Novo Nordisk's obesity treatment Wegovy (semaglutide) has received U.S. Food and Drug Administration approval in oral pill form, officially opening the oral obesity drug market. As the market prepares to take shape, expectations are rising for R&D achievements from Korean developers including D&D Pharmatech (347850.KQ), Ennobia, and Celltrion (068270.KS).
Novo Nordisk announced Wednesday that Rybelsus (oral semaglutide 25mg), taken once daily, received FDA approval for weight reduction and long-term weight management in overweight and obese adults, as well as for reducing major adverse cardiovascular events (MACE) risk. When launched in the U.S. in January, it will become the world's first oral GLP-1 class obesity drug.
In a Phase 3 clinical trial involving 307 obese or overweight adults without diabetes, Rybelsus showed an average weight reduction of 16.6%. Novo Nordisk has set the U.S. price at $149 per month (approximately 220,000 won).
Experts view the introduction of the oral formulation as a turning point for expanding the obesity treatment market. Timothy Garvey, a professor at the University of Alabama School of Medicine, said, "This can meet demand from patients who are reluctant to use injectable GLP-1 agents," adding, "From physicians' perspective, the range of treatment options tailored to patient characteristics has widened."
With the oral obesity drug market now officially open, expectations are growing for R&D achievements from Korean developers. D&D Pharmatech, a Pfizer partner, has licensed multiple oral obesity drug candidates to Pfizer-acquired Metsera based on its oral peptide platform "OralLink." MET-GGo, an oral GLP-1/GIP dual agonist co-developed by D&D Pharmatech and Metsera, showed 29.1% weight reduction in preclinical studies. This overwhelms same-dose dual agonists including Eli Lilly's tirzepatide (17.7%) and Viking Therapeutics' VK2735 (18.5%). With a half-life of 101 hours, there is also increased potential for development as a long-acting formulation with extended dosing intervals.
Small-molecule oral obesity drugs are also gaining attention in global markets for their high production efficiency, raising the value of ID110521156 developed by Ildong Pharmaceutical (249420.KS) subsidiary Ennobia. ID110521156 is an oral GLP-1 class small-molecule compound obesity drug. Recently released Phase 1 clinical trial results from a 4-week repeat-dose study recorded up to 13.8% weight reduction with no serious adverse reactions such as gastrointestinal side effects or liver toxicity. Ennobia is proceeding with global Phase 2 clinical trial design and technology licensing discussions.
Celltrion also recently announced development of CT-G32, an oral quadruple-agonist obesity drug. The strategy aims to maximize efficacy and minimize side effects by simultaneously regulating multiple pathways. Celltrion Chairman Seo Jung-jin said, "CT-G32 is being developed with a target of at least 25% weight reduction," adding, "We have secured efficacy data superior to global companies' products."
Chong Kun Dang (185750.KS) is also developing CKD-514, a small-molecule compound-based oral obesity drug. According to preclinical research disclosed by Chong Kun Dang last month, CKD-514 showed significant weight reduction effects at lower doses compared to Eli Lilly's orforglipron, based on excellent bioavailability.
