Medytox Applies for Domestic Approval of Fat-Dissolving Injection 'NewV'

Medytox announced on the 18th that it had applied for product approval of the fat-dissolving injection 'NewV (development name MT921)' to the Ministry of Food and Drug Safety on the 15th.

NewV is a fat-dissolving injection that improves moderate to severe submental fat. It is characterized by being the world's first to use cholic acid (CA) as the main ingredient. Compared to existing injections containing deoxycholic acid (DCA), it has lower surfactant activity, reducing adverse reactions such as pain, swelling, bruising, and pigmentation, and is regarded as the next-generation fat-dissolving injection.

Medytox completed a Phase 3 clinical trial in February at 10 domestic medical institutions with a total of 240 patients. According to Medytox, NewV showed significantly higher improvement rates in submental fat, patient satisfaction, and volume reduction of submental fat measured by MRI compared to the placebo group. The company also stated that the incidence rate of adverse reactions was similar to that of existing DCA products in terms of safety.

Medytox plans to launch NewV in the second half of next year. Joo Hee-seok, Vice President of Medytox, emphasized, “NewV is a symbolic product marking Medytox’s full-scale entry into the synthetic drug sector. Developed with cholic acid as the main ingredient, NewV has excellent competitiveness, and we will make thorough preparations to ensure it achieves results that meet future market expectations.”