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

Electroconvulsive Therapy for Treatment-Resistant Late-Onset Bipolar Disorder. (PubMed, Cureus) - "She was diagnosed with bipolar I disorder and underwent multiple trials of antipsychotic and mood-stabilizing medications, including cariprazine, olanzapine, lumateperone, lithium, and valproate. Despite several pharmacological interventions, the patient continued to exhibit mood instability, frequent panic attacks, and functional decline. Following a course of 12 electroconvulsive therapy (ECT) sessions, she showed significant clinical improvement, including remission of manic symptoms, reduction in panic attacks, and regained occupational functioning."

Journal • Bipolar Disorder • CNS Disorders • Depression • General Anxiety Disorder • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

Disproportionality signal for myopia associated with aripiprazole: Analysis of the FAERS database and review of the literature. (PubMed, Schizophr Res) - No abstract available

Journal • CNS Disorders • Ophthalmology

Real-World Disability Outcomes Among Patients Treated with Cariprazine vs Other Atypical Antipsychotics as Adjunctive Treatment for Major Depressive Disorder. (PubMed, Clinicoecon Outcomes Res) - "In this real-world analysis of patients with MDD using AAs adjunctively to antidepressants, significantly greater reductions were observed in disability claims and days for cariprazine vs brexpiprazole and in disability costs for cariprazine vs aripiprazole. These results suggest that adjunctive cariprazine may have beneficial effects on disability outcomes for patients with MDD."

Journal • Real-world evidence • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Point of Care Apps for Facilitating Guideline Uptake by Clinicians (WFSBP 2025) - " The preference-based tool incorporates ten first-line interventions—aripiprazole, asenapine, cariprazine, divalproate, lamotrigine, lithium, lurasidone, paliperidone, quetiapine, and risperidone—and evaluates them against 17 safety outcomes... This point-of-care app provides a promising solution to the challenges of implementing evidence-based clinical guidelines in BD care. By incorporating patient preferences and utilizing multicriteria decision analysis, the tool enhances treatment adherence, fosters personalized care, and improves clinical outcomes. It offers a more accessible and tailored approach to BD management, benefiting both clinicians and patients in everyday practice."

Clinical • Bipolar Disorder • CNS Disorders • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

Should Dopamine Receptor Partial Agonist Antipsychotics (DRPA) Be co-Administered? - Similarities and Differences (WFSBP 2025) - " A comparative review of pharmacodynamic and -kinetic properties of the three DRPAs – aripiprazole (ARI), brexpiprazole (BREX) and cariprazine (CAR) – was done based on literature (2-4). From a pharmacodynamic perspective, the combination of DRPAs to enhance antipsychotic efficacy is not supported, because their mechanism of action is similar and not complementary. They also overlap with respect to pharmacokinetic characteristics, although CAR is the longest acting. Better combinations with DRPAs may be the -pines (clozapine, quetiapine, olanzapine) (1)."

CNS Disorders • Psychiatry • Schizophrenia

Glutamate Modulation as Adjunctive Therapy in Patients with Schizophrenia Not Adequately Responding to Second-Generation antipsychotics: Clinical Benefits of Evenamide in a Phase 2/3, international, randomized, double-Blind, Placebo-Controlled Trial (WFSBP 2025) - "Patients were randomized 1:1 to receive evenamide 30 mg bid or placebo bid added to a stable therapeutic dose of one of the following SGA: aripiprazole, cariprazine, clozapine, quetiapine, olanzapine, paliperidone, or risperidone. Study 008A represents the first randomized, placebo-controlled trial to demonstrate statistically significant and clinically meaningful benefits of adding a glutamate modulator in patients with schizophrenia poorly responding to treatment with SGAs. A phase 3 trial with evenamide will determine the benefits of glutamate modulation in TRS."

Clinical • Late-breaking abstract • P2/3 data • CNS Disorders • Epilepsy • Psychiatry • Schizophrenia

Glutamate Modulation as Adjunctive Therapy in Patients with Schizophrenia Not Adequately Responding to Second-Generation antipsychotics: Clinical Benefits of Evenamide in a Phase 2/3, international, randomized, double-Blind, Placebo-Controlled Trial (WFSBP 2025) - "Patients were randomized 1:1 to receive evenamide 30 mg bid or placebo bid added to a stable therapeutic dose of one of the following SGA: aripiprazole, cariprazine, clozapine, quetiapine, olanzapine, paliperidone, or risperidone. Study 008A represents the first randomized, placebo-controlled trial to demonstrate statistically significant and clinically meaningful benefits of adding a glutamate modulator in patients with schizophrenia poorly responding to treatment with SGAs. A phase 3 trial with evenamide will determine the benefits of glutamate modulation in TRS."

