Abilify Asimtufii Approved for Schizophrenia, Bipolar I Disorder

The FDA has approved Abilify Asimtufii (aripiprazole), administered every 2 months, for schizophrenia and bipolar I disorder.

The Food and Drug Administration (FDA) has approved Abilify Asimtufii® (aripiprazole extended-release injectable suspension) for the treatment of schizophrenia in adults and as maintenance monotherapy treatment of bipolar I disorder in adults.

Abilify Asimtufii, an atypical antipsychotic, is intended for dosing every 2 months via intramuscular injection in the gluteal muscle. The approval was based on safety and efficacy data from Abilify Maintena (once monthly dosing) trials, as well as findings from an open-label, multiple-dose, parallel-arm phase 1/2 study (ClinicalTrials.gov Identifier: NCT04030143) that included  266 adults with schizophrenia or bipolar I disorder.

Study participants were randomly assigned to receive either Abilify Asimtufii 960 mg (n=132) administered every 56 days (total of 4 injections) or Abilify Maintena 400 mg (n=134) administered every 28 days (total of 8 injections). Results showed that treatment with Abilify Asimtufii met the primary endpoint demonstrating similar aripiprazole plasma concentrations and comparable efficacy to Abilify Maintena.

Treatment with the every 2-month injectable was found to be safe and well tolerated; no new safety concerns were reported with multiple administrations. The most common adverse reactions reported were increased weight, akathisia, injection site pain, and sedation.

Each dose of Abilify Asimtufii is provided in a single-chamber, prefilled syringe, and is administered by a health care provider. The product is available in 720 mg/2.4 mL and 960 mg/3.2 mL dosage strengths.

This article originally appeared on MPR


  1. FDA approves Otsuka and Lundbeck’s Abilify Asimtufii® (aripiprazole), the first once-every-two-months long-acting Injectable (LAI) for the treatment of schizophrenia or maintenance monotherapy treatment of bipolar I disorder in adults. News release. Otsuka and Lundbeck. April 27, 2023. https://www.businesswire.com/news/home/20230427006070/en/FDA-Approves-Otsuka-and-Lundbeck%E2%80%99s-ABILIFY-ASIMTUFII%C2%AE-aripiprazole-the-First-Once-Every-Two-Months-Long-acting-Injectable-LAI-for-the-Treatment-of-Schizophrenia-or-Maintenance-Monotherapy-Treatment-of-Bipolar-I-Disorder-in-Adults.
  2. Abilify Asimtufii. Package insert. Otsuka and Lundbeck; 2023. Accessed April 28, 2023. https://www.otsuka-us.com/sites/g/files/qhldwo7066/files/media/static/Abilify-Asimtufii-PI.pdf.