Semaglutide.
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Semaglutide is a synthetic GLP-1 receptor agonist developed by Novo Nordisk: a human GLP-1 analogue with amino-acid substitutions and a fatty-diacid side chain that binds albumin and extends the half-life to about one week. The FDA approved it as Ozempic for type 2 diabetes on 5 December 2017, as the oral tablet Rybelsus on 20 September 2019 and as the weight-management injection Wegovy on 4 June 2021; the medicines are also authorised by the EMA.

The SUSTAIN trial programme characterised its glucose-lowering action through GLP-1 receptor agonism in adults with type 2 diabetes, and SUSTAIN-6 (Marso et al., 2016) examined cardiovascular outcomes. The STEP programme (Wilding et al., 2021) studied its effect on body weight through appetite- and satiety-regulating GLP-1 pathways in adults with obesity or overweight, and SELECT (Lincoff et al., 2023) examined cardiovascular outcomes in obesity without diabetes; the PIONEER programme evaluated the oral formulation.

As Ozempic, Wegovy and Rybelsus, semaglutide is a prescription-only medicine manufactured and reviewed under FDA and EMA oversight. Research-use-only semaglutide vials sold outside that supply chain are not those products, have not been reviewed for safety, effectiveness or quality, and carry no human-use instructions. The FDA has warned of counterfeit Ozempic in the US supply chain, of fraudulently compounded semaglutide including unapproved salt forms, and has warned companies that illegally sold unapproved semaglutide falsely labelled ‘for research purposes’.