Clinical • P2/3 data • CNS Disorders • Epilepsy • Psychiatry • Schizophrenia

Mechanism of Action of Antipsychotics and Its Impact on Tolerability and Safety (WFSBP 2025) - "KarXT (xanomeline/trospium): xanomeline is an agonist of muscarinic M1, and M4 receptors. Our review indicates that mechanism of action influences the type and pattern of AEs associated of the drug. Lumateperone’s side effects reflect muscarinic, serotoninergic and autonomic adverse effects consistent with its multiple neurotransmitter affinities although muscaninic activity was not reported. Cariprazine’s side effects reflect dopamine antagonism (akathisia, EPs, restlessness), muscarinic (constipation) and serotoninergic activity (headache, insomnia)."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Defining Treatment-Resistant Bipolar Depression: Recommendations From the ISBD Task Force. (PubMed, Bipolar Disord) - "This consensus definition aims to provide clarity for clinical trials, improve consistency in research, and guide treatment approaches and inform regulatory pathways. It represents a foundational step in addressing the unmet needs in TRBD and promoting the development of innovative therapeutic strategies. Future efforts will focus on adapting the definition to better align with real-world clinical challenges and optimize patient care."

Journal • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

The Efficacy of Pharmacological Interventions in the Treatment of Major Depressive Disorder and Bipolar Depression With Mixed Features: A Systematic Review. (PubMed, Bipolar Disord) - "Select atypical antipsychotics are effective in alleviating depressive symptoms in persons with mixed features; albeit, much of the data is obtained from post hoc analysis. Minimal evidence exists for the efficacy of lithium or valproate in the treatment of depressive episodes with mixed features. Antidepressant monotherapy has not been adequately evaluated in depressive episodes with mixed features. In addition, there is a pressing need for a consistent definition of mixed presentations to guide future interventional studies."

Journal • Review • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Antipsychotic-Related Prolactin Changes: A Systematic Review and Dose-Response Meta-analysis. (PubMed, CNS Drugs) - "The prolactin-increasing property varies among antipsychotics, is dose-related, and is greater in females. These findings in adults with acutely exacerbated schizophrenia can help clinicians titrate and adapt antipsychotic doses and consider patients' sex in treatment decisions. The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO); registration no. CRD42020181467."

Journal • Retrospective data • Review • CNS Disorders • Psychiatry • Schizophrenia

Lithium versus cariprazine in the acute phase treatment for depressive episodes in patients with bipolar disorder: a protocol for a pragmatic open, randomised multicentre study - the 9th trial of the Danish University Antidepressant Group, DUAG-9. (PubMed, BMJ Open) - P4 | "Results will be disseminated in peer-reviewed international journals. EU-CTR, 2024-517170-20-01; NCT05913947."

Journal • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Restless revelations - Unveiling Uncommon Occurrence of Cariprazine-Induced Akathisia. (PubMed, Ind Psychiatry J) - No abstract available

Journal

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=170 | Recruiting | Sponsor: AbbVie | Trial completion date: Jul 2025 ➔ Feb 2026 | Trial primary completion date: Jul 2025 ➔ Feb 2026

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

BEVocCapATCO: Bioequivalence Assessment Between Two Cariprazine Hard Capsule Formulations (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Aya Mohammed Abdel Magid Abdel Hamid

New P1 trial

Sexual dysfunctions related to use of antipsychotics: A protocol for a systematic review and meta-analysis. (PubMed, PLoS One) - "The antipsychotic medications of interest are amisulpride, aripiprazole, asenapine, brexpiprazole, cariprazine, chlorpromazine, clopenthixol, clozapine, droperidol, flupenthixol, fluphenazine, haloperidol, iloperidone, levomepromazine, loxapine, lurasidone, molindone, olanzapine, paliperidone, penfluridol, perphenazine, perazine, pimozide, prochlorperazine, quetiapine, risperidone, sertindole, sulpiride, thiothixene, thioridazine, trifluoperazine, ziprasidone, zuclopenthixol and zotepine. The Cochrane Risk of Bias tool and RoB 2.0 will be used to assess the risk of bias in studies. We will evaluate the quality of the evidence contributing to network estimates for the primary outcomes using the GRADE framework, and key factors that may affect the observed effects will be analysed for consistency across studies."

Journal • Retrospective data • CNS Disorders • Sexual Disorders • PRL

AbbVie Beats on Q2 Earnings & Sales, Stock Up on Raised '25 EPS View (Yahoo Finance) - "Sales from the neuroscience portfolio increased 24% to $2.68 billion, driven by higher sales of Botox Therapeutic, depression drug Vraylar and migraine drugs Ubrelvy and Qulipta. Neuroscience sales beat the Zacks Consensus Estimate and our model estimate of $2.47 billion and $2.48 billion, respectively. While Botox Therapeutic sales rose 14.2% to $928 million, sales of Vraylar increased 16.3% to $900 million. Sales of Ubrelvy totaled $338 million, up 47.2%. Qulipta sales increased 76.9% to $267 million. Sales of Vyalev, the recently approved transformative therapy for advanced Parkinson’s disease, totaled $98 million, compared with $63 million in the first quarter."

