加西糖(Gaxilose) - 药物靶点：β-galactosidase_在研适应症：乳糖不耐症_专利_临床

概要

基本信息

药物类型

小分子化药

别名

4-galactosylxylose、Gaxilosa、LacTEST

靶点

β-galactosidase

作用机制

β-galactosidase调节剂(β-半乳糖苷酶调节剂)

治疗领域

遗传病与畸形消化系统疾病内分泌与代谢疾病

在研适应症

乳糖不耐症

非在研适应症-

原研机构

Venter Pharma SL

在研机构

Venter Pharma SL

非在研机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C11H20O10

InChIKeyBYZQBCIYLALLPA-NOPGXMAYSA-N

CAS号14087-31-1

关联

2

项与加西糖相关的临床试验

CTIS2023-504232-18-00 / Not yet recruiting

A Phase I, Single-Centre, Double-Blind, Randomized, Placebo-Controlled Clinical Trial To Determine Urinary Xylose Cut-Off Point For The Diagnosis Of Hypolactasia, After A Single Dose Of Gaxilose in Children Between 5 – 11 Years Of Age. - VPH-GXL-2022-511

开始日期2023-06-22

申办/合作机构-

NCT02636413 / Completed临床4期

Evaluation of the Impact of LacTEST on Diagnostic Thinking and on Patient Management, and of the Reproducibility (Test-Retest), for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance

The purpose of this study is to evaluate both the impact of LacTEST on diagnostic thinking and on patient management, and its reproducibility (Test-Retest), for the diagnosis of hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose intolerance.

开始日期2015-10-01

申办/合作机构

Venter Pharma SL

100 项与加西糖相关的临床结果

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100 项与加西糖相关的转化医学

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100 项与加西糖相关的专利（医药）

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5

项与加西糖相关的文献（医药）

2021-01-01·Carbohydrate Research4区 · 化学

Characterization of crystalline forms of gaxilose, a diagnostic drug

4区 · 化学

Article

作者: Gallego, Santos Hernández ; Benito, Mónica ; Molins, Elies ; Catti, Federica ; Olóndriz, Francisco Marquillas

Lactose intolerance is a pathology caused by lactase enzyme deficiency, usually produced in the intestinal cells provoking symptoms as abdominal pain, bloating, diarrhea, gas and nausea. Gaxilose, 4-O-β-D galactopyranosyl-d-xylose, is used as a diagnostic drug for a non-invasive method for hypolactasia diagnosis. To date, no definitive guide for identifying gaxilose and distinguishing between crystalline forms is available. Data have been collected from a number of different analytical techniques in order to provide a full characterization of the compound and a simple method to discriminate between two solid forms.

2017-01-01·BioMed Research International3区 · 生物学

Analytical Validation of a New Enzymatic and Automatable Method for d-Xylose Measurement in Human Urine Samples

3区 · 生物学

ArticleOA

作者: Gaspar, María Jesús ; Sánchez-Moreno, Israel ; Martín, José Luis ; Illa, Luis ; García-Junceda, Eduardo ; Hermida, Carmen ; Fernández-Mayoralas, Alfonso ; Muñoz, Guillermo Manuel ; Díaz, Ana ; Godino, Ana ; Monsalve-Hernando, Carmen

Hypolactasia, or intestinal lactase deficiency, affects more than half of the world population. Currently, xylose quantification in urine after gaxilose oral administration for the noninvasive diagnosis of hypolactasia is performed with the hand-operated nonautomatable phloroglucinol reaction. This work demonstrates that a new enzymatic xylose quantification method, based on the activity of xylose dehydrogenase fromCaulobacter crescentus, represents an excellent alternative to the manual phloroglucinol reaction. The new method is automatable and facilitates the use of the gaxilose test for hypolactasia diagnosis in the clinical practice. The analytical validation of the new technique was performed in three different autoanalyzers, using buffer or urine samples spiked with different xylose concentrations. For the comparison between the phloroglucinol and the enzymatic assays, 224 urine samples of patients to whom the gaxilose test had been prescribed were assayed by both methods. A mean bias of −16.08 mg of xylose was observed when comparing the results obtained by both techniques. After adjusting the cut-off of the enzymatic method to 19.18 mg of xylose, the Kappa coefficient was found to be 0.9531, indicating an excellent level of agreement between both analytical procedures. This new assay represents the first automatable enzymatic technique validated for xylose quantification in urine.

2014-11-01·Journal of Clinical Laboratory Analysis4区 · 医学

Improvement and Validation of d‐Xylose Determination in Urine and Serum as a New Tool for the Noninvasive Evaluation of Lactase Activity in Humans

4区 · 医学

ArticleOA

作者: Fernández‐Mayoralas, Alfonso ; Ariza, María J. ; Sánchez, Valentina ; Sarrión, Dolores ; Hermida, Carmen ; Teruel, Cristina ; Aragón, Juan J. ; Martínez‐Costa, Oscar H. ; Codoceo, Rosa ; Sánchez, José J. ; Calvo, Idoya ; Corrales, Guillermo

BackgroundThe phloroglucinol assay is the current method for d‐xylose determination in urine/plasma/serum. However, its sensitivity is limited when low amounts of d‐xylose are to be measured, such as in the noninvasive evaluation of intestinal lactase with 4‐galactosylxylose (gaxilose). An improved assay was therefore needed.MethodsWe developed and validated a modified version of the phloroglucinol‐based assay for quantification of d‐xylose in urine/serum samples. A method for gaxilose determination by gas chromatography (GC) was also optimized.ResultsLinearity ranged from 0.125 to 5.0 mg/l (5–200 mg/l in original sample). Accuracy at LOQ (0.125 mg/l) was 0.97/2.49% in spiked urine/serum; for other quality controls (QC), it was <1.27%. Intra‐ and interassay precision at LOQ were 6.02% and 6.45% for urine, and 8.86% and 10.00%, respectively, for serum; for other QC, precision was <2.15%. Linearity of gaxilose determination by GC was 3.90–195.17 for urine and 9.75–195.17 mg/l for serum with acceptable sensitivity and reproducibility. The method proved adequate for the d‐xylose determination in healthy and hypolactasic subjects after oral administration of gaxilose.ConclusionsThe modified method provides high sensitivity and robustness for d‐xylose quantification in urine/serum for routine clinical use especially in the noninvasive diagnosis of intestinal lactase deficiency with the gaxilose test.

100 项与加西糖相关的药物交易

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