Postoperative anemia is highly prevalent among patients undergoing cardiac surgery and is associated with delayed functional recovery, increased morbidity, and impaired long-term outcomes. Preoperative iron deficiency is common in this population and contributes to inadequate erythropoietic recovery after surgery. Functional iron deficiency frequently develops even in patients without preoperative deficiency due to blood loss, hemodilution, and inflammation-mediated disruption of iron homeostasis. Despite this clinical burden, standardized strategies for postoperative anemia management have not been established.
This prospective, randomized, double-blind, placebo-controlled clinical trial evaluates whether early postoperative intravenous iron supplementation improves long-term anemia outcomes in patients undergoing cardiac surgery with cardiopulmonary bypass. Adult patients with preoperative anemia (hemoglobin <13 g/dL) or iron deficiency (ferritin <100 ng/mL or transferrin saturation <20%) will be screened. Eligible participants with postoperative day (POD) 1 hemoglobin <10 g/dL will be randomized in a 1:1 ratio to receive either ferric derisomaltose (20 mg/kg, maximum 1,000 mg) or a matched placebo administered intravenously over 30 minutes on POD 1. All perioperative management outside the intervention follows current institutional standards.
The primary outcome is the incidence of anemia at 6 months following surgery. Secondary outcomes include perioperative hemoglobin trends, functional recovery assessed by cardiopulmonary exercise testing and the 6-minute walk test at 6 months, transfusion requirements, postoperative complications including MAKE-90 and STS major morbidity, and changes in biomarkers of erythropoiesis and iron metabolism (erythroferrone, erythropoietin, hepcidin, and iron profile). Blood samples for biomarker analysis are collected at predefined perioperative timepoints.
Ferric derisomaltose allows high-dose single-session iron repletion with a favorable safety profile and minimal risk of anaphylaxis when administered slowly. Prior studies in cardiac surgery and heart failure populations support its efficacy and safety at doses up to 20 mg/kg. The intervention is expected to facilitate erythropoietic recovery, reduce the duration of postoperative anemia, and improve long-term functional status. The trial aims to generate evidence to inform postoperative anemia management strategies in cardiac surgery patients.

开始日期2025-12-01

申办/合作机构

Yonsei University

NCT06884280

/ Not yet recruiting临床3期IIT

Proactive High Dose Versus Low-dose Reactive Intravenous or Oral Iron in People on Peritoneal Dialysis (PALaDIN) - an Open-label, Feasibility Randomised Study

Chronic kidney disease affects a significant portion of the UK population, with approximately 3.5 million adults diagnosed. At its most severe stage, end-stage kidney disease, individuals require frequent dialysis treatment. One form of dialysis, known as peritoneal dialysis, involves introducing and removing fluid from the abdominal cavity to help filter out toxins from the body.
The kidneys are involved in various hormonal processes, including those responsible for producing red blood cells, making anaemia a common consequence of kidney failure. When designing a clinical trial to evaluate the effectiveness of any treatment, it is essential to determine the number of suitable and willing participants, as well as those who can complete all required tests and measurements. Identifying the most appropriate measurement to assess the impact of intravenous iron (iron injected directly into veins) is crucial to ensure that any observed changes are meaningful to people with CKD and their carers. To address these considerations, the investigators will conduct a pilot feasibility trial.
In this trial, individuals with kidney disease undergoing peritoneal dialysis will be randomly assigned to receive either high-dose or low-dose intravenous iron, or oral iron therapy. Over twelve months, the investigators will monitor their anaemia response, symptoms of kidney disease, quality of life, physical performance (such as the ability to walk for six minutes), and cognitive function. Additionally, the investigators will assess the impact of each intervention on the frequency of blood transfusions, whether those on oral iron require intravenous iron, and any changes in the dosage of erythropoietin-stimulating agents (drugs that increase blood production).

开始日期2025-10-01

申办/合作机构

The University of Hull

[+1]

ChiCTR2500108117

/ Not yet recruiting临床4期IIT

The effect of preoperative intravenous ferric derisomaltose and EPO and tranexamic acid versus usual treatment in patients with preoperative anemia or iron deficiency in bone tumor: a single-center, prospective, open-label, RCT study

开始日期2025-09-01

申办/合作机构

北京大学人民医院

[+1]

100 项与异麦芽糖酐铁相关的临床结果

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100 项与异麦芽糖酐铁相关的转化医学

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100 项与异麦芽糖酐铁相关的专利（医药）

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209

项与异麦芽糖酐铁相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Evaluating the cost-utility of ferric derisomaltose versus ferric carboxymaltose in patients with inflammatory bowel disease and iron deficiency anaemia in Norway

Article

作者: Detlie, T. E. ; Karlsen, L. N. ; Pollock, R. F. ; Nanu, N. ; Jørgensen, E.

