Delving into the Latest Updates on Azelastine/mometasone with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Nasaflex

Target

GR x H1 receptor

Mechanism

GR agonists(Glucocorticoid receptor agonists), H1 receptor antagonists(Histamine H1 receptor antagonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [1]

Active Indication

Rhinitis, Allergic, Perennial

Inactive Indication-

Originator Organization

Hanlim Pharm Co., Ltd.

Active Organization

Hanlim Pharm Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

KR (16 Nov 2012),

Rhinitis, Allergic, Perennial

Regulation-

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Structure

Molecular FormulaC22H24ClN3O

InChIKeyMBUVEWMHONZEQD-UHFFFAOYSA-N

CAS Registry58581-89-8

View All Structures (2)

An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents (12 to 17 Years of Age) and Young Adults (18 to 24 Years of Age) With Seasonal Allergic Rhinitis

This study will compare the PK parameters of the combination test formulation to monotherapy reference products (mometasone furoate and azelastine hydrochloride) in adolescents and young adult patients with seasonal allergic rhinitis.

Start Date08 Jun 2023

Sponsor / Collaborator

Sandoz International GmbH

NCT05590598 / CompletedPhase 3

Prospective, Multicenter, Open-label, Randomized, Parallel, Clinical Study for Assessment of Comparative Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis.

Prospective, multicenter, open, randomized, parallel, clinical study for assessment of comparative efficacy and safety of Azelastine +Mometasone Sandoz (main group) and Momat Rino Advance (control group) administered as a monotherapy to patients with seasonal allergic rhinitis (SAR).

Start Date13 Feb 2023

Sponsor / Collaborator

Sandoz AG

NCT01470053 / CompletedPhase 3

A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Mometasone Furoate/Azelastine Hydrochloride Combination Group and Mometasone Furoate and Azelastine Hydrochloride Group 4 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Perennial Allergic Rhinitis Patient.

The purpose of this study is to evaluate of efficacy and safety of mometasone furoate plus azelastine HCl in patients with perennial allergic rhinitis.

Start Date01 Mar 2011

Sponsor / Collaborator