Abilify Maintena (aripiprazole extended release) / Otsuka, BMS, Lundbeck - LARVOL DELTA

Real-world adherence, healthcare resource utilization, and costs following a transition to aripiprazole once every 2 months among patients diagnosed with bipolar I disorder in the United States. (PubMed, Front Psychiatry) - "Aripiprazole monohydrate is available as LAI formulations administered once-monthly [aripiprazole once-monthly (AOM)] or once every 2 months (aripiprazole 2-month ready-to-use [Ari 2MRTU]). Inpatient visits (all-cause, BP-I-related), and all-cause LOS decreased, along with all-cause ED and total medical costs. Transitioning to Ari 2MRTU was associated with improved treatment adherence and reduced selected HCRU measures and total medical costs, supporting its value as a treatment option for BP-I."

HEOR • Journal • Real-world evidence • Bipolar Disorder • CNS Disorders • Psychiatry

Real-world adherence and healthcare resource utilization following transition to aripiprazole once-every-2-months from oral or once-monthly aripiprazole among patients diagnosed with schizophrenia in the United States. (PubMed, Curr Med Res Opin) - "All-cause LOS was lower post- versus pre-transition (0.64 ± 2.63 vs 1.05 ± 3.93 days, p = 0.047). Transitioning to Ari 2MRTU was associated with significantly improved adherence and reductions in certain HCRU measures in patients diagnosed with schizophrenia."

HEOR • Journal • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

Apparent Cerebellar Volumetric Stabilization and Emergent Cortical Hyperexcitability During Long-Acting Injectable Aripiprazole Maintenance in Adolescent Bipolar Disorder. (PubMed, Pediatr Rep) - "Introduction of levetiracetam (500 mg BID) and cessation of adjunct methylphenidate led to complete clinical and neurophysiological remission. LAI aripiprazole may favorably influence the macrostructural trajectory of the cerebellum/vermis in adolescent BD, suggesting volume stabilization. However, clinicians must monitor for a drug-induced lowering of the seizure threshold, where macrostructural volume preservation coexists with microstructural electrical destabilization."

Journal • Bipolar Disorder • CNS Disorders • Epilepsy • Mood Disorders • Movement Disorders • Psychiatry • Substance Abuse

Strong growth from Vyepti nd focused commercial execution drive total revenue growth of +16% CER (+13% CER underlying) in H1 2026 (TradingView) - "Revenue from Lundbeck's strategic brands increased by +17% CER (+11% DKK), reaching DKK 10,463 million, representing 77% of total revenue: Rexulti: DKK 3,297 million (+17% CER; +8% DKK; underlying +16% CER); Vyepti: DKK 2,865 million (+46% CER; +36% DKK; underlying +46% CER); Brintellix/Trintellix: DKK 2,331 million (+0% CER; -2% DKK; underlying -5% CER); Abilify LAI franchise: DKK 1,970 million (+7% CER; +4% DKK; underlying +4% CER)."

Sales • Autism Spectrum Disorder • Bipolar Disorder • Major Depressive Disorder • Migraine • Schizophrenia • Tourette Syndrome

Atypical Neuroleptic Malignant Syndrome Without Hyperthermia: A Case Report. (PubMed, Cureus) - "We present the case of a 21-year-old male admitted for psychosis and behavioral dysregulation who developed elevated creatine kinase (CK), hypertension, and tachycardia following treatment with multiple antipsychotics, including olanzapine and long-acting injectable aripiprazole...This case highlights the diagnostic challenges of atypical NMS and emphasizes the importance of maintaining clinical suspicion in patients with autonomic instability and elevated CK in the absence of classic features. Early recognition is essential to prevent morbidity and mortality."

