Medytox said Thursday the Ministry of Food and Drug Safety has approved its investigational new drug (IND) application to conduct the phase 3 clinical trial of MBA-P01, a next-generation botulinum toxin (BTX) formulation.

Medytox plans to conduct a phase 3 clinical trial on 318 patients who need moderate to severe forehead wrinkle improvement at four local medical institutions to launch the product next year.

Unlike the existing BTX products in freeze-dried formulation, MBA-P01 uses a stock solution with a new manufacturing process. It also applies the latest technology to improve production yield and quality, according to Medytox.

Also, the formulation uses a non-animal raw material medium instead of the conventional animal-derived material protein used in the botulinum strain culture step during the manufacturing process.

“MBA-P01 is a next-generation BTX formulation with infinite potential to reshape the market with improved quality,” a company official said. “We will carry out phase 3 clinical trial without any setbacks and launch it next year.”

The company will also discuss license out deals with global pharmaceutical companies for overseas expansion, the official added.