Delving into the Latest Updates on Mirabegron/Solifenacin Succinate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

EB-178, YM178/YM905

Target

M3 receptor x β3-adrenergic receptor

Action

antagonists, agonists

Mechanism

M3 receptor antagonists(Muscarinic acetylcholine receptor M3 antagonists), β3-adrenergic receptor agonists(Beta-3 adrenergic receptor agonists)

Therapeutic Areas

Urogenital Diseases

Active Indication

Overactive bladder syndromeUrinary Bladder, Overactive

Inactive Indication-

Originator Organization

Astellas Pharma, Inc.

Active Organization

Astellas Pharma Europe Ltd.Astellas Pharma Technologies, Inc.

Adalvo Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC21H24N4O2S

InChIKeyPBAPPPCECJKMCM-IBGZPJMESA-N

CAS Registry223673-61-8

View All Structures (2)

A multi-centric, randomized, double blind, parallel group, active controlled, comparative Phase III clinical trial to evaluate the efficacy and safety of FDC of Mirabegron 25mg/50mg (ER) plus Solifenacin succinate 5mg/5mg tablet versus Mirabegron 25mg/50mg (ER) tablet, Solifenacin succinate 5mg tablet in subjects diagnosed with Overactive bladder.

Start Date28 Aug 2019

Sponsor / Collaborator

Windlas Biotech Ltd.

NCT02010944

/ CompletedPhase 1

An Open-label, Parallel Group, Randomized, Two-sequence, Three-way Crossover Study to Assess the Relative Bioavailability of Solifenacin Succinate and Mirabegron Fixed-dose Combination Tablets Compared to Co-administration of Single Entity Tablets at Three Dose Strengths in Healthy Male and Female Subjects

This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablets containing solifenacin succinate and mirabegron with the co-administration of single entity tablets (SET), at three dose strengths.

Start Date01 Sep 2012

Sponsor / Collaborator

Astellas Pharma Europe Ltd.

100 Clinical Results associated with Mirabegron/Solifenacin Succinate

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100 Translational Medicine associated with Mirabegron/Solifenacin Succinate

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100 Patents (Medical) associated with Mirabegron/Solifenacin Succinate

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1

News (Medical) associated with Mirabegron/Solifenacin Succinate

15 Nov 2024

·www.adalvo.com

Adalvo Announces Successful EU Approval for Mirabegron 50mg Prolonged-Release Tablets

Adalvo secures successful DCP approval for Mirabegron 50mg prolonged-release tablets. Developed based on the reference brand Betmiga prolonged-release tablets, Mirabegron is indicated for the treatment of urgency, increased micturition frequency, and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. According to IQVIA, Mirabegron achieved approximately $3.3Bn in global sales in 2023, with a 3-year CAGR of 2%. Additionally, registrations for Mirabegron 25mg are currently ongoing, demonstrating Adalvo's commitment to providing a wide range of treatment options. Adalvo’s success in securing this approval reflects our capabilities to develop complex, differentiated products. Building on the success of Mirabegron, Adalvo is also progressing well with the development of Mirabegron+Solifenacin, further expanding our portfolio and enhancing treatment options for patients. There are no half-measures at Adalvo – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward. Partner Up Now! Click Here To Get In Touch! © 2022-2024 Adalvo Limited. All right reserved

Drug Approval

100 Deals associated with Mirabegron/Solifenacin Succinate

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Overactive bladder syndrome	NDA/BLA	European Union	Adalvo Ltd.	29 Jan 2026
Urinary Bladder, Overactive	Phase 3	United States	Astellas Pharma Europe Ltd.	03 Dec 2013
Urinary Bladder, Overactive	Phase 3	United States	Astellas Pharma Technologies, Inc.	03 Dec 2013
Urinary Bladder, Overactive	Phase 3	Argentina	Astellas Pharma Europe Ltd.	03 Dec 2013
Urinary Bladder, Overactive	Phase 3	Argentina	Astellas Pharma Technologies, Inc.	03 Dec 2013
Urinary Bladder, Overactive	Phase 3	Australia	Astellas Pharma Technologies, Inc.	03 Dec 2013
Urinary Bladder, Overactive	Phase 3	Australia	Astellas Pharma Europe Ltd.	03 Dec 2013
Urinary Bladder, Overactive	Phase 3	Belgium	Astellas Pharma Europe Ltd.	03 Dec 2013
Urinary Bladder, Overactive	Phase 3	Belgium	Astellas Pharma Technologies, Inc.	03 Dec 2013
Urinary Bladder, Overactive	Phase 3	Brazil	Astellas Pharma Technologies, Inc.	03 Dec 2013