Delving into the Latest Updates on Sodium Feredetate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Ferric sodium EDTA, Ferric sodium ethylenediaminetetraacetate, Ferrostrene

+ [13]

Target-

Mechanism

Fe modulators

Therapeutic Areas

Endocrinology and Metabolic DiseaseHemic and Lymphatic Diseases

Active Indication

Anemia, Iron-Deficiency

Inactive Indication

Arthritis

Originator Organization-

Active Organization

Sichuan Baili Pharmaceuticals Co.,Ltd

Furen Pharmaceutical Group Xinyang Co. Ltd.Beijing Rundekang Medical Tech. Co., Ltd.

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC10H12FeN2NaO8

InChIKeyMKWYFZFMAMBPQK-UHFFFAOYSA-J

CAS Registry15708-41-5

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。

[Translation]

Main purpose: To evaluate the pharmacokinetic differences between sodium ferric edetate oral solution and iron protein succinate oral solution in healthy volunteers through a comparative pharmacokinetic study of sodium ferric edetate oral solution and iron protein succinate oral solution on an empty stomach. To provide a basis for the design rationality of the clinical research, biological sample analysis and detection, and statistical analysis methods of the formal trial of the comparative pharmacokinetic study of sodium ferric edetate oral solution. Secondary purpose: To evaluate the clinical safety of sodium ferric edetate oral solution.

Start Date-

Sponsor / Collaborator

Beijing Rundekang Medical Tech. Co., Ltd.

[+1]

CTR20130013

/ RecruitingPhase 2

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

[Translation] A multicenter, randomized, blinded, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of sodium ferric edetate oral solution in the treatment of iron deficiency anemia in children

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。

[Translation]

To evaluate the efficacy and safety of sodium ferric edetate oral solution produced by Sichuan Baili Pharmaceutical Co., Ltd. in the treatment of iron deficiency anemia in children.

Start Date23 Jan 2014

Sponsor / Collaborator

Beijing Rundekang Medical Tech. Co., Ltd.

[+1]

CTRI/2011/10/002097

/ RecruitingPhase 4

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

Start Date01 Nov 2011

Sponsor / Collaborator-

100 Clinical Results associated with Sodium Feredetate

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100 Translational Medicine associated with Sodium Feredetate

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100 Patents (Medical) associated with Sodium Feredetate

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145

Literatures (Medical) associated with Sodium Feredetate

01 Jan 2024·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

Author: 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.

14 Mar 2023·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

Author: 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.

01 Jan 2023·Frontiers in pharmacology

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

Article

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

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.

100 Deals associated with Sodium Feredetate

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External Link

KEGG	Wiki	ATC	Drug Bank
D07145	Sodium Feredetate	B03AB03	DB13381

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia, Iron-Deficiency	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anemia, Iron-Deficiency	Phase 2	CN	Sichuan Baili Pharmaceuticals Co.,Ltd	23 Jan 2014
Anemia, Iron-Deficiency	Phase 2	CN	Beijing Rundekang Medical Tech. Co., Ltd.	23 Jan 2014
Arthritis	Preclinical	CN	Beijing Rundekang Medical Tech. Co., Ltd.	08 May 2014
Arthritis	Preclinical	CN	Sichuan Baili Pharmaceuticals Co.,Ltd	08 May 2014