Lilly's Oral Small-Molecule GLP-1 Receptor Agonist Orforglipron Granted IND Approval in China for Stress Urinary Incontinence in Overweight or Obese Adult Women

On October 10, the CDE website showed that a new indication for Eli Lilly's Orforglipron tablets has been approved for clinical trials in China, intended for the treatment ofStress Urinary Incontinence in Obese or Overweight Adult Female Patients。

Screenshot source: CDE official website

Orforglipron is an investigational, once-daily oral small molecule(Non-peptide)Glucagon-Like Peptide-1 Receptor Agonist（GLP-1 RA）. The drug was initially discovered by Sino-Foreign Pharmaceuticals and licensed to Eli Lilly and Company for development in 2018.

Currently, Eli Lilly and Company is conducting a series of Phase III studies on Orforglipron for the treatment of type 2 diabetes, as well as for weight management in overweight adults with obesity or at least one weight-related comorbidity.Is the small molecule with the fastest global progress GLP-1 RAIn addition, Eli Lilly is also studying the potential of Orforglipron in treating obstructive sleep apnea and hypertension in obese adults.

In China, Orforglipron has previously been approved for multiple clinical studies, with treatment indications covering knee osteoarthritis pain in overweight or obese adult patients, blood glucose control in adult patients with type 2 diabetes, long-term weight management in adult patients who are obese or overweight, hypertension in adult patients who are obese or overweight, and moderate to severe obstructive sleep apnea in adult patients who are obese or overweight.（OSA）。

The clinical trial approved this time targets a new indication — stress urinary incontinence in obese or overweight adult female patients.

On October 2 this year, Eli Lilly and Company registered a Phase III clinical trial on ClinicalTrials.gov.（NCT07202884）, aimed to evaluate the efficacy and safety of Orforglipron compared with placebo in female subjects with obesity or overweight stress urinary incontinence. The study will be conducted in mainland China, the United States, Japan, the Czech Republic, Poland, Romania, Canada, India, South Korea, and Mexico.

Screenshot source: Insight database