Latuda

(Lurasidone)

ApprovedSmall molecule

Lurasidone is used to treat schizophrenia and bipolar depression. It helps reduce symptoms like hallucinations, delusions, and depressed mood by affecting certain chemicals in the brain.[2] Latuda is currently approved and in use across 6 indications[4].[1]

Latuda is one of 161 small molecule programs targeting Depressive Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

160

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Depressive DisorderApproved

Schizoaffective DisorderApproved

PsychosisActive, not recruiting

SchizophreniaCompleted

Bipolar DisorderCompleted

Bipolar DepressionActive, not recruiting

Depressive DisorderApproved

Approved

Schizoaffective DisorderApproved

Approved

PsychosisApproved

Active, not recruiting

SchizophreniaApproved

Completed

Bipolar DisorderApproved

Completed

Bipolar DepressionApproved

Active, not recruiting

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Latuda

SSunovion Respiratory Development Inc.

Approved

18 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Persantine

Boehringer Ingelheim

Preclinical

1 10

Catapres

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Study completion

NCT05480150

Q4 2027

Phase 3Not yet recruiting

Major Depressive Disorder (MDD)

NCT07781293

Q3 2028

ApprovedNot yet recruiting

Bipolar Disorder

NCT07806227

Q1 2030

Post-ApprovalActive, not recruiting

Bipolar Depression

NCT06433635

Clinical

Trials by Indication[1]

Schizophrenia18 trials

A Study of Lurasidone HCl in Subjects With Schizophrenia

Completed·SStandard Chem. & Pharm. Co., Ltd.·Phase 4·NCT03393026·54 enrolled

Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00615433·478 enrolled

Observational Study on the Effect of Switch to Lurasidone in Subjects With Schizophrenia"

Completed·AAziende Chimiche Riunite Angelini Francesco S.p.A··NCT04312503·95 enrolled

Show 15 more trials

Lurasidone Non-Interventional Study in Schizophrenia Patients

Completed·AAziende Chimiche Riunite Angelini Francesco S.p.A··NCT06527885·61 enrolled

The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia

Completed·SSumitomo Pharma (Suzhou) Co., Ltd.·Phase 4·NCT05011669·200 enrolled

Lurasidone Effects on Tissue Glutamate in Schizophrenia

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT02199743·35 enrolled

The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine

Terminated·SSumitomo Pharma (Suzhou) Co., Ltd.·Phase 4·NCT05213143·13 enrolled

A Clinical Trial of Lurasidone in Treatment of Schizophrenia

Completed·SSumitomo Pharma (Suzhou) Co., Ltd.·Phase 3·NCT02002832·388 enrolled

Safety and Tolerability Study of Drug to Treat Schizophrenia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 2·NCT00044005·98 enrolled

A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 2·NCT00044044·356 enrolled

Pediatric Schizophrenia Efficacy and Safety Study

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01911429·327 enrolled

A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 2·NCT00088621·61 enrolled

High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia

Completed·NNorthwestern University·Phase 4·NCT01569659·101 enrolled

Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00790192·488 enrolled

A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 2·NCT00088634·180 enrolled

A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01566162·191 enrolled

Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in Unmedicated Schizophrenia

Completed·—·Phase 4·NCT03304457·100 enrolled

PEARL Schizophrenia Maintenance

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01435928·676 enrolled

Major Depressive Disorder3 trials

Major Depressive Disorder With Mixed Features - Extension

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01423253·48 enrolled

Major Depressive Disorder With Mixed Features

Withdrawn· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01423240

Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01421134·211 enrolled

Bipolar Disorder3 trials

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

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

Completed·NNew York State Psychiatric Institute·Phase 4·NCT03902613·1 enrolled

Broadband Near Infrared Spectroscopy to Elucidate the of Role Cortical Brain Cytochrome C Oxidase Activity in the Pathophysiology of Bipolar Disorder

Not yet recruiting·MMartin Lan·Approved·NCT07806227·60 enrolled

Depression3 trials

Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00868959·817 enrolled

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00868452·348 enrolled

Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01284517·356 enrolled

Bipolar Depression3 trials

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Active, not recruiting·MMassachusetts General Hospital·Phase 4·NCT06433635·2,726 enrolled

Sequential Therapy for the Treatment of Severe Bipolar Depression.

Completed·NNeuroRx, Inc.·Phase 2·NCT02974010·22 enrolled

Biosignatures of Latuda for Bipolar Depression

Completed·NNew York State Psychiatric Institute·N/A·NCT02239094·20 enrolled

16 more indications

Cognitive impairment2 trials

A 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

Completed· Astellas logo

Astellas·Phase 2·NCT03557931·233 enrolled

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

Unknown status·FFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico·Phase 4·NCT05351736·10 enrolled

Pediatric2 trials

Lurasidone Pediatric Bipolar Study

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT02046369·350 enrolled

Lurasidone Pediatric Pharmacokinetics Study

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1·NCT01620060·105 enrolled

Bipolar I Disorder2 trials

Lurasidone and Cognition in Bipolar I Disorder

Completed·UUniversity of British Columbia·Phase 3·NCT02147379·53 enrolled

This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01575561·377 enrolled

Oral2 trials

Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects

Completed·SSumitomo Pharma (Suzhou) Co., Ltd.·Phase 1·NCT02174523·14 enrolled

A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects

Completed·SSumitomo Pharma (Suzhou) Co., Ltd.·Phase 1·NCT02174510·37 enrolled

Cognitive Function1 trial

Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar Patients

Completed·LLakshmi N Yatham·Phase 3·NCT02731612·100 enrolled

Drug1 trial

An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)

