依尼碘铵(Enisamium iodide) - 在研适应症：流感病毒感染_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Carbabenzpyride、Enisamium iodide (INN)、FAV00A

+ [1]

靶点-

作用方式

抑制剂

作用机制

RNA合成抑制剂

治疗领域

感染呼吸系统疾病

在研适应症

流感病毒感染

非在研适应症

新型冠状病毒感染甲型流感病毒感染病毒性呼吸道感染

原研机构

Farmak

在研机构

Farmakon JSCFarmak

非在研机构

Farmak As

权益机构-

最高研发阶段批准上市

首次获批日期

俄罗斯 (2011-02-16),

流感病毒感染

最高研发阶段(中国)临床申请批准

特殊审评-

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结构/序列

分子式C14H15IN2O

InChIKeyILSOAHPXYZRFBA-UHFFFAOYSA-N

CAS号201349-37-3

关联

2

项与依尼碘铵相关的临床试验

NCT04682873

/ Completed临床3期

A Multi-centre, Double-blind, Randomised, Placebo-controlled, Trial to Assess the Efficacy and Safety of Amizon® Max, Manufactured by Farmak JSC, in Combination With Basic Treatment, in Subjects With Moderate Covid-19, Which is Caused by the SARS-CoV-2 Virus

Adult female and male patients, hospitalized with Covid-19 infection (confirmed by reverse transcription polymerase chain reaction [RT-PCR]), will be screened for participation in this prospective, multi-center, double-blind, randomised, placebo-controlled trial.
Enrolled patients will be randomized (1:1) into 2 treatment groups: Group 1 will receive the active treatment with Amizon® Max (international nonproprietary name enisamium iodide), one capsule (each containing 500 mg of enisamium iodide) 4 times daily every 6 hours for 7 days; patients in treatment Group 2 will receive a matching placebo capsule, 4 times daily every 6 hours for 7 days. Patient observation and follow-up are planned for 29 days, unless discharged before Day 29.
The effect of treatment on Covid-19 will be evaluated by time from day of randomization to an increase of at least two points (from the status at randomization) on the severity rating scale (SR), the Time to Clinical Recovery (TTCR) of main Covid-19 symptoms / complications and the Sum of Severity Rating from Day 2 to Day 15 (SSR-15). Safety and tolerability of the study drug will be evaluated based on the intensity and course of adverse events (Es).
Enisamium iodide is an antiviral small molecule. Enisamium inhibits replication of alpha- and beta- coronaviruses (human coronavirus NL63 and SARS-CoV-2, respectively) and influenza virus A and B. Mechanism of action against SARS-CoV-2 includes the direct inhibition of the viral RNA polymerase.

开始日期2020-05-15

申办/合作机构

Farmak

NCT04682444

/ Completed临床2/3期

A Prospective Single-blind Comparative Clinical Study of Efficacy and Safety of Amizon 0.25 g Tablets, Manufactured by Farmak JSC, in Patients With ARVI, Including Influenza.

This randomized, single blind clinical study was conducted to investigate the clinical efficacy and safety of the drug Amizon (enisamium iodide), in comparison with placebo for the treatment of patients with acute respiratory viral infections (ARVI), including influenza. Enisamium iodide is an antiviral small molecule.
Adult patients were enrolled and randomised into 2 groups. On the first day of the onset of symptoms of ARVI, one group of patients took Amizon tablets (active ingredient enisamium iodide) for 7 days; the other group of patients took matching placebo tablets for 7 days. Examination and observation of all participants was done for up to 14 days after the first intake of the study drug.
The effect of treatment was assessed by subjective reporting of the symptoms of ARVI and influenza, using a predefined symptom scale score system.
Objective assessment was performed by measuring vitals signs, laboratory tests (including blood and urine assessment), as well as evaluating the immune status (including measuring the relative concentration of interferon and immunoglobulins).

开始日期2009-04-13

申办/合作机构

Farmak

100 项与依尼碘铵相关的临床结果

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100 项与依尼碘铵相关的转化医学

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100 项与依尼碘铵相关的专利（医药）

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28

项与依尼碘铵相关的文献（医药）

2023-01-01·PHARMACEUTICAL CHEMISTRY JOURNAL

To the Calculation of Heat-Exchange Parameters During Drying of Enisamium Iodide

作者: Ovcharenko, A. G. ; Kukhlenko, A. A. ; Ivanov, O. S. ; Karpov, A. G. ; Vasilishin, M. S.

