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Lurasidone - Sumitomo Pharma

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Drug Profile

Lurasidone - Sumitomo Pharma

Alternative Names: DSP-1349M; Latuda; Lurasidone HCl; Lurasidone hydrochloride; Lurasidone injectable suspension; Lurasidone injection suspension; SM-13496; SMP-13496

Latest Information Update: 12 Jan 2026

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At a glance

  • Originator Dainippon Sumitomo Pharma
  • Developer Angelini Group; Bukwang Pharmaceutical; Daiichi Sankyo Company; DKSH Singapore; DKSH Thailand; Standard Chemical & Pharmaceutical Company; Sumitomo Pharma; Sumitomo Pharma America; Takeda
  • Class Antidepressants; Antipsychotics; Cyclohexanes; Isoindoles; Piperazines; Small molecules; Thiazoles
  • Mechanism of Action 5-HT1A serotonin receptor agonists; 5-HT2C serotonin receptor antagonists; Dopamine D2 receptor antagonists; Serotonin 5-HT2A receptor antagonists; Serotonin 7 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 depression; Schizophrenia
  • Preregistration Bipolar disorders
  • Phase III Autistic disorder; Major depressive disorder; Psychiatric disorders

Most Recent Events

  • 12 Jan 2026 Lurasidone is still in phase III trials for Schizophrenia (indication) in Japan (In adolescents, In children) and in Japan, Slovakia, Poland (In adolescents, In children) (Dainippon Sumitomo Pharma pipeline, January 2026)
  • 21 Feb 2023 First generic equivalent launched in USA by Lupin
  • 31 Jan 2023 Discontinued - Phase-III for Bipolar depression in China (PO) prior to January 2023

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