MedPath

Lurasidone

Generic Name
Lurasidone
Brand Names
Latuda
Drug Type
Small Molecule
Chemical Formula
C28H36N4O2S
CAS Number
367514-87-2
Unique Ingredient Identifier
22IC88528T
Background

Lurasidone is an atypical antipsychotic developed by Dainippon Sumitomo Pharma. It was approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia on October 29, 2010 and is currently pending approval for the treatment of bipolar disorder in the United States.

Indication

Lurasidone is indicated for the treatment of schizophrenia in patients ≥13 years old. It is also indicated as a monotherapy for the treatment of bipolar depression in patients ≥10 years old, or in combination with lithium or valproate for the treatment of bipolar depression in adults.

Associated Conditions
Depression, Bipolar, Schizophrenia

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

Phase 3
Completed
Conditions
Bipolar Depression
Interventions
First Posted Date
2009-03-25
Last Posted Date
2016-04-14
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
817
Registration Number
NCT00868959
Locations
🇺🇸

Clinical Innovations Inc., Santa Ana, California, United States

🇺🇸

Accurate Clinical Trials, Kissimmee, Florida, United States

🇺🇸

Sheppard Pratt Health System, Baltimore, Maryland, United States

and more 144 locations

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

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2008-11-13
Last Posted Date
2016-03-17
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
488
Registration Number
NCT00790192
Locations
🇺🇸

CNRI-Los Angeles. LLC, Pico Rivera, California, United States

🇺🇸

Florida Clinical Research Center, Bradenton, Florida, United States

🇷🇴

Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos", Bdul Nicolae Grigorescu nr. 41, Bucuresti, Romania

and more 58 locations

Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia

Phase 3
Completed
Conditions
Chronic Schizophrenia
Interventions
First Posted Date
2008-11-13
Last Posted Date
2015-06-12
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
240
Registration Number
NCT00789698
Locations
🇺🇸

Florida Clinical Research Center LLC, Bradenton, Florida, United States

🇺🇸

Pillar Clinical Research, Dallas, Texas, United States

🇮🇳

Deenanath Mangeshkar Hospital and Research Centre, Pune, Maharastra, India

and more 59 locations

Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Schizoaffective Disorder
Interventions
First Posted Date
2008-03-24
Last Posted Date
2015-06-22
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
629
Registration Number
NCT00641745
Locations
🇺🇸

K&S Professional Research Services LLC, Little Rock, Arkansas, United States

🇺🇸

Woodland International Research Group, LLC, Little Rock, Arkansas, United States

🇺🇸

Fidelity Clinical Research Inc., North Miami, Florida, United States

and more 66 locations

Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2008-02-14
Last Posted Date
2015-06-12
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
478
Registration Number
NCT00615433
Locations
🇺🇸

Lousiana Clinical Research, LLC, Shreveport, Louisiana, United States

🇺🇸

UCSD Medical Center, San Diego, California, United States

🇺🇸

Clinical Pharmacological Studies, Inc., Cerritos, California, United States

and more 49 locations

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

Phase 1
Completed
Conditions
Pharmacokinetics
Interventions
First Posted Date
2007-10-26
Last Posted Date
2011-09-14
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
23
Registration Number
NCT00549666
Locations
🇺🇸

Covance Global Clinical Pharmacology, Inc., San Diego, California, United States

Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2007-10-26
Last Posted Date
2014-06-11
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
489
Registration Number
NCT00549718
Locations
🇺🇸

Clinical Innovations, Inc., Costa Mesa, California, United States

🇺🇸

Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3, Garden Grove, California, United States

🇺🇸

Center for Behavioral Health, LLC, Rockville, Maryland, United States

and more 45 locations

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

Phase 2
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2004-08-02
Last Posted Date
2014-04-17
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
61
Registration Number
NCT00088621
Locations
🇺🇸

Segal Institute for Clinical Research, North Miami, Florida, United States

🇺🇸

Optimum Health Services, La Mesa, California, United States

🇺🇸

Birmingham Psychiatry Pharmaceutical, Birmingham, Alabama, United States

and more 16 locations

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

Phase 2
Completed
Conditions
Schizophrenia
Interventions
Drug: Placebo
First Posted Date
2004-08-02
Last Posted Date
2016-04-08
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
180
Registration Number
NCT00088634
Locations
🇺🇸

Birmingham Psychiatry Pharmaceutical, Birmingham, Alabama, United States

🇺🇸

Summit Research Group, Little Rock, Arkansas, United States

🇺🇸

Comprehensive NeuroScience, Cerritos, California, United States

and more 19 locations

Safety and Tolerability Study of Drug to Treat Schizophrenia

Phase 2
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2002-08-20
Last Posted Date
2014-04-17
Lead Sponsor
Sumitomo Pharma America, Inc.
Target Recruit Count
98
Registration Number
NCT00044005
Locations
🇺🇸

University of California, Irvine, Orange, California, United States

🇺🇸

University of South Florida, Tampa, Florida, United States

🇺🇸

Lake Mead Hospital, North Las Vegas, Nevada, United States

and more 23 locations
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