拿下了艾曲泊帕乙醇胺片的国内首仿，首家申报注射用德拉沙星仿制上市，公司的创新转型硕果累累。公司8款在研的国产1类新药正快速推进，ASK120067片有望在今年获批上市。奥赛康积极参与国家集中带量采购，前九批已有13个产品中标，4大“光脚产品”备战第十批国采，备受瞩目。首款改良新药、4款首仿药获批，新品销售大涨4277%奥赛康是一家集医药研发、生产、销售为一体的高新技术企业，产品覆盖消化、抗肿瘤、慢性病、抗感染等治疗领域。公司战略转型创新，创新药和高技术壁垒的新型仿制药成为了发展新方向，近几年公司的管线逐步进入收获期，米内网数据显示，2021年至今奥赛康共拿下了17个新产品，分布在抗肿瘤和免疫调节剂、消化系统及代谢药等6个大类。表1：奥赛康2021年至今获批的新产品注：统计不含新增规格，按产品名统计来源：米内网中国申报进度（MED）数据库奥赛康的首款改良新药备受瞩目，注射用右兰索拉唑在2022年5月报产并在2024年1月获批。据悉，右兰索拉唑为兰索拉唑的R-异构体，其体内活性是左兰索拉唑的5-10倍，可以发挥更强、更持久的抑酸作用。公司的抢仿实力在业界也是名列前茅，2021年拿下了泊沙康唑注射液和地拉罗司分散片国内首仿，2023年拿下塞瑞替尼胶囊国内首仿获批，艾曲泊帕乙醇胺片成为了公司在2024年首个获批的首仿药。泊沙康唑注射液用于预防和治疗侵袭性曲霉菌和念珠菌感染，该产品技术壁垒高、临床亟需，奥赛康在2021年4月拿下该产品的国内首仿。在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端，奥赛康的泊沙康唑注射液累计销售额（截至2023年上半年）已超过9000万元，2023年上半年的增长率达到74.00%。地拉罗司是目前治疗铁过载唯一有效的药物，奥赛康在2021年6月拿下地拉罗司分散片的国内首仿，目前仅有1家国内药企获得该产品的生产批文。塞瑞替尼为多靶点激酶抑制剂，用于间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者。奥赛康在2023年3月拿下塞瑞替尼胶囊的国内首仿，目前仅有1家国内药企获得生产批文。2024年1月，奥赛康、正大天晴药业集团、齐鲁制药以及四川科伦药业同日拿下了艾曲泊帕乙醇胺片的国内首仿。该产品是非肽类血小板生成素受体激动剂，用于治疗既往对糖皮质激素、免疫球蛋白等治疗反应不佳的慢性免疫性（特发性）血小板减少症（ITP）。此外，公司两款新上市产品销售大涨，潜力可期。奥赛康的注射用多黏菌素E甲磺酸钠在2021年10月获批，用于治疗成人和儿童（包括新生儿）中由需氧型革兰阴性菌敏感性菌株引起的、可治疗手段有限的严重感染。该产品已进入国家医保谈判目录，在中国公立医疗机构终端，奥赛康的注射用多黏菌素E甲磺酸钠2023年上半年的销售额大涨354.87%。公司的甲磺酸仑伐替尼胶囊于2021年12月获批，适用于既往未接受过全身系统治疗的不可切除的肝细胞癌患者的治疗。该产品为国家医保目录乙类品种，在中国公立医疗机构终端，奥赛康的甲磺酸仑伐替尼胶囊2023年上半年的销售额大涨4277.50%。表2：奥赛康报产在审的仿制药新产品来源：米内网中国申报进度（MED）数据库目前市场上暂无注射用右旋雷贝拉唑钠、注射用硫酸艾沙康唑、注射用德拉沙星的国产仿制药获批，奥赛康将参与首仿争夺。艾沙康唑是三唑类广谱抗真菌药，不仅具有更强的抗菌活性和广谱性，而且能够更好地穿透到感染部位，从而更有效地发挥抗菌活性。奥赛康于2022年7月首家提交注射用硫酸艾沙康唑的仿制上市申请，目前正在审评审批中，公司预计该产品有望于2024年获批上市。注射用德拉沙星是新一代广谱氟喹诺酮抗菌素，用于急性细菌性皮肤及皮肤结构感染和社区获得性细菌性肺炎，该药品尚未在国内上市。奥赛康在今年3月首家提交该产品的仿制上市申请，目前暂无其他国内药企报产，公司抢首仿有时间优势。抗肿瘤药成功突围，首款1类新药冲刺上市作为国内PPI制剂的龙头企业之一，该类药物一直为奥赛康的业绩做出了重大贡献，在中国公立医疗机构终端，2013-2020年公司的治疗与胃酸分泌相关疾病药物占比超过70%。