# Pharmacokinetics, efficacy, and safety of a novel aripiprazole microsphere-based long-acting injectable formulation for schizophrenia: A multicenter, randomized controlled trial

**Authors:** An-Ning Li, Sheng-Chun Jin, De-Wei Shang, Jian-Xiong Guo, Hua-Li Lin, Ming Zhang, Bo Wei, Feng Wan, Yun-Long Tan, Li-Li Wang, Jian-Chu Zhou, Ping Liu, Lian-Lian Fan, Ju-Shui Sun, Bin Chen, Yimin Cui, Gang Wang

PMC · DOI: 10.1016/j.jpha.2025.101350 · 2025-05-22

## TL;DR

A new long-acting injectable aripiprazole formulation (MS350) was tested and found to be as effective as the current version but with more stable levels in the blood and fewer side effects.

## Contribution

MS350, a novel microsphere-based formulation of aripiprazole, offers improved pharmacokinetics and safety compared to existing formulations.

## Key findings

- MS350 is bioequivalent to the microcrystalline formulation of aripiprazole.
- MS350 provides more stable plasma levels over time.
- MS350 demonstrates a better safety profile with fewer adverse events.

## Abstract

Image 1

•A microsphere-based formulation of aripiprazole (MS350) was investigated.•MS350 was bioequivalent to microcrystalline formulation with more stable plasma levels.•MS350 had fewer adverse events, demonstrating a better safety profile.

A microsphere-based formulation of aripiprazole (MS350) was investigated.

MS350 was bioequivalent to microcrystalline formulation with more stable plasma levels.

MS350 had fewer adverse events, demonstrating a better safety profile.

## Linked entities

- **Chemicals:** aripiprazole (PubChem CID 60795)
- **Diseases:** schizophrenia (MONDO:0005090)

## Full-text entities

- **Diseases:** schizophrenia (MESH:D012559)
- **Chemicals:** aripiprazole (MESH:D000068180)

## Figures

2 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12856284/full.md

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Source: https://tomesphere.com/paper/PMC12856284