AIMS:

Iron deficiency anemia (IDA) is among the most common extraintestinal sequelae of inflammatory bowel disease (IBD). Intravenous iron is often the preferred treatment in patients with active inflammation with or without active bleeding, iron malabsorption, or intolerance to oral iron. The aim of the present study was to evaluate the cost-utility of ferric derisomaltose (FDI) versus ferric carboyxymaltose (FCM) in patients with IBD and IDA in Norway.

MATERIALS AND METHODS:

A published patient-level simulation model was used to evaluate the cost-utility of FDI versus FCM in patients with IBD and IDA from a Norwegian national payer perspective. Iron need was modelled based on bivariate distributions of hemoglobin and bodyweight combined with simplified tables of iron need from the FDI and FCM summaries of product characteristics. Patient characteristics and disease-related quality of life data were obtained from the PHOSPHARE-IBD trial. Cost-utility was evaluated in Norwegian Kroner (NOK) over a five-year time horizon.

RESULTS:

Patients required 1.64 fewer infusions of FDI than FCM over five years (5.62 versus 7.26), corresponding to 0.41 fewer infusions per treatment course. The reduction in the number of infusions resulted in cost savings of NOK 5,236 (NOK 35,830 with FDI versus NOK 41,066 with FCM). The need for phosphate testing in patients treated with FCM resulted in further cost savings with FDI (no costs with FDI versus NOK 4,470 with FCM). Total cost savings with FDI were therefore NOK 9,707. FDI also increased quality-adjusted life expectancy by 0.071 quality-adjusted life years (QALYs) driven by reduced incidence of hypophosphatemia and fewer interactions with the healthcare system.

CONCLUSIONS:

FDI resulted in cost savings and improved quality-adjusted life expectancy versus FCM in patients with IDA and IBD in Norway. FDI therefore represents the economically preferable iron formulation in Norwegian patients with IBD and IDA in whom it is indicated.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

A Swedish cost-utility analysis of ferric derisomaltose versus ferric carboxymaltose in the treatment of iron deficiency anemia in patients with inflammatory bowel disease

Article

作者: Manxhuka, Bardh ; Lindgren, Stefan C. ; Strid, Hans ; Nanu, Neesha ; Hjortswang, Henrik ; Pollock, Richard F.

OBJECTIVES:

Iron deficiency anemia (IDA) is a common extraintestinal manifestation of inflammatory bowel disease (IBD), driven by impaired iron absorption, inflammation of intestinal mucosa and blood loss due to intestinal bleeding. Exogenous iron is indicated to correct iron deficiency, with intravenous iron preferred in patients with malabsorption or intolerance of oral iron, active bleeding, systemic inflammation, or a need for rapid iron replenishment. The objective was to assess the cost-utility of two high-dose, rapid-infusion iron formulations-ferric derisomaltose (FDI) and ferric carboxymaltose (FCM)-in the treatment of patients with IBD and IDA in Sweden.

METHODS:

The analysis used a previously-published micro-simulation model. Phosphate monitoring was modeled based on the product labelling, while iron need and disease-related quality of life (QoL) were modeled based on data from the PHOSPHARE-IBD randomized controlled trial. Cost-utility was evaluated from the national healthcare payer perspective over a five-year time horizon. Sensitivity and scenario analyses were performed.

RESULTS:

For each iron treatment course, patients treated with FDI required 0.41 fewer infusions than those treated with FCM. The reduced number of infusions resulted in savings of SEK 9,876 over five years from iron administration costs alone (SEK 44,216 with FCM versus SEK 34,340 with FDI). Phosphate monitoring in patients treated with FCM cost SEK 2,776 over five years versus no monitoring costs with FDI. Total cost savings with FDI were SEK 14,962. FDI also resulted in a 0.076 quality-adjusted life year (QALY) improvement versus FCM driven primarily by the QoL improvements reported in PHOSPHARE-IBD, and FDI was therefore the dominant intervention.