Journal • Cardiovascular • CNS Disorders • Hypertension • Psychiatry

A Claims Data-Based Comparison of Treatment Continuation between Aripiprazole Once-monthly and Paliperidone Palmitate in Routine Practice. (PubMed, Clin Psychopharmacol Neurosci) - "Aripiprazole once-monthly (AOM) and paliperidone palmitate once-monthly (PP1M) are commonly used long-acting injectable APs (LAIs) in routine practice. In this nationwide real-world study, AOM was associated with a lower risk of treatment discontinuation than PP1M over 12 months. These findings suggest differences in treatment continuation between the two LAIs and warrant confirmation in studies using more robust designs and diverse clinical data."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Effectiveness and safety of long-acting aripiprazole 960 mg: preliminary findings from a prospective real-world observational study. (PubMed, Int Clin Psychopharmacol) - "In 2023 a 2-month 960 mg formulation of aripiprazole 2 months ready-to-use (Ari 2MRTU) was introduced. The findings were also consistent with an overall favorable tolerability profile of Ari 2MRTU. Although adverse events were commonly reported, no unexpected safety signals emerged during the follow-up period, and patients' attitudes toward LAI treatment generally improved over time."

Journal • Observational data • Real-world evidence • CNS Disorders • Mental Retardation • Psychiatry

Real-world comparison of one- versus two-injection start regimens of aripiprazole once-monthly in bipolar disorder: implications for relapse-related outcomes. (PubMed, Nord J Psychiatry) - "Exploratory findings suggested a potential trend toward a less intensive relapse course and delayed acute psychiatric service utilization among patients receiving TIS. Given the exploratory nature of these analyses, these observations require confirmation in larger prospective studies."

Journal • Real-world evidence • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

Population Pharmacokinetic Modeling and Simulation to Support the Regulatory Submission of the Two-Injection Start Regimen with Aripiprazole Once-Monthly Long-Acting Injectable Intramuscular Administration in Japanese Patients with Schizophrenia or Bipolar I Disorder. (PubMed, J Clin Pharmacol) - "The aripiprazole TIS regimen provides a new option by reducing the oral aripiprazole administration period to a single day. This is expected to reduce the medication burden on patients and, consequently, reduce the burden on healthcare professionals and caregivers."

Journal • PK/PD data • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Anemia associated with long-acting injectable aripiprazole in an elderly man. (PubMed, Indian J Psychiatry) - No abstract available

Journal • Anemia • Hematological Disorders

Aripiprazole once-monthly for patients diagnosed with bipolar I disorder: Number needed to treat, number needed to harm, and likelihood to be helped or harmed. (PubMed, J Affect Disord) - P3 | "Data suggest a favorable benefit-risk profile for AOM 400 versus placebo as a long-term maintenance treatment for BP-I."

Journal • Bipolar Disorder • CNS Disorders • Depression • Psychiatry

Healthcare Pattern of Use Before and After Initiating a Long-Acting Antipsychotic Among a Cohort of 6221 Patients With a History of Psychosis. (PubMed, Can J Psychiatry) - "Antipsychotic exposure and health-service usage (hospitalizations, emergency visits, outpatient and community care) trajectories were analyzed weekly using state-sequence analysis; pre- versus post-initiation comparisons used paired statistical tests.ResultsOf 6,221 patients (63.4% male; mean age 41.6 years), initial treatments consisted of paliperidone LAI (55.7%), aripiprazole LAI (21.5%), risperidone LAI (6.9%), first-generation LAI (15.6%), and LAI combinations (0.2%); 40% received LAI only, 5% LAI + clozapine, 55% LAI + an oral antipsychotic. Observed differences in sociodemographic and clinical profiles between SCZ and non-SCZ patients-and among SCZ treatment subgroups-suggest the need for tailored care pathways. These findings support LAI-AP effectiveness in reducing healthcare utilization and inform resource planning."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Second-Generation Long-Acting Injectable Antipsychotics: A Comprehensive Assessment of Effectiveness, Safety, and Cost. (PubMed, Neuropsychiatr Dis Treat) - "The survey rated the four SG-LAIs available in Romania (aripiprazole, olanzapine, paliperidone, and risperidone) on efficacy, tolerability, dosing flexibility, monitoring needs, prescribing frequency, and perceived obstacles/facilitators. Romanian psychiatrists show a strong preference for aripiprazole LAI, with decisions driven mainly by clinical benefits. Reducing patient concerns and system-level limitations-especially availability, indications, and communication- may support increased use of SG-LAIs in everyday clinical care."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Change-points in patient-reported side effects following initiation of long-acting injectable antipsychotics: a longitudinal LUNSERS analysis (CINP 2026) - " We analyzed longitudinal LUNSERS data from patients treated with paliperidone palmitate (Invega Sustenna) or aripiprazole LAI (Abilify Maintena). Patient-reported side effects following LAI antipsychotic initiation do not appear to improve in a simple linear manner. Instead, many side effects demonstrate a clinically meaningful change-point after an early adaptation phase, beyond which improvement begins or accelerates. Recognizing these temporal patterns may help clinicians refine monitoring strategies, provide realistic expectations to patients during LAI initiation, and support treatment continuation."

