Mirabegron/solifenacin

Drug Profile

Mirabegron/solifenacin

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

Latest Information Update: 13 Dec 2016

Price : $50

At a glance

  • Originator Astellas Pharma Europe Ltd
  • Class Antispasmodics; 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III Overactive bladder

Most Recent Events

  • 01 Sep 2016 Astellas Pharma completes the SYNERGY II trial in Overactive bladder in US, Australia, Belgium, Bulgaria, Canada, the Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Thailand, Ukraine and United Kingdom (NCT02045862)
  • 31 Jan 2014 Astellas Pharma initiates the phase III SYNERGY II trial in Overactive bladder in Italy and Estonia (EudraCT2012-005736-29)
  • 01 Nov 2013 Phase-III clinical trials in Overactive bladder in Belgium, Slovakia, Czech Republic, Taiwan, Slovenia, Peru, Mexico, Greece, Colombia, Argentina, United Kingdom, Sweden, Romania, Poland, Norway, Netherlands, Germany, USA, France, Spain, Hungary, Finland and Denmark (PO)
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