Modeling Supports One-Day Oral Overlap for Aripiprazole LAI Start in Japan

This population pharmacokinetic simulation provides the regulatory basis for the two-injection start regimen of aripiprazole once-monthly long-acting injectable in Japanese patients, eliminating the 14-day oral overlap requirement.

aripiprazolelong-acting injectableatypical antipsychoticschizophreniabipolar I disordertwo-injection startpopulation pharmacokineticsCYP2D6Japanregulatory submissionmodeling and simulation Psychiatry / Psychopharmacology

Background Information

New aripiprazole regimen may enhance adherence in schizophrenia and bipolar I disorder.

Improving medication adherence in schizophrenia and bipolar I disorder is crucial for effective management, particularly in the Japanese population. The two-injection start (TIS) regimen for aripiprazole showed similar plasma concentration profiles compared to the original regimen, without new safety concerns. The TIS regimen potentially eases the medication process by reducing the need for extended oral dosing, thus likely enhancing adherence and reducing healthcare burden. Notably, this study supports a regulatory submission but is based on simulated data. The aripiprazole two-injection start regimen offers a streamlined option with reduced medication burden.

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Authors: Yamasaki Y, Sasaki T, Martinecz A, Hasegawa M, Kuwahara K, Soga A, Yamada K, Katayama S, Maeda K, Ichimura T, Kawai Y

Citation: Yamasaki Y, Sasaki T, Martinecz A, et al. 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. Journal of clinical pharmacology. 2026;66(7):e70230. doi:10.1002/jcph.70230

Article Links: PubMed · Journal / DOI · Free Full Text (PMC)

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