"Already Secured Sufficient Quantities"... Once-Daily Oral Anti-Obesity Drug Expected to Enter Korea Next Year

Lilly and Novo Accelerate Launch of Next-Generation Obesity Treatments
Competition Heats Up for Oral and High-Dose Therapies

As next-generation anti-obesity drugs are being developed one after another, the obesity drug market is expected to be reshaped next year, centering on so-called "oral Mounjaro" and "high-dose Wegovy." Domestically developed anti-obesity drugs are also set to enter the market in earnest.

Anti-obesity drug Wegovy. Reuters Yonhap News

According to the pharmaceutical industry on December 4, Eli Lilly is expediting preparations to launch its oral anti-obesity drug, Orforglipron, in the United States next year. Orforglipron, which is taken once daily, is a glucagon-like peptide-1 (GLP-1) anti-obesity drug and is referred to as "oral Mounjaro."

Eli Lilly plans to apply for approval of Orforglipron to the U.S. Food and Drug Administration (FDA) within this year, aiming for a launch next year. If the FDA’s expedited approval process is used, a decision could be made within the year.

In a recent interview, Eli Lilly CEO Dave Ricks stated, "We have already secured sufficient quantities ahead of the product launch," and added, "We have completed production of billions of doses of Orforglipron."

If the product receives FDA approval, it is expected to be introduced quickly in Korea as well. Eli Lilly Korea is reportedly in discussions with Eli Lilly to facilitate the rapid introduction of Orforglipron to the domestic market.

Eli Lilly also plans to launch a high-dose version of Mounjaro in Korea within the first half of next year. By utilizing the higher-dose 12.5 mg and 15 mg anti-obesity drugs, which exceed the currently available 2.5-10 mg doses in Korea, greater weight loss effects can be expected.

Novo Nordisk is also developing an oral anti-obesity drug to be taken once daily, targeting a market launch next year. Novo Nordisk has applied to the FDA for approval of "semaglutide 25 mg," an oral GLP-1 anti-obesity drug. This product increases the dosage from the previously available 7 mg and 14 mg, which were used as treatments for type 2 diabetes.

In addition, last month Novo Nordisk applied to the FDA for approval of a 7.2 mg high-dose formulation of Wegovy. Currently, the approved dose of Wegovy for weight management is 2.4 mg. This application is subject to the FDA's expedited review, which is expected to be completed within the next one to two months, with approval anticipated either by the end of this year or early next year.

Domestic Anti-Obesity Drugs Such as Hanmi Pharmaceutical and Caregen Show Clinical Results, Prepare for Launch

Hanmi Pharmaceutical aims to launch its anti-obesity drug "efeglenatide" in the second half of next year. Hanmi Pharmaceutical previously announced that interim topline results from its domestic Phase 3 clinical trial showed up to 30% weight loss effects. Topline results refer to key indicators released before the final clinical results are announced.

Caregen also raised expectations for the launch of a health functional food-type anti-obesity drug by announcing clinical results for its GLP-1-based oral weight loss peptide "Coglutaide."

Seo Jungjin, Chairman of Celltrion, also revealed plans to lead the next-generation anti-obesity drug market through the development of a "quadruple-action anti-obesity drug." This drug is designed to simultaneously activate four metabolic and hormonal receptors with a single medication, thereby enhancing weight loss effects.

Meanwhile, on December 1, the World Health Organization (WHO) issued a "conditional recommendation" for the use of GLP-1-based anti-obesity drugs such as Wegovy and Mounjaro for obese patients. WHO recognized obesity as a chronic disease and announced that GLP-1 medications could help treat millions of obese patients.

This is the first time that WHO has recommended anti-obesity drugs. As a result, there are now expectations that GLP-1-based anti-obesity drugs could be incorporated into public healthcare systems in various countries starting next year.