Drug Profile


Alternative Names: Lu AE58054; LU-AE58054; SGS-518

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Eli Lilly
  • Developer Lundbeck A/S; Otsuka Pharmaceutical
  • Class Antipsychotics; Benzylamines; Fluorobenzenes; Indoles; Nootropics; Phenyl ethers; Small molecules
  • Mechanism of Action Serotonin 6 receptor antagonists
  • Orphan Drug Status

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

  • 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.

    Alzheimer's disease
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Alzheimer's disease
  • No development reported Cognition disorders

Most Recent Events

  • 23 Jan 2017 Lundbeck and Otsuka completes the phase III STARBRIGHT trial in Alzheimer's disease (Adjunctive treatment) in USA, Australia, Brazil, Czech Republic, Germany, Israel, Mexico, South Korea, Serbia, Singapore, Slovakia, Spain, Switzerland, Turkey and United Kingdom (NCT02006654)
  • 01 Dec 2016 Lundbeck and Otsuka completes the phase III STARBEAM trial in Alzheimer's disease (Adjunctive treatment) in USA, Argentina, Brazil, Canada, Croatia, Czech Republic, Estonia, Finland, France, Israel, Italy, South Korea, Lithuania, Poland, Portugal, Hungary, Ireland, Taiwan and United Kingdom (NCT02006641)
  • 06 Oct 2016 Lundbeck and Otsuka completes the phase III STARSHINE trial (Adjunctive treatment) in Alzheimer's disease in USA, Argentina, Belgium, Bulgaria, Canada, Chile, Czech Republic, Denmark, France, Germany, Italy, Poland, Romania, South Africa, Spain, Sweden and Ukraine (NCT01955161, EudraCT2012-004763-45)
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