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FDA Approves Mezofy

FDA Approves Mezofy (aripiprazole) Oral Film for the Treatment of Schizophrenia

Seoul, Korea -- April 16, 2025 -- CMG Pharmaceuticals, an affiliate of Cha Biotech, announced on the 16th that it had received product approval for the schizophrenia treatment drug Mezofy (formerly Depibzo) from the U.S. Food and Drug Administration (FDA).

Mezofy is an oral film-type schizophrenia treatment drug (ingredient name: aripiprazole) developed by CMG Pharmaceuticals. Patients with mental illnesses including schizophrenia often refuse or spit out medication, but the film-type drug can be taken without water and easily dissolves in the mouth, solving this problem.

CMG Pharmaceuticals first applied for FDA approval in December 2019. At that time, CMG Pharmaceuticals was the world’s first film-type schizophrenia treatment company to knock on the FDA’s door. However, the supplementary inspection was delayed due to problems with overseas raw material factories and the impact of the COVID-19 pandemic.

Meanwhile, Opipza, aripiprazole film treatment from China's LP Pharma, received FDA approval in July of last year. CMG Pharmaceuticals then reapplied for product approval in October of last year and received marketing approval.

Mezofy is the fourth product from a domestic pharmaceutical company to receive FDA approval for an improved new drug. An improved new drug is not simply a copy of a new drug whose patent has expired, but rather an improvement in the dosage method by changing the efficacy or formulation. Unlike simple generic drugs, it is protected separately by a patent.

The company explained, “The price of improved new drugs is set higher than that of generic drugs, and they can be marketed and prescribed under the product name rather than the ingredient name, which is advantageous in increasing awareness in the market.”


CMG Pharmaceuticals expects Mezofy to be launched in the US in the first half of 2026. According to Data Monitor, a US market research and analysis firm, the US schizophrenia treatment market is the largest in the world, at 12 trillion won.

The company predicted that the market for Mezofy would expand to over KRW 22 trillion when its indications are expanded to include bipolar disorder, major depressive disorder, autism spectrum disorder, and Tourette's disorder.

The company said, “We plan to complete the selection of a local distribution partner in the U.S. by the second half of this year,” and “We will work with our distribution partners to establish a competitive drug pricing strategy.”

CMG Pharmaceuticals has set a goal of achieving annual sales of over 100 billion won within five years of entering the U.S. market. CMG Pharmaceuticals CEO Lee Ju-hyung said, “After proving the excellence of Mezofy in the U.S. market, we will advance into other overseas markets.”

At the time of the initial application for product approval, the product name was Depipzo. The company explained that in collaboration with the global pharmaceutical branding specialist Brand Institute, it decided on Mezofy as a name that is easier to remember and less likely to cause prescription errors.

Source: CMG Pharmaceutical

Posted: April 2025

Mezofy (aripiprazole) FDA Approval History

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