Abilify Asimtufii (aripiprazole two-month) / Lundbeck, Otsuka - 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

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

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

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

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

Aripiprazole two-month long-acting injectable may increase time to readmission compared to aripiprazole one-month in patients with schizophrenia and schizoaffective disorder. (PubMed, Schizophr Res) - "This real-world study found that receiving bimonthly aripiprazole LAI may be associated with 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."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Cost-Minimization Analysis of Aripiprazole 2-Month Ready-to-Use vs. Other Long-Acting Injectable Antipsychotics: Evidence From Ontario (ISPOR-EU 2025) - "Pharmacokinetic bridging data demonstrates comparable exposure to aripiprazole once-monthly (AOM) with prolonged post dose protection.Objective: To evaluate the economic impact on the Ontario Drug Benefit (ODB) program of funding Ari 2MRTU by comparing annual treatment costs with existing reimbursed LAI antipsychotics for maintenance therapy in adults diagnosed with schizophrenia A cost-minimization model was developed from the ODB perspective over a 1-year time horizon, assuming therapeutic equivalence among comparators...Comparators (AOM, risperidone LAI, paliperidone palmitate once monthly [PP1M], and three-monthly [PP3M]) were evaluated per label dosing... These results demonstrate that Ari 2MRTU may deliver cost savings for maintenance treatment of schizophrenia when compared to other LAIs, and this was acrossdifferent initiation scenarios and care settings"

HEOR • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

Efficacy and tolerability of Aripiprazole 2-month ready-to-use 960 mg in adults patients with schizophrenia (ECNP 2025) - "- Two-Injection Start: On the day of initiation, administer two separate injections—one injection of Aripiprazole 2-Month Ready-to-Use 960 mg and one injection of Aripiprazole Once-Monthly 400 mg at different sites—along with a single 20 mg oral dose of aripiprazole. The proportion of patients on antipsychotic monotherapy increased from 70% at baseline to 90% at study completion. CONCLUSIONSAripiprazole 2-Month Ready-to-Use 960 mg was found to be effective, safe, and well-tolerated under real-world clinical practice conditions."

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

Shifting the paradigm: the use of long-acting atypical antipsychotics in acute care (ECNP 2025) - "There is one study evaluating the use of aripiprazole once-monthly (AOM) versus placebo in acute inpatients [1]. Loading strategies have since been developed for AOM [2], and aripiprazole two-monthly (ATM) with two simultaneous injections and single oral dose, which have been shown to achieve therapeutic plasma levels within 24 hours. The two loading deltoid doses of 150 and 100 mg paliperidone palmitate once-monthly (PP1M) can be completed within 4 days, and oral supplementation is not required [3]... The pharmacokinetics of atypical LAIs and new loading strategies with the rapid achievement of therapeutic plasma levels suggest the potential consideration of earlier initiation in a variety of acute care settings. Further research is recommended to evaluate safe and effective protocols for early initiation of LAIs which may improve the care pathways of hospital and community management of schizophrenia. Guidelines should be developed or updated to incorporate the most..."

CNS Disorders • Psychiatry • Schizophrenia

Efficacy of Aripiprazole Once-Monthly and Aripiprazole 2-Month Ready-To-Use on Illness Insight in Bipolar I Disorder: Post Hoc Analysis of Data From Two Randomized Controlled Trials (ISBD 2025) - P1/2, P3 | "AOM 400 and Ari 2MRTU 960 may improve illness insight in patients with BP-I."

Clinical • Retrospective data • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

Clinical Application of Aripiprazole Monohydrate Long-Acting Injectables for the Treatment of Schizophrenia: A Consensus Panel Report. (PubMed, J Clin Psychiatry) - "Two LAI formulations of aripiprazole monohydrate are available: aripiprazole once-monthly 400 mg and aripiprazole 2-month ready-to-use 960 mg, offering options to accommodate patient needs and preferences and support adherence. To support earlier and more informed use of aripiprazole monohydrate LAIs, a panel of psychiatric experts convened to review the latest evidence and share clinical strategies for integrating this agent into a comprehensive treatment plan. This Academic Highlights section presents the main points of their consensus recommendations, offering practical guidance for prescribers seeking to optimize outcomes in patients with schizophrenia."

Journal • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia

Pharmacokinetic evaluation of Aripiprazole Monohydrate as a once every 2-months long-acting injectable for schizophrenia. (PubMed, Expert Opin Drug Metab Toxicol) - "Aripiprazole Monohydrate (AM, Abilify Maintena®) was approved in 2013 as a monthly formulation, but a 2-month interval formulation (Ari2M, Abilify Asimtufii®) was approved by the FDA in 2023 for the treatment of schizophrenia in adults and maintenance monotherapy of Bipolar I disorder in adults, and by the EMA as Abilify Maintena® 960 mg in 2024 with the indication of maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. The new formulation employs a ready-to-use prefilled syringe, must be administered in the gluteal muscle, and can be given within ±2 weeks of the scheduled injection date. Reinitiation is only necessary if ≥14 weeks have passed since the prior injection."