Sales • Depression • Migraine • Pain • Parkinson's Disease

Transdiagnostic Efficacy of Cariprazine: A Systematic Review and Meta-Analysis of Efficacy Across Ten Symptom Domains. (PubMed, Pharmaceuticals (Basel)) - "Previous reports of cariprazine's anti-craving and anti-abuse effects come from real-world evidence rather than RCT data. Cariprazine appears to be promising in addressing a broad range of symptom domains across psychiatric conditions."

Journal • Retrospective data • Review • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Psychiatry

Dopamine Partial Agonists in Pregnancy and Lactation: A Systematic Review. (PubMed, Pharmaceuticals (Basel)) - "Of these drugs, aripiprazole, brexpiprazole, and cariprazine are currently marketed and used in schizophrenia spectrum and mood disorders. There were serious concerns about the use of dopamine D2/D3 partial agonists during lactation. The use of dopamine partial agonists during pregnancy appears to be safe, but during breastfeeding they should be better avoided."

Journal • Review • CNS Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Exploring the Therapeutic Potential of Ar-tur in Alzheimer Disease: A Cheminformatics, Pharmacokinetics, and System Pharmacology Approach. (PubMed, ACS Chem Neurosci) - "Molecular docking of DRs with dopamine, cariprazine, brexpiprazole, RO-10-5824, CP226269, and donepezil connotes that Ar-tur behaves like an agonist of DR2 and DR4 by binding to the active site residues like the dopamine and DR agonists. This is the first report stating the impressive drug-like properties of Ar-tur and holds the potential to rescue the vulnerable dopaminergic system by regulating DRs."

Journal • PK/PD data • Alzheimer's Disease • CNS Disorders

Effects of adjunctive cariprazine formulary restrictions in major depressive disorder. (PubMed, Am J Manag Care) - "Patients with MDD who had an initial adjunctive cariprazine claim rejected for a formulary-related reason and subsequently received an atypical antipsychotic experienced significantly higher hospitalization rates than those with approved initial cariprazine claims, suggesting that formulary restrictions on adjunctive cariprazine may be associated with negative downstream effects."

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

Investigating Psychopharmaceutical Effects on Early Vertebrate Development Using a Zebrafish Model System. (PubMed, J Dev Biol) - "Exposure to cariprazine, aripiprazole, trazodone, and AY9944 increased 7-dehydrocholesterol levels compared to vehicle-treated zebrafish. Significant differences in disease-associated gene expression, brain structure, and functional behaviors were observed in psychopharmaceutical and AY9944-treated zebrafish compared to controls. These data reveal that the high-throughput zebrafish model system can discern psychopharmaceutical effects on cholesterol synthesis, gene transcription, and key features of early vertebrate development that influences behavior."

Journal • Developmental Disorders

Cariprazine & Clozapine: A systematic review of a promising antipsychotic combination for treatment-resistant schizophrenia. (PubMed, Int J Neuropsychopharmacol) - "Overall, the combination appears safe and promising, especially for persistent negative symptoms, likely due to complementary neuroreceptor effects. Larger controlled trials are needed to confirm these findings."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Expert Guidelines on the Use of Cariprazine in Bipolar I Disorder: Consensus from Southeast Asia. (PubMed, Healthcare (Basel)) - "Cariprazine was also considered suitable as first-line therapy, including for first-episode bipolar depression (Mdn: 8, IQR: 7-9) and first-episode mania (Mdn: 8; IQR: 8-9). The consensus recommendations may serve as practical guidance for clinicians to make informed decisions regarding the management of adult patients with BP1D, while considering the preferences and circumstances of individual patients."

Journal • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Prescription pattern and medical expenses in executive psychiatric clinic - RSUD Dr. Chasbullah Abdulmadjid (Type B government hospital) Bekasi City Indonesia - period March – November 2024 (CINP-AsCNP 2025) - "The most commonly prescribed medications were antidepressants (Vortioxetine, Escitalopram, Fluvoxamine, Mirtazapine, Duloxetine), antipsychotics (Brexpiprazole, Cariprazine, Aripiprazole, Quetiapine IR, Sulpiride) and non-benzodiazepines (Lemborexant). The coverage expenses for Psychiatric Clinic Type B Hospital with Indonesian national health insurance using Indonesia Case Base Groups (INA-CBGs) per month is 196.100 IDR / 12 USD / 20 AUD for consultation and medications (7 days to hospital) and the rest 23 days is fee for service. In comparison, the expenses at Executive Psychiatric Clinic Type B Government Hospital Bekasi City Indonesia are five times higher than national health insurance could cover to the hospital. And indeed each payment system has its own advantages and disadvantages."

Clinical • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Schizophrenia • Sleep Disorder