Drug Profile


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

Latest Information Update: 18 Oct 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

  • 22 Sep 2017 Lundbeck initiates enrolment in a phase I trial for Alzheimer's disease in USA (NCT03307993)
  • 16 Jul 2017 Pooled safety and efficacy data from the phase III STAR program in Alzheimer’s disease presented at the Alzheimer's Association International Conference 2017 (AAIC-2017)
  • 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)
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