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

Korea Otsuka Launches Abilify Asimtufii, a Schizophrenia Treatment [Google translation] (HIT News) - "Korea Otsuka Pharmaceutical...announced on the 1st that it has launched 'Abilify Asimtufii (ingredient: Aripiprazole Monohydrate)', a maintenance treatment for schizophrenia and bipolar 1 disorder."

Launch non-US • Bipolar Disorder • Schizophrenia

Lundbeck raises financial guidance following strong start to the year with strategic brands growth of +24% CER (Lundbeck Press Release) - "The revenue of Lundbeck’s strategic brands increased by +24% CER (+28% DKK), reaching DKK 4,801 million, representing 77% of total revenue: Rexulti: DKK 1,491 million (+28% CER; +34% DKK); Brintellix/Trintellix: DKK 1,254 million (+7% CER; +7% DKK); Vyepti: DKK 1,042 million (+62% CER; +69% DKK); Abilify LAI franchise: DKK 1,014 million (+16% CER; +18% DKK)."

Sales • Major Depressive Disorder • Migraine • Schizophrenia

[Approval/Clinical] Approval of 2-month-long anti-schizophrenia drug 'Abilify Asimtufii' [Google translation] (HIT News) - "...product approval from the Ministry of Food and Drug Safety....Abilify Asimtufii (ingredient: aripiprazole monohydrate), a treatment for schizophrenia and bipolar disorder type 1 developed by Otsuka Pharmaceutical and Lundbeck, was approved on the 26th of last month. It must be administered intramuscularly by a medical professional, and there are two approved doses: 720 mg and 960 mg."

Korea approval • Bipolar Disorder • Schizophrenia

A review of clinical applications of pharmacokinetic simulations for a 2-month long-acting injectable formulation of aripiprazole. (PubMed, Curr Med Res Opin) - "Aripiprazole 2-month ready-to-use (Ari 2MRTU) is a long-acting injectable antipsychotic that was approved for use in Europe in March 2024, for the maintenance treatment of schizophrenia in adult patients stabilized with aripiprazole; it is administered via gluteal intramuscular injection once every two months...Various simulations conducted across 8 weeks (representing the first dosing interval), or 32 weeks (representing maintenance dosing) demonstrated an aripiprazole exposure profile for Ari 2MRTU that was similar to aripiprazole once-monthly (AOM), but with an extended dosing interval...The availability of Ari 2MRTU extends the range of options for the maintenance treatment of schizophrenia in Europe. Ari 2MRTU may provide adherence benefits due to its extended dosing interval and the option to initiate treatment using a two-injection start regimen, which does not require 14 days of overlapping oral supplementation."

Journal • PK/PD data • Review • CNS Disorders • Psychiatry • Schizophrenia

Health Canada Approves Otsuka and Lundbeck's (Pr)ABILIFY ASIMTUFII (aripiprazole), the First-and-Only, Once-Every-Two-Months, Long-Acting Injectable (LAI) Treatment for Schizophrenia and for Maintenance Monotherapy of Bipolar I Disorder in Adults (Canada Newswire) - "Otsuka Pharmaceutical Canada Inc. (Otsuka) and Lundbeck Canada Inc. (Lundbeck) announce that Health Canada has issued a Notice of Compliance for ABILIFY ASIMTUFII (aripiprazole prolonged release injectable suspension) for intramuscular use, a once-every-two-months treatment for schizophrenia and maintenance monotherapy of bipolar I disorder in adults....ABILIFY ASIMTUFII, a long-acting treatment, offers continuous delivery of medication, which may help those living with schizophrenia or bipolar I disorder."

Canada approval • Bipolar Disorder • Schizophrenia

Use of an injection of aripiprazole given once every 2 months (Abilify Asimtufii®) in people with bipolar I disorder: a Plain Language Summary of Publication. (PubMed, Ther Adv Psychopharmacol) - "The purpose of this summary is to explain key findings from a study that included people with bipolar I disorder, as described in two separate articles (see the 'Further Information' section for more details). The study compared a new formulation of aripiprazole, given as an injection once every 2 months, with a once‑monthly injection of aripiprazole."

Journal • Review • Bipolar Disorder • CNS Disorders • Psychiatry

Aripiprazole 2-month ready-to-use: a novel long-acting injectable antipsychotic formulation for administration once every 2 months (ECNP 2024) - "Until recently, aripiprazole has been available in a daily oral formulation and as an extended-release, once-monthly formulation for intramuscular (IM) injection (aripiprazole once-monthly 400 mg [AOM 400]). Ari 2MRTU is a novel LAI formulation of aripiprazole monohydrate for gluteal IM administration that comes in a ready-to-use syringe and does not require reconstitution. Increasing the dosing interval to 2 months has the potential to reduce the treatment burden for patients and clinicians."

