Ildong to report Phase 1 topline for oral GLP-1 ID110521156 on September 29

Ildong Pharmaceutical said it will present topline Phase 1 clinical trial results for ID110521156, an experimental oral GLP-1 receptor agonist, at an investor briefing in Seoul on September 29 ^[1]. The drug is being developed by Yunovia, an Ildong affiliate ^[1]. The results have not been released.

The presentation will be led by Ildong president and COO Lee Chae-joon and Park Joon-tae, who heads R&D at Yunovia ^[1]. The topline release will add weight-loss results from the high-dose group and data on safety and tolerability; the interim report presented in June covered the 100 mg dose cohort ^[1].

That interim data, shown as a poster at the American Diabetes Association meeting in Chicago, reported an average weight reduction of 6.9 percent and a maximum reduction of 11.9 percent over four weeks in the 100 mg group ^[1]. In the same dose-dependent cohorts, no participant in the placebo group lost 5 percent or more of body weight, compared with 55.6 percent in the 50 mg group and 66.7 percent in the 100 mg group ^[1]. The company also reported a low incidence of gastrointestinal side effects, even at higher doses ^[1].

ID110521156 has been under development at Yunovia since 2019 and entered Phase 1 testing in September 2023, with topline results arriving about two years later ^[1]. It is described as the most advanced oral obesity candidate in clinical development in Korea, ahead of programs at Hanmi Pharmaceutical, D&D Pharmatech and ProGen ^[1]. KoreaBio, an industry group, forecasts the global obesity treatment market growing at a compound annual rate of 48.4 percent, from $6.68 billion in 2023 to $48 billion by 2028 ^[1].

Oral GLP-1 drugs are difficult to formulate because digestive enzymes can break them down before they reach the intestine, limiting absorption ^[1]. Rybelsus, Novo Nordisk's oral semaglutide, has a bioavailability of about 1 percent ^[1]. Shares of Ildong rose roughly 78 percent, from 12,840 won (about $9.20) on June 25 to 22,800 won on September 2 ^[1].

In the US, oral GLP-1s are already on the market. Novo Nordisk's Wegovy pill accounted for about 90 percent of weekly oral obesity prescriptions as of July, or roughly 1.5 million people, and Eli Lilly's oral Foundayo (orforglipron) is approved with regulatory reviews under way in more than 40 markets ^[2]. Obesity drug sales reached $66 billion last year and could rise to between $105 billion and $200 billion by 2027 and beyond, according to IQVIA estimates ^[2]. None of those figures involve ID110521156.

Why it matters for patients

Phase 1 is the earliest stage of testing in people, and the June numbers covered just four weeks in one dose cohort. The number of participants, their health status, and whether the weight loss held up after treatment stopped have not been reported. Results from a four-week early study cannot be compared directly with approved GLP-1 drugs, which were tested in much larger trials lasting many months.

Gastrointestinal side effects such as nausea are a common reason people stop taking GLP-1 medications, and Ildong reported fewer of them at effective doses in the interim data ^[1]. The September 29 briefing is expected to give a fuller picture of tolerability across doses ^[1], but it will still be early-stage data.

Oral options already exist in the US, including Rybelsus and the Wegovy pill, both semaglutide, and Foundayo, orforglipron ^[1][2]. A new oral GLP-1 would not reach US patients until it clears later-phase trials and FDA review. No US development or filing plan for ID110521156 has been reported.

What happens next

Ildong's briefing is set for September 29 in Yeouido, Seoul, where the company will also outline its follow-up development strategy ^[1]. Whether that includes a Phase 2 start date, a US trial, or a partnership has not been disclosed ^[1].