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Olanzapine/samidorphan - Alkermes

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Drug Profile

Olanzapine/samidorphan - Alkermes

Alternative Names: ALKS 33/olanzapine; ALKS-3831; LYBALVI; Olanzapine/ALKS 33; OLZ/SAM - Alkermes plc; Samidorphan/olanzapine

Latest Information Update: 11 Aug 2026

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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 5-HT2A receptor antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Bipolar disorders; Schizophrenia
  • No development reported Psychotic disorders

Most Recent Events

  • 29 Jul 2026 Alkermes initiates an Expanded Access Program for Schizophrenia and Bipolar disorder(In children, In adolescents) in USA (PO)(NCT07744113)
  • 27 Feb 2026 Alkermes has patent protection for Olanzapine/samidorphan in USA
  • 31 Jan 2025 Alkermes has patent protection for olanzapine/samidorphan in USA

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