CNS Disorders • Psychiatry • Schizophrenia • CYP3A4 • DRD2

Population Pharmacokinetics and Dosing Simulations for Aripiprazole 2-Month Ready-to-Use Long-Acting Injectable in Adult Patients With Schizophrenia or Bipolar I Disorder. (PubMed, Clin Pharmacol Drug Dev) - "A previously developed and validated population pharmacokinetic model for characterizing aripiprazole plasma concentrations following administration of oral aripiprazole or aripiprazole once-monthly (AOM) intramuscular injection was expanded to include the RTU LAI formulation of aripiprazole (Ari RTU LAI). Additional simulations accounted for missed/delayed doses, cytochrome (CYP) 2D6 metabolizer status, and concomitant use of CYP2D6 or CYP3A4 inhibitors. Overall, simulations across a variety of scenarios demonstrated an Ari RTU LAI pharmacokinetic exposure profile that was comparable to AOM, with a longer dosing interval."

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

Development of a Population Pharmacokinetic Model to Describe the Pharmacokinetics of Aripiprazole 2-Month Ready-To-Use, a Novel Long-Acting Injectable Formulation of Aripiprazole for Administration Once Every 2 Months (SIRS 2024) - "Ari 2MRTU 960 will offer an extended dosing interval versus aripiprazole once-monthly 400 mg (AOM 400). A 3-compartment model with linear elimination and different absorption models for each formulation best described the data. Absorption of the Ari 2MRTU formulation was modeled by a parallel zero-order and lagged first-order process that accounted for an identified double peak in plasma concentrations of aripiprazole post-administration of Ari 2MRTU. All disposition parameters were shared between the formulations except Vc/F (oral and AOM formulations, 93.4 L; Ari 2MRTU formulation, 2035 L); the different Vc/F value for the Ari 2MRTU formulation was attributed to the terminal half-life being absorption driven."

Clinical • PK/PD data • CNS Disorders • Schizophrenia

Aripiprazole 2-Month Ready-To-Use: A Novel Long-Acting Injectable Antipsychotic Formulation for Administration Once Every 2 Months (SIRS 2024) - "Background: Schizophrenia and bipolar I disorder (BP-I) are chronic mental health conditions that require maintenance pharmacological treatment to ensure symptom control. Ari 2MRTU has been shown to be generally well tolerated; investigators’ assessments of the injection site reflected minimal reactions in adults with schizophrenia or BP-I. Ari 2MRTU is a prolonged-release suspension for injection in a single-use pre-filled syringe; it is provided in its final container, with no dilution or reconstitution required prior to administration. Each Ari 2MRTU pre-filled syringe contains 960 mg of aripiprazole monohydrate (total volume 3.2 mL) for administration once every 2 months, providing a dose of aripiprazole that is comparable with a monthly dose of AOM 400."

CNS Disorders • Schizophrenia • CYP2D6 • CYP3A4 • DRD2

Pharmacokinetic Simulations of Aripiprazole 2-Month Ready-To-Use Long-Acting Injectable to Inform Administration in Adult Patients With Schizophrenia (SIRS 2024) - "Background: Ongoing symptom control in patients with schizophrenia relies on long term, consistent antipsychotic treatment. Across multiple simulated initiation scenarios, Ari 2MRTU 960 resulted in aripiprazole 2024 Congress of the Schizophrenia International Research Society concentrations that were comparable to AOM 400, and within the established aripiprazole therapeutic window (95–534 ng/mL) (2,3). This was the case for: • initiation of Ari 2MRTU 960 after a direct transition from AOM 400 • initiation of Ari 2MRTU 960 plus 14 days of overlapping oral aripiprazole 10 or 20 mg/day following stabilization on oral aripiprazole 10 or 20 mg/day, and • initiation of Ari 2MRTU 960 on Day 28 after administration of AOM 400 on Day 0 plus 14 days of overlapping oral aripiprazole 20 mg/day following stabilization on oral aripiprazole 20 mg/day. In maintenance scenarios, median trough concentrations were 191, 144, 110, and 80.1 ng/mL after an Ari 2MRTU 960 dosing delay of 2, 4,..."

Clinical • PK/PD data • CNS Disorders • Schizophrenia • CYP2D6 • CYP3A4

Aripiprazole 2-month ready-to-use 960 mg (Ari 2MRTU): review of its possible role in schizophrenia therapy. (PubMed, Curr Med Res Opin) - "Additional advantages of longer injection intervals are more room for non-medication-related communication between healthcare professionals and patients, patient and physician preferences, reduced caregiver burden and easier transitioning from inpatient to outpatient treatment. Taken together, since aripiprazole may be a good treatment choice for many patients based on its favorable safety and tolerability profile, and given the advantages of LAI treatment over oral treatment and the advantages of reduced dosing frequency, Ari 2MRTU 960 may become an important treatment option for many clinically stable patients with schizophrenia."

Journal • Review • CNS Disorders • Psychiatry • Schizophrenia

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder (clinicaltrials.gov) - P1/2 | N=266 | Completed | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Phase classification: P1b ➔ P1/2

Phase classification • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia