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
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
- First Posted Date
- 2016-02-01
- Last Posted Date
- 2019-01-30
- Lead Sponsor
- Forest Laboratories
- Target Recruit Count
- 488
- Registration Number
- NCT02670551
- Locations
- 🇺🇸
Carman Research, Smyrna, Georgia, United States
🇺🇸Neuroscience Research Institute Inc., Winfield, Illinois, United States
🇺🇸Midwest Clinical Research Center, Dayton, Ohio, United States
Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder
- First Posted Date
- 2016-02-01
- Last Posted Date
- 2019-03-12
- Lead Sponsor
- Forest Laboratories
- Target Recruit Count
- 493
- Registration Number
- NCT02670538
- Locations
- 🇺🇸
Atlanta Center for Medical Research, Atlanta, Georgia, United States
🇧🇬Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD, Burgas, Bulgaria
🇭🇷Polyclinic Neuron, Zagreb, Croatia
Cariprazine: Comparison of Slow- and Immediate-release Forms
- Conditions
- Pharmacokinetic Profile
- Interventions
- First Posted Date
- 2014-06-17
- Last Posted Date
- 2016-03-24
- Lead Sponsor
- Gedeon Richter Plc.
- Target Recruit Count
- 160
- Registration Number
- NCT02165098
- Locations
- 🇬🇧
Hammersmith Medicines Research, London, United Kingdom
Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Antidepressant Therapy (ADT)
- First Posted Date
- 2013-04-24
- Last Posted Date
- 2019-08-21
- Lead Sponsor
- Forest Laboratories
- Target Recruit Count
- 442
- Registration Number
- NCT01838876
- Locations
- 🇺🇸
Forest Investigative Site 049, Gaithersburg, Maryland, United States
🇺🇸Forest Investigative Site 077, Rockville, Maryland, United States
🇵🇷Forest Investigative Site 033, San Juan, Puerto Rico
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Interventions
- First Posted Date
- 2012-10-29
- Last Posted Date
- 2019-08-28
- Lead Sponsor
- Forest Laboratories
- Target Recruit Count
- 1022
- Registration Number
- NCT01715805
- Locations
- 🇺🇸
Forest Investigative Site 067, Bismarck, North Dakota, United States
🇺🇸Forest Investigative Site 018, Little Rock, Arkansas, United States
🇺🇸Forest Investigative Site 080, Redlands, California, United States
A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
- First Posted Date
- 2012-06-25
- Last Posted Date
- 2021-04-13
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Target Recruit Count
- 42
- Registration Number
- NCT01626885
A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia
- First Posted Date
- 2012-06-22
- Last Posted Date
- 2021-04-13
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Target Recruit Count
- 125
- Registration Number
- NCT01625897
Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder
- First Posted Date
- 2011-11-10
- Last Posted Date
- 2018-05-01
- Lead Sponsor
- Forest Laboratories
- Target Recruit Count
- 819
- Registration Number
- NCT01469377
- Locations
- 🇺🇸
Forest Investigative Site 070, Houston, Texas, United States
🇪🇪Forest Investigative Site 202, Võru, Estonia
🇪🇪Forest Investigative Site 208, Tartu, Estonia
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
- First Posted Date
- 2011-08-08
- Last Posted Date
- 2018-07-06
- Lead Sponsor
- Forest Laboratories
- Target Recruit Count
- 765
- Registration Number
- NCT01412060
- Locations
- 🇺🇸
Forest Investigative Site 002, Oceanside, California, United States
🇺🇸Forest Investigative Site 008, Long Beach, California, United States
🇺🇸Forest Investigative Site 011, Little Rock, Arkansas, United States
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
- First Posted Date
- 2011-07-18
- Last Posted Date
- 2018-05-01
- Lead Sponsor
- Forest Laboratories
- Target Recruit Count
- 584
- Registration Number
- NCT01396447
- Locations
- 🇺🇸
Forest Investigative Site 007, Dallas, Texas, United States
🇺🇸Forest Investigative Site 038, Atlanta, Georgia, United States
🇺🇸Forest Investigative Site 005, Atlanta, Georgia, United States
Drug Development Updates
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