Adverse events • Clinical • CNS Disorders • Schizophrenia

Intranasal esketamine in treatment-resistant bipolar depression maintained on long-acting aripiprazole (CINP 2026) - " Case 1: A 30-year-old female with bipolar disorder was maintained on a monthly aripiprazole injection of 400 mg since June 2024 in combination with clomipramine 150mg, quetiapine 300mg, and lisdexamfetamine 30mg...Case 2: A 21-year-old female with bipolar disorder was maintained on a monthly aripiprazole injection 400 mg since February 2025 in combination with lithium 400 mg, lamotrigine 400mg, Zyprexa 10 mg, and bupropion 300mg...Case 3: A 31-year-old male with bipolar disorder was maintained on a monthly aripiprazole injection of 400 mg since May 2024in combination with desvenlafaxine 150mg...Case 4: A 38-year-old female with bipolar disorder was maintained on a monthly aripiprazole injection of 400 mg since July 2025 in combination with escitalopram 20 mg, Wellbutrin 300 mg, and lithium 400 mg. These cases demonstrated that there may be a role for adding intranasal esketamine in treatment-resistant bipolar depression in patients already maintained on monthly..."

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

An evaluation of aripiprazole long-acting injectable monthly and bimonthly in the maintenance treatment of bipolar I disorder. (PubMed, Ther Deliv) - "Both aripiprazole LAI formulations were established as efficacious in the reduction of manic and mixed episodes in adults with BD-I; however, their efficacy for bipolar depression prevention remains unproven. Aripiprazole LAI is well tolerated and safe, with injection site pain, sedation, weight increase, and akathisia being the most common adverse events."

Journal • Review • Anesthesia • Bipolar Disorder • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Pain • Psychiatry

Navigating long-acting antipsychotic decision-making in schizophrenia: clinical considerations and best practices. (PubMed, Expert Rev Neurother) - No abstract available

Journal • CNS Disorders • Psychiatry • Schizophrenia

Initiation of aripiprazole once-monthly via a two‑injection start in adult patients diagnosed with schizophrenia: real-world experiences of healthcare professionals from five European countries. (PubMed, Ann Gen Psychiatry) - "This survey provides a pan-European account of HCPs' views and experiences with the AOM 400-TIS in adults diagnosed with schizophrenia. Initiatives to overcome barriers to AOM 400-TIS use include providing clearer evidence and education on its efficacy and safety and consideration of how the regimen is presented in patient-provider discussions."

Journal • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

A Retrospective Review of Long-Acting Injectable Antipsychotic Administration Timing and Associated Length of Hospitalization (APA 2026) - "Additional criteria included administration of Paliperidone Palmitate or the long acting Aripiprazole (Abilify Maintena) during the inpatient psychiatric admission... Due to the irreversibility and long duration of LAIs, clinical guidelines and medication manufacturers recommend establishing ehicacy and tolerability with oral formulations prior to LAI initiation. The results of this study suggest that the LOS is longer for patients on oral antipsychotics for over 14 days prior to LAI administrations compared to those on oral antipsychotics for less than 14 days. However, the time until an LAI was administered was positively correlated with LOS suggesting that delays in transitioning to LAIs may contribute to prolonged hospitalization, potentially reflecting greater severity of the patient's illness that require longer oral trials to establish efficacy."

