Regulatory & Policy

United Labs' oral GLP-1 drug cleared for US trials

The United Laboratories International Holdings Limited (HKEX: 03933) announced on August 11 that the US FDA has cleared two investigational new drug...

United Labs' oral GLP-1 drug cleared for US trials

An oral, non-peptide GLP-1R agonist from China-based United Laboratories (HKEX: 03933) is set to enter human testing in the US after the US FDA cleared UBT48128 for studies in obesity and type 2 diabetes. As per United Labs' announcement, UBT48128 is an oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist that will be developed in the US by wholly-owned subsidiary United Bio-Technology (Hengqin) Co., Ltd.

UBT48128 activates the GLP-1 receptor via a non-peptide small-molecule mechanism, stimulating glucose-dependent insulin secretion, suppressing glucagon release, and modulating appetite and energy metabolism. The oral tablet formulation distinguishes it from the dominant injectable GLP-1R agonists on the market. The company said preclinical studies across multiple animal models demonstrated reductions in body weight and blood glucose, and asserted superior weight-loss efficacy compared to currently marketed products in the same category.

The competitive pressure in oral GLP-1R agonism has intensified considerably. Eli Lilly's orforglipron (Foundayo), a non-peptide small-molecule GLP-1R agonist, received FDA approval for chronic weight management in 2026 and represents the most direct mechanistic comparator for UBT48128 in the obesity indication. Novo Nordisk's oral semaglutide (Rybelsus), a peptide-based GLP-1R agonist formulated with a sodium N-[8-(2-hydroxybenzoyl) aminocaprylate absorption enhancer, remains the only approved oral GLP-1R agonist for type 2 diabetes. Injectable agents — including Novo Nordisk's semaglutide (Wegovy, Ozempic) and Eli Lilly's tirzepatide (Zepbound, Mounjaro) — continue to set the efficacy benchmark, with tirzepatide delivering approximately 20% mean body weight reduction in pivotal obesity trials.

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United Laboratories' broader GLP-1 pipeline includes UBT251, a GLP-1/GIP/glucagon triple receptor agonist that was licensed to Novo Nordisk in March 2025 in a deal valued at up to USD 2 billion and is currently in Phase III development. UBT48128 represents a distinct modality — oral, small-molecule — and an earlier development stage, with the IND clearances marking the transition from preclinical to clinical evaluation.


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