drug
as of 2026-07-01Lurasidone
Lurasidone 20 mgLurasidone 40mgLurasidone 80 mgLurasidone HClLurasidone 120 mgLurasidone 160 mgLurasidone HC140mg lurasidone
UNII O0P4I5851IRxCUI 1040031, 1040036, 1040041, 1040043, 1235247, 1235249FDA_ApplNo NDA200603SPL_set_id afad3051-9df2-4c54-9684-e8262a133af8FDA_sponsor SUNOVION PHARMS INCOrangeBook_Appl A208002, A208016, A208028, A208031, A208037, A208045, A208047, A208049
at a glance
small molecule
US-approved (2010) as Latuda
Developed by Sumitomo Pharmaceuticals America
Orange Book protection to 2031
42 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
Mechanism of action
12.1 Mechanism of Action The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D 2 and serotonin Type 2 (5HT 2A ) receptor antagonism.
Indications
Labeled
SchizophreniaBipolar depressionMajor depressive disorder
Investigational (via trials)
Autistic DisorderSchizophreniaChronic SchizophreniaSevere Major Depression With Psychotic FeaturesPsychosisSevere Mood Disorder With Psychotic FeaturesMood Disorder NOSAsperger SyndromeAsperger SyndromeBipolar DisorderSchizophreniform DisorderMental DisordersSchizophreniaDepressive Disorder, MajorMajor Depressive DisorderMood Disorders
Patents & exclusivity
Orange Book
patent 9259423*PED2031-11-23
patent 9827242 · U-21992031-05-23
patent 9259423 · U-18222031-05-23
patent 8883794*PED2026-11-26
patent 8729085*PED2026-11-26
patent 9907794*PED2026-11-26
patent 87290852026-05-26
patent 9555027 · U-5432026-05-26
patent 99077942026-05-26
patent 88837942026-05-26
Adverse-event signal
FAERS spontaneous · within-drug share
Eps Akathisia9.5%
top term: DYSKINESIA
Sedation6.7%
top term: SOMNOLENCE
Weight Metabolic5.0%
top term: WEIGHT INCREASED
Gi4.8%
top term: NAUSEA
Mortality2.7%
top term: SUICIDE ATTEMPT
Prolactin1.0%
top term: BLOOD PROLACTIN ABNORMAL
Anticholinergic0.8%
top term: VISION BLURRED
Qt Cardiac0.4%
top term: PALPITATIONS
Spontaneous reports — a signal of reporting share, not incidence.
Trials
42
Sleep Quality, Cognitive Performance, and Computerized Cognitive Training
NCT06328140—Withdrawn
Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)
NCT05351736Phase 4Unknown
Lurasidone Non-Interventional Study in Schizophrenia Patients
NCT06527885—Completed
The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia
NCT05011669Phase 4Completed
The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients
NCT04432688—Completed
The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine
NCT05213143Phase 4Terminated
Observational Study on the Effect of Switch to Lurasidone in Subjects With Schizophrenia"
NCT04312503—Completed
A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia
NCT03465787Phase 3Completed
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
NCT03557931Phase 2Completed
A Study of Lurasidone HCl in Subjects With Schizophrenia
NCT03393026Phase 4Completed
Pediatric Open-Label Extension Study
NCT01914393Phase 3Completed
Lurasidone Vs Olanzapine on Neurotrophic Biomarkers and Cardiometabolic Parameters in Unmedicated Schizophrenia
NCT03304457Phase 4Completed
Lurasidone Effects on Tissue Glutamate in Schizophrenia
NCT02199743Phase 4Completed
Pediatric Schizophrenia Efficacy and Safety Study
NCT01911429Phase 3Completed
High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
NCT01569659Phase 4Completed
A Clinical Trial of Lurasidone in Treatment of Schizophrenia
NCT02002832Phase 3Completed
Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
NCT01731119Phase 2Completed
Lurasidone Low-Dose - High-Dose Study Study
NCT01821378Phase 3Completed
Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects
NCT02174523Phase 1Completed
A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects
NCT02174510Phase 1Completed
Lurasidone Extended Use Study
NCT01485640Phase 3Completed
A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
NCT01566162Phase 3Completed
A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone
NCT01979679Phase 3Completed
PEARL Schizophrenia Maintenance
NCT01435928Phase 3Completed
KOLs & investigators
12
Paolo Brambilla, ProfessorKOL score 11
Yifeng XuKOL score 7
Marina Bussel, MDKOL score 5
Carol A. Tamminga, M.D.KOL score 5
Steven G Potkin, MDKOL score 5
Lev G Gertsik, MDKOL score 5
Debasish Hota, MD, DMKOL score 2
Facts & assertions
24 sourced
Anda Generic Count
94
Boxed Warning
present
Dosing Frequency
once daily
Faers Share Anticholinergic
0.008
Faers Share Eps Akathisia
0.095
Faers Share Gi
0.048
Faers Share Mortality
0.027
Faers Share Prolactin
0.01
Faers Share Qt Cardiac
0.004
Faers Share Sedation
0.067
Faers Share Weight Metabolic
0.05
Has Generic Competition
yes
Latest Patent Expiry
2031-11-23
Latest Protection Date
2031-11-23
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D 2 and serotonin Type 2 (5HT 2A ) receptor an
Originator Company
Sunovion Pharms Inc
Safety Eps Akathisia
present in label
Safety Nms
present in label
Safety Orthostatic
present in label
Safety Prolactin
present in label
Safety Sedation Somnolence
present in label
Safety Weight Metabolic
present in label
Us Approved
yes
Us Original Approval Date
2010-10-28
relationships
The graph out of here
developer
trial
indication
indication
indication
indication
KOL
Paolo Brambilla, Professor
personKOL score 11
Yifeng Xu
personKOL score 7
Marina Bussel, MD
personKOL score 5
Carol A. Tamminga, M.D.
personKOL score 5