HRS-7535
HRS-7535 (KAI-7535), oral GLP-1 receptor agonist
Also known as: KAI-7535, HRS7535
Hengrui's once-daily oral GLP-1 pill with two positive Chinese Phase 3 trials (about 11% weight loss at 50 weeks), filed in China and in global Phase 2 through Kailera.
Overview
HRS-7535 is a small-molecule GLP-1 receptor agonist. In July 2026 Hengrui and Kailera reported that the HARBOR-1 obesity trial produced 9.8% to 10.9% weight loss at 44 weeks (11.1% at week 50) on 180 mg against 2.4% on placebo, and the OUTSTAND-2 diabetes trial cut HbA1c by 1.5% to 1.7%. A Chinese filing has been submitted, which could make it the second oral small-molecule GLP-1 approved anywhere after orforglipron.
Mechanism of action
Oral small-molecule agonism of the GLP-1 receptor.
Key studies & citations
- Human2026
Positive topline data from two Phase 3 trials of oral GLP-1 HRS-7535 / KAI-7535
About 11% weight loss at 50 weeks; HbA1c down 1.5% to 1.7%.
Kailera press release
Frequently asked questions
Will HRS-7535 be sold in the US?
Not soon. Kailera holds global rights and has only started a global Phase 2; US approval would require its own Phase 3 program.