Retrospective data • Review • CNS Disorders • Mental Retardation

Intranasal Esketamine in Treatment-Resistant Depression and Other Mental Disorders Maintained on Long-Acting Aripiprazole (APA 2026) - " Case 1: A 30-year old female with anger issues and a diagnosis of borderline personality disorder received a monthly aripiprazole injection of 400 mg for 14 months, along with clomipramine 150 mg and quetiapine 300 mg...Case 2: A 21-year-old female diagnosed with bipolar illness was sustained on a monthly aripiprazole injection of 400 mg for 7months, in conjunction with lithium 400 mg, lamotrigine 400 mg, olanzapine 10 mg, and bupropion 300 mg...Case 3: A 31-year-old male diagnosed with bipolar disorder was administered a monthly aripiprazole injection of 400 mg for 15 months, in conjunction with desvenlafaxine 150 mg...Case 4: A 38-year-old female diagnosed with bipolar illness was administered a monthly aripiprazole injection of 400-mg for 2 months, in conjunction with escitalopram 20 mg, bupropion 300 mg, and lithium 400 mg... These examples indicated a potential role for the use of intranasal esketamine in various mental health disorders alongside sustained monthly..."

Bipolar Disorder • Borderline Personality Disorder • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Personality Disorder • Post-traumatic Stress Disorder • Psychiatry

Adherence Tolerability and Effective Doses of Aripiprazole Once-monthly in the Long-term Treatment of Patients with Severe Schizophrenia (APA 2026) - "AOM therapy, at a wide range of very tolerable doses, increases adherence, reduces clinical severity and disability, and hospital admissions compared to other AP therapies. And should be more considered for patients with severe schizophren"

Adherence • Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia

Choosing Between Aripiprazole and Paliperidone/Risperidone Long-Acting Injectables in Inpatient Psychiatric Youth (APA 2026) - " This IRB-approved retrospective review examined 190 inpatients 25 years old or younger who received either aripiprazole LAI (n=61) or paliperidone/risperidone LAI (n=129). Aripiprazole LAIs may be more frequently used when there is history of suicidal behavior or mood disturbance, while paliperidone/risperidone LAIs may be more frequently used in psychosis or when there is history of more contact with the psychiatric healthcare system. Limitations of this study include its retrospective nature and multiple comparisons. While this study demonstrates there are predictors to suggest which LAI a patient will receive, further research should investigate if the chosen LAI is effective by looking at length of hospital stay, time to readmission, and number of psychiatric ED visits/readmissions within one year."

Clinical • CNS Disorders • Mental Retardation • Psychiatry

Aripiprazole 2-month long-acting injectable increases time to readmission compared to aripiprazole 1-month in schizophrenia/schizoaffective disorder (APA 2026) - "Description Introduction: Schizophrenia and schizoaffective disorder are chronic psychotic illnesses affecting approximately 0.3-0.8% of the global population. This real-world study found that receiving bimonthly aripiprazole LAI may lead to improved outcomes over the course of one year compared to monthly, specifically in delaying time to rehospitalization. Our results are consistent with prior literature. Further research is needed to directly compare ARI-1 and ARI-2 over longer periods of time."

CNS Disorders • Psychiatry • Schizophrenia

Longitudinal Trajectories and Change-Points in LUNSERS Side Effects After Initiation of Long-Acting Injectable Antipsychotics (APA 2026) - " This study analyzed patients treated with LAI antipsychotics, specifically paliperidone palmitate (Invega Sustenna) and aripiprazole (Abilify Maintena). Patient-reported side effects following LAI initiation with Invega Sustenna or Abilify Maintena may not decline linearly; instead, improvement may begin or accelerate after an early adaptation period with a clinically meaningful change-point. Identifying when and which side effects improve can refine monitoring strategies during LAI initiation and support clinical expectations regarding tolerability over time. Future work should incorporate advanced missing-data approaches and relevant covariates (e.g., LAI formulation, dose, concomitant medications) in mixed-effects frameworks."

Adverse events • CNS Disorders

The role of pharmaceutical formulation development in clinical trials of new medicinal products. (PubMed, Eur J Pharm Biopharm) - "Case studies of posaconazole and long-acting injectable aripiprazole demonstrate how rational reformulation and process optimization can significantly improve pharmacokinetic consistency and therapeutic performance while introducing technological and regulatory complexity. Integration of formulation science with predictive modeling and data-driven approaches enables earlier identification of translational risks, improves development efficiency, and enhances the probability of clinical success. Overall, formulation development should be regarded as a central determinant of clinical outcomes and regulatory success, rather than a downstream technical activity, supporting more predictive and efficient pharmaceutical development."

Journal • Review • Cerebral Hemorrhage