Mezofy FDA Approval History

FDA Approved: Yes (First approved April 15, 2025)
Brand name: Mezofy
Generic name: aripiprazole
Dosage form: Oral Film
Company: CMG Pharmaceutical Co., Ltd.
Treatment for: Schizophrenia

Last updated by Judith Stewart, BPharm on May 4, 2025.

Mezofy (aripiprazole) is an oral film formulation of the approved atypical antipsychotic aripiprazole indicated for the treatment of schizophrenia in adult and pediatric patients ages 13 years and older.

• Schizophrenia is a chronic psychiatric disorder characterised by hallucinations, delusions, and disorganized thinking and behavior.
• Mezofy contains aripiprazole, an atypical antipsychotic that is thought to work through a combination of partial agonist activity at dopamine D₂ and serotonin 5-HT_1A receptors and antagonist activity at 5-HT_2A receptors.
• Aripiprazole is a well established treatment for schizophrenia that has been approved in multiple dosage forms under multiple brand names:
  - Abilify (aripiprazole) tablets (2002)
  - Abilify (aripiprazole) oral solution (2004 - now discontinued)
  - Abilify Discmelt (aripiprazole) orally disintegrating tablets (2006 - now discontinued)
  - Abilify (aripiprazole) intramuscular injection (2006 - now discontinued)
  - Abilify Maintena (aripiprazole) extended release intramuscular injection (2013)
  - Aristada (aripiprazole) extended release intramuscular injection (2015)
  - Abilify MyCite (aripiprazole) tablet embedded with Proteus® sensor for use with sensor patch (2017 - now discontinued)
  - Aristada Initio (aripiprazole) extended release intramuscular injection (2018)
  - Abilify Asimtufii (aripiprazole) extended release intramuscular injection (2023)
  - Opipza (aripiprazole) oral film (2024)
  - Mezofy (aripiprazole) oral film (2025)
• Mezofy is an oral film administered once daily with or without food. It is placed on top of the tongue and swallowed after it has completely dissolved.
• Mezofy carries a Boxed Warning for an increased risk of death in elderly patients with dementia-related psychosis. Additional warnings and precautions associated with Mezofy include cerebrovascular adverse reactions in elderly patients with dementia-related psychosis; neuroleptic malignant syndrome; tardive dyskinesia; metabolic changes; pathological gambling and other compulsive behaviors; orthostatic hypotension and syncope; leukopenia, neutropenia, and agranulocytosis; seizures; and potential for cognitive and motor impairment.
• Common adverse reactions with aripiprazole (incidence ≥ 5% and at least twice that for placebo) in adult patients with schizophrenia include akathisia.
  Common adverse reactions with aripiprazole (incidence ≥ 5% and at least twice that for placebo) in pediatric patients (13 to 17 years) with schizophrenia include extrapyramidal disorder, somnolence, and tremor.

Add as a preferred source on Google

Development timeline for Mezofy

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer