Vraylar (cariprazine) / Tanabe Pharma, Recordati, Gedeon Richter, AbbVie, Hwanin Pharma - LARVOL DELTA

Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia (clinicaltrials.gov) - P3 | N=330 | Suspended | Sponsor: Gedeon Richter Plc. | Recruiting ➔ Suspended

Trial suspension • CNS Disorders • Psychiatry • Schizophrenia

Treatment of bipolar depression: results from a comprehensive network meta-analysis and updated systematic review. (PubMed, Eur Neuropsychopharmacol) - "The original NMA showed that olanzapine plus fluoxetine, quetiapine, olanzapine, lurasidone, lumateperone, cariprazine, and lamotrigine were more efficacious than placebo in reducing depressive symptoms in BD with good confidence. The complementary systematic review identified 24 clinical trials, seven of which had published results suitable for meta-analysis; the remaining 17 studies were either ongoing or completed with no available results. Collectively, the NMA and systematic review findings can inform evidence-based care and the development of international treatment guidelines for bipolar depression."

Journal • Retrospective data • Review • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Differential effects of cariprazine, LY379268 and donepezil on EEG oscillations and auditory steady-state response in MK-801-treated rats: relevance for schizophrenia drug development. (PubMed, Neuropharmacology) - "These results highlight shed new lights on potential pharmacological strategies focused on circuits dysfunction andsymptoms in SZ. These differential normalization profiles, including cariprazine's unique broad-spectrum signature, reveal distinct patterns of circuit engagement and provide a translational pharmaco-EEG framework for circuit-level target engagement in SZ drug development."

Journal • Preclinical • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia

Case Report: Four cases for cariprazine and alcohol use disorder. (PubMed, Front Psychiatry) - "All four patients were treated during the years with many different pharmacologic protocols, involving antipsychotics (olanzapine, quetiapine), mood stabilizers (carbamazepine, lamotrigine), anxiolytics (clonazepam, bromazepam), SSRI antidepressants (fluoxetine, paroxetine, escitalopram), but without achieving of the alcohol abstinence. The consistent achievement of full abstinence across all four patients suggests that it may have potential relevance in the management of alcohol use disorder (AUD). However, in the future, well conducted and highly controlled studies are needed to explore a potential cariprazine's role and its place in the management of alcohol dependence."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders

Delayed-Onset Cariprazine-Induced Akathisia: A Case Report. (PubMed, Clin Neuropharmacol) - "This case highlights the challenge of distinguishing akathisia from primary anxiety disorders, in addition to considering this diagnosis beyond the initial treatment period. Akathisia symptoms most commonly present within 4 weeks of initiation or titration of antidopaminergic treatment. However, this timeline may be delayed with cariprazine due to its pharmacokinetic and pharmacodynamic properties."

Journal • Bipolar Disorder • CNS Disorders • General Anxiety Disorder • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia (clinicaltrials.gov) - P3 | N=330 | Active, not recruiting | Sponsor: Allergan | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Psychiatry • Schizophrenia

Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia (clinicaltrials.gov) - P3 | N=330 | Recruiting | Sponsor: Allergan | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

MEDICAID DRUG REBATE AND SAVINGS IMPLICATIONS OF MOST FAVORED NATION PRICING UNDER THE GENEROUS MEDICAID MODEL (ISPOR 2026) - "At product level, the largest price reductions were observed for Vraylar (79.8%), Ozempic (69.19%), and Entresto (62.44%). The largest contributors to aggregate Medicaid savings were Abilify (910 million), Ozempic (377 million), and Trikafta (292 million). MFN reference pricing under Medicaid GENEROUS model would reduce Medicaid spending for some, but not all, high-cost drugs. Estimated savings are highly sensitive to the choice of reference price benchmark, highlighting the importance of benchmark design in any future implementation of international reference pricing."

Medicaid • Pricing • Reimbursement • US reimbursement

Unexpected resolution of clozapine-induced obsessive-compulsive symptoms with cariprazine augmentation: a case report. (PubMed, BMC Psychiatry) - No abstract available

Journal • CNS Disorders • Psychiatry • Schizophrenia

High-density EEG study IN patients with schizophrenia treated with CARIPRAZINE. (PubMed, Int J Neuropsychopharmacol) - "Together, our results demonstrate that resting-state EEG spectral measures reflect neurophysiological correlates of cariprazine response. Furthermore, the findings reinforce the cross-species translatability of spectral measures, and support EEG biomarkers as promising translational tools for predicting and monitoring treatment outcomes in schizophrenia."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia (clinicaltrials.gov) - P3 | N=330 | Not yet recruiting | Sponsor: Allergan

New P3 trial • CNS Disorders • Psychiatry • Schizophrenia

Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia (clinicaltrials.gov) - P3 | N=330 | Recruiting | Sponsor: Gedeon Richter Plc. | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2022 ➔ Apr 2025 | Trial primary completion date: Dec 2022 ➔ Apr 2025

Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia

COMPARATIVE EFFICACY AND SAFETY OF LUMATEPERONE AND OTHER ATYPICAL ANTIPSYCHOTICS APPROVED AS ADJUNCTIVE THERAPY FOR MAJOR DEPRESSIVE DISORDER: A NETWORK META-ANALYSIS (ISPOR 2026) - "This network meta-analysis (NMA) compared efficacy and safety of lumateperone with other approved atypical antipsychotics: aripiprazole, brexpiprazole, cariprazine, and quetiapine XR for MDD with inadequate response to antidepressants (ADT). Ten short-term, randomized, double-blind, placebo-controlled registration trials formed a star-shaped network of 11 treatment- and dose-specific nodes anchored on placebo+ADT. In this NMA, lumateperone demonstrated a favorable efficacy profile versus other approved adjunctive antipsychotics, with no increased risk of weight gain. Balancing efficacy and safety is crucial when selecting adjunctive antipsychotic treatment for MDD."

