What Is Semaglutide Approved For? Label Indications, Per the Research

Semaglutide's Regulatory Status, Stated Plainly

Semaglutide is a prescription medicine. It is a glucagon-like peptide-1 (GLP-1) receptor agonist that has been authorised by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and numerous other national regulators, and in the United States it reaches patients under three brand names: Ozempic (once-weekly subcutaneous injection), Rybelsus (once-daily tablet) and Wegovy (once-weekly subcutaneous injection at weight-management strengths). A state-of-the-art review of the GLP-1 receptor agonist class described these agents as established glucose-lowering therapies in type 2 diabetes with additional effects on body weight (PMID 33068776).

Approved indications are set by regulators, not by trial investigators, and the wording differs between jurisdictions and changes as labels are updated. The sections below separate what has been approved from what has only been studied. This page is for educational purposes only and is not medical advice; consult a licensed physician about any medical condition or treatment.

US Label Indications and Approval Dates

Type 2 Diabetes

The original approved use of semaglutide, for both the injectable and oral formulations, concerns glycaemic control in adults with type 2 diabetes as an adjunct to diet and exercise. Head-to-head trial evidence in this population includes SURPASS-2, in which researchers compared tirzepatide with semaglutide 1 mg once weekly over 40 weeks in adults with type 2 diabetes and reported reductions in glycated haemoglobin in all treatment groups (PMID 34170647). The broader class review placed semaglutide among the GLP-1 receptor agonists used for glucose lowering and noted the associated weight effects observed across the class (PMID 33068776).

Chronic Weight Management

Chronic weight management is a separate approved indication, held by the 2.4 mg once-weekly product rather than by the diabetes-dose products, and it is labelled for use alongside a reduced-calorie diet and increased physical activity. The STEP programme supplied the pivotal evidence. In STEP 2, researchers randomised adults with overweight or obesity and type 2 diabetes and reported a mean body-weight change of −9.6% with semaglutide 2.4 mg once weekly versus −3.4% with placebo at week 68 (PMID 33667417). In the STEP 8 randomised clinical trial, the study compared once-weekly semaglutide 2.4 mg with daily liraglutide 3.0 mg in adults with overweight or obesity without diabetes and reported a mean weight change of −15.8% versus −6.4% at week 68 (PMID 35015037). A narrative review of semaglutide for the treatment of obesity summarised the pharmacology and the phase 3 weight-management results that supported this indication (PMID 34942372).

Cardiovascular and Kidney Outcome Indications

Two outcome-based indications sit on US semaglutide labels: reduction of major adverse cardiovascular events, added for the diabetes product in 2020 and for the weight-management product in 2024 in people with established cardiovascular disease and obesity or overweight, and reduction of the risk of kidney disease progression and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, added in 2025. These indications were granted on the basis of dedicated cardiovascular and kidney outcome trials, which are distinct from the glycaemic and weight-loss trials described above.

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

In 2025 the FDA granted accelerated approval for semaglutide 2.4 mg in non-cirrhotic metabolic dysfunction-associated steatohepatitis with moderate-to-advanced fibrosis, used together with diet and physical activity. The supporting phase 3 trial randomised adults with biopsy-confirmed MASH and fibrosis, and researchers reported higher rates of steatohepatitis resolution without worsening of fibrosis, and of fibrosis improvement without worsening of steatohepatitis, with semaglutide 2.4 mg than with placebo at week 72 (PMID 40305708). Accelerated approval pathways typically require confirmatory outcome data to be completed after marketing.

Approvals Outside the United States

The European Commission authorised semaglutide injection for type 2 diabetes in 2018 following EMA review, oral semaglutide for type 2 diabetes in 2020, and semaglutide 2.4 mg for weight management in 2022; the United Kingdom, Canada, Japan, Australia and many other regulators have issued their own authorisations with locally worded indications and population criteria. Because eligibility wording — body-mass-index thresholds, comorbidity requirements, age limits — differs by country, the authoritative statement of what semaglutide is approved for in any given place is the current locally approved product information, interpreted by a prescribing clinician.

Studied but Not Approved: Investigational and Off-Label Uses

Several well-publicised semaglutide findings come from trials of populations, doses or formulations that regulators have not granted as indications. They are presented here as research, not as approved uses.

