主要目的：通过依地酸铁钠口服液和蛋白琥珀酸铁口服液空腹给药的药代动力学比较研究，评价依地酸铁钠口服液和蛋白琥珀酸铁口服液在健康志愿者中的药代动力学差异。为依地酸铁钠口服液比较药代动力学研究的正式试验的临床研究、生物样本分析检测和统计分析方法等的设计合理性提供依据。次要目的：评价依地酸铁钠口服液的临床安全性。

开始日期-

申办/合作机构

北京润德康医药技术有限公司

[+1]

CTR20130013 / Recruiting临床2期

多中心、随机、盲法、阳性药平行对照临床试验评价依地酸铁钠口服溶液治疗儿童缺铁性贫血的有效性及安全性

评价由四川百利药业生产的依地酸铁钠口服溶液治疗儿童缺铁性贫血的有效性和安全性。

开始日期2014-01-23

申办/合作机构

北京润德康医药技术有限公司

[+1]

CTRI/2011/10/002097 / Recruiting临床4期

Randomized controlled trial of evaluation of safety, efficacy and pharmacoeconomics of sodium feredetate and ferrous fumarate in the iron deficiency anemia (IDA) in a tertiary care hospital in central India

开始日期2011-11-01

申办/合作机构-

100 项与依地酸铁钠相关的临床结果

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100 项与依地酸铁钠相关的转化医学

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100 项与依地酸铁钠相关的专利（医药）

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138

项与依地酸铁钠相关的文献（医药）

2024-01-01·Journal of Parenteral and Enteral Nutrition

Cost‐utility analysis of 4% tetrasodium ethylenediaminetetraacetic acid, taurolidine, and heparin lock to prevent central line–associated bloodstream infections in children with intestinal failure

Article

作者: Belza, Christina ; Yan, Han ; Gattini, Daniela ; Avitzur, Yaron ; Wales, Paul W

AbstractBackgroundCentral line–associated bloodstream infections (CLABSI) are a serious complication in children with intestinal failure. This study assessed the incremental costs of 4% tetrasodium ethylenediaminetetraacetic acid (EDTA) compared with taurolidine lock and heparin lock per quality‐adjusted life‐year (QALY) gained in children with intestinal failure from the healthcare payer and societal perspective.MethodsA Markov cohort model of a 1‐year‐old child with intestinal failure was simulated until the age of 17 years (time horizon), with a cycle length of 1 month. The health outcome measure was QALYs, with results expressed in terms of incremental costs and QALYs. Model parameters were obtained from published literature and institutional data. Deterministic, probabilistic, and scenario sensitivity analyses were performed.Results4% Tetrasodium EDTA was dominant (more effective and less expensive) compared with taurolidine and heparin, yielding an additional 0.17 QALYs with savings of CAD$88,277 compared with heparin, and an additional 0.06 QALYs with savings of CAD$52,120 compared with taurolidine lock from the healthcare payer perspective. From the societal perspective, 4% tetrasodium EDTA resulted in savings of CAD$90,696 compared with heparin and savings of CAD$36,973 compared with taurolidine lock.ConclusionsThis model‐based analysis indicates that 4% tetrasodium EDTA can be considered the optimal strategy compared with taurolidine and heparin in terms of cost‐effectiveness. The decision uncertainty can be reduced by conducting further research on the model input parameters. An expected value of perfect information analysis can identify what model input parameters would be most valuable to focus on.

2023-03-14·International journal of molecular sciences

Differential Effects of Iron Chelates vs. Iron Salts on Induction of Pro-Oncogenic Amphiregulin and Pro-Inflammatory COX-2 in Human Intestinal Adenocarcinoma Cell Lines.