Issues with thermal calculation of the process of drying the antiviral agent enisamium iodide under pilot production conditions are considered.Calculation of the heat-exchange intensity using the exptl. relation between the Rehbinder criterion and the moisture content of the material was proposed.An empirical equation for calculation of the average temperature of a dryable material is derived.Satisfactory convergence between the calculated and exptl. data makes it possible to use them in the development of an automatic process control system.

2022-02-01·Acta crystallographica. Section E, Crystallographic communications

4-[(Benzylamino)carbonyl]-1-methylpyridinium halogenide salts: X-ray diffraction study and Hirshfeld surface analysis

Article

作者: Shaposhnik, Anna M ; Baumer, Vyacheslav M ; Levandovskiy, Igor A ; Shishkina, Svitlana V ; Rudiuk, Vitalii V

Two salts of 4-[(benzylamino)carbonyl]-1-methylpyridinium (Am) with chloride (C14H15N2O+·Cl−) and bromide (C14H15N2O+·Br−) anions were studied and compared with the iodide salt. AmCl crystallizes in the centrosymmetric space group P21/n while AmBr and AmI form crystals in the Sohncke space group P212121. Crystals of AmBr are isostructural to those of AmI. The cation and anion are bound by an N–H...Hal hydrogen bond. Hirshfeld surface analysis was used to compare different types of intermolecular interactions in the three structures under study.

2020-08-01·PHARMACEUTICAL CHEMISTRY JOURNAL

Development of Technology and Equipment for Enisamium Iodide Drying

作者: A. V. Balakhnina ; O. S. Ivanov ; S. V. Sysolyatin ; M. S. Vasilishin ; A. G. Karpov ; Yu. A. Kryukov ; D. B. Ivanova

A methodol. approach to selecting the optimal drying method for enisamium iodide, an antiviral agent with a broad spectrum of pharmacol. activities, is considered.A vacuum drying method in an apparatus with a tape mixing device is proposed and verified based on studies of the main properties of the product.An industrial setup prototype and design features of the apparatus are described.The basic technol. regimes of enisamium iodide drying ensuring the product quality are established.The kinetic drying and heating curves of the product, including those in the optimal regime, are presented.Test results were used to determine the specific tech. parameters of the setup operation.

100 项与依尼碘铵相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11249	-	J05AX	-

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
流感病毒感染	俄罗斯	Farmak	2011-02-16

未上市

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床3期	乌克兰	Farmak	2020-05-15
病毒性呼吸道感染	临床3期	-	Farmak	2009-04-13
甲型流感病毒感染	临床2期	奥地利	Farmak As	-

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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


NCT04682444 (CTgov)	临床2/3期	病毒性呼吸道感染 \| 流感病毒感染	100	Enisamium Iodide (Group 1 - Active Treatment - Amizon)	範網齋鑰繭淵簾範餘膚 = 選壓夢鏇願襯廠鑰繭簾觸蓋夢構窪醖鹹觸願積 (鏇衊壓窪膚醖顧艱積繭, 遞憲齋鏇遞獵鹹選顧選 ~ 觸膚願壓鑰獵醖廠製衊) 更多	-	2026-01-08
				Placebo (Group 2 - Placebo)	範網齋鑰繭淵簾範餘膚 = 鏇夢夢鹽餘積衊艱夢鹽觸蓋夢構窪醖鹹觸願積 (鏇衊壓窪膚醖顧艱積繭, 觸壓遞遞遞淵製獵蓋蓋 ~ 範範鹹選願網糧窪顧襯) 更多
NCT04682444 (Pubmed \| Antimicrob Agents Chemother)	临床2/3期	流感病毒感染	-	Enisamium iodide	艱願餘獵膚積蓋淵鏇選(衊襯夢鑰窪願憲艱鹹築) = 範網獵顧積製獵鹹構壓齋醖膚構齋築膚憲窪鏇 (衊積選遞襯醖淵築鏇獵 ) 更多	-	2021-03-18
				Placebo	艱願餘獵膚積蓋淵鏇選(衊襯夢鑰窪願憲艱鹹築) = 膚選鏇廠製構選範觸鹹齋醖膚構齋築膚憲窪鏇 (衊積選遞襯醖淵築鏇獵 ) 更多