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

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

Phase 4
Completed
Conditions
Bipolar Depression
Interventions
First Posted Date
2019-04-04
Last Posted Date
2023-11-13
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
1
Registration Number
NCT03902613
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

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

First Posted Date
2018-06-15
Last Posted Date
2024-11-11
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
233
Registration Number
NCT03557931
Locations
🇺🇸

CNS Research Science, Inc., Jamaica, New York, United States

🇺🇸

Synergy East, Lemon Grove, California, United States

🇺🇸

Pacific Research Partners, LLC, Oakland, California, United States

and more 22 locations

A 6-week Study to Evaluate the Efficacy and Safety of Lurasidone HCL in Acutely Psychotic Patients With Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2018-03-14
Last Posted Date
2023-02-08
Lead Sponsor
Bukwang Pharmaceutical
Target Recruit Count
210
Registration Number
NCT03465787
Locations
🇰🇷

Borame Medical Center, Seoul, Seoul, Dongjak-gu, Korea, Republic of

NRX101 Glx Biomarker Validation Study

Phase 2
Completed
Conditions
Bipolar Depression
Suicidal Ideation
Interventions
First Posted Date
2018-01-18
Last Posted Date
2022-08-09
Lead Sponsor
NeuroRx, Inc.
Target Recruit Count
8
Registration Number
NCT03402152
Locations
🇺🇸

New York State Psychiatric Institute, New York, New York, United States

NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation

Phase 3
Active, not recruiting
Conditions
Bipolar Depression
Suicidal Ideation
Interventions
First Posted Date
2018-01-10
Last Posted Date
2024-01-19
Lead Sponsor
NeuroRx, Inc.
Target Recruit Count
72
Registration Number
NCT03396068
Locations
🇺🇸

JP Smith Hospital, Fort Worth, Texas, United States

🇺🇸

Research Site, Birmingham, Birmingham, Alabama, United States

🇺🇸

Research Centers of America, Hollywood, Florida, United States

and more 1 locations

NRX-101 for Bipolar Depression With Subacute Suicidal Ideation

Phase 2
Completed
Conditions
Bipolar Depression
Suicidal Ideation and Behavior
Interventions
First Posted Date
2018-01-10
Last Posted Date
2024-05-08
Lead Sponsor
NeuroRx, Inc.
Target Recruit Count
74
Registration Number
NCT03395392
Locations
🇺🇸

iResearch Atlanta, LLC, Decatur, Georgia, United States

🇺🇸

iResearch Savannah, Savannah, Georgia, United States

🇺🇸

Peace Health Medical Group, Eugene, Oregon, United States

and more 11 locations

A Study of Lurasidone HCl in Subjects With Schizophrenia

Phase 4
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2018-01-08
Last Posted Date
2020-02-05
Lead Sponsor
Standard Chem. & Pharm. Co., Ltd.
Target Recruit Count
54
Registration Number
NCT03393026
Locations
🇨🇳

Tri-Service General Hospital, Taipei, Taiwan

🇨🇳

Taipei City Hospital, Songde Branch, Taipei, Taiwan

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

Phase 4
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2017-10-09
Last Posted Date
2020-03-31
Lead Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Target Recruit Count
100
Registration Number
NCT03304457
Locations
🇮🇳

AIIMS, Bhubaneshwar, Odisha, India

Sequential Therapy for the Treatment of Severe Bipolar Depression.

Phase 2
Completed
Conditions
Bipolar Depression
Suicidal Ideas
Suicidal Ideation
Suicide, Attempted
Interventions
Drug: NRX-101 Oral Capsule
Drug: Saline Solution Intravenous Infusion
First Posted Date
2016-11-28
Last Posted Date
2021-05-25
Lead Sponsor
NeuroRx, Inc.
Target Recruit Count
22
Registration Number
NCT02974010
Locations
🇺🇸

Research Site, Birmingham, Birmingham, Alabama, United States

🇺🇸

Research Site, Charlotte, Charlotte, North Carolina, United States

🇺🇸

Research Site, Houston, Houston, Texas, United States

and more 1 locations

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated
Conditions
Bipolar Disorder
First Posted Date
2016-09-08
Last Posted Date
2024-03-12
Lead Sponsor
University of New Mexico
Target Recruit Count
1037352
Registration Number
NCT02893371
Locations
🇺🇸

Christophe G Lambert, Albuquerque, New Mexico, United States

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