Retrospective data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Antipsychotic Drug Cariprazine Induces Distinct Cell Death Mechanisms in HeLa and HCT116 Cells as a Potential Inhibitor of Qi-Site of Cytochrome bc1 Reductase. (PubMed, Biomedicines) - "The findings from molecular docking studies predicted that CAR had stable binding at the Qi site and showed interactions at the Qi site that were comparable to those of antimycin A, thereby suggesting its possible inhibitory effect on complex III. The results from our study indicate the engagement of CAR-activated apoptotic pathways that are specific to different types of cancer cells, and hence suggest that CAR may act as a new anticancer drug by potentially directing its action towards the mitochondrial Qi-sites of complex III."

Journal • CNS Disorders • Metabolic Disorders • Oncology • BAX • BCL2 • CASP3

Effect of cariprazine versus aripiprazole on cardiometabolic profile in patients with schizophrenia switched from olanzapine due to weight gain: A randomized controlled trial. (PubMed, J Psychiatr Res) - "Over the 12-week study period, cariprazine demonstrated greater reductions in weight than aripiprazole while maintaining comparable clinical efficacy; however with small magnitude of difference, any potential metabolic advantage should be interpreted cautiously. Larger, multicentre long-term studies are needed to confirm these findings."

Journal • Cardiovascular • CNS Disorders • Metabolic Disorders • Psychiatry • Schizophrenia

An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine (clinicaltrials.gov) - P4 | N=5 | Terminated | Sponsor: Ohio State University | N=60 ➔ 5 | Trial completion date: Jun 2026 ➔ Jan 2026 | Recruiting ➔ Terminated; Not able to recruit enough subjects

Enrollment change • Trial completion date • Trial termination • CNS Disorders • Inflammation • Psychiatry • Schizophrenia

CReW BP-I: Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder (clinicaltrials.gov) - P=N/A | N=120 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

HEOR • Real-world evidence • Trial completion • Bipolar Disorder • CNS Disorders • Psychiatry

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) (clinicaltrials.gov) - P4 | N=120 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Intranasal Chitosan Nanoparticles for Direct Nose-to-Brain Delivery of Cariprazine: A Noninvasive Strategy for Targeted CNS Therapy. (PubMed, ACS Chem Neurosci) - "Relative plasma bioavailability was 91%, with no nasal epithelial or ciliary damage observed. CZNPs exhibited effective brain targeting, controlled release, and mucosal safety, highlighting their potential as a noninvasive intranasal system for CNS delivery of cariprazine in neuropsychiatric disorders."

Journal • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

Tailoring cariprazine for dual disorders via secondary pharmacophore optimization. (PubMed, Eur J Med Chem) - "Compared to cariprazine, these derivatives behaved functionally as D3R partial agonists and retained a similar off-target profile; however, the most promising compounds also exhibited improved metabolic stability in rat liver microsomes (t1/2 ≥ 61.3 min). Taken together, our findings support further study of the lead candidate (8) for treating dual disorders that may have a reduced side effect profile."

Journal • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia • DRD2

Bioequivalence evaluation of two cariprazine hard capsule formulations. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - P1 | "The two hard capsule formulations were bioequivalent, in terms of rate and extent of absorption, with a comparable safety profile, supporting the use of vocarzine as a safe, effective, and potentially cost-saving alternative. Clinical trial number: The ClinicalTrials.gov registration number is NCT07121868, retrospectively registered on August 13, 2025."

Journal • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Third-Generation Antipsychotics as Augmentation in Treatment-Resistant Obsessive-Compulsive Disorder: A Narrative Review of Efficacy and Tolerability. (PubMed, Biomedicines) - "Two cohort studies were included on brexpiprazole, with no active or placebo comparator. The current state of evidence supports the clinical utility of TGAs, particularly aripiprazole, in augmenting SRI treatment in patients with refractory OCD. Evidence regarding cariprazine and lumateperone is scarce, but still contributes to the discussion on the use of TGAs in OCD."

Journal • CNS Disorders • Mental Retardation • Mood Disorders • Obsessive-Compulsive Disorder • Psychiatry

Development and Validation of a Novel and Cost-Effective RP-HPLC Method for the Separation of an Isomeric Impurity in Cariprazine Hydrochloride, an Antipsychotic Agent. (PubMed, Biomed Chromatogr) - "The developed method is robust, precise, accurate and linear in a series of LOQ to 500% level from the specification concentration limit. The newly developed RP-HPLC method is applicable for the analysis of cis isomer in cariprazine hydrochloride samples."

HEOR • Journal • Bipolar Disorder • Cerebral Hemorrhage • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia

Clinical Effects of Recently Developed Antipsychotic Drugs in Schizophrenia. (PubMed, Cent Nerv Syst Agents Med Chem) - "Promising new antipsychotic drugs include cariprazine, brexpiprazole, lumateperone, ulotaront, and xanomeline combined with trospium. Phase 3 clinical studies have shown therapeutic effects superior to those achieved with second-generation antipsychotic drugs."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Transferrin-Functionalized Chitosan Nanoparticles Enable Intranasal Brain Delivery of Cariprazine with Enhanced Neuropharmacological Efficacy. (PubMed, ACS Chem Neurosci) - "Behavioral studies in ketamine-induced schizophrenia models confirmed the normalization of locomotor activity, anxiolytic effects, and reduced catalepsy. These findings establish TfCZNP as a safe, effective nose-to-brain delivery platform that enhances Cariprazine's therapeutic potential in neuropsychiatric disorders."

Journal • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia