Delving into the Latest Updates on Abediterol/AZD-7594 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

AZD7594/abediterol, Abediterol/AZ13189620, Abediterol/AZD 7594

Target

GR x β2-adrenergic receptor

Action

modulators, agonists

Mechanism

GR modulators(Glucocorticoid receptor modulators), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)

Therapeutic Areas

Immune System DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

AsthmaPulmonary Disease, Chronic Obstructive

Originator Organization

AstraZeneca Pharmaceuticals Co. Ltd.

Active Organization-

Inactive Organization

AstraZeneca PLC

License Organization-

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC25H30F2N2O4

InChIKeySFYAXIFVXBKRPK-QFIPXVFZSA-N

CAS Registry915133-65-2

View All Structures (2)

This study will assess the efficacy and safety of multiple dose levels of AZD7594 administered once daily (QD) by inhalation in a 12-week treatment period on asthma subjects. The activity will be assessed by comparing AZD7594 to placebo. The comparison between active comparator (FF) and placebo will be used for bench marking. The efficacy is assessed by the evaluation of change in trough forced expiratory volume in 1 second (FEV1). The aim is to develop AZD7594 as a once daily inhaled non-steroidal selective GR modulator (SGRM), which may ultimately lead to better disease control of both chronic obstructive pulmonary disease (COPD) and asthma through improved efficacy and compliance. The overall rationale for developing a once daily AZD7594 in a dry powder inhaler (DPI) is to provide a safe and effective future treatment option for both asthma and COPD subjects.

Start Date02 Jan 2019

Sponsor / Collaborator

AstraZeneca PLC

[+1]

EUCTR2017-002483-40-BG

/ Not yet recruitingPhase 2

A Phase 2b Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi Centre Study to Assess Efficacy and Safety of Multiple Dose Levels of AZD7594 DPI Given Once Daily for twelve weeks, compared to placebo, in Asthmatics symptomatic on low dose ICS - GRANIT

Start Date16 Oct 2018

Sponsor / Collaborator

AstraZeneca AB

NCT02967159

/ CompletedPhase 1

A RANDOMIZED OPEN LABEL CROSS-OVER STUDY TO EVALUATE PHARMACOKINETICS AND SAFETY OF SINGLE INHALED DOSES OF ABEDITEROL AND AZD7594 GIVEN ALONE, IN FIXED DOSE COMBINATION (FDC) AND IN FREE COMBINATION, USING DPI, IN MALE HEALTHY VOLUNTEERS

AZD7594 is a non steroidal, potent and selective modulator of the glucocorticoid receptor (GR) under development for once daily inhaled treatment of chronic obstructive pulmonary disease (COPD) and asthma. Abediterol is a novel and selective β2 adrenergic receptor agonist with the potential for once daily treatment of asthma and COPD in fixed dose combination (FDC) with an ICS or a novel anti inflammatory (AI) agent. This study will be the first clinical study for the combination exposure of AZD7594 with abediterol as 2 compounds in FDC or in free combination via 2 separate dry powder inhalers (DPIs). This study will be conducted in healthy male subjects to minimize the effects of concomitant disease states or medications on study measurements.

Start Date24 Nov 2016

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Abediterol/AZD-7594

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100 Translational Medicine associated with Abediterol/AZD-7594

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100 Patents (Medical) associated with Abediterol/AZD-7594

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100 Deals associated with Abediterol/AZD-7594

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 2	Germany	AstraZeneca PLC	02 Jan 2019
Asthma	Phase 2	Hungary	AstraZeneca PLC	02 Jan 2019
Asthma	Phase 2	Poland	AstraZeneca PLC	02 Jan 2019
Asthma	Phase 2	Japan	AstraZeneca PLC	02 Jan 2019
Asthma	Phase 2	Bulgaria	AstraZeneca PLC	02 Jan 2019
Asthma	Phase 2	Ukraine	AstraZeneca PLC	02 Jan 2019
Asthma	Phase 2	United States	AstraZeneca PLC	02 Jan 2019
Asthma	Phase 2	South Africa	AstraZeneca PLC	02 Jan 2019
Pulmonary Disease, Chronic Obstructive	Phase 2	United States	AstraZeneca PLC	12 Jan 2016