VP-20621(VP-20621) - 在研适应症：梭菌感染_专利_临床

概要

基本信息

药物类型

活菌制剂

别名

CDAD therapies、NTCD、NTX

+ [4]

靶点-

作用方式

调节剂

作用机制

细菌替代物、微生物调节剂

治疗领域

感染

在研适应症

梭菌感染

非在研适应症

艰难梭菌感染

原研机构

Edward Hines, Jr. VA Hospital

在研机构

Edward Hines, Jr. VA Hospital

非在研机构

Shire Plc

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 VP-20621 相关的临床试验

NCT05693077

/ Recruiting临床1期IIT

Establishing Colonisation With Non-toxigenic Clostridioides Difficile in Healthy Volunteers

This study will investigate experimental colonisation with non-toxigenic C.difficile (NTCD) in healthy volunteers. Main outcomes will be safety, tolerability, dose needed to obtain colonisation with NTCD to ultimately determine host microbiota factors associated with susceptibility to colonisation.

开始日期2023-09-22

申办/合作机构

Academisch Ziekenhuis Leiden

NCT01259726

/ Completed临床2期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of VP 20621 for Prevention of Recurrence of Clostridium Difficile Infection (CDI) in Adults Previously Treated for CDI

The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.

开始日期2011-06-27

申办/合作机构

Shire Plc

100 项与 VP-20621 相关的临床结果

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100 项与 VP-20621 相关的转化医学

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100 项与 VP-20621 相关的专利（医药）

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17

项与 VP-20621 相关的文献（医药）

2024-07-01·International Journal of Antimicrobial Agents

Fighting against Clostridioides difficile infection: Current medications

Review

作者: Quan, Min ; Lv, Xiaoju ; Zhang, Xiaoxia ; Wang, Xiaohui ; Fang, Qingqing ; Zong, Zhiyong

Clostridioides difficile (formerly Clostridium difficile) has been regarded as an 'urgent threat' and a significant global health problem, as life-threatening diarrhoea and refractory recurrence are common in patients with C. difficile infection (CDI). Unfortunately, the available anti-CDI drugs are limited. Recent guidelines recommend fidaxomicin and vancomycin as first-line drugs to treat CDI, bezlotoxumab to prevent recurrence, and faecal microbiota transplantation for rescue treatment. Currently, researchers are investigating therapeutic antibacterial drugs (e.g. teicoplanin, ridinilazole, ibezapolstat, surotomycin, cadazolid, and LFF571), preventive medications against recurrence (e.g. Rebyota, Vowst, VP20621, VE303, RBX7455, and MET-2), primary prevention strategies (e.g. vaccine, ribaxamase, and DAV132) and other anti-CDI medications in the preclinical stage (e.g. Raja 42, Myxopyronin B, and bacteriophage). This narrative review summarises current medications, including newly marketed drugs and products in development against CDI, to help clinicians treat CDI appropriately and to call for more research on innovation.

2024-02-01·Journal of Ocular Pharmacology and Therapeutics

Improved Topical Ophthalmic Natamycin Suspension for the Treatment of Fungal Keratitis

Article

作者: Cai, Chuntian ; Dudhipala, Narendar ; Joshi, Poorva H. ; Majumdar, Soumyajit ; Youssef, Ahmed Adel Ali ; Varner, Corinne

Purpose: Natamycin (NT) is used as a first-line antifungal prescription in the treatment of fungal keratitis (FK) and is commercially available as a 5% w/v ophthalmic suspension. NT shows poor water solubility and light sensitivity. Thus, the present investigation is aimed to enhance the fraction of NT in solution in the commercial formulation by adding cyclodextrins (CDs), thereby improving the delivery of the drug into deeper ocular tissues. Methods: The solubility of NT in different CDs, the impact of ultraviolet (UV) light exposure, stability at 4°C and 25°C, in vitro release, and ex vivo transcorneal permeation studies were performed. Results: NT exhibited the highest solubility (66-fold) in randomly methylated-β-cyclodextrin (RM-βCD) with hydroxypropyl-βCD (HP-βCD) showing the next highest solubility (54-fold) increase in comparison to market formulation Natacyn^® as control. The stability of NT-CD solutions was monitored for 2 months (last-time point) at both storage conditions. The degradation profile of NT in NT-RM-βCD and NT-HP-βCD solutions under UV-light exposure followed first-order kinetics exhibiting half-lives of 1.2 h and 1.4 h, respectively, an almost 3-fold increase over the control solutions. In vitro release/diffusion studies revealed that suspensions containing RM-βCD and HP-βCD increased transmembrane flux significantly (3.1-fold) compared to the control group. The transcorneal permeability of NT from NT-RM-βCD suspension exhibited an 8.5-fold (P < 0.05) improvement compared to Natacyn eyedrops. Furthermore, the addition of RM-βCD to NT suspension increases the solubilized fraction of NT and enhances transcorneal permeability. Conclusion: Therefore, NT-RM-βCD formulations could potentially lead to a decreased frequency of administration and significantly improved therapeutic outcomes in FK treatment.