LIMITATIONS:

The analysis did not capture costs or outcomes associated with hypophosphatemic osteomalacia or fractures.

CONCLUSION:

Relative to FCM, fewer infusions of FDI were required, there was no need for phosphate monitoring, and disease-related QoL was improved, while overall costs were reduced.

2025-12-01·PEDIATRIC BLOOD & CANCER

Pediatric Intravenous Iron Therapy: Evaluating the Safety and Efficacy of Iron Isomaltoside and Low‐Molecular‐Weight Dextran

Article

作者: Trakymas, Gaudas Benediktas ; Vaišnorė, Ramunė ; Morkūnaitė, Agnė ; Dragūnė, Ernesta ; Šaulytė Trakymienė, Sonata

ABSTRACT:

Background:

Iron deficiency (ID) and iron deficiency anemia (IDA) are prevalent among children and adolescents, affecting growth and development. Although oral iron is the first‐line treatment, intravenous (IV) iron is required in cases of poor tolerance or inadequate response. While some IV formulations are used in pediatric clinical practice, no published data on the safety and efficacy of iron isomaltoside (IIM) in the pediatric population exist, while data on low‐molecular‐weight dextran (LMWD) remain limited.

Procedure:

Our retrospective cohort study at Vilnius University Hospital Santaros Klinikos (2021–2023) included pediatric patients (<18 years) with ID/IDA receiving IIM or LMWD. Hematological response assessment was based on reticulocyte hemoglobin equivalent (Ret‐He) and reticulocyte percentage at 3–7 days (early response), and red blood cell count, hemoglobin (HGB), mean corpuscular volume, serum ferritin, and transferrin saturation at 4–6 weeks (late response).

Results:

Seventy‐two patients (IIM: 50, LMWD: 22; 135 infusions), 68% female, with a median age of 13.5 years, were included in the study. Mean HGB increase was 32.4 g/L (IIM) versus 33.1 g/L (LMWD) ( p = 0.9). Median ferritin increase was 71.4 µg/L (IIM) versus 117.8 µg/L (LMWD) ( p = 0.3). Ret‐He improved significantly ( p < 0.05). Mild AEs occurred in 5.6%, with similar AE rates in both groups (IIM: 6.0%, LMWD: 4.5%).

Conclusion:

Our findings suggest that IIM and LMWD are effective and safe IV iron therapies for pediatric ID/IDA. Given the lack of data on the safety and efficacy of IIM in the pediatric population, our findings provide valuable preliminary evidence.

