Delving into the Latest Updates on Enisamium iodide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Carbabenzpyride, Enisamium iodide (INN)

Target-

Mechanism

RNA synthesis inhibitors

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, Human

Inactive Indication

Acute respiratory infectionsCOVID-19Influenza A virus infection

Originator Organization

Farmak

Active Organization

Shanghai Nulife Pharmaceutical Co., Ltd.FarmakFarmakon JSC

Inactive Organization

Farmak As

Drug Highest PhaseApproved

First Approval Date

RU (16 Feb 2011),

Influenza, Human

Regulation-

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Structure

Molecular FormulaC14H15IN2O

InChIKeyILSOAHPXYZRFBA-UHFFFAOYSA-N

CAS Registry201349-37-3

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.

Start Date15 May 2020

Sponsor / Collaborator

Farmak

EUCTR2010-018564-17-DE / Not yet recruitingNot Applicable

A Phase II, multicenter, multinational, randomized, double-blinded, placebo-controlled dose-finding study to evaluate the efficacy and safety of carbabenzpyride in the treatment of uncomplicated influenza A.Prospective, multicenter, multinational, randomized, double-blinded, placebo-controlled dose-finding study in parallel groups (Phase II)

Start Date30 Dec 2010

Sponsor / Collaborator

Farmak International Holding GmbH

NCT04682444 / CompletedPhase 2/3

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).

Start Date13 Apr 2009

Sponsor / Collaborator

Farmak

100 Clinical Results associated with Enisamium iodide

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100 Translational Medicine associated with Enisamium iodide

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100 Patents (Medical) associated with Enisamium iodide

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24

Literatures (Medical) associated with Enisamium iodide

18 Mar 2021·Antimicrobial agents and chemotherapyQ2 · MEDICINE

Enisamium Reduces Influenza Virus Shedding and Improves Patient Recovery by Inhibiting Viral RNA Polymerase Activity

Q2 · MEDICINE

Article

Author: Shaw, Megan ; Gmeinwieser, Norbert ; Zubkova, Tatiana G. ; Stammer, Holger ; Milde, Jens ; Mehle, Andrew ; Boltz, David ; te Velthuis, Aartjan J. W. ; Margitich, Victor ; Müller, Lutz

Infections with respiratory viruses constitute a huge burden on our health and economy. Antivirals against some respiratory viruses are available, but further options are urgently needed. Enisamium iodide (laboratory code FAV00A, trade name Amizon) is an antiviral marketed in countries of the Commonwealth of Independent States for the treatment of viral respiratory infections, but its clinical efficacy and mode of action are not well understood.

01 Jan 2020·Medical archives (Sarajevo, Bosnia and Herzegovina)

Histomorphological Study of a New Nasal Spray with Anti-inflammatory Properties Efficacy in Rabbits with Rhinosinusitis

Article

Author: Hladkykh, Dmytro ; Zupanets, Igor ; Shebeko, Sergii ; Otrishko, Inna ; Zhulai, Tetiana

INTRODUCTION:

The high world prevalence of rhinosinusitis (RS) initiates the ways of a favorable search for effective and safe medicines for its pathogenetic treatment. The important part of this process is the choice of the most comfortable dosage form, which will enhance therapeutic compliance and ensure the appropriate medicine efficacy and safety.

AIM:

To substantiate the efficacy of a new nasal spray with anti-inflammatory properties containing Enisamium Iodide (EI) at a concentration of 10 mg/mL by histomorphological study of the nasal cavity and paranasal sinuses mucosal in rabbits with experimental rhinosinusitis (ERS).

METHODS:

EI (nasal spray) was a test object. Sinupret^® was a reference drug. ERS was induced in rabbits on the first day of the study by tamponade of the right half of the nasal cavity under general anesthesia. The study was performed using 24 rabbits (4 groups, 6 rabbits in each group). The histomorphological examination was performed on the 25^th day of the study by the standard light microscopy methods.

RESULTS:

The histomorphological examination of EI 10 mg/mL (nasal spray) impact on RS in rabbits, which administered during 10 days intranasally, revealed the significant therapeutic effect presented by reduced inflammation signs in the epithelium of the nasal cavities and paranasal sinuses mucosal. Besides, the EI impact was not inferior to the reference drug Sinupret^® in tablets. The study of the pharmacological properties of the EI (nasal spray) on ERS showed the high rate of onset of EI actions when used intranasally which was superior to the rate of actions of the reference drug Sinupret^® (tablets) administered intragastrically.

CONCLUSION:

The EI (nasal spray) is a promising drug for a pathogenetic therapy of acute RS, which demands further pre-clinical and clinical studies aiming to substantiate its implementation to the clinical practice.

01 Jan 2018·Acta virologicaQ4 · MEDICINE

Antiviral effect of a derivative of isonicotinic acid enisamium iodide (FAV00A) against influenza virus

Q4 · MEDICINE

Article

Author: Boltz, D. A. ; Syarkevych, O. ; Cinatl, J. ; Cocking, D. ; Margitich, V. I. ; Mueller, L. ; Peng, X. ; Muzzio, M. ; Goy, A. ; Kostyuk, G. ; Johnson, W.

With only a single class of antiviral drugs existing for treatment of influenza (neuraminidase inhibitors), the search for novel effective compounds is urgently needed. We evaluated a low molecular mass compound, enisamium iodide (FAV00A), against influenza virus infections in primary differentiated normal human bronchial epithelial (NHBE) cells, and in ferrets. FAV00A (500 µg/ml) markedly inhibited influenza virus replication and reduced viral M-gene expression in NHBE cells. Treatment of ferrets with FAV00A (200 mg/kg once daily for 7 days) initiated 24 h after inoculation with 105 TCID50 of influenza A/Wisconsin/67/2005 (H3N2) virus resulted in a significant decrease in virus titers in the upper respiratory tract. Our data show that FAV00A exhibits an antiviral effect against influenza virus in NHBE cells and provides some benefits in a ferret model. Thus, further Keywords: antiviral agents; enisamium iodide; influenza virus; MDCK cells; NHBE cells; ferrets.

100 Deals associated with Enisamium iodide

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