Article

作者: Tarczykowska, Agata ; Powell, Jonathan ; Engström, Niklas ; Dobermann, Darja ; Scheers, Nathalie

We previously showed that two iron compounds that are orally ingested by humans, namely ferric EDTA and ferric citrate, can induce an oncogenic growth factor (amphiregulin) in human intestinal epithelial adenocarcinoma cell lines. Here, we further screened these iron compounds, plus four other iron chelates and six iron salts (i.e., 12 oral iron compounds in total), for their effects on biomarkers of cancer and inflammation. Ferric pyrophosphate and ferric EDTA were the main inducers of amphiregulin and its receptor monomer, IGFr1. Moreover, at the maximum iron concentrations investigated (500 µM), the highest levels of amphiregulin were induced by the six iron chelates, while four of these also increased IGfr1. In addition, we observed that ferric pyrophosphate promoted signaling via the JAK/STAT pathway by up-regulating the cytokine receptor subunit IFN-γr1 and IL-6. For pro-inflammatory cyclooxygenase-2 (COX-2), ferric pyrophosphate but not ferric EDTA elevated intracellular levels. This, however, did not drive the other biomarkers based on COX-2 inhibition studies and was probably downstream of IL-6. We conclude that of all oral iron compounds, iron chelates may particularly elevate intracellular amphiregulin. Ferric pyrophosphate additionally induced COX-2, probably because of the high IL-6 induction that was observed with this compound.

2023-01-01·Frontiers in pharmacology

Paraben exposure through drugs in the neonatal intensive care unit: a regional cohort study.

Article

作者: Lorrain, Simon ; Ramful, Duksha ; Iacobelli, Silvia ; Gouyon, Jean-Bernard ; Gouyon, Beatrice ; Richard, Magali ; Bonsante, Francesco ; Commins, Marie ; Grondin, Anthony

Background and objectives: Environmental factors influence the development of very preterm infants (VPIs, born at less than 32 weeks of gestation). It is important to identify all potential sources of paraben exposure in these vulnerable infants. We aimed to quantify paraben exposure via drug administration in a cohort of VPI cared for in neonatal intensive care units (NICUs). Methods: A prospective, observational study was carried out over a five-year period in a regional setting (two NICUs using the same computerized order-entry system). The main outcome was exposure to paraben-containing drugs. The secondary outcomes were: time of the first exposure, daily intake, number of infants exceeding paraben acceptable daily intake (ADI: 0-10 mg/kg/d), duration of exposure, and cumulative dose. Results: The cohort consisted of 1,315 VPIs [BW 1129.9 (±360.4) g]. Among them, 85.5% were exposed to paraben-containing drugs. In 40.4% of infants, the first exposure occurred during the second week of life. Mean paraben intake and duration of exposure were, respectively, 2.2 (±1.4) mg/kg/d and 33.1 (±22.3) days. The cumulative paraben intake was 80.3 (±84.6) mg/kg. The ADI was exceeded in 3.5% of exposed infants. Lower GA was associated with higher intake and longer exposure (p < 0.0001). The main molecules involved in paraben exposure were: sodium iron feredetate, paracetamol, furosemide, and sodium bicarbonate + sodium alginate. Conclusion: Commonly used drugs are potential source of parabens, and ADI can be easily exceeded in VPIs cared for in NICUs. Efforts are needed to identify paraben-free alternative formulations for these vulnerable infants.

项与依地酸铁钠相关的新闻（医药）

2021-11-11

·Endpoints

Too much iron? Pharmacosmos is betting $225M on a new potential solution for that

Danish biotech Pharmacosmos has come a long way since it was launched back in 1965 as an active pharmaceutical ingredient (API) manufacturer. While it’s still in the same family, the company now has three drugs approved to treat iron deficiency in humans (and a fourth for piglets). Now, with its latest buyout, the company is looking to add a therapy for just the opposite: iron overload. Pharmacosmos is putting down $225 million to purchase AbFero, a spinout from Raymond Bergeron’s lab at the University of Florida. Its lead candidate, SP-420, recently completed Phase I safety studies as a treatment for transfusional iron overload. While frequent red blood cell transfusions are needed for conditions like ß-thalassemia, sickle-cell disease, and myelofibrosis, a common side effect is iron overload. Red blood cells contain iron, so each time a patient gets a transfusion, they’re adding more iron without any way to get rid of the excess. This extra iron can build up in the internal organs, such as the liver, pancreas or heart, and cause damage over time. To address this problem, doctors prescribe iron chelators — small molecules designed to recognize, bind and remove iron from the body. Novartis has an injectable drug, Desferal, approved, as well as oral options Exjade and Jadenu. But they come with a long list of side effects ranging from impaired vision to kidney problems. SP-420, on the other hand, belongs to a novel class of iron chelators called desferrithiocins — and according to AbFero, it’s designed as a potentially safer alternative with greater efficacy than the currently available drugs. “The role of iron in disease has been vastly underappreciated,” AbFero CEO and co-founder Thomas Neenan said in a statement. “As a leader in iron metabolism disorders, Pharmacosmos is uniquely positioned to realize the full potential of our chelation platform.” Lars Christensen, the youngest son of Pharmacosmos founder Henry Christensen, called the acquisition a “perfect strategic fit,” adding that the company plans on completing the development of SP-420 in transfusional iron overload in addition to exploring other iron-mediated conditions.

