Daewoong Enters Phase 1 Clinical Trial for 'Semaglutide Patch'

Innovating Obesity Treatment with a Patch

Daewoong Pharmaceutical and Daewoong Therapeutics announced on October 1 that their micro-needle patch containing semaglutide (DWRX5003) has received approval for a Phase 1 clinical trial plan (IND) from the Ministry of Food and Drug Safety.

This clinical trial will evaluate the safety and pharmacokinetic characteristics of the micro-needle patch in healthy adults, and will also assess its relative bioavailability compared to Novo Nordisk's injectable obesity and diabetes treatments, Ozempic and Wegovy.

A micro-needle patch developed by Daewoong Therapeutics, with dye added to visually represent the drug layer, photographed at 4.2 times magnification. Daewoong Pharmaceutical

Daewoong's micro-needle patch is a patch-type formulation that, when applied to the skin, delivers the drug directly into the dermal layer through micro-needles composed of semaglutide that dissolve upon application. It is designed for once-weekly use. The patch utilizes Daewoong Therapeutics' proprietary drug delivery platform, CLOPAM®, which employs differentiated technologies such as pressurized drying and airtight packaging to maximize drug uniformity and stability, and enables precise dosing without contamination concerns.

CLOPAM® is notable for achieving a relative bioavailability of over 80% compared to subcutaneous injections, a figure that is significantly higher than the approximately 30% reported for existing micro-needle patches, and about 160 times higher than that of oral formulations.

As a result, patients are expected to experience reduced burden from oral medication and improved treatment adherence compared to injectable therapies. For healthcare professionals, the patch can reduce the time required for injections and monitoring, allowing them to focus more on patient care and ultimately improving clinical efficiency.

Kang Bokki, CEO of Daewoong Therapeutics, stated, "Entering this clinical trial is an important first step in proving the global competitiveness of our micro-needle platform. Through a new formulation that is both safe and effective, we aim to change the paradigm of obesity treatment and demonstrate that Korean technology can compete in the global market."

Park Sungsoo, CEO of Daewoong Pharmaceutical, said, "Daewoong Pharmaceutical seeks to go beyond technology-driven drug development and introduce innovative formulations recognized in the global market. The convenient once-weekly patch formulation will be a next-generation option that can increase patient adherence and improve efficiency in clinical settings."