brexpiprazole / Generic mfg. - LARVOL DELTA

Brexpiprazole's impacts on patients and caregivers in agitation in Alzheimer's dementia. (PubMed, Alzheimers Dement) - P2/3 | "Brexpiprazole is suggested to improve patient symptoms and to reduce caregiver distress in the treatment of AAD in Japanese patients."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry

Predictive Validity of the 5-Factor PANSS Model in Acute Schizophrenia: Early Response to Aripiprazole and Brexpiprazole. (PubMed, J Clin Psychopharmacol) - "This study is the first to evaluate the predictive validity of the PANSS 5-factor model in patients with acute schizophrenia treated with ARI/BRE. Early symptom improvements, particularly in negative domains, are stronger predictors of overall response, while excitement symptom improvements showed a weaker relationship. These findings underscore the importance of early, symptom-specific assessments to optimize treatment strategies for acute schizophrenia. Further studies with larger samples are necessary to validate these results."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry • Schizophrenia

Brexpiprazole Oral Soluble Film: A Randomized, Open-Label, Single-Dose, Crossover Bioequivalence Study in Healthy Chinese Volunteers. (PubMed, Clin Ther) - "Brexpiprazole OSF 2 mg is bioequivalent to brexpiprazole ODT 2 mg with favorable safety, tolerability and acceptability under fasting and postprandial conditions. Due to its ease of administration, brexpiprazole OSF 2 mg may be expected to improve medication adherence, and provide a viable treatment option for patients with schizophrenia."

Journal • CNS Disorders • Psychiatry • Schizophrenia • POSTN

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

Strategies for Switching between Oral Postsynaptic Antidopaminergic Antipsychotics in Patients with Schizophrenia: A Systematic Review. (PubMed, CNS Drugs) - "Despite the importance and frequency of antipsychotic switching, few studies have specifically investigated outcomes of different switch strategies. General clinical preference appears to utilize gradual switching approaches to avoid potential rebound symptoms. Future research with current and emerging antipsychotics is needed, especially for switching between antipsychotics with different receptor profiles and for switches that are potentially vulnerable to rebound and withdrawal symptoms."

Journal • Review • CNS 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

Safety and Tolerability of Brexpiprazole in Participants with Agitation Associated with Dementia due to Alzheimer's Disease: Pooled Analysis of Three Randomized Trials and an Extension Trial. (PubMed, CNS Drugs) - P3 | "Considering pooled data from > 1000 participants on brexpiprazole or placebo, brexpiprazole appears to be generally well tolerated for up to 24 weeks in participants with agitation associated with dementia due to Alzheimer's disease."

Clinical • Journal • Retrospective data • Alzheimer's Disease • Anesthesia • Cardiovascular • CNS Disorders • Cognitive Disorders • Dementia • Pain

Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) (Otsuka Press Release) - "Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the...FDA met to discuss the supplemental New Drug Application (sNDA) of REXULTI (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The committee voted 1-10, concluding that the efficacy of brexpiprazole, when initiated concurrently with sertraline, has not been established for the treatment of PTSD based on the available data presented. The feedback from the committee will be taken into consideration by the FDA as it reviews the application for REXULTI (brexpiprazole) in combination with sertraline for the treatment of adults with PTSD....The sNDA is based on previously disclosed data from two Phase 3 trials (NCT04124614 - flexible-dose trial, n=416 and NCT04174170 - fixed-dose trial, n=553), and one Phase 2 trial (NCT03033069 -flexible-dose trial, n=321)."

FDA event • Post-traumatic Stress Disorder

MainRexult: Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia (clinicaltrials.gov) - P=N/A | N=10 | Recruiting | Sponsor: The University of Hong Kong | Trial completion date: Jun 2025 ➔ Jan 2026 | Trial primary completion date: Dec 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry • Schizophrenia

ReSD: Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders (clinicaltrials.gov) - P=N/A | N=40 | Recruiting | Sponsor: Dr. Albert Kar-Kin Chung | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry • Schizophrenia

Real-World Evidence of Brexpiprazole Use and 6-Month Mortality, Hospitalization, and Emergency Department Visits Among Persons With Dementia. (PubMed, Neurology) - "Brexpiprazole use is not associated with differential mortality risk compared with aripiprazole use among PLWD. Brexpiprazole offers a treatment option which is important given the heterogeneity of effects of antipsychotics on persons. A two-stage least squares method is used to eliminate bias on estimates because of observed and unobserved differences between the 2 groups, but the small sample size is a limitation."

