Drug

Lurasidone

Approved · EMA

Emerging researchLate-stage developmentRising momentum

Also known as Latuda, Lurasidona, Lurasidonum.

RxNorm1040028 ChEMBLCHEMBL1237021UNII22IC88528T

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Clinical trial2025-12-16Results expected Q1 2030 · ClinicalTrials.gov

High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia

Clinical trial2025-02-28Results posted · ClinicalTrials.gov

A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Patients (ELICE-BD)

Clinical trial2024-12-31Completed · ClinicalTrials.gov

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

Clinical trial2024-11-12Results posted · ClinicalTrials.gov

Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)

Clinical trial2024-01-28Primary completion · ClinicalTrials.gov

18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder

Clinical trial2023-11-13Results posted · ClinicalTrials.gov

The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia: A Multi-Center, Prospective, Open-Label Study for 6 Weeks

Clinical trial2023-06-16Completed · ClinicalTrials.gov

Approval: Latuda (EMA)

Regulatory2014-03-21EMA

Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study.

Research2014-02-01The American journal of psychiatry

Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia.

Research2013-12-13CNS spectrums

Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension.

Research2013-08-27European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial.

Research2013-02-13Schizophrenia research

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Lurasidone

Aliases & brands

LatudaLurasidonaLurasidonum

RxNorm CUI

1040028

ChEMBL ID

CHEMBL1237021

UNII

22IC88528T

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2014-03-21

Latest approval

2014-03-21

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2014-03-21Approval

Approval: Latuda (EMA)

Indication: Treatment of schizophrenia in adults aged 18 years and over.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

44 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2024

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 44

Phase 16Phase 26Phase 321Phase 49Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Active, not recruitingPH IVKey trialMassachusetts General Hospitaln=2,7262030

Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)

Unknown statusPH IVFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinicon=102024

The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia: A Multi-Center, Prospective, Open-Label Study for 6 Weeks

CompletedPH IVMarubeni Pharmaceuticals (Suzhou) Co., Ltd.n=2002023

The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine: An Open-label, Single-arm And Multi-center Study for 16 Weeks

TerminatedPH IVMarubeni Pharmaceuticals (Suzhou) Co., Ltd.n=132022

A Multi-Center, Open-Label, Single Arm and Flexible Dose Study of the Effectiveness and Safety of Oral Use Lurasidone HCl Tablet (LATUDA®) for 40-160 mg/Day in Subjects With Schizophrenia

CompletedPH IVStandard Chem. & Pharm. Co., Ltd.n=542019

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH IIILakshmi N Yathamn=1002024

The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia: A Multi-Center, Prospective, Open-Label Study for 6 Weeks

CompletedPH IVMarubeni Pharmaceuticals (Suzhou) Co., Ltd.n=2002023

Sequential Therapy (NRX-100 Followed by NRX-101) for the Treatment of Acute Suicidal Ideation and Behavior in Bipolar Depression: the STABIL-B Study

CompletedPH IINeuroRx, Inc.n=222019

CompletedPH IIAstellas Pharma Global Development, Inc.n=2332019

A Multi-Center, Open-Label, Single Arm and Flexible Dose Study of the Effectiveness and Safety of Oral Use Lurasidone HCl Tablet (LATUDA®) for 40-160 mg/Day in Subjects With Schizophrenia

CompletedPH IVStandard Chem. & Pharm. Co., Ltd.n=542019

18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder

CompletedPH IVNew York State Psychiatric Instituten=12019

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20092014

Most influential

Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study.

The American journal of psychiatry · 2014 · 214 cites

Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial.

The Journal of clinical psychiatry · 2009 · 150 cites

Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial.

Schizophrenia research · 2013 · 125 cites

Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2013 · 58 cites

Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia.

CNS spectrums · 2014 · 25 cites