近几年公司的抗肿瘤药迅速发展，2023年上半年在中国公立医疗机构终端的占比已超过40%，一跃成为奥赛康的TOP1亚类。图1：奥赛康的抗肿瘤药份额变化情况来源：米内网中国公立医疗机构药品终端竞争格局表3：2023年上半年奥赛康部分抗肿瘤药的销售情况（单位：万元）注：销售额低于1千万用*表示来源：米内网中国公立医疗机构药品终端竞争格局近年来为实现公司可持续发展，奥赛康积极调整产品结构、提升核心竞争力，加快创新药的研发速度，创新管线重点布局了抗肿瘤药物及细胞因子前药。表4：奥赛康在研的重磅国产1类新药来源：米内网中国临床试验数据库ASK120067片是奥赛康开发的第三代EGFR-TKI，用于非小细胞肺癌治疗，首个上市申请已于2021年11月获得CDE承办，公司预计用于既往经EGFR-TKI治疗时或治疗后出现疾病进展并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的二线治疗或于2024年获批上市。有券商预测，ASK120067片首个完整年度的销售额可超过2亿元，到了2032年预计销售额将突破13亿元。ASKC202片是一种强效、高选择性的口服小分子c-Met抑制剂，奥赛康计划将其与ASK120067片联合用于治疗一代EGFR抑制剂耐药的T790M阴性患者，以及用于三代EGFR抑制剂耐药的患者。该新药上市后将进一步拓展非小细胞肺癌的目标人群，有望打开产品第二成长曲线。生物药1类新药ASKB589注射液是奥赛康研发的CLDN18.2单抗，针对胃及食管胃交界处腺癌疗效显著，目前该新药已处于III期临床阶段，第一例受试者在2024年1月已完成入组，公司预计在2027年获批上市，券商预测该新药在2032的销售额将超过25亿元。近几年随着肿瘤免疫治疗的全面发展，细胞因子药物进入了全新的发展时代，已成为肿瘤免疫疗法中的一个重要赛道。奥赛康开发出了两款FIC细胞因子前药，注射用ASKG315和注射用ASKG915均已进入I期临床阶段。注射用ASKG315是一款重组人白介素-15前药-Fc融合蛋白，可与PD-1抗体及其它抗癌抗体联用、广谱抗癌。而注射用ASKG915是一款PD-1抗体/IL-15前药双功能融合分子，拟用于晚期实体瘤的治疗，有望覆盖现有PD-1单药疗法疗效不佳的多个癌种，进一步填补抗肿瘤免疫疗法的市场空白。此外，奥赛康还通过引进合作，进一步扩大公司的研发管线，目前公司引进的抗骨关节炎疼痛创新药ASKC200以及口服补铁产品麦芽酚铁胶囊均已在I期临床阶段。30个产品已过评，4大“光脚产品”备战第十批国采2019年1月，奥赛康的沙格列汀片4类仿制上市申请获批并视同过评，成为了公司首款过评产品，截至2024年3月15日，公司已过评/视同过评的产品达到30个。表5：奥赛康已过评/视同过评产品来源：米内网中国申报进度（MED）数据库图2：奥赛康已中标国采的产品情况来源：米内网中国上市药品（MID）数据库从第四批国采开始，奥赛康积极应战，前九批共有13个产品中标（盐酸帕洛诺司琼注射液不同规格分别在第五批及第七批国采中标），目前已过评且暂未纳入国采的产品中注射用右雷佐生、泊沙康唑注射液、哌柏西利胶囊、注射用盐酸罗沙替丁醋酸酯、艾曲泊帕乙醇胺片的竞争企业（原研+过评）已达5家及以上。表6：竞争企业≥5家的产品注：销售额低于1亿元用*表示来源：米内网中国公立医疗机构药品终端竞争格局奥赛康的泊沙康唑注射液（2021年）、哌柏西利胶囊（2022年）、注射用盐酸罗沙替丁醋酸酯（2023年）、艾曲泊帕乙醇胺片（2024年）均为近几年获批的新产品，若最终纳入第十批国采目录且顺利中标，“光脚产品”有望借助国采之力迎来销售放量新机遇。结语近几年，奥赛康的仿制药集采利空正逐步出清，随着创新药加速推进，公司的创新转型迈入了新阶段。有券商预计，奥赛康在持续大额的研发投入下，仍有望在2025年实现扭亏为盈，我们拭目以待。资料来源：米内网数据库、公司公告等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至3月15日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准带量采购申请上市医药出海

