Delving into the Latest Updates on Enisamium iodide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Carbabenzpyride, Enisamium iodide (INN), FAV00A

+ [1]

Target-

Action

inhibitors

Mechanism

RNA synthesis inhibitors

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, Human

Inactive Indication

COVID-19Influenza A virus infectionViral respiratory infection

Originator Organization

Farmak

Active Organization

FarmakFarmakon JSC

Inactive Organization

Farmak As

License Organization-

Drug Highest PhaseApproved

First Approval Date

Russia (16 Feb 2011),

Influenza, Human

Regulation-

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Structure/Sequence

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-AT

/ 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 Date16 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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60

Literatures (Medical) associated with Enisamium iodide

01 Jan 2023·PHARMACEUTICAL CHEMISTRY JOURNAL

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

Author: Kukhlenko, A. A. ; Ovcharenko, A. G. ; 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.

01 Feb 2022·Acta crystallographica. Section E, Crystallographic communications

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

Article

Author: 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.

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 ; Mehle, Andrew ; Milde, Jens ; 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.

100 Deals associated with Enisamium iodide

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External Link

KEGG	Wiki	ATC	Drug Bank
D11249	-	J05AX	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	Russia	Farmak	16 Feb 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	Ukraine	Farmak	15 May 2020
Viral respiratory infection	Phase 3	-	Farmak	13 Apr 2009
Influenza A virus infection	Phase 2	Austria	Farmak As	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04682444 (Pubmed \| Antimicrob Agents Chemother)	Phase 2/3	Influenza, Human	-	Enisamium iodide	vspjgnlgrf(yzuqpvcizo) = zlcqvcegoh cfuntubggg (najrwkxzxn ) View more	-	18 Mar 2021
				Placebo	vspjgnlgrf(yzuqpvcizo) = uldwphpnie cfuntubggg (najrwkxzxn ) View more