Delving into the Latest Updates on Amikacin Sulfate/Fosfomycin sodium with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms-

Target

30S subunit

Mechanism

30S subunit inhibitors(30S ribosomal subunit inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Gram Negative Pneumonia

Originator Organization

Cardeas Pharma Corp.

Active Organization-

Inactive Organization

Cardeas Pharma Corp.

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Structure

Molecular FormulaC3H7NaO4P

InChIKeyBLLKJRKIOJQXCC-LJUKVTEVSA-N

CAS Registry26016-99-9

View All Structures (3)

This study will evaluate systemic and urine pharmacokinetics in spontaneously breathing healthy volunteers following a single dose of amikacin/fosfomycin, using the PARI Investigational eFlow Nebulizer System or the PARI LC Sprint Nebulizer. Three doses (30/12 mg, 60/24 mg, 90/36 mg amikacin/fosfomycin) will be evaluated. Following this evaluation, a single dose and nebulizer will be chosen to further evaluate systemic, bronchoalveolar, and urine pharmacokinetics in spontaneously breathing healthy volunteers.

Start Date01 Apr 2016

Sponsor / Collaborator

Cardeas Pharma Corp.

NCT02218359 / WithdrawnPhase 2

A Randomized Double-Blind, Placebo-Controlled, Crossover to Open Label, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the Investigational eFlow® AFIS Inline System in Mechanically Ventilated Patients With Gram-negative and/or Gram-positive Bacterial Colonization

To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin Fosfomycin Inhalation System (AFIS) versus aerosolized placebo in mechanically ventilated patients with Gram-negative and / or Gram-positive bacterial colonization.

Start Date01 Oct 2014

Sponsor / Collaborator

Cardeas Pharma Corp.

NCT01969799 / CompletedPhase 2

A Randomized Blinded, Placebo-Controlled, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the Investigational eFlow® Inline System in Mechanically Ventilated Patients With Gram-negative Bacterial Pneumonia (IASIS)

To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.

Start Date01 Dec 2013

Sponsor / Collaborator

Cardeas Pharma Corp.

100 Clinical Results associated with Amikacin Sulfate/Fosfomycin sodium

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100 Translational Medicine associated with Amikacin Sulfate/Fosfomycin sodium

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100 Patents (Medical) associated with Amikacin Sulfate/Fosfomycin sodium

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100 Deals associated with Amikacin Sulfate/Fosfomycin sodium

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gram Negative Pneumonia	Phase 2	US	Cardeas Pharma Corp.	01 Dec 2013
Gram Negative Pneumonia	Phase 2	FR	Cardeas Pharma Corp.	01 Dec 2013
Gram Negative Pneumonia	Phase 2	GR	Cardeas Pharma Corp.	01 Dec 2013
Gram Negative Pneumonia	Phase 2	HU	Cardeas Pharma Corp.	01 Dec 2013
Gram Negative Pneumonia	Phase 2	PR	Cardeas Pharma Corp.	01 Dec 2013
Gram Negative Pneumonia	Phase 2	ES	Cardeas Pharma Corp.	01 Dec 2013
Gram Negative Pneumonia	Phase 2	TR	Cardeas Pharma Corp.	01 Dec 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01969799 (IASIS, CTgov)	Phase 2	Gram Negative Pneumonia	143	Amikacin fosfomycin inhalation solution (Amikacin Fosfomycin Inhalation Solution)	mgvypaoudv(zjiphrhkoo) = sbumtbrriy sxebfhfpeh (bnospcvjfo, cjvkyzbrxd - jkodxfuxih) View more	-	02 Jul 2017
				Aerosolized placebo (Aerosolized Placebo)	mgvypaoudv(zjiphrhkoo) = xyplhlfejb sxebfhfpeh (bnospcvjfo, jvpzkhpthw - hzentiwnxr) View more