JW Pharmaceutical Accelerates Phase 3 Trials of Twice-Monthly GLP-1 Drug Targeting Diabetes and Obesity

JW Pharmaceutical has submitted a plan to the Ministry of Food and Drug Safety (MFDS) for a domestic phase 3 trial of the GLP-1 diabetes treatment injection Bofanglutide, for which it secured exclusive development rights in South Korea from China’s Gan & Lee Pharmaceuticals. The 44-week trial will enroll 174 patients with type 2 diabetes whose blood glucose is not adequately controlled despite combination treatment with metformin and an SGLT-2 inhibitor. The trial is scheduled to begin in January 2027 and end in February 2029.

Notably, the diabetes phase 3 application is not a standalone effort. Just days earlier, in mid-August 2026, JW Pharmaceutical also submitted an investigational new drug application for a phase 3 trial in the obesity indication involving 300 Korean adults with obesity. The company is pursuing phase 3 trials simultaneously in both diabetes and obesity, underscoring a race to establish an early position in South Korea’s metabolic disease market.

Bofanglutide’s key competitive advantage: dosing convenience

The main reason Bofanglutide is attracting attention is its dosing interval. GLP-1 drugs that currently dominate the global market, including Novo Nordisk’s Ozempic (semaglutide) and Eli Lilly’s Mounjaro (tirzepatide), are all administered once weekly. Bofanglutide, by contrast, is administered once every 2 weeks, reducing the number of annual injections by half, from 52 to 26. If commercialized, it would become the world’s first once-every-2-weeks GLP-1 treatment.

Clinical data also support its efficacy. According to phase 2b results published in the international journal Annals of Internal Medicine in June 2026, HbA1c in the Bofanglutide 18 mg group decreased by 2.28% from baseline. In the same study, the reduction in the group receiving once-weekly semaglutide 1 mg was 1.60%. Ming Liu, MD, PhD, of Tianjin Medical University Hospital in China, the principal investigator of the phase 2b trial, said, “Bofanglutide’s blood glucose-lowering effect was comparable to or greater than that of the highest dose of semaglutide currently approved for clinical use.”

A 110 billion won wager with a 10% probability of success

JW Pharmaceutical’s investment in Bofanglutide is substantial. The domestic exclusive development and commercialization agreement signed with Gan & Lee Pharmaceuticals in April 2026 is worth a total of $81.1 million, including a $5 million upfront payment, or approximately 110 billion won. The actual investment will be larger once the costs of phase 3 trials in the diabetes and obesity indications are included. JW Pharmaceutical itself stated in a regulatory disclosure that “the statistical probability that a clinical trial drug will ultimately receive approval as a pharmaceutical product is approximately 10%.” In effect, the company directly informed investors that it is betting more than 110 billion won on a project with a one-in-10 probability of success.

Gan & Lee Pharmaceuticals, the original developer, has also begun a global phase 3 study, GRADUAL-3, investigating an ultra-long-acting formulation that extends Bofanglutide’s dosing interval to once every 4 weeks, or once monthly. If the interval evolves from once every 2 weeks to once monthly, its competitive advantage could widen further. Morgan Stanley forecasts that the global obesity and diabetes treatment market will grow to $190 billion, or approximately 250 trillion won, by 2035, with the Asia-Pacific region alone expected to grow at an annual average rate of 14% through 2033. Industry analysts say a once-every-2-weeks formulation could become a turning point in increasing patient adoption of the drug.

If the two phase 3 trials are completed successfully, JW Pharmaceutical will have a metabolic disease portfolio spanning obesity and diabetes in South Korea. However, considering the time required for regulatory review after the trials end in 2029, a market launch remains some distance away. The key question is whether the drug can overcome the 10% approval probability and establish itself in the market.