Lurasidone

Generic Name: Lurasidone

Brand Names: Latuda

Drug Type: Small Molecule

Chemical Formula: C_₂₈H_₃₆N_₄O_₂S

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

Clinical Trials

A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents

Phase 3

Completed

Conditions: Schizophrenia
Schizoaffective Disorder

Interventions: Drug: Lurasidone HCl

First Posted Date: 2010-06-14

Last Posted Date: 2013-04-17

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 244

Registration Number: NCT01143077

Locations: 🇺🇸
Collaborative Neuroscience Network, South Bay, Torrance, California, United States
🇺🇸
Comprehensive NeuroScience, Inc., Atlanta, Georgia, United States
🇺🇸
CRI Worldwide - Kirkbride Center, Philadelphia, Pennsylvania, United States

and more 24 locations

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

Phase 1

Completed

Conditions: Metabolism
Pharmacokinetics

Interventions: Drug: Lurasidone

First Posted Date: 2010-03-08

Last Posted Date: 2014-04-03

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 6

Registration Number: NCT01082146

Locations: 🇺🇸
Covance Global Clinical Research Unit Inc., Madison, Wisconsin, United States

Rifampin Drug-Drug Interaction Study With Lurasidone HCl

Phase 1

Completed

Conditions: Male, Healthy Normal Subjects

Interventions: Drug: Lurasidone HCl

First Posted Date: 2010-03-08

Last Posted Date: 2011-09-08

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 20

Registration Number: NCT01082276

Locations: 🇺🇸
PAREXEL Clinical Pharmacology Research Unit, Baltimore, Maryland, United States

Midazolam Drug-Drug Interaction Study With Lurasidone HCl

Phase 1

Completed

Conditions: Schizophrenia Patients

Interventions: Drug: Lurasidone HCl

First Posted Date: 2010-03-08

Last Posted Date: 2011-09-08

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 24

Registration Number: NCT01082263

Locations: 🇺🇸
CCT/Parexel, Culver City, California, United States

The Bioequivalence Of Two Different Lurasidone Formulations In Patients

Phase 1

Completed

Conditions: Schizophrenia

Interventions: Drug: Lurasidone HCl

First Posted Date: 2010-03-08

Last Posted Date: 2011-09-08

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 52

Registration Number: NCT01082250

Locations: 🇺🇸
California Clinical Trials (CCT), Glendale, California, United States

Digoxin Drug-Drug Interaction With Lurasidone HCl

Phase 1

Completed

Conditions: Schizophrenia

First Posted Date: 2010-03-08

Last Posted Date: 2011-09-08

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 24

Registration Number: NCT01082289

Locations: 🇺🇸
California Clinical Trials, Culver City, California, United States

Lithium Drug-Drug Interaction Study With Lurasidone HCl

Phase 1

Completed

Conditions: Schizophrenia

Interventions: Drug: Lurasidone HCl

First Posted Date: 2010-02-24

Last Posted Date: 2011-09-08

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 24

Registration Number: NCT01074073

Locations: 🇺🇸
CCT/Parexel, Culver City, California, United States

Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl

Phase 1

Completed

Conditions: Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

First Posted Date: 2010-02-24

Last Posted Date: 2011-09-08

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 26

Registration Number: NCT01074632

Locations: 🇺🇸
Clinical Research Institute, Wichita, Kansas, United States
🇺🇸
California Clinical Trials, Glendale, California, United States

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

Phase 3

Completed

Conditions: Bipolar Depression

Interventions: Drug: Placebo
Drug: lurasidone

First Posted Date: 2009-03-25

Last Posted Date: 2014-04-17

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 505

Registration Number: NCT00868699

Locations: 🇺🇸
CRI Worldwide, LLC, Philadelphia, Pennsylvania, United States
🇺🇸
Mood Disorders Program-UHCMC, Cleveland, Ohio, United States
🇮🇳
R.K. Yadav Memorial Mental Health & De-Addiction Hospital, Jaipur, Rajasthan, India

and more 52 locations

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

Phase 3

Completed

Conditions: Bipolar Depression

Interventions: Drug: lurasidone + (lithium or divalproex)
Drug: Placebo + (lithium or divalproex)

First Posted Date: 2009-03-25

Last Posted Date: 2014-04-17

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 348

Registration Number: NCT00868452

Locations: 🇨🇿
Clintrial, s.r.o., Praha, Czech Republic
🇮🇳
Manobal Med. Research Centre, Lucknow, Uttar Prad, India
🇷🇴
Spitalul Clinic Judetean de Urgenta Cluj, Cluj-Napoca, Romania

and more 68 locations

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