Semaglutide is a GLP-1 receptor agonist from Novo Nordisk, marketed as Ozempic and Rybelsus (type 2 diabetes) and Wegovy (chronic weight management and cardiovascular risk reduction). It is FDA- and EMA-approved and TGA-registered, supported by the SUSTAIN, STEP, and SELECT trial programs.

Is Semaglutide approved for medical use?

Semaglutide is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Approved. Ozempic for type 2 diabetes (2017, cardiovascular risk reduction added 2020); Rybelsus oral for type 2 diabetes (2019); Wegovy for chronic weight management (2021) and cardiovascular risk reduction (2024); oral Wegovy for weight management approved in 2025. European Union (EMA): Authorized - Ozempic and Rybelsus for type 2 diabetes and Wegovy for weight management. Australia (TGA): Registered on the ARTG - Ozempic for type 2 diabetes and Wegovy for weight management, available on prescription.

Is Semaglutide legal in Australia?

Semaglutide in Australia (TGA): Registered on the ARTG - Ozempic for type 2 diabetes and Wegovy for weight management, available on prescription.

Is Semaglutide banned in sport?

Semaglutide under the World Anti-Doping Agency (WADA) code: Not prohibited. On the WADA Monitoring Program (introduced 2024, continued into 2026); it is tracked but not a banned substance.

Glucagon-like peptide-1 (GLP-1) receptor agonist

Semaglutide

Approvedaka Ozempic, Wegovy, Rybelsus

Semaglutide is an approved once-weekly injectable (and once-daily oral) GLP-1 therapy for type 2 diabetes and, at higher doses, for chronic weight management. Randomized trials demonstrate meaningful reductions in HbA1c and body weight, and the SELECT trial showed reduced cardiovascular events in people with overweight or obesity and established cardiovascular disease. It is a prescription medicine used under medical supervision.

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Mechanism

In plain terms, semaglutide copies a natural gut hormone that signals fullness and helps control blood sugar. Technically, it is a GLP-1 analogue with high homology to human GLP-1 that agonizes the GLP-1 receptor, stimulating glucose-dependent insulin secretion, suppressing glucagon release, slowing gastric emptying, and acting on appetite-regulating centers to reduce energy intake. Structural modifications extend its half-life to allow once-weekly (injectable) dosing.

Regulatory Status by Region

United States (FDA)Approved. Ozempic for type 2 diabetes (2017, cardiovascular risk reduction added 2020); Rybelsus oral for type 2 diabetes (2019); Wegovy for chronic weight management (2021) and cardiovascular risk reduction (2024); oral Wegovy for weight management approved in 2025.
Australia (TGA)Registered on the ARTG - Ozempic for type 2 diabetes and Wegovy for weight management, available on prescription.
European Union (EMA)Authorized - Ozempic and Rybelsus for type 2 diabetes and Wegovy for weight management.
WADANot prohibited. On the WADA Monitoring Program (introduced 2024, continued into 2026); it is tracked but not a banned substance.

See the full regulatory status matrix

Key Studies

Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1; Wilding et al.) (opens in a new tab) (N Engl J Med 2021;384:989-1002; DOI 10.1056/NEJMoa2032183; PMID 33567185)
Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT; Lincoff et al.) (opens in a new tab) (N Engl J Med 2023;389:2221-2232; DOI 10.1056/NEJMoa2307563; PMID 37952131)
Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (SUSTAIN-6; Marso et al.) (opens in a new tab) (N Engl J Med 2016;375:1834-1844; DOI 10.1056/NEJMoa1607141; PMID 27633186)

Related Clinical Trials

Latest research

Economic evaluation of tirzepatide, semaglutide, and liraglutide in the treatment of obese and overweight patients without diabetes: a short-term cost-effectiveness analysis in Iran. (opens in a new tab)
Journal of diabetes and metabolic disorders · Oct 17, 2026
The pharmacotherapy for pediatric obesity: insights and challenges from adult weight-loss medications. (opens in a new tab)
Journal of diabetes and metabolic disorders · Oct 12, 2026

See all recent Semaglutide research

Common Questions

What is Semaglutide?: Semaglutide is a GLP-1 receptor agonist from Novo Nordisk, marketed as Ozempic and Rybelsus (type 2 diabetes) and Wegovy (chronic weight management and cardiovascular risk reduction). It is FDA- and EMA-approved and TGA-registered, supported by the SUSTAIN, STEP, and SELECT trial programs.
Is Semaglutide approved for medical use?: Semaglutide is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Approved. Ozempic for type 2 diabetes (2017, cardiovascular risk reduction added 2020); Rybelsus oral for type 2 diabetes (2019); Wegovy for chronic weight management (2021) and cardiovascular risk reduction (2024); oral Wegovy for weight management approved in 2025. European Union (EMA): Authorized - Ozempic and Rybelsus for type 2 diabetes and Wegovy for weight management. Australia (TGA): Registered on the ARTG - Ozempic for type 2 diabetes and Wegovy for weight management, available on prescription.
How does Semaglutide work?: In plain terms, semaglutide copies a natural gut hormone that signals fullness and helps control blood sugar. Technically, it is a GLP-1 analogue with high homology to human GLP-1 that agonizes the GLP-1 receptor, stimulating glucose-dependent insulin secretion, suppressing glucagon release, slowing gastric emptying, and acting on appetite-regulating centers to reduce energy intake.
Is Semaglutide legal in Australia?: Semaglutide in Australia (TGA): Registered on the ARTG - Ozempic for type 2 diabetes and Wegovy for weight management, available on prescription.
Is Semaglutide banned in sport?: Semaglutide under the World Anti-Doping Agency (WADA) code: Not prohibited. On the WADA Monitoring Program (introduced 2024, continued into 2026); it is tracked but not a banned substance.