小分子药物并购

2021-02-17

·BioSpace

AbFero Pharmaceuticals Announces Funding From Cure Parkinson's For Lead Compound SP-420

HARWELL, England, Feb. 17, 2021 /PRNewswire/ -- AbFero Ltd., a subsidiary of AbFero Pharmaceuticals, Inc., a privately-held clinical stage pharmaceutical company dedicated to treating diseases of iron overload, today announced the award of a grant from Cure Parkinson's for the development of their lead, brain-penetrant iron chelating agent, SP-420, as a disease modifying therapy for Parkinson's disease (PD). The funding will be used to develop biomarkers to demonstrate that SP-420 is an effective targeted therapy for Parkinson's. This is the second grant AbFero has received to support development of SP-420 for the condition, following recent funding from Eureka EUROSTARS. "The role of iron in neurodegenerative diseases grows more compelling every day. Cure Parkinson's has been a strong proponent of iron chelation for Parkinson's, so this grant is particularly meaningful. It further accelerates AbFero's drive towards our first clinical study in Parkinson's," said AbFero CEO Thomas Neenan. Removal of excess brain iron via chelation has long been considered an attractive disease modifying approach, but a therapy with sufficient safety and proven efficacy remains lacking. AbFero expects SP-420 will limit iron accumulation in the brain, reducing iron-related oxidative stress, iron related neuronal death (i.e., ferroptosis), and alpha-synuclein aggregation, well-known neuropathological hallmarks of Parkinson's. Dr Richard Wyse, Director of Research & Development at Cure Parkinson's said: "Iron chelation is an extremely promising line of investigation in Parkinson's. Our funding for this project adds new impetus and expands our long-standing interest in the future relevance of this approach in slowing or stopping long-term neurodegeneration in patients with Parkinson's disease." The grant will fund ongoing development of the small molecule in the laboratory of Professor David Devos, MD, PhD, University of Lille, CHU of Lille, INSERM. "We believe SP-420 is one of the greatest iron chelators, given it has excellent kinetics, high oral bioavailability and biodistribution, and no evidence to date of inappropriate competition with the native iron transport and storage mechanisms of the body," Dr. Devos notes. "AbFero is working urgently to develop best-in-class, next generation iron chelators that will slow progression and improve the quality of life for the nearly 10 million people living with Parkinson's today," Neenan adds. "We're grateful to Cure Parkinson's for their support as we press forward." About AbFero, Ltd. AbFero, Ltd., is a subsidiary of AbFero Pharmaceuticals, Inc., a privately-held clinical stage pharmaceutical dedicated to treating diseases of iron overload. AbFero's technology is based upon the discoveries of a pioneer in the field of iron chelator medicinal chemistry, Professor Raymond Bergeron, University of Florida. Our therapeutic platform addresses transfusional iron overload (TIO) and iron accumulation associated with retinal and neurologic diseases including age-related macular degeneration (AMD), Parkinson's disease (PD), and traumatic brain injury (TBI). AbFero has completed three clinical trials with the company's lead chelator, SP-420. AbFero Ltd., is located in Harwell, UK. For more information, visit . Investor & Media Contact: Mih-Ho Cha mcha@abfero.com

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外链

KEGG	Wiki	ATC	Drug Bank
D07145	依地酸铁钠	B03AB03	DB13381

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适应症	国家/地区	公司	日期
缺铁性贫血	-	-	-

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适应症	最高研发状态	国家/地区	公司	日期
关节炎	临床2期	中国	四川百利药业有限责任公司	2014-05-08
关节炎	临床2期	中国	北京润德康医药技术有限公司	2014-05-08
缺铁性贫血	临床2期	中国	四川百利药业有限责任公司	2014-01-23
缺铁性贫血	临床2期	中国	北京润德康医药技术有限公司	2014-01-23