Mezofy FDA Approval History

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

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

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.

Development timeline for Mezofy

Further information

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