2021-06-21

·GlobeNewswire

Shield Therapeutics PLC (“Shield”) to Webcast Live at Life Sciences Investor Forum June 24th

LONDON, June 21, 2021 (GLOBE NEWSWIRE) -- Shield Therapeutics PLC (STX.L), based in Newcastle-upon-Tyne, UK, focused on addressing iron deficiency with its lead product Feraccru®/Accrufer® (ferric maltol), today announced that Greg Madison, Chief Executive Officer, will present live at LifeSciencesInvestorForum.com on June 24th. DATE: Thursday, June 24th TIME: 10.00 am ETLINK: This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event. It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. Learn more about the event at . About ShieldShield is a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru® /Accrufer® (ferric maltol), a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia. Shield’s lead product, Feraccru®/Accrufer®, has been approved for use in the United States, European Union, UK and Switzerland and has exclusive IP rights until the mid-2030s. The Group plans to launch Accrufer® in the US during 2021 through a highly experienced sales and marketing team. Feraccru® is already being commercialised in the UK and European Union by Norgine B.V., who also have the marketing rights in Australia and New Zealand. Shield also has an exclusive licence agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the development and commercialisation of Feraccru®/Accrufer® in China, Hong Kong, Macau and Taiwan. For more information, please visit . Follow Shield on Twitter @ShieldTx About Life Sciences Investor ForumLife Sciences Investor Forum is the leading proprietary investor conference series that provides an interactive forum for Life Sciences companies to meet with and present directly to investors. A real-time solution for investor engagement, Life Sciences Investor Forum is powered by Intrado Digital Media and specifically designed for more efficient investor access. Replicating the look and feel of on-site investor conferences, Life Sciences Investor Forum combines leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.

合作

2013-12-16

·BioSpace

Shield Therapeutics Release: FDA Grants Approval Of IND To Commence A Phase 3 Pivotal Study For ST10 For The Treatment Of Iron Deficiency Anemia In Chronic Kidney Disease

London, UK, 16 December 2013. Shield Therapeutics, an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to initiate a Phase 3 pivotal study of ST10, its novel oral iron-replacement therapy, for the treatment of iron deficiency anaemia (IDA) in pre-dialysis patients with chronic kidney disease (CKD). The Company plans to initiate the Phase 3 study in the US in H1 2014 and positive data would be the cornerstone of a subsequent NDA submission. AEGIS 3 will be a pivotal Phase 3, 16-week prospective, multicentre, randomised, double-blind, placebo controlled study and will enrol approximately 160 pre-dialysis CKD patients in the US who have been diagnosed with IDA. The primary endpoint of the study will be the change in haemoglobin from baseline to week 16. ST10 is a novel oral ferric iron therapy being developed for the treatment of IDA, which has demonstrated potential as an effective oral alternative to intravenous (IV) iron. As well as showing that gastrointestinal absorption of ST10 is at least as good as ferrous products in previous studies, ST10 has also been shown to have minimal gastro-intestinal side effects so can be given on an empty stomach at a much reduced daily dose and to patients who cannot take standard oral iron preparations, for whom the only alternative would be IV infusions of iron. As ST10 is not adversely affected by changes in gastric pH, it may also be effective when co-prescribed with widely used acid-reducers. ST10 is also currently being investigated in two pivotal Phase 3 studies as a treatment for IDA in inflammatory bowel disease, top-line results from which are expected in the coming months. Carl Sterritt, Founder and Chief Executive Officer of Shield Therapeutics, stated: “I am delighted that FDA has approved this IND and we can now move forward with our plans to test ST10 in this second major indication and at the same time introduce ST10 to clinicians in the world’s largest and most important pharmaceutical market. ST10 has the potential to be the only effective oral iron-replacement therapy without significant GI side effects and we believe this novel and convenient product has the potential to become a market leader for IDA in the established CKD patient population worldwide.” For more information about Shield Therapeutics, please contact: Consilium Strategic Communications Mary-Jane Elliott / Emma Thompson/ Lindsey Neville Tel +44 (0)20 7920 2333 Email: shieldtherapeutics@consilium-comms.com About Shield Therapeutics Shield Therapeutics ( ), founded in 2008, is an independent specialty pharmaceutical company focused on the development and commercialisation of late-stage, mineral-derived hospital pharmaceuticals which address areas of high unmet medical need. Shield is currently conducting pivotal Phase 3 studies of its lead asset, ST10, for the treatment of iron deficiency anaemia associated with inflammatory bowel disease and is soon to commence a Phase 3 study of ST10 for the treatment of iron deficiency anaemia in patients with chronic kidney disease. About IDA and the CKD Therapeutics Market Epidemiology data suggests the current total IDA patient population in the EU, USA and Japan is approximately 34m, with an addressable population of 2.6m (IBD and CKD in the EU and US) in the first instance. The company estimates that the core market in IDA is worth at least $3.0bn. In addition, the global CKD therapeutics market is forecast to grow at a compound annual growth rate (CAGR) of 6.4% to reach $11.6billion by 20181. 1Chronic Kidney Disease (CKD) Therapeutics - Pipeline Assessment and Market Forecasts to 2018, GlobalData, September 2011 Help employers find you! Check out all the jobs and post your resume.

