Mirabegron/solifenacin - Astellas Pharma

Drug Profile

Mirabegron/solifenacin - Astellas Pharma

Alternative Names: EB 178; Solifenacin/mirabegron; YM178/YM905

Latest Information Update: 24 Mar 2018

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At a glance

  • Originator Astellas Pharma Europe Ltd
  • Class Acetamides; Antispasmodics; Esters; Ethanolamines; Isoquinolines; Quinuclidines; Small molecules; Thiazoles; Urologics
  • Mechanism of Action Beta 3 adrenergic receptor agonists; Cholinergic receptor antagonists; Muscarinic receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Overactive bladder

Most Recent Events

  • 12 Sep 2017 FDA assigns PDUFA action date of 28/04/2018 for mirabegron/solifenacin for Overactive bladder
  • 12 Sep 2017 The US FDA accepts sNDA for mirabegron/solifenacin for Overactive bladder for review
  • 31 Aug 2017 Mirabegron/solifenacin is at phase III development stage for Overactive bladder in countries worldwide, except USA (PO) (Astellas Pharma Annual Report, August 2017)
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