HEOR • Journal • Real-world evidence • Alzheimer's Disease • CNS Disorders • Dementia • Depression • Psychiatry

Adjunctive Brexpiprazole in Patients With Unresolved Symptoms of Depression on Antidepressant Treatment Who are Early in the Disease Course: Post Hoc Analysis of Randomized Controlled Trials. (PubMed, Int J Neuropsychopharmacol) - P3 | "Adjunctive brexpiprazole improved depressive symptoms earlier in the disease course, when benefits to patients and healthcare systems can be maximized. Adjunctive brexpiprazole also improved depressive symptoms later in the disease course; there was no advantage of delaying brexpiprazole treatment."

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

Evidence-Based Dosing of Brexpiprazole in Patients with Agitation Associated with Dementia Due to Alzheimer's Disease: An Exposure–Response Analysis (ASCP 2025) - P3 | "Supportive of clinical trial results, the exposure–efficacy analysis demonstrated a dose–response relationship for brexpiprazole in patients with agitation associated with dementia due to Alzheimer's disease. Brexpiprazole dosed at 2–3 mg/day is expected to achieve meaningful reduction in agitation frequency, while brexpiprazole 1 mg/day is unlikely to be effective in reducing frequency of agitation. These findings should be considered when selecting appropriate treatment for individual patients."

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Psychiatry

Study Design of BALANCE-AAD-1, a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the FAAH/MAGL Inhibitor BMS-986368 for Treatment of Agitation in Patients with Alzheimer Disease (ASCP 2025) - "Brexpiprazole is the only treatment approved for AD-related agitation, highlighting the need for alternative treatment options with improved side effect profiles. The endocannabinoid pathway is a promising target for treatment of agitation in patients with AD. Pending efficacy and safety results, BMS-986368 could provide a novel and important new treatment option for AD-associated agitation"

Clinical • Late-breaking abstract • P2 data • Alzheimer's Disease • CNS Disorders • Psychiatry

Safety and Tolerability of Brexpiprazole in Adolescents With Schizophrenia: A Long-Term, Open-Label Study. (PubMed, JAACAP Open) - P3 | "• This study aimed to answer the question of whether oral doses of brexpiprazole, 1-4 mg once-daily, were safe and tolerated maintenance treatment in adolescents with schizophrenia.• In an interim analysis of a 24-month study (67.5% of patients ongoing; 13.6% completed; 18.9% discontinued), 1.2% of adolescents with schizophrenia reported an adverse event that led to treatment discontinuation.• Clinicians should consider safety profiles when selecting an antipsychotic for the treatment of adolescents with schizophrenia; brexpiprazole has a similar safety profile in adolescents as in adults. Safety and Tolerability of Open-Label Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia; https://www.clinicaltrials.gov/study/NCT03238326?cond=NCT03238326."

Journal • CNS Disorders • Infectious Disease • Pain • Psychiatry • Schizophrenia

A US-based practitioner's guide to diagnosis, evaluation, and evidence-based treatment of agitation in Alzheimer's dementia - recommendations of an expert, multispecialty advisory panel. (PubMed, Postgrad Med) - "While several pharmacologic agents have been studied in high-quality clinical trials for the treatment of agitation in Alzheimer's dementia, brexpiprazole is the only US Food and Drug Administration - approved treatment and it can be prescribed if warranted...A patient-centered approach that includes a strong partnership with caregivers/family as a vital part of the patient's larger care team is encouraged. Following these recommendations for timely detection, accurate diagnosis, and appropriate management of agitation in patients with Alzheimer's dementia is likely to improve outcomes for most patients and caregivers."

Journal • Alzheimer's Disease • CNS Disorders • Dementia

Pharmacological Properties of Brexpiprazole for the Treatment of Agitation in Alzheimer's Disease (CINP-AsCNP 2025) - No abstract available

Alzheimer's Disease • CNS Disorders

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

Retraction notice to "Identification of metabolites of brexpiprazole in human urine for use in monitoring patient compliance" [Clin. Mass Spectrom. 6 (2017) 21-24]. (PubMed, J Mass Spectrom Adv Clin Lab) - "[This retracts the article DOI: 10.1016/j.clinms.2017.11.001.]."