项与异麦芽糖酐铁相关的新闻（医药）

2025-11-07

·梅斯医学

降低治疗负担与改善预后的双重获益：异麦芽糖酐铁在IDA中的经济学评价

缺铁性贫血（IDA）是全球最常见的营养缺乏症之一，影响着约30%的人口，在中国尤为突出，约有1.76亿人和13.9%的孕妇受其影响。IDA不仅显著降低患者生活质量，还可能导致心绞痛、腹痛等严重健康问题。随着中国儿童肥胖率上升，IDA负担可能进一步加重。口服铁剂是IDA的主要治疗方式，但对于口服铁剂无效或需要快速补铁的患者，静脉铁剂（如异麦芽糖酐铁FDI和羧基麦芽糖铁FCM）成为更有效的选择1。然而，有研究结果显示，FCM的低磷血症发生率高于FDI（74.4% vs 8.0%）2，并且重复使用FCM可能引发低磷血症相关骨软化症，进而导致骨痛和骨折等症状，增加健康风险和经济负担3。此外，FDI在单次输注剂量上的优势（可超过1000 mg）可能减少治疗次数，进一步降低医疗成本。因此，在中国IDA高发病率的背景下，评估FDI与FCM的成本效用具有重要意义1。研究方法本研究基于既往发表的类似设计的成本-效用模型，使用 Microsoft Excel 开发了一个患者水平模拟模型。模型设计遵循英国国家卫生与临床优化研究所的技术指导文件，结合患者基线特征（如血红蛋白水平、体重）与铁需求量之间的非线性关系，并纳入参数水平随机变化和个体患者变异性，确保结果的科学性和可靠性。研究通过蒙特卡洛模拟，随机分配患者的年龄、体重和血红蛋白基线值，并基于铁需求简化量表计算每位患者的铁需求量和输注次数。根据模拟的每个周期的输注次数，计算了与治疗过程相关的生活质量（QoL）负效用（与患者接受特定治疗过程相关的QoL下降情况），以及与静脉铁剂输注相关的成本。成本结果以 2023 年人民币 (RMB) 报告，并报告和总结了以质量调整生命年 (QALY) 衡量的质量调整预期寿命结果和生存结果。使用FDI和FCM组之间的上述这些结果差异计算最终的增量成本效用比 (ICUR)。从中国医疗卫生系统的视角出发，采用5年时间范围和5.0%的年贴现率，评估FDI与FCM的成本效用。资源使用方面，假设FCM治疗患者需进行两次血清磷酸盐检测，并根据低磷血症严重程度进行磷酸盐治疗，而FDI治疗患者无需检测。健康相关QoL数据来自PHOSPHARE- IBD RCT中采用的 SF-36v2问卷，结合中国特定治疗过程负效用模型，量化静脉铁剂治疗对QoL的影响。成本分析涵盖了铁剂采购、输注、磷酸盐检测及治疗费用，并进行了单因素敏感性分析和概率敏感性分析，以评估模型参数的稳健性。此外，研究还通过FCM价格盈亏平衡分析，探讨了药品价格变化对成本效益结论的影响。研究结果 FDI输注次数相对较少，铁剂采购和输注成本相对较低，QALY有所提高在5年的时间范围内，患者平均接受了3.98个疗程的铁剂输注，FDI的平均输注次数比FCM少0.9次（FCM 7.69次 vs. FDI 6.79次）；输注次数的差异导致FDI铁剂采购和输注成本减少了206元（FCM为3,519元 vs. FDI为3,312元）。总体上，FDI相对FCM节省了989元的成本，并在5年内提高了0.0705 QALY的质量调整预期寿命。与FCM相比，FDI以更低的成本增加了临床获益（表1）。因此，FDI是更具优势的干预措施。表1 基础情景分析的卫生经济学结果概率敏感性分析：验证FDI始终具有优势在概率敏感性分析（PSA）中，所有模型迭代的ICUR均位于成本效用平面的东南象限内（代表成本降低和QALY增加）。本研究显示，与FCM相比，FDI始终是更具优势的干预措施。当意愿支付（WTP）P阈值处于0.00元~161,952元（每QALY增量）之间时，可百分百确定FDI是一种具有成本效益的策略。图1 成本效益平面的概率敏感性分析结果散点图：灰色圆圈为所有1,000次模型迭代的平均结果，蓝色椭圆为基于多变量T分布的95%数据 FCM价格盈亏平衡分析从中国医疗卫生保健系统的角度来看，FCM标价较基础情景中降低了31%时，FDI在绝对成本方面与FCM达到盈亏平衡；然而，根据模型分析结果并参照中国当前采用的 85,698元/QALY 这一健康获益价值标准来看，相较于FDI，FCM不存在具有成本效益的正价格点，也不存在任何表示相较于FDI采用FCM可获得净货币效益的价格点（图2）。图2 分析获得的增量成本、增量成本效用比和净货币收益结果，其中羧基麦芽糖铁的单价在基础情景值的100%到0%之间变化讨论本研究显示，与FCM相比，FDI是更具优势的干预措施，部分原因是FDI显著降低了低磷血症的发生率。此外，FDI还在成本节省和生活质量提升方面展现出明显效益。具体而言，在5年的时间范围内，FDI相比FCM能节省206元的铁剂采购和输注成本，同时增加了0.07个QALY，这主要得益于FDI避免了782元的低磷血症监测和治疗费用。此外，由于FDI单次输注剂量更高，减少了患者前往医院的次数，因此在5年内，FDI治疗的患者相比FCM治疗的患者少输注0.9次，进一步降低了治疗成本。本研究采用中国特定数据作为关键模型输入源，结果支持FDI在中国医疗环境中作为IDA患者的优选静脉铁剂治疗方案，这与在欧洲医疗环境中开展的研究结果相一致。但本研究亦存在一定局限性：在无法获得中国特定数据的情况下，尽管寻找合适的替代参数，但可能会影响其在中国人群中的普遍适用性，在解读本研究结果时，应将QoL数据的欧洲来源和IDA病因（即IBD）考虑在内；与中国一般IDA患者相比，不同地区具有不同潜在病因的IDA患者可能会出现不同的QoL结果；其次，模型未纳入静脉铁剂输注预约就诊的依从率和到访率。相对于FDI，由于FCM需要更多次的预约才能纠正铁水平（尤其是在较高剂量下），FCM治疗患者的依从率可能低于FDI治疗患者，并且研究模型主要侧重于慢性IDA患者，此类患者体更加需要多次、高剂量的静脉铁剂治疗，这可能会使得FDI相对于FCM更具优势。然而，FDI对于仅需短期静脉铁剂治疗的急性IDA患者（如围手术期静脉铁剂治疗）可能仍具有优势，即非慢性急性IDA患者，具有相同比例的临床QoL和成本影响，只是所用时间更短。综上所述，在5年的时间范围内，与FCM相比，FDI所需的输注次数更少，且不会产生与低磷血症相关的监测或治疗费用，也不会引起与低磷血症相关的疲劳，具有成本效益，有望成为中国IDA患者改善生活质量并减少医疗支出的有效治疗选择。参考文献： 1.Zhang F, Shen A, Ahmed W, et al. A Cost-Utility Analysis of Ferric Derisomaltose Versus Ferric Carboxymaltose in Patients with Iron Deficiency Anemia in China. Adv Ther. 2024 Nov;41(11):4191-4204. 2.Wolf M, Rubin J, Achebe M, et al. Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials. JAMA. 2020 Feb 4;323(5):432-443. 3.Boots JMM, Quax RAM. High-Dose Intravenous Iron with Either Ferric Carboxymaltose or Ferric Derisomaltose: A Benefit-Risk Assessment. Drug Saf. 2022 Oct;45(10):1019-1036. 免责声明：本文仅作最新前沿信息交流之目的，仅供医疗卫生行业专业人士阅读参考，文中所有观点不代表梅斯医学立场，亦不代表梅斯医学支持或反对文中观点。如需获得治疗方案指导，请前往正规医院就诊！

