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
A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone
- Conditions
- Schizophrenia
- Interventions
- First Posted Date
- 2013-11-08
- Last Posted Date
- 2013-11-08
- Lead Sponsor
- University of California, Irvine
- Target Recruit Count
- 28
- Registration Number
- NCT01979679
- Locations
- 🇺🇸
UCI Medical Center, Orange, California, United States
Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old
- Conditions
- Bipolar IIBipolar Spectrum DisorderBipolar IManiaBipolar Disorder
- Interventions
- First Posted Date
- 2013-08-30
- Last Posted Date
- 2018-07-20
- Lead Sponsor
- Massachusetts General Hospital
- Registration Number
- NCT01932541
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
Pediatric Open-Label Extension Study
- Conditions
- SchizophreniaAutismBipolar Depression
- Interventions
- First Posted Date
- 2013-08-02
- Last Posted Date
- 2019-12-19
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 702
- Registration Number
- NCT01914393
- Locations
- 🇺🇸
Neuropsychiatric Research Center of Orange County, Santa Ana, California, United States
🇺🇸Kennedy Krieger Institute, Baltimore, Maryland, United States
🇺🇸University of South Florida, Saint Petersburg, Florida, United States
Lurasidone Pediatric Autism Study
- Conditions
- Autism
- Interventions
- First Posted Date
- 2013-07-30
- Last Posted Date
- 2016-02-25
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 150
- Registration Number
- NCT01911442
- Locations
- 🇺🇸
Florida Clinical Research Center, LLC, Maitland, Florida, United States
🇺🇸Institute for Behavioral Medicine, LLC, Smyrna, Georgia, United States
🇺🇸Capstone Clinical Research, Inc., Libertyville, Illinois, United States
Pediatric Schizophrenia Efficacy and Safety Study
- Conditions
- Schizophrenia
- Interventions
- First Posted Date
- 2013-07-30
- Last Posted Date
- 2017-04-18
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 327
- Registration Number
- NCT01911429
- Locations
- 🇧🇬
MHAT-Targovishte, AD, Targovishte, Bulgaria
🇨🇴Centro de Investigaciones y Proyectos en Neurociencias CIPNA, Barranquilla, Colombia
🇫🇷Hôpitaux Pédiatriques de Nice CHU-Lenval, Nice, France
Lurasidone Low-Dose - High-Dose Study Study
- Conditions
- Schizophrenia
- Interventions
- First Posted Date
- 2013-04-01
- Last Posted Date
- 2016-07-21
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 412
- Registration Number
- NCT01821378
- Locations
- 🇺🇸
Center for Behavioral Health, LLC, Rockville, Maryland, United States
🇷🇴Spitalul Universitar de Urgenta Militar Central "Dr Carol Davila", Bucuresti, Romania
🇷🇴Spitalul Judetean de Urgenta "Sf. Pantelimon" Focsani, Focsani, Romania
Lurasidone Pediatric Pharmacokinetics Study
- First Posted Date
- 2012-06-15
- Last Posted Date
- 2016-04-08
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 105
- Registration Number
- NCT01620060
- Locations
- 🇺🇸
Atlanta Center for Medical Research, Atlanta, Georgia, United States
🇺🇸Woodland International Research Group, Inc., Little Rock, Arkansas, United States
🇺🇸Woodland Northwest Research, LLC, Springdale, Arkansas, United States
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
- First Posted Date
- 2012-06-08
- Last Posted Date
- 2022-04-12
- Lead Sponsor
- Sumitomo Pharma Co., Ltd.
- Target Recruit Count
- 284
- Registration Number
- NCT01614912
- Locations
- 🇲🇾
10 Sites, Kuala Lumpur, Etc, Malaysia
🇯🇵69 Sites, Tokyo, Etc, Japan
🇰🇷22 Sites, Seoul, Etc, Korea, Republic of
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
- First Posted Date
- 2012-04-11
- Last Posted Date
- 2016-08-22
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 377
- Registration Number
- NCT01575561
- Locations
- 🇺🇸
Atlanta Center for Medical Research, Atlanta, Georgia, United States
🇺🇸Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center, Dallas, Texas, United States
🇵🇱NZOZ BioMed, Kielce, Poland
High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
- First Posted Date
- 2012-04-03
- Last Posted Date
- 2025-02-28
- Lead Sponsor
- Northwestern University
- Target Recruit Count
- 101
- Registration Number
- NCT01569659
- Locations
- 🇺🇸
Northwestern University Psychiatric Clinical Research Program, Chicago, Illinois, United States
🇺🇸Northwestern University Department of Psychiatry and Behavioral Sciences, Chicago, Illinois, United States
Drug Development Updates
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