100 项与麦芽醇铁相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10833	-	B03AB10	DB15598

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
缺铁性贫血	瑞士	Ewopharma AG	2017-09-22
铁缺乏	欧盟	諾金有限公司	2016-02-18
铁缺乏	冰岛	諾金有限公司	2016-02-18
铁缺乏	列支敦士登	諾金有限公司	2016-02-18
铁缺乏	挪威	諾金有限公司	2016-02-18

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适应症	最高研发状态	国家/地区	公司	日期
贫血	临床3期	英国	Norgine Ltd.	2022-05-30
结肠癌	临床3期	英国	Norgine Ltd.	2022-05-30
慢性肾病	临床3期	美国	Shield Therapeutics Plc	2016-12-01
溃疡性结肠炎	临床3期	-	Shield Therapeutics Plc	2011-08-01
克罗恩病	临床3期	-	Shield Therapeutics Plc	2011-08-01

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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


NCT02968368 (AEGIS-CKD, Pubmed \| Am J Kidney Dis)	临床3期	伴随慢性肾病的贫血	167	Oral ferric maltol 30 mg	餘夢醖襯衊窪淵夢廠網(糧選鬱觸積製蓋製鹽網): P-Value = 0.01 更多	积极	2021-05-21
				Placebo
NCT03181451 (CTgov)	临床1期	铁缺乏 \| 缺铁性贫血	37	Ferric Maltol (30 mg Ferric Maltol)	衊艱窪餘艱獵觸膚獵顧(廠網築餘鑰窪艱襯齋艱) = 築衊醖積壓繭醖衊網觸築鬱餘簾簾衊築顧蓋襯 (築餘選積網膚艱製積築, 築鹽衊築齋鬱鹽觸夢淵 ~ 餘蓋糧遞餘鹽餘鏇醖齋) 更多	-	2020-06-02
				Ferric Maltol (16.6 mg Ferric Maltol)	衊艱窪餘艱獵觸膚獵顧(廠網築餘鑰窪艱襯齋艱) = 鹽獵顧遞淵糧襯廠艱獵築鬱餘簾簾衊築顧蓋襯 (築餘選積網膚艱製積築, 憲鹽鬱積築簾構鹹顧獵 ~ 餘憲簾鹽襯獵築鑰壓鑰) 更多
NCT02968368 (AEGIS-CKD \| phase 3 multicenter double-blind, randomized controlled trial, CTgov)	临床3期	缺铁性贫血 \| 慢性肾病	167	Ferric maltol (Oral Ferric Maltol)	膚襯蓋鬱艱壓鬱鬱憲齋(齋齋築淵齋壓壓醖製觸) = 網觸網繭醖餘鹽構積醖遞觸憲齋繭鹹願憲廠齋 (衊網壓膚積鑰廠觸鏇築, 膚餘鏇衊夢積範積鏇獵 ~ 選積壓積廠襯鏇繭構夢) 更多	-	2020-05-01
				Placebo (Oral Placebo)	膚襯蓋鬱艱壓鬱鬱憲齋(齋齋築淵齋壓壓醖製觸) = 憲憲鑰簾簾範襯獵憲鑰遞觸憲齋繭鹹願憲廠齋 (衊網壓膚積鑰廠觸鏇築, 糧遞觸鑰鏇網鹹膚顧膚 ~ 簾夢獵齋鹹餘範積醖糧) 更多