• Prediabetes. STEP 10 randomised people with obesity and prediabetes, and the study reported a greater proportion achieving normoglycaemia at week 52 with semaglutide 2.4 mg once weekly than with placebo (PMID 39089293). Prediabetes is not itself a labelled indication; the weight-management indication is defined by obesity or overweight with a weight-related condition.
• Higher weight-management doses. The STEP UP phase 3b trial evaluated once-weekly semaglutide 7.2 mg in adults with obesity and researchers reported greater mean body-weight reduction at week 72 than with placebo (PMID 40961952). A 7.2 mg strength was investigational at the time of that publication.
• Oral semaglutide for obesity. OASIS 1 tested oral semaglutide 50 mg once daily in adults with overweight or obesity and reported a mean body-weight change of −15.1% versus −2.4% with placebo at week 68 (PMID 37385278). The long-standing oral product approval covers type 2 diabetes, and any obesity indication for an oral formulation depends on separate regulatory action in each jurisdiction.
• Combination regimens. A phase 2 trial co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in people with type 2 diabetes and researchers reported glycaemic and body-weight changes versus active comparators (PMID 37364590). Fixed or co-administered combinations are investigational until separately authorised.

Off-label prescribing — the use of an approved medicine outside its labelled indication — is a clinical and regulatory matter decided between a prescriber and a patient, and the existence of a published trial does not make a use approved.

Semaglutide Adverse Events: What Studies Report

Safety wording in approved labels derives from the same trial programme. A 2021 safety review of semaglutide reported that gastrointestinal events, chiefly nausea, vomiting and diarrhoea, were the most commonly observed adverse events and discussed signals examined across the programme, including gallbladder-related events, pancreatitis, diabetic retinopathy complications and thyroid C-cell tumours seen in rodents (PMID 34305810). In STEP 2, researchers reported gastrointestinal disorders as the most frequent adverse events and more frequent discontinuation for adverse events with semaglutide 2.4 mg than with placebo (PMID 33667417). The STEP 8 trial likewise reported gastrointestinal adverse events as the most common in both the semaglutide and liraglutide groups (PMID 35015037), and the STEP UP trial of 7.2 mg reported gastrointestinal events as the predominant adverse events observed (PMID 40961952). A 2025 review asked whether sex influences responses to GLP-1 and its analogues, examining reported differences in physiology and treatment response (PMID 39715341). Contraindications, warnings and monitoring requirements are specified in the approved product information and assessed individually by a prescribing clinician.

How Labels and Trial Evidence Differ

Three distinctions explain most confusion about what semaglutide is approved for:

1. Brand and strength matter. The diabetes products and the weight-management product contain the same active substance but carry different indications, populations and labelling.
2. Trial populations are narrower than everyday practice. STEP 2 enrolled adults with overweight or obesity and type 2 diabetes (PMID 33667417), while STEP 8 enrolled adults without diabetes (PMID 35015037); label wording reflects the populations studied.
3. Approval follows review, not publication. A positive phase 3 result, such as the MASH trial findings (PMID 40305708), becomes an indication only after a regulator assesses the full dossier and amends the label.

Related reading: the PeptideU semaglutide overview.

Questions Only a Clinician Can Answer

Whether any approved indication applies to a particular person, how a label interacts with medical history and concurrent medicines, and what monitoring an approved use entails are prescribing decisions. This page summarises published regulatory status and trial findings for educational purposes only; it is not medical advice, and a licensed physician is the appropriate source for any question about treatment.

References

• GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art (Molecular Metabolism, 2021)
• Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes (New England Journal of Medicine, 2021)
• Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2) (Lancet, 2021)
• Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial (JAMA, 2022)
• Semaglutide for the treatment of obesity (Trends in Cardiovascular Medicine, 2023)
• Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis (New England Journal of Medicine, 2025)
• Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10) (Lancet Diabetes & Endocrinology, 2024)
• Once-weekly semaglutide 7·2 mg in adults with obesity (STEP UP) (Lancet Diabetes & Endocrinology, 2025)
• Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1) (Lancet, 2023)
• Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes (Lancet, 2023)
• Safety of Semaglutide (Frontiers in Endocrinology, 2021)
• GLP-1 and Its Analogs: Does Sex Matter? (Endocrinology, 2025)