Oral Wegovy enters market...prompts change in market strategy

Commercialization of oral GLP-1 therapies forces latecomers to revise strategies

Technology licensing and commercialization plans reshaped, with formulation innovation and muscle-loss mitigation emerging as key differentiators

The emergence of ‘oral Wegovy’ in the global obesity treatment market, which has long been dominated by injectable GLP-1 therapies, is expected to intensify competition for companies in Korea and abroad. Domestic pharmaceutical and biotech firms are shifting their development focus beyond simple formulation competition, eyeing niche strategies like muscle loss improvement.

According to industry sources, Novo Nordisk's oral obesity treatment, Wegovy (semaglutide), received approval from the U.S. Food and Drug Administration (FDA) on the 22nd (local time).

The oral version converts the company’s injectable GLP-1 class obesity therapy into a once-daily pill, eliminating key drawbacks of the injectable version, such as the need for refrigerated storage and the hassle of self-injection. Novo Nordisk plans to launch the product in the U.S. market in early January next year.

Eli Lilly, which developed the GLP-1/GIP dual receptor agonist obesity drug Mounjaro, is also preparing to commercialize its oral GLP-1 therapy orforglipron. The company recently submitted a new drug application to the FDA, and industry observers expect a full-scale duopoly to emerge starting next year.

The introduction of oral obesity drugs is widely seen as a potential game-changer for a market previously dominated by injectables. This is because it could significantly improve patient accessibility by reducing the psychological aversion to injections. Indeed, competition to develop oral GLP-1s is accelerating, particularly among global big pharma.

Korean pharmaceutical companies are also developing GLP-1–based obesity drugs, but their commercialization timelines are likely to lag behind global frontrunners. As a result, incremental formulation improvements, as well as strategies aimed at reducing side effects associated with injectable or oral therapies, are gaining prominence. Approaches targeting multiple mechanisms beyond GLP-1 alone, such as inhibiting muscle loss and improving comorbid metabolic disorders, are also drawing attention.

Daewoong Pharmaceutical is pursuing a non-injectable competitive edge with a microneedle patch-based obesity therapy. The microneedle patch reduces pain and needle phobia, allows room-temperature storage, and offers logistical advantages in distribution and handling. The absence of syringe waste is also cited as an additional benefit.

A key feature of the microneedle patch is its potential to overcome the low bioavailability that has been a limitation of oral formulations. Oral drugs suffer significant peptide loss during passage through the digestive tract, requiring larger doses of active ingredients to achieve weight loss effects, which can increase the risk of side effects.

According to human pharmacokinetic data released by Daewoong Pharmaceutical in August last year, the bioavailability of its microneedle patch was over 80% compared to injectables. This represents a significant improvement compared to the absorption rate of conventional patch formulations, which was around 30%.

Hanmi Pharmaceutical has adopted a strategy to simultaneously improve muscle loss and gastrointestinal side effects, which are considered major limitations of GLP-1 class obesity drugs. The company is developing new drug candidates such as ‘HM15275’, which minimizes muscle loss while achieving weight loss effects, and ‘HM17321’, a muscle-increasing obesity treatment.

Development of oral treatments is also active in Korea. However, as oral formulations are already well established in the global market, Korean companies are increasingly prioritizing early-stage technology licensing over direct competition with finished products. Some companies are concurrently pursuing joint development or license-out strategies targeting global pharmaceutical companies from the early clinical stages.

Ildong Pharmaceutical's GLP-1 oral obesity treatment candidate ‘ID110521156’ showed an average weight loss of 9.9% and a maximum of 13.8% in the 200mg dose group in its Phase I clinical trial topline results. Weight loss effects of 5.5% and 6.9% on average over 4 weeks were also confirmed in the 50mg and 100mg dose groups, respectively. Based on these results, Ildong Pharmaceutical is preparing to enter global Phase II clinical trials and is targeting technology transfer to offset rising development costs at later clinical stages.

DND Pharmatech is developing the oral GLP-1 drug ‘MET-002o’ based on its proprietary oral drug delivery platform ‘ORALINK’. Its partner company, Metsera, is conducting a Phase I clinical trial in North America.

Industry expectations are growing for next-generation obesity therapies that go beyond simple weight-loss metrics to comprehensively address long-term use, side-effect management, and post-treatment weight regain.

An industry official commented, “Convenience in administration has long been considered a key competitive factor in obesity therapies requiring long-term administration. The launch of oral Wegovy goes beyond a simple formulation change and improvements in efficacy and side effects. It is prompting Korean companies to fundamentally reassess their technology-licensing approaches and development strategies.”