Completed·OOrganon and Co··NCT01498770·42 enrolled

Monotherapy1 trial

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00868699·505 enrolled

AIN1 trial

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01358357·965 enrolled

Sleep Quality1 trial

Sleep Quality, Cognitive Performance, and Computerized Cognitive Training

Withdrawn·GGeorge West Mental Health Foundation d/b/a Skyland Trail··NCT06328140

Autism1 trial

Lurasidone Pediatric Autism Study

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01911442·150 enrolled

Interaction1 trial

Digoxin Drug-Drug Interaction With Lurasidone HCl

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1·NCT01082289·24 enrolled

Randomized1 trial

A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1·NCT00549666·23 enrolled

MRI1 trial

A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone

Completed·UUniversity of California, Irvine·Phase 3·NCT01979679·28 enrolled

Bipolar Disorder (BD)1 trial

A Retrospective Observational Study on Weight Change, Effectiveness, and Safety Following Switching to Lurasidone in Korean Patients With Bipolar Disorder Under Routine Clinical Practice

Completed·DDong-Wook Kim··NCT07834112·155 enrolled

Major Depressive Disorder (MDD)1 trial

Evaluating the Efficacy and Safety of Lurasidone as Adjunctive Therapy in Adult Patients Diagnosed With Major Depressive Disorder Who Have an Inadequate Response to Antidepressant Monotherapy: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Not yet recruiting·BBukwang Pharmaceutical·Phase 3·NCT07781293·364 enrolled

Unspecified4 trials

Lurasidone Extended Use Study

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01485640·162 enrolled

Chinese Longitudinal and Systematic Study of Bioplar Disorder

Recruiting·FFirst Affiliated Hospital of Zhejiang University·N/A·NCT05480150·10,000 enrolled

Lurasidone Low-Dose - High-Dose Study Study

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT01821378·412 enrolled

Show 1 more trial

RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1·NCT01082146·6 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 10, 2010

LATUDA

NDA NDA200603

Dec 7, 2011

LATUDA

NDA NDA200603

Dec 7, 2011

LATUDA

NDA NDA200603

Dec 7, 2011

LATUDA

NDA NDA200603

Apr 26, 2012

LATUDA

NDA NDA200603

Apr 26, 2012

LATUDA

NDA NDA200603

Jan 22, 2013

LATUDA

NDA NDA200603

Jan 22, 2013

LATUDA

NDA NDA200603

Jun 13, 2013

LATUDA

NDA NDA200603

Jun 28, 2013

LATUDA

NDA NDA200603

Jun 28, 2013

LATUDA

NDA NDA200603

Jul 12, 2013

LATUDA

NDA NDA200603

Sep 3, 2013

LATUDA

NDA NDA200603

Feb 28, 2014

LATUDA

NDA NDA200603

May 21, 2014

LATUDA

NDA NDA200603

Jan 5, 2015

LATUDA

NDA NDA200603

Jul 30, 2015

LATUDA

NDA NDA200603

Mar 29, 2016

LATUDA

NDA NDA200603

Jul 8, 2016

LATUDA

NDA NDA200603

Dec 20, 2016

LATUDA

NDA NDA200603

Jan 11, 2017

LATUDA

NDA NDA200603

Jan 27, 2017

LATUDA

NDA NDA200603

Jan 27, 2017

LATUDA

NDA NDA200603

Feb 23, 2017

LATUDA

NDA NDA200603

Sep 25, 2017

LATUDA

NDA NDA200603

Mar 5, 2018

LATUDA

NDA NDA200603

Dec 4, 2019

LATUDA

NDA NDA200603

Jan 22, 2025

LATUDA

NDA NDA200603

Sources

References

[1]
ClinicalTrials.gov — 53 trial records for Lurasidone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Latuda drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lurasidone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lurasidone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA200603). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Latuda. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Sunovion Respiratory Development Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dopamine D2 Receptor Antagonist; Serotonin 2a (5-Ht2a) Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSunovion Respiratory Development Inc.

Patent Landscape[6]

Patent Cliff

Nov 26, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8729085May 26, 2026

9555027May 26, 2026

9907794May 26, 2026

8883794May 26, 2026

9907794*PEDNov 26, 2026

5 more patents

8883794*PEDNov 26, 2026

8729085*PEDNov 26, 2026

9259423May 23, 2031

9827242May 23, 2031

9259423*PEDNov 23, 2031

Latuda

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q3 2028

Q1 2030

Trials by Indication[1]

Schizophrenia18 trials

Major Depressive Disorder3 trials

Bipolar Disorder3 trials

Depression3 trials

Bipolar Depression3 trials

Cognitive impairment2 trials

Pediatric2 trials

Bipolar I Disorder2 trials

Oral2 trials

Cognitive Function1 trial

Drug1 trial

Monotherapy1 trial

AIN1 trial

Sleep Quality1 trial

Autism1 trial

Interaction1 trial

Randomized1 trial

MRI1 trial

Bipolar Disorder (BD)1 trial

Major Depressive Disorder (MDD)1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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