After 5-year delay, CMC Pharmaceutical wins FDA nod for oral schizophrenia drug

CMG Pharmaceutical stumbled out of the gate—but five years and a pandemic later, the CHA Biotech affiliate has finally won U.S. FDA approval for Mezofy, a film-based version of the antipsychotic aripiprazole that dissolves on the tongue without water. 

According to CMG on Wednesday, the approval marks a first-of-its-kind for a Korean drugmaker: Mezofy is the first oral aripiprazole film treatment for schizophrenia to win FDA clearance and the first Korean-developed incrementally modified drug (IMD) to get there by changing the drug’s dosage form—rather than its salt type or active ingredient combination.

Patients with schizophrenia often skip or stop meds altogether, so CMG is betting that a waterless, fast-dissolving formulation could address one of the field’s most persistent adherence problems. The film format, developed with CMG’s proprietary STAR FILM technology, is aimed at improving convenience without compromising stability or efficacy.

CMG said it aims to launch the drug in the U.S. by the first half of 2026 and rack up more than 100 billion won (roughly $70 million) in annual sales within five years.

“Until now, FDA approvals for IMDs have been the domain of big pharma,” said CEO Lee Joo-hyung in a statement. “CMG has built the internal know-how and global partnerships to become the first mid-sized Korean firm to achieve this milestone.”

Still, the road to approval wasn’t smooth. CMG Pharmaceutical first filed its application to the FDA in 2019 under the product’s former name, Depipzo, but was hit with a delay after impurities were found in another drug made by its third-party ingredient supplier. The pandemic further postponed FDA inspections, the company said. By the time CMG refiled in October 2024, China’s Xiamen LP Pharmaceutical had beaten them to market with its own aripiprazole film product, Opipza.

To make up for lost ground, CMG rebranded Depipzo as Mezofy, working with branding firm Brand Institute to vet the name with U.S. physicians. The new name, the company said, is easier to remember and less likely to be misprescribed.

Mezofy is manufactured at Germany’s Labtec GmbH, an oral thin film making site certified under both U.S. and European good manufacturing practices.  CMG said it plans to secure a U.S. distribution partner by the end of this year and is preparing for price negotiations.