临床结果

2025-10-01

·FiercePharma

Sanofi's German, French premises hit by EU probe amid vaccines market abuse concerns

The European Commission is “investigating possible exclusionary practices that may amount to anticompetitive disparagement.” The EU has carried out unannounced inspections at certain Sanofi premises related to concerns that the French pharma may have abused its market position in the vaccines sector, Fierce Pharma has learned.The European Commission—the EU's executive arm—announced in a statement Monday that it conducted inspections at the premises of a company “active in the vaccines sector” in relation to “concerns that the inspected company may have violated EU antitrust rules that prohibit abuses of a dominant market position.” At the time, the commission wouldn't reveal the identity of the company nor the location of the premises, only explaining that it was “investigating possible exclusionary practices that may amount to anticompetitive disparagement.”However, a Sanofi spokesperson confirmed to Fierce Wednesday morning that it is the company at the center of the investigation. The inspections took place at Sanofi sites in France and Germany on Monday, according to the Big Pharma, which added that the visits were related to “an investigation into conduct in the seasonal flu vaccine space.” “Sanofi is confident that it is compliant with the relevant rules and regulations,” the spokesperson added. “Sanofi will not comment further given the ongoing investigation and will cooperate fully with the European Commission.”The Paris-based pharma is a major flu vaccine player, selling several products in Europe including Vaxigrip, Supemtek Tetra and Efluelda. Details of the alleged market abuse have not been revealed by the commission or Sanofi. This is typically a busy time for all vaccine drugmakers, with most beginning to ship out their products in the summer along with a marketing push as we look ahead to flu season, which can begin in early autumn and continue on until spring.Sanofi’s chief competitors in this space include CSL Seqirus and GSK.Last year, Vifor was also under the shadow of a European Commission probe for alleged antitrust abuse surrounding its “potential disparagement” of Pharmacosmos’ high-dose intravenous iron replacement therapy Monofer. The drug is a competitor to Vifor’s flagship iron medicine, Ferinject, in Europe.In the end, Vifor cleared up the probe last year with a “comprehensive and multi-channel communication campaign” to address the alleged anticompetitive actions.

