22 May 2024
There are various approved formulations of semaglutide, to be administered orally or subcutaneously.
Oral semaglutide Oral semaglutide is a once-daily peptide-based GLP-1 receptor agonist that is highly effective in achieving and maintaining glycaemic targets while also promoting weight loss in people with type 2 diabetes. Its cardiovascular and weight-management indications have now been approved, having been anticipated filings at the time of earlier drafting. In October 2025 the FDA approved oral semaglutide to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high cardiovascular risk, covering both primary and secondary prevention, based on the SOUL trial. In December 2025 the FDA approved a higher-dose oral semaglutide 25 mg for chronic weight management and for reducing the risk of major adverse cardiovascular events in adults with overweight or obesity and established cardiovascular disease, making it the first oral GLP-1 receptor agonist approved for weight management, with US launch from early January 2026 and supported by the OASIS and SELECT trial programmes. The oral formulation is heat stable, which may make it particularly appropriate for use in resource-limited settings. Primary patents on semaglutide, expiring between 2024 and 2026, have been filed or granted in few LMICs. Secondary patents on semaglutide solid compositions with salcaprozate sodium (SNAC), an important excipient of the oral product, have been filed in about seventeen LMICs, including major manufacturing countries such as India, South Africa, China and Brazil, where they are expected to expire in 2031. Novo Nordisk owns many secondary patents that may extend exclusivity until 2040.
Subcutaneous semaglutide Subcutaneous semaglutide is a once-weekly peptide-based GLP-1 receptor agonist that is highly effective in achieving and maintaining glycaemic targets in people with type 2 diabetes. It also promotes weight loss in adults with overweight or obesity and reduces the risk of major adverse cardiovascular events in this population. Its therapeutic profile has since broadened considerably across several approved indications. In January 2025 it became the first GLP-1 receptor agonist approved to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, based on the FLOW trial. In August 2025 it received accelerated FDA approval for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced fibrosis, becoming the first GLP-1 receptor agonist approved for MASH, alongside resmetirom as the only approved therapies for this indication, on the basis of the Phase 3 ESSENCE trial in which resolution of steatohepatitis without worsening of fibrosis was achieved in 63% of patients on semaglutide versus 34% on placebo at week 72. In heart failure with preserved ejection fraction (HFpEF) and obesity, the STEP-HFpEF programme demonstrated clinically meaningful improvements in heart-failure symptoms, physical limitations, exercise function and weight, alongside reduced inflammation; a regulatory submission for an HFpEF indication has been made on this basis, with a decision anticipated in 2026, though the indication is not yet approved. Taken together, semaglutide remains the GLP-1 receptor agonist with the most advanced and broadest clinical profile. Primary patents on semaglutide, expiring between 2024 and 2026, have been filed or granted in few LMICs, and patents on the subcutaneous formulation expired in 2024; however, Novo Nordisk owns many secondary patents that may extend exclusivity until 2040 in some jurisdictions.