According to data from PharmNet, Eli Lilly has submitted a marketing application to the NMPA for orforglipron . Previously, at the end of 2025, Eli Lilly had submitted a New Drug Application (NDA) for the same drug to the U.S. FDA for the treatment of obesity or overweight in adults.

Orforglipron (formerly known as OWL833) was first discovered by Chugai Pharmaceutical Co., Ltd. In September 2018, Chugai Pharmaceutical signed a global exclusive licensing agreement with Eli Lilly and Company, under which Eli Lilly and Company will obtain the global rights to develop and commercialize OWL833.

According to the results of Eli Lilly's Phase 3 clinical trial ATTAIN-2, orforglipron showed significant efficacy and a safety profile consistent with injectable GLP-1RA drugs.

In obese or overweight participants with type 2 diabetes (a population that is more difficult to lose weight), during the 72-week treatment period, the mean weight loss was 10.4 kg (10.5%) in the highest dose of orforglipron (36 mg group) compared to 2.3 kg (2.2%) in the placebo group, and the mean reduction in glycated hemoglobin (A1C) was 1.8%.

According to the results of the phase 3 clinical trial ACHIEVE-3, in a head-to-head trial of patients with type 2 diabetes, Orforglipron resulted in greater improvements in glycated hemoglobin (A1C) and body weight compared to Novo Nordisk's oral smegglutinin.

At week 52, patients treated with 12 mg and 36 mg orforglipron showed an average decrease in A1C levels of 1.9 and 2.2 percentage points, respectively ; while patients treated with 7 mg and 14 mg of the control drug showed a decrease in A1C levels of 1.1 and 1.4 percentage points, respectively.

Patients treated with 12 mg and 36 mg orforglipron experienced mean weight loss of 14.6 lbs (6.7%) and 19.7 lbs (9.2%), respectively ; while patients treated with 7 mg and 14 mg of the control drug experienced weight loss of 7.9 lbs (3.7%) and 11.0 lbs (5.3%), respectively. In the highest dose group comparison, the orforglipron group showed a 73.6% greater reduction in weight.

In late 2025, Novo Nordisk's daily oral semaglutide tablets (trade name: Wegovy) received FDA approval, becoming the world's first oral GLP-1 receptor agonist for weight management.

Compared to the injectable version, Wegovy tablets have unique requirements regarding administration. Patients must take them daily on an empty stomach, with only a small amount of water, and must not eat, drink, or take other medications for half an hour after taking the medication.

Eli Lilly's Orforglipron is a non-peptide, small-molecule oral GLP-1 receptor agonist that has no restrictions on diet or water intake. Moreover, compared to peptide GLP-1 agonists, the small molecule is expected to be cheaper to manufacture.

Currently, the drug has submitted marketing applications in the United States and China, and is expected to be approved this year, helping the competition among GLP-1 drugs enter a new stage.

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