疫苗

2025-09-23

·汇聚南药

超难品种，首仿再被拒！

仿制药中有部分品种，技术壁垒高，研发难度大，原研上市多年，仿制却一直未突破，令人沮丧。静脉铁剂，就是其中之一。 9月8日，NMPA的通知件里，仁合益康的羧基麦芽糖铁注射液收到了通知件，继先声药业仿制失败之后，仁合益康也再度失败了。缺铁及缺铁性贫血是目前全球范围内的健康问题之一，缺铁性贫血的治疗药物主要为补铁剂，按照服用方式分为口服铁剂和静脉铁剂，口服铁剂为首选方案，但是对于口服铁剂不耐受、胃肠道吸收障碍以及需要快速大剂量补铁的患者，则需选用静脉铁。国内静脉铁市场常年保持在8亿元左右，非常平稳，竞争企业也很少，目前国内现行有效的文号就十几个，企业9家，7家是国内企业，这7家国内企业虽有产品仿制上市，但无一款产品过评。静脉铁剂研发难度颇高，至今没有一款顺利过评的品种。上市二十多年，无过评目前一代静脉铁因过敏反应严重已经退市，二代静脉铁占据主导市场，国内二代有蔗糖铁注射液和右旋糖酐铁注射液上市。铁蔗糖铁注射液，目前市场占比接近80%，原研为Vifor (International) Inc，2003年进口批准上市，国内有仿制上市企业，但无一家过评。此前南光化学制药股份有限公司2018年有过一次上市失败，直到2023年参比确立后又增加了几家企业竞争，但未有好消息传来。倒是FDA传来了顺利仿制成功消息，今年8月，全球最大的仿制药巨头之一Viatris宣布，其仿制药品种蔗糖铁注射液液获FDA批准，用于治疗慢性肾病患者的缺铁性贫血。右旋糖酐铁注射液，原研Pharmacosmos，2002年就在国内上市，跟蔗糖铁一样，国内有仿制企业，但没有过评，虽然该品种参比已确认，但目前没有企业有仿制进度。从这两款二代产品研发情况就可以看出，静脉铁研发难度不低。二代静脉铁剂还未仿制成功，三代就已重磅来袭。对于一次性需要输注大剂量铁剂的患者，二代静脉铁每次输注的剂量小，需多次输注，三代静脉铁可实现短时间内给予大剂量治疗。 2021年后，第三代静脉铁异麦芽糖酐铁和羧基麦芽糖铁在国内上市，三代上市后，销售额迅速增长，有取代二代静脉铁的趋势。仁合益康被驳回的品种就是三代静脉铁，羧基麦芽糖铁注射液，原研Vifor，2022年11月进口中国上市，2024年就涨到了近4千万，对一个适应症较窄的品类来说，这样的增长速度已经算惊人了。羧基麦芽糖铁，参比在2020年就已确立，2023年先声药业冲击该药品首仿，以失败告终，这两家企业均在首轮审评结束后收到不批准通知。当前，仅有四川汇宇进入补充资料审评阶段，有望成为该品种首仿的最终胜利者。异麦芽糖酐铁，原研Pharmacosmos，2021年1月进口中国上市，无国内仿制上市，市场增速同样惊人，三年到达3千万以上，参比于2022年确立，暂无厂家报产，仁合益康和正大天晴正在进行BE试验。仿制这么难？从被驳回的羧基麦芽糖铁注射液进行简单分析。羧基麦芽糖铁并非传统小分子药物，而是一种典型的非生物复杂药物，特点在于结构不可完全表征和工艺决定产品，这意味着，简单的化学成分复制（Q1/Q2一致）是远远不够的。羧基麦芽糖铁从原料药到制剂工艺难度都很高：原料制备需要将三价铁离子与特定分子量的羧基化多糖配体络合，形成结构稳定的纳米胶体。此过程涉及多个关键步骤，每一步都必须精确控制，以确保最终产物的关键质量属性与原研药一致。制剂工艺相对简单，主要是将API溶解于注射用水中，调节pH值和渗透压，然后进行除菌过滤和无菌灌装，尽管处方简单，但工艺控制依然是关键。再者羧基麦芽糖铁证明BE等效难度同样不低，FDA发布过羧基麦芽糖铁的BE指南，依据FDA发布的指导原则，体外BE研究是强制性的，其核心是证明仿制药与原研药在粒径分布上的等效性。 FDA为体内BE研究提供了两种战略路径，方案一（患者）、方案二（健康人）、需要在风险、成本和时间之间进行权衡。羧基麦芽糖铁注射液仿制从原料到制剂再到BE试验都要求极高，稍微出错就将前功尽弃，难度确实大。希望汇宇能成功首仿。参考： [1] 最新！羧基麦芽糖铁注射液首仿被拒 [2] 羧基麦芽糖铁注射液—阳村指南喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~ 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。信息来源：药通社往期推荐本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