Compliance • Journal

Adverse events associated with four atypical antipsychotics used as augmentation treatment for major depressive disorder: A pharmacovigilance study based on the FAERS database. (PubMed, J Affect Disord) - "It is suggesting a potential increased risk of various ADEs in patients with MDD when taking AAPs. The causal relationship and the exact mechanism between drugs and ADEs remains unclear, requiring further research."

Adverse events • Journal • Cardiovascular • CNS Disorders • Depression • Glaucoma • Inflammation • Major Depressive Disorder • Mental Retardation • Metabolic Disorders • Mood Disorders • Movement Disorders • Obsessive-Compulsive Disorder • Ophthalmology • Psychiatry • Restless Legs Syndrome • Sleep Disorder

Cost-effectiveness of brexpiprazole for the treatment of major depressive disorder in Japan. (PubMed, J Affect Disord) - "Brexpiprazole, especially when initiated early, was a cost-effective adjunctive treatment for patients with MDD and a history of inadequate response to SSRI/SNRI."

HEOR • Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Comparing Xanomeline/Trospium With Novel Muscarinic Mechanism to Dopaminergic Second Generation Antipsychotics in the Treatment of Schizophrenia (APA 2025) - "Atypical dopaminergic alternatives like brexpiprazole (B) and lumateperone (L) are similar in efficacy, side effect profile, and clinical trial study design. X/T is at least equally as effective as B and L, with novel mechanism showing promise for those who cannot tolerate dopamine blockers or require adjunctive therapy. Differences in inclusion criteria may explain differences in demographics. Limitations to using X/T involve its contraindication for use in moderate to severe liver disease and its twice a day dosing."

CNS Disorders • Hepatology • Psychiatry • Renal Disease • Schizophrenia

Comparative Efficacy, Safety, and Tolerability of Xanomeline and Trospium Chloride versus Eight Atypical Antipsychotics for the Acute Treatment of Adults with Schizophrenia - A Network Meta-Analysis (ISPOR 2025) - " Xanomeline/trospium treatment significantly improved odds of clinical response versus aripiprazole (odds ratio [OR]: 1.85; 95% credible interval [CrI]: 1.11, 3.11), brexipiprazole (OR: 2.23; 95% CrI: 1.34, 3.83), and cariprazine (OR: 2.05; 95% CrI: 1.19, 3.57), increased odds of all-cause discontinuation versus all comparators except cariprazine, and reduced odds of clinically significant weight gain versus aripiprazole, brexipiprazole, cariprazine, lumateperone, olanzapine, quetiapine, and risperidone. Xanomeline/trospium demonstrated improved clinical response and reduced weight gain compared with several existing oral antipsychotics."

Retrospective data • Anesthesia • CNS Disorders • Psychiatry • Schizophrenia

The Role of Astrocytes in the Molecular Pathophysiology of Schizophrenia: Between Neurodevelopment and Neurodegeneration. (PubMed, Biomolecules) - "These processes may underlie both the core symptoms of schizophrenia and the increased susceptibility to cognitive decline-clinically resembling neurodegeneration but driven by a distinct, poorly understood molecular substrate. Finally, astrocytes are emerging as potential pharmacological targets for antipsychotics such as clozapine, which may modulate their function by regulating glutamate clearance, redox balance, and synaptic remodeling."

Journal • Review • CNS Disorders • Developmental Disorders • Mental Retardation • Psychiatry • Schizophrenia • SOX9

Neuroleptic Malignant Syndrome Following Brexpiprazole Initiation in a Treatment-Resistant Schizophrenia Patient With Influenza A: A Case Report. (PubMed, Cureus) - "Early recognition and prompt intervention are crucial in preventing morbidity and mortality. Furthermore, this case highlights the importance of regular influenza vaccination, particularly in individuals with serious mental illness and on long-term antipsychotic therapy."

Journal • CNS Disorders • Cough • Infectious Disease • Influenza • Movement Disorders • Psychiatry • Respiratory Diseases • Schizophrenia