Daewoong Pharmaceutical is expanding the indications for its fat-dissolving injection, Violette. The company aims to secure clinical evidence for localized fat management, starting with the front axillary fat.
On July 15, Daewoong Pharmaceutical signed a memorandum of understanding (MOU) for joint research on new indications for Violette with Bundang Seoul National University Hospital and 365mc at Daewoong's headquarters in Samsung-dong, Seoul. The signing ceremony was attended by Yoon Jun-soo, head of Daewoong's Nabota business division, Kim Nam-cheol, CEO of 365mc, and Professor Heo Chang-hoon from the dermatology department at Bundang Seoul National University Hospital.
Violette is the first domestically produced deoxycholic acid (DCA) injection, an original drug that has proven its safety and efficacy in clinical trials involving Koreans. It is the only DCA injection in South Korea with its own authorized clinical data.
Daewoong Pharmaceutical has noted an increase in demand for managing residual fat and skin elasticity following weight loss due to the rise of glucagon-like peptide-1 (GLP-1) obesity treatments. The company is expanding Violette's indications beyond its current approval for double chin improvement to include various localized areas, such as the front axillary fat. Daewoong has built an aesthetic lineup targeting body contouring needs by adding the botulinum toxin Nabota and the filler D-Classy to its fat-dissolving injection.
Daewoong plans to enhance the clinical value of Violette by combining its five years of market experience and research and development capabilities with the clinical research expertise of Bundang Seoul National University Hospital and the body contouring know-how of 365mc. The company intends to accumulate clinical evidence for various localized areas, including the abdomen, arms, and thighs, starting with this research.
Professor Heo Chang-hoon's research team at Bundang Seoul National University Hospital will conduct a researcher-initiated clinical trial (IIT) to confirm the effectiveness of Violette in reducing front axillary fat. This clinical trial is set to begin following the approval of the clinical trial plan (IND) by the Ministry of Food and Drug Safety in October of last year and the Institutional Review Board (IRB) approval in April of this year. 365mc contributed to the development of evaluation indicators for front axillary fat during the IND approval process.
Yoon Jun-soo, head of Daewoong's Nabota business division, stated, "This agreement marks the starting point for expanding Violette's indications based on its originality and leadership. We will combine the strengths of the three institutions to enhance the value of DCA formulations and lead the evidence-based body contouring market."
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.