Active Filter(s):
Details:
VRAYLAR (cariprazine) is an oral, once-daily atypical antipsychotic approved as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults (1.5 or 3 mg/day), for the treatment of depressive episodes associated with bipolar I disorder.
Lead Product(s): Cariprazine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Vraylar
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2022
Details:
In Study 3111-301-001, cariprazine (VRAYLAR®; 1.5mg/day) achieved the primary endpoint of statistically significant improvement on MADRS total score in patients with major depressive disorder with an inadequate response to ongoing antidepressant therapy.
Lead Product(s): Cariprazine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Vraylar
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
Submission based on clinical trial results findings showing clinically and statistically significant improvement in the Montgomery-Åsberg Depression Rating Scale total score in patients with major depressive disorder treated with VRAYLAR (cariprazine) and an antidepressant.
Lead Product(s): Cariprazine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Vraylar
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2022
Details:
VRAYLAR® (cariprazine), a partial agonist at dopamine D3, D2, and serotonin 5-HT1A receptors used as atypical antipsychotic, met its primary endpoint demonstrating statistically significant change from baseline to week six in MADRS total score in major depressive disorder.
Lead Product(s): Cariprazine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Vraylar
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2021
Details:
Tentative approval recieved from USFDA to market Cariprazine-Generic an atypical antipsychotic drug for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar disorder.
Lead Product(s): Cariprazine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Cariprazine-Generic
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2021