Drug Profile


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

Latest Information Update: 31 Jul 2017

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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.

  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 06 Jul 2017 Lundbeck completes the phase III STAR extension trial for Alzheimer's disease (Adjunctive treatment) in USA, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Israel, Italy, South Korea, Lithuania, Poland, Portugal, Romania, South Africa, Spain, Taiwan, Ukraine and United Kingdom (NCT02079246)
  • 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)
  • 15 Dec 2016 Biomarkers information updated
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