Lactation Safety Information
No published evidence of safety
Long half-life of cariprazine and its active metabolites increases risk of accumulation in breastfed infants. However, high protein binding may mitigate high milk levels
Monitor infant for sedation, poor feeding, behavioural effects, extrapyramidal symptoms, and developmental milestones
9 November 2018
Reagila (EU), Vraylar (US)Major depressive disorder - adjunctive therapy
Reagila (EU), Vraylar (US)
Licence extension / variation
Development and Regulatory status
Phase II Clinical Trials
Feb 22Filed in US for add-on to antidepressant therapy for treatment of Major Depressive Disorder .
Oct 21Despite mixed PIII trial results AbbVie still plans to file in the first half of 2022 to FDA .
Oct 21Reagila not listed in Recordati pipeline for MDD, only a paediatric post-approval development plan in schizophrenia. Development of the MDD indication for the EU/UK markets seems unlikely .
Sep 20Vraylar has been added to the Abbvie pipeline .
Sep 20Gedeon Richter is the originator of cariprazine. In Aug 16, it entered into an agreement with Recordati, under which the latter acquired the exclusive rights to commercialise cariprazine in Western Europe. Previously in Nov 2004, Gedeon Richter and Forest Laboratories entered into a collaboration to develop cariprazine and related compounds. In exchange for exclusive rights to the product in Canada and the US, Forest paid Richter an upfront payment and Richter will be eligible to milestone payments, as well as royalties on sales. In Jul 14, Forest Laboratories was acquired by Actavis. Subsequently, in Jun 15, Actavis changed its name to Allergan. In May 2020, Allergan was acquired and merged into AbbVie .
Dec 17Will be filed in US H2 18 .
Dopamine D2 & D3 receptor antagonist
Annually, 5% of adults have an episode of depression. About one in four women and one in ten men will develop depression severe enough to require treatment at some time in their lives. Most depressive states are at the mild-to-moderate end of the spectrum and it is these that are mainly seen in primary care.
Major depressive disorder - adjunctive therapy
Trial or other data
Oct 21AbbVie announces results from PIII study (NCT03738215) which showed statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score vs placebo (1.5mg/day p=0.0050, 3mg/day p=0.0727). The PIII study NCT03739203 showed numerical improvement in depressive symptoms from baseline to week six in MADRS total score vs placebo but did not meet its primary endpoint for either dose (1.5 or 3.0 mg/day) 
Aug 21PIII trials (NCT03738215 and NCT03739203) have finished recruiting and now due to complete collection of primary outcome data in Sep 21 .
Sep 20PIII trials (NCT03738215 and NCT03739203) are still recruiting, with timescales unchanged .
Nov 19PIII trials (NCT03738215 and NCT03739203) are recruiting. Collection of primary outcome data is due to complete Jul 21 .
Nov 18Two PIII trials to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone starts (NCT03738215 and NCT03739203). Both are enrolling 750 patients in the US .
Dec 17Allergan/Gedeon Richter announce that top-line results from a PIII trial show that the primary efficacy objective was met for both cariprazine 1.5mg and 3mg formulations, with showing a significantly greater improvement than placebo for the change from baseline to week 6 on MADRS total score. Also, the drug was well-tolerated in the study, with sedation, somnolence, dizziness, akathisia and nausea the most commonly reported adverse events. Five percent of cariprazine treated patients discontinued due to adverse events versus 2.5 percent of those in the placebo arm .
Aug 16Top-line results from PIII trial (NCT01715805) show no separation of flexible doses of cariprazine from placebo .
Dec 15The two US PIII studies are ongoing, with one still recruiting subjects. Both studies expected to complete 2Q 2016 .
Apr 13NCT01715805 is a PIII, double-blind, placebo-controlled study of cariprazine as adjunctive therapy in 1100 patients with major depressive disorder. The primary outcome is Montgomery-Asberg Depression Rating Scale at 8 weeks. The study started Nov 12 and is due to complete Jul 14 .
Apr 13NCT01838876 is a long-term, open-label PIII study of safety and tolerability of cariprazine (1.5, 3 or 4.5 mg/d) as adjunctive therapy in 500 patients with major depressive disorder. The study starts Apr 13 and is due to complete Apr 15 .