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Olanzapine/samidorphan - Alkermes plc

Drug Profile

Olanzapine/samidorphan - Alkermes plc

Alternative Names: ALKS 33/olanzapine; ALKS-3831; LYBALVI; Olanzapine/ALKS 33; Samidorphan/olanzapine

Latest Information Update: 06 Aug 2021

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At a glance

  • Originator Alkermes plc
  • Class Amides; Antipsychotics; Benzodiazepines; Cyclopropanes; Mood stabilisers; Morphinans; Oxazepines; Phenanthrenes; Small molecules; Thiazepines
  • Mechanism of Action Dopamine D1 receptor antagonists; Dopamine D2 receptor antagonists; Opioid mu receptor antagonists; Serotonin 2A 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

  • Registered Bipolar disorders; Schizophrenia
  • Phase III Psychotic disorders

Most Recent Events

  • 03 Aug 2021 Alkermes plans the phase III ENLIGHTEN-Youth Extension trial for Schizophrenia and Bipolar disorders (In Child, In adolescents) (PO) in August 2021 (NCT04987229)
  • 22 Jul 2021 Phase-I clinical trials in Bipolar disorders (In children, Treatment-experienced) in USA (PO) (NCT04987658)
  • 03 Jun 2021 Olanzapine/samidorphan label in USA carries a boxed warning
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