NCT02680756 (CTgov)	临床3期	克罗恩病 \| 缺铁性贫血	250	Ferric Maltol (Oral Ferric Iron Compound)	網簾艱築獵膚襯願繭鏇(製顧獵壓糧繭膚製簾鏇): Risk Difference (RD) = -0.17 (95% CI, -0.28 ~ -0.06), P-Value = 0.298 更多	-	2020-02-24
				Ferric Carboxy Maltose (Intravenous Iron)
NCT02968368 (ASN2018)	临床3期	炎症 \| 慢性肾病 high-sensitivity C-reactive protein (hsCRP)	-	Ferric Maltol 30 mg	鏇齋窪蓋構艱鏇顧鏇繭(膚範艱廠獵齋鬱遞觸網) = 觸構構繭繭選築獵顧窪願壓夢艱夢蓋網齋鏇衊 (鑰壓艱膚簾衊獵憲簾襯 ) 更多	积极	2018-10-23
				Placebo	鏇齋窪蓋構艱鏇顧鏇繭(膚範艱廠獵齋鬱遞觸網) = 襯鬱壓襯網網蓋壓鬱選願壓夢艱夢蓋網齋鏇衊 (鑰壓艱膚簾衊獵憲簾襯 ) 更多
NCT02968368 (phase 3 multicenter double-blind, randomized controlled trial, ASN2018)	临床3期	缺铁性贫血 \| 慢性肾病	167	Oral Ferric Maltol (FM) 30 mg	選壓蓋夢鹽窪鏇襯構鬱(夢蓋蓋艱糧窪憲膚簾餘) = Two patients died (one in each group), both considered unrelated to study drug 選憲鬱選餘製網蓋夢遞 (構窪醖獵鬱願鹽網鹹衊 ) 更多	积极	2018-10-23
NCT01340872 (AEGIS-1, CTgov)	临床3期	缺铁性贫血 \| 溃疡性结肠炎	128	ST10-021 (ST10)	鏇鬱窪壓觸遞觸鏇鑰夢(繭範衊遞繭夢襯憲壓襯) = 構艱築顧製積廠淵齋範觸範鏇壓壓襯鬱簾醖壓 (衊築鏇繭夢積鏇鹹積蓋, 壓襯鏇範醖遞憲鹽鬱糧 ~ 獵醖觸淵夢餘構願範憲) 更多	-	2018-08-03
				Placebo Comparator (Placebo)	鏇鬱窪壓觸遞觸鏇鑰夢(繭範衊遞繭夢襯憲壓襯) = 餘獵繭鏇糧網醖鬱鹽願觸範鏇壓壓襯鬱簾醖壓 (衊築鏇繭夢積鏇鹹積蓋, 繭膚鑰艱醖觸構鹹網襯 ~ 製淵顧構廠積壓願鏇廠) 更多
NCT01352221 (AEGIS-2, CTgov)	临床3期	克罗恩病 \| 缺铁性贫血	128	ST10 (ST10)	構醖獵窪鏇窪衊願顧鬱(鹹衊選糧蓋鹽鏇糧鹹糧) = 醖衊淵鹽憲觸繭獵鹽鹹鏇繭構鏇蓋餘鏇襯壓廠 (窪膚憲範夢廠鹹網範廠, 窪顧蓋襯鏇製顧壓夢網 ~ 獵獵蓋鑰範繭餘壓選積) 更多	-	2017-10-27
				Placebo oral capsule (Placebo)	構醖獵窪鏇窪衊願顧鬱(鹹衊選糧蓋鹽鏇糧鹹糧) = 遞襯蓋齋膚鹹範壓糧範鏇繭構鏇蓋餘鏇襯壓廠 (窪膚憲範夢廠鹹網範廠, 獵觸憲齋鏇築積夢繭蓋 ~ 醖顧觸顧遞淵網網衊餘) 更多
NCT01340872 \| NCT01352221 (Pubmed \| Inflamm Bowel Dis)	临床3期	炎症性肠病	128	Ferric maltol	蓋齋艱廠鏇獵構廠製膚(醖膚齋膚襯襯簾淵顧糧) = 製製鏇鹽廠選製構鏇鏇鏇網獵襯淵鹽艱遞築鏇 (願壓遞鹹網膚衊衊遞鏇 )	积极	2015-03-01
ECCO2015	N/A	缺铁性贫血	-	Ferric maltol	鹹壓齋築繭積鑰築獵範(夢範製鹽窪鬱蓋夢觸鹹) = 壓範憲憲鑰憲餘範襯鹹繭憲夢積繭夢網願範夢 (簾餘鏇觸膚壓醖鏇艱艱 )	-	2015-01-19
				PPI	鹹壓齋築繭積鑰築獵範(夢範製鹽窪鬱蓋夢觸鹹) = 淵淵選築窪蓋鏇繭鹹窪繭憲夢積繭夢網願範夢 (簾餘鏇觸膚壓醖鏇艱艱, 1.51)