SEP 363856

Drug Profile

SEP 363856

Alternative Names: SEP-363856; SEP-856

Latest Information Update: 15 Feb 2017

Price : $50

At a glance

  • Originator Dainippon Sumitomo Pharma
  • Developer Sumitomo Dainippon Pharma; Sunovion Pharmaceuticals
  • Class Antipsychotics
  • Mechanism of Action Serotonin 1A receptor agonists; Trace amine-associated receptor 1 agonists
  • 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 Yes

Highest Development Phases

  • Phase II Psychotic disorders; Schizophrenia
  • Discontinued Major depressive disorder

Most Recent Events

  • 31 Jan 2017 Sunovion initiates a phase II extension trial for Schizophrenia in Hungary (PO) (EudraCT2016-001556-21)
  • 02 Dec 2016 Phase-II clinical trials in Psychotic disorders in USA (PO) (NCT02969382,
  • 27 Oct 2016 Phase-II clinical trials in Schizophrenia in Hungary (PO) (EudraCT2016-001555-41)
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