2022-06-01·Early Human Development

Effects of Omega-3-6-9 fatty acid supplementation on behavior and sleep in preterm toddlers with autism symptomatology: Secondary analysis of a randomized clinical trial

Article

作者: Rogers, Lynette K ; Rausch, Joseph ; Boone, Kelly M ; Keim, Sarah A ; Klebanoff, Mark A ; Coury, Daniel L

BACKGROUNDChildren born extremely preterm disproportionately experience sequelae of preterm birth compared to those born at later gestational ages, including higher prevalence of autism spectrum disorder (ASD) and associated behaviors.AIMExplore effects of combined dietary docosahexaenoic acid, eicosapentaenoic acid, gamma-linolenic acid, and oleic acid (omega 3-6-9) on caregiver-reported behavior and sleep in toddlers born at ≤29 weeks' gestation who were exhibiting symptoms commonly seen with ASD.STUDY DESIGN90-day randomized (1:1), double blinded, placebo-controlled trial.SUBJECTSThirty-one children aged 18-38 months received omega 3-6-9 (n = 15) or canola oil placebo (n = 16).OUTCOME MEASURESMixed effects regression analyses followed intent to treat and explored treatment effects on measures of caregiver-reported behavior (Child Behavior Checklist 1.5-5, Toddler Behavior Assessment Questionnaire - Short Form, Vineland Adaptive Behavior Scales, 2nd Edition) and sleep (Children's Sleep Habits Questionnaire, Brief Infant Sleep Questionnaire).RESULTSTwenty-nine of 31 (94%; n_tx = 13, n_placebo = 16) children randomized had data available for at least one outcome measure, 27 (87%; n_tx = 12, n_placebo = 15) had complete outcome data. Children randomized to omega 3-6-9 experienced a medium magnitude benefit of supplementation on anxious and depressed behaviors (Δ_Difference = -1.27, d = -0.58, p = 0.049) and internalizing behaviors (Δ_Difference = -3.41, d = -0.68, p = 0.05); and a large magnitude benefit on interpersonal relationship adaptive behaviors (Δ_Difference = 7.50, d = 0.83, p = 0.01), compared to placebo. No effects were observed on other aspects of behavior or sleep.CONCLUSIONSFindings provide preliminary support for further exploration of omega 3-6-9 during toddlerhood to improve socioemotional outcomes among children born preterm, especially for those showing early symptoms commonly seen with ASD. Results need to be replicated in a larger sample.TRIAL REGISTRATIONRegistered with ClinicalTrials.gov: NCT01683565.

100 项与 VP-20621 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
梭菌感染	临床2期	-	Edward Hines, Jr. VA Hospital	-
艰难梭菌感染	药物发现	加拿大	Shire Plc	2011-06-27
艰难梭菌感染	药物发现	美国	Shire Plc	2011-06-27
艰难梭菌感染	药物发现	德国	Shire Plc	2011-06-27
艰难梭菌感染	药物发现	瑞士	Shire Plc	2011-06-27
艰难梭菌感染	药物发现	西班牙	Shire Plc	2011-06-27
艰难梭菌感染	药物发现	比利时	Shire Plc	2011-06-27

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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


DDW2023	N/A	炎症	-	NTX-1175 50 mg/kg	鏇簾選繭範衊獵襯構鹹(願蓋夢餘願鹽鬱顧膚艱) = 鑰艱夢遞鏇糧選壓憲襯繭廠襯簾積構簾餘願糧 (夢膚鏇糧窪蓋艱觸蓋繭 )	-	2023-05-09
				Vehicle	鏇簾選繭範衊獵襯構鹹(願蓋夢餘願鹽鬱顧膚艱) = 顧艱夢壓選繭選窪繭繭繭廠襯簾積構簾餘願糧 (夢膚鏇糧窪蓋艱觸蓋繭 )
NCT01259726 (Pubmed \| J Coll Physicians Surg Pak \| JAMA) 人工标引	临床2期	艰难梭菌感染	168	nontoxigenic Clostridium difficile strain M3	(餘構蓋餘顧壓範觸遞製) = 齋願糧製衊積築觸夢範夢衊鏇範衊廠顧蓋簾壓 (築獵鹽窪醖壓繭餘鑰淵 ) 更多	积极	2015-05-05
				Placebo	(餘構蓋餘顧壓範觸遞製) = 鏇蓋築願鑰顧齋鏇齋築夢衊鏇範衊廠顧蓋簾壓 (築獵鹽窪醖壓繭餘鑰淵 ) 更多
NCT01259726 (CTgov)	临床2期	艰难梭菌感染	173	Placebo	壓壓糧艱憲窪願網壓製(觸艱蓋鹽艱構鹹繭糧範) = 窪鬱鑰網襯艱憲遞壓鑰餘糧鏇積糧製積蓋鏇淵 (製獵淵構糧築築壓鑰鹹, 鏇繭鹹鏇範醖壓窪範顧 ~ 夢選觸鏇鹹淵蓋鹹餘鹹) 更多	-	2015-02-12