上市批准引进/卖出核酸药物

100 项与异麦芽糖酐铁相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11808	异麦芽糖酐铁	B03AC	DB15617

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
铁缺乏	加拿大	Pharmacosmos A/S	2018-06-22
缺铁性贫血	澳大利亚	Pharmacosmos A/S	2017-12-04

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
慢性心力衰竭	临床3期	美国	Pharmacosmos A/S	2025-05-01
女性生殖器官肿瘤	临床3期	-	Pharmacosmos A/S	2022-09-30
子宫出血	临床3期	美国	Pharmacosmos Therapeutics Inc.	2022-09-15
低磷血症	临床3期	美国	Pharmacosmos A/S	2017-10-24
慢性肾衰竭贫血	临床3期	中国	Pharmacosmos A/S	2015-09-21
慢性肾衰竭贫血	临床3期	中国	泰州希科颂医药有限公司	2015-09-21
慢性肾衰竭贫血	临床3期	中国	Wasserburger Arzneimittelwerk GmbH	2015-09-21
产后出血	临床3期	丹麦	Pharmacosmos A/S	2013-06-01
贫血	临床3期	奥地利	Pharmacosmos A/S	2011-06-01
贫血	临床3期	匈牙利	Pharmacosmos A/S	2011-06-01

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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


