Oral GLP-1 Race Heats Up with Chinese Data, Aleniglipron Results, and Tolerability Challenges; EU Approves Oral Semaglutide; FDA Approves Oral Small-Molecule GLP-1s
Key Questions
What weight loss results have been seen with Chinese oral GLP-1 candidates like HRS-7535?
Phase 3 data for HRS-7535 in China shows around 10% weight loss, while other agents like VCT220 and HRS-7535 reach about 12% at 52 weeks. Aleniglipron achieved up to 16% at 44 weeks with lower discontinuation rates.
What tolerability challenges are associated with oral GLP-1 agonists like aleniglipron?
Aleniglipron Phase 2b data reports 79-89% of patients experiencing any GI event and 10% discontinuation due to side effects. Nausea and vomiting rates reached around 70% in some Chinese trials, making tolerability a key development hurdle.
Which companies are advancing oral GLP-1 candidates in the US and globally?
Lilly (orforglipron) and Novo Nordisk (amycretin) are progressing oral options alongside Chinese developers. US Phase 2 results for aleniglipron are still pending amid ongoing competition in the oral GLP-1 space.
Kailera/Hengrui's HRS-7535 Phase 3 in China shows ~10% weight loss but nausea/vomiting ~70%. New Chinese data: VCT220 and HRS-7535 achieve ~12% weight loss at 52 weeks, Aleniglipron 16% at 44 weeks with lower discontinuation. New aleniglipron Phase 2b data: 9-12% at 36 weeks, 15-16% at 56 weeks, with GI tolerability concerns (79-89% any GI event, 10% discontinuation). US Phase 2 results pending. Competitors Lilly (orforglipron) and Novo (amycretin) also advancing. Tolerability remains key hurdle. Major milestone: EU approves oral semaglutide (Wegovy pill) for weight management (OASIS 4: ~17% loss), adding a potent oral competitor. New FDA approval of oral small-molecule GLP-1s (orforglipron, danuglipron) in April 2026 marks a shift to nonpeptide oral agents; CV outcomes questions remain.