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Cariprazine: First Global Approval.

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  • 1Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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Cariprazine (Vraylar) is an atypical antipsychotic approved for schizophrenia and bipolar I disorder. Its development milestones highlight its potential therapeutic applications.

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Area of Science:

  • Psychiatry and Pharmacology
  • Neuroscience

Background:

  • Cariprazine is an oral atypical antipsychotic developed by Gedeon Richter.
  • It acts as a potent partial agonist at dopamine D3 and D2 receptors, with a preference for D3.
  • Cariprazine also exhibits partial agonism at serotonin 5-HT1A receptors.

Purpose of the Study:

  • To summarize the key development milestones of cariprazine.
  • To detail the drug's journey leading to its initial US approval.

Main Methods:

  • Review of developmental data and regulatory submissions for cariprazine.
  • Analysis of pharmacological profile including receptor binding affinities.

Main Results:

  • Cariprazine received its first US approval in September 2015.
  • Indications include schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.
  • Ongoing development for negative symptoms of schizophrenia, major depressive disorder, and bipolar depression.

Conclusions:

  • Cariprazine's unique pharmacological profile supports its efficacy in treating schizophrenia and bipolar I disorder.
  • Further clinical trials are investigating its potential in other psychiatric conditions.