MedPath

Cariprazine

Generic Name
Cariprazine
Brand Names
Vraylar, Reagila
Drug Type
Small Molecule
Chemical Formula
C21H32Cl2N4O
CAS Number
839712-12-8
Unique Ingredient Identifier
F6RJL8B278
Background

Cariprazine is an atypical antipsychotic agent and a piperazine derivative that was first developed in Hungary. It works as a partial agonist at central dopamine D2, dopamine D3, and serotonin 5-HT receptors and as an antagonist at serotonin 5-HT receptors. Cariprazine has been investigated in a variety of psychiatric disorders, including schizophrenia, bipolar disorders, and major depressive disorder. Cariprazine gained its first global approval in the US in September 2015 and was later approved by Health Canada in April 2022. It is currently used to treat schizophrenia, and manic or mixed episodes and depressive episodes associated with bipolar I disorder.

Indication

Cariprazine is indicated for the treatment of schizophrenia in adults to manage both positive and negative symptoms. It is also indicated to monotherapy for acute management of manic or mixed episodes associated with bipolar I disorder (bipolar mania) in adults, and acute management of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.

Associated Conditions
Bipolar Disorder With Manic or Mixed Episodes, Depressive Episodes, Schizophrenia

Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

Phase 1
Completed
Conditions
Schizophrenia
Interventions
Drug: Risperidone/Moxifloxacin
First Posted Date
2011-06-20
Last Posted Date
2012-02-08
Lead Sponsor
Forest Laboratories
Target Recruit Count
129
Registration Number
NCT01376076
Locations
🇺🇸

Forest Investigative Site 003, Houston, Texas, United States

🇺🇸

Forest Investigative Site 002, Willingboro, New Jersey, United States

🇺🇸

Forest Investigative Site 004, Long Beach, California, United States

and more 1 locations

Safety and Efficacy of Cariprazine in Patients With Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2010-04-15
Last Posted Date
2018-10-29
Lead Sponsor
Forest Laboratories
Target Recruit Count
617
Registration Number
NCT01104766
Locations
🇺🇸

Synergy Clinical Research of Escondido, Escondido, California, United States

🇺🇸

Excell Research, Inc, Oceanside, California, United States

🇺🇸

Colorado Clinical Trials, Inc., Littleton, Colorado, United States

and more 55 locations

Long-term Study of Cariprazine in Patients With Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2010-04-15
Last Posted Date
2019-07-26
Lead Sponsor
Forest Laboratories
Target Recruit Count
752
Registration Number
NCT01104792
Locations
🇺🇸

Forest Investigative Site 044, Rockville, Maryland, United States

🇺🇸

Forest Investigative Site 007, Flowood, Mississippi, United States

🇺🇸

Forest Investigative Site 082, North Miami, Florida, United States

and more 83 locations

Safety and Efficacy of Cariprazine in Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Interventions
Drug: Placebo
First Posted Date
2010-04-15
Last Posted Date
2018-11-14
Lead Sponsor
Forest Laboratories
Target Recruit Count
446
Registration Number
NCT01104779
Locations
🇮🇳

Forest Investigative Site 503, Ahmedabad, Gujarat, India

🇨🇴

Forest Investigative Site 604, Pereira, Risaralda, Colombia

🇮🇳

Forest Investigative Site 505, Vijayawada, Andhra Pradesh, India

and more 38 locations

Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

Phase 3
Completed
Conditions
Bipolar I Disorder
Interventions
First Posted Date
2010-02-01
Last Posted Date
2019-06-13
Lead Sponsor
Forest Laboratories
Target Recruit Count
403
Registration Number
NCT01059539
Locations
🇺🇸

Forest Investigative Site 015, Springdale, Arkansas, United States

🇺🇸

Forest Investigative Site 004, Garden Grove, California, United States

🇺🇸

Forest Investigative Site 010, Carson, California, United States

and more 32 locations

Safety and Efficacy of Cariprazine for Bipolar I Disorder

Phase 3
Completed
Conditions
Mania
Bipolar I Disorder
Interventions
Drug: Placebo
First Posted Date
2010-01-29
Last Posted Date
2017-04-12
Lead Sponsor
Forest Laboratories
Target Recruit Count
497
Registration Number
NCT01058668
Locations
🇺🇸

Forest Investigative Site 025, St. Louis, Missouri, United States

🇷🇴

Forest Investigative Site 206, Bucuresti, Romania

🇺🇦

Forest Investigative Site 307, Kharkiv, Ukraine

and more 63 locations

Safety and Efficacy of Cariprazine for Mania

Phase 3
Completed
Conditions
Bipolar Disorder
Mania
Interventions
Drug: Placebo
First Posted Date
2010-01-28
Last Posted Date
2017-04-17
Lead Sponsor
Forest Laboratories
Target Recruit Count
323
Registration Number
NCT01058096
Locations
🇮🇳

Forest Investigative Site 112, Vizag, Andhra Pradesh, India

🇮🇳

Forest Investigator Site 108, Varanasi, Durgakund, India

🇮🇳

Forest Investigative Site 106, Vijayawada, Andhra Pradesh, India

and more 25 locations

Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia

Phase 2
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2009-03-17
Last Posted Date
2021-04-12
Lead Sponsor
Mitsubishi Tanabe Pharma Corporation
Target Recruit Count
34
Registration Number
NCT00862992
Locations
🇯🇵

Hoyu Hospital, Kure-City, Hiroshima-ken, Japan

Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

Phase 2
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2009-03-02
Last Posted Date
2019-03-05
Lead Sponsor
Forest Laboratories
Target Recruit Count
231
Registration Number
NCT00854100
Locations
🇺🇸

Forest Investigative Site 031, Memphis, Tennessee, United States

🇺🇸

Forest Investigative Site 023, Memphis, Tennessee, United States

🇺🇸

Forest Investigative Site 033, Atlanta, Georgia, United States

and more 18 locations

Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

Phase 2
Completed
Conditions
Bipolar Depression
Interventions
Drug: placebo
First Posted Date
2009-02-26
Last Posted Date
2018-08-23
Lead Sponsor
Forest Laboratories
Target Recruit Count
234
Registration Number
NCT00852202
Locations
🇺🇸

Forest Investigative Site 026, Orlando, Florida, United States

🇺🇸

Forest Investigative Site 005, Encino, California, United States

🇺🇸

Forest Investigative Site 006, Media, Pennsylvania, United States

and more 23 locations
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