EHA2024	N/A	-	50	Iron Isomaltoside	選鏇膚選糧製齋廠餘簾(構糧衊醖壓鹽構窪糧積) = 94.0% experienced no adverse effects, while 6.0% reported mild transient adverse effects 膚憲觸淵糧繭壓願憲壓 (觸鏇願獵廠觸淵製憲鹽 )	积极	2024-05-14
NCT02642562 (IRONMAN, ESC2024)	临床4期	铁缺乏 \| 肾功能不全 \| 心脏衰竭 transferrin saturation (TSAT) \| ferritin \| haemoglobin (Hb) ... 更多	-	Ferric derisomaltose (FDI)	襯糧範鑰顧鏇衊衊積膚(憲築餘顧鏇製選鏇醖選): HR = 0.51 (95% CI, 0.29 ~ 0.9) 更多	积极	2024-05-12
				ferric derisomaltose (Usual care)
UEGW2023	N/A	注射部位反应	-	Ferric Derisomaltose (FDI)	積糧製製範襯醖選遞夢(襯繭壓製選窪顧觸觸獵) = Two patients with reactions to FDI were administered adrenaline (both reactions classified as Fishbane) with one requiring hospitalisation. No other patients required hospitalisation. 願鏇齋壓衊選餘窪餘繭 (夢願鹽簾齋夢齋鏇簾壓 )	-	2023-10-15
				Ferric Carboxymaltose (FCM)
NCT02642562 (IRONMAN, Pubmed \| Lancet)	临床4期	铁缺乏 \| 心脏衰竭	1,137	Intravenous ferric derisomaltose	簾鹽觸範範鹹鹹繭鹹糧(夢夢鏇艱遞蓋構鹹繭膚) = 憲鬱夢廠鑰齋獵觸餘遞鑰遞鑰觸蓋選夢獵艱艱 (衊獵糧積願廠顧艱選鹽 )	积极	2022-11-04
				ferric derisomaltose (Usual care)	簾鹽觸範範鹹鹹繭鹹糧(夢夢鏇艱遞蓋構鹹繭膚) = 憲憲鹽糧齋壓廠鏇簾廠鑰遞鑰觸蓋選夢獵艱艱 (衊獵糧積願廠顧艱選鹽 )
NCT03188445 (Pubmed \| Arch Gynakol) 人工标引	临床4期	铁缺乏	201	Ferric Derisomaltose	繭醖淵築鏇鏇鹹構鹹繭(構繭糧鬱窪積餘齋鹽築) = 構鹽遞鏇製鹹蓋範糧窪選窪衊簾壓獵窪鬱顧鏇 (鬱獵築壓壓壓繭壓範淵 ) 更多	积极	2022-09-15
				Ferrous Fumarate	繭醖淵築鏇鏇鹹構鹹繭(構繭糧鬱窪積餘齋鹽築) = 壓願鹽憲窪獵獵艱壓顧選窪衊簾壓獵窪鬱顧鏇 (鬱獵築壓壓壓繭壓範淵 ) 更多
I4RON-HF (ESC2022)	N/A	心脏衰竭	65	IV Iron Isomaltoside	窪範窪醖鑰繭鏇艱夢衊(糧獵廠願壓鏇蓋願夢簾) = 蓋範鏇鏇獵廠窪醖廠鹽膚製積築獵艱構選餘鬱 (積顧繭鹹構糧簾鏇憲壓 ) 更多	-	2022-08-27
				Routine iron supplements	窪範窪醖鑰繭鏇艱夢衊(糧獵廠願壓鏇蓋願夢簾) = 窪簾壓構積獵鏇構醖襯膚製積築獵艱構選餘鬱 (積顧繭鹹構糧簾鏇憲壓 ) 更多
NCT04206228 (IIISAS, Pubmed \| Eur J Heart Fail)	临床2期	铁缺乏	149	Ferric derisomaltose	遞糧夢窪簾膚醖壓膚艱(蓋壓選積鑰選鏇簾艱襯) = 顧製構壓夢糧簾簾網鹽艱範構夢築網網廠艱憲 (蓋簾餘鹽選鹽糧積廠蓋 )	不佳	2022-05-17
				Placebo	遞糧夢窪簾膚醖壓膚艱(蓋壓選積鑰選鏇簾艱襯) = 構鏇繭壓積鏇糧窪窪衊艱範構夢築網網廠艱憲 (蓋簾餘鹽選鹽糧積廠蓋 )
NCT03565354 (Pubmed \| PLoS One)	临床3期	结直肠癌 \| 缺铁性贫血	40	Intravenous iron isomaltoside	糧遞鏇膚窪醖顧襯襯遞(獵醖襯糧廠獵衊襯壓壓) = 醖膚觸簾觸遞鏇願蓋艱憲淵齋顧夢簾壓觸窪顧 (鏇鏇壓齋網窪餘鹹憲顧, 3.2 ~ 12.3)	积极	2022-01-01
				intravenous iron isomaltoside (Usual preoperative care (control))	糧遞鏇膚窪醖顧襯襯遞(獵醖襯糧廠獵衊襯壓壓) = 鬱膚網糧顧顧廠餘餘鹹憲淵齋顧夢簾壓觸窪顧 (鏇鏇壓齋網窪餘鹹憲顧, -1.9 ~ 5.3)
NCT03662789 (IronIC, CTgov)	临床2/3期	铁缺乏	102	Iron Isomaltoside 1000 (Iron Isomaltoside 1000)	醖鑰築鬱觸壓遞餘夢淵(廠廠餘範壓蓋獵鬱鏇襯) = 夢鬱憲齋選衊鑰網積獵餘壓憲鑰顧膚構糧繭餘 (窪衊醖夢獵築鑰積窪顧, 6.6) 更多	-	2021-05-25
				Placebo: NaCl 0,9% (Placebo)	醖鑰築鬱觸壓遞餘夢淵(廠廠餘範壓蓋獵鬱鏇襯) = 夢獵襯餘醖壓築製觸壓餘壓憲鑰顧膚構糧繭餘 (窪衊醖夢獵築鑰積窪顧, 6.1) 更多
NCT03470649 (Pubmed \| Eur J Anaesthesiol)	N/A	贫血	89	Iron isomaltoside	網餘艱壓願廠遞艱網艱(鹽觸鏇築鑰廠憲蓋構糧) = 觸鏇選獵積選簾鹹壓夢積鏇艱構鏇窪願鹽餘餘 (構壓壓鏇襯鹽夢願襯築 )	-	2021-04-01
				Placebo	網餘艱壓願廠遞艱網艱(鹽觸鏇築鑰廠憲蓋構糧) = 鹽願蓋獵蓋淵鏇憲壓願積鏇艱構鏇窪願鹽餘餘 (構壓壓鏇襯鹽夢願襯築 )