Semaglutide: Medicine Overview
Semaglutide is a GLP-1 receptor agonist sold under several brands; this overview covers what US and EU regulators approved it for, the main trials, and the label safety information.
Content last updated . This page has not been medically reviewed.
What semaglutide is
Semaglutide is a modified copy of GLP-1, a gut hormone that helps control blood sugar and appetite. The US label describes it as a GLP-1 analogue with 94% sequence homology to human GLP-1, and says its peptide backbone is made by yeast fermentation. [1] Small changes to the molecule make it resist the enzyme DPP-4 and bind to albumin in the blood, which is why one injection lasts about a week. [1] For the biology behind this, see GLP-1 and GIP biology.Evidence labels on this page: approved medicine (a regulator reviewed it for a named use), no good evidence of benefit (a proper trial found none) and insufficient evidence. A brand name, the molecule and the tablet or injection form are different things, explained in active ingredient, brand, formulation and indication.
What the trials showed
- Heart events, type 2 diabetes. In a trial of 3,297 people with type 2 diabetes and heart disease, heart attack, stroke or death occurred in 6.6% on Ozempic versus 8.9% on placebo; deaths from heart causes were similar. [1][2]
- Kidney disease, type 2 diabetes. The FLOW trial randomized 3,533 people to Ozempic or placebo for a median of 41 months. The combined kidney and heart outcome occurred in 18.7% versus 23.2% (hazard ratio 0.76). [1]
- Heart events without diabetes. In 17,604 adults with heart disease and obesity or overweight, a major heart event occurred in 6.5% on Wegovy versus 8% on placebo (hazard ratio 0.80). [3]
- Weight. In a trial of adults with obesity or overweight plus a related condition, average weight change at 68 weeks was -14.9% with Wegovy versus -2.4% with placebo; in people with type 2 diabetes it was -9.6% versus -3.4%. [3]
- Tablets. In 9,650 people with type 2 diabetes at high heart risk, major heart events were 12% on semaglutide tablets versus 13.8% on placebo. [5]
These are trial results in specific groups. The label notes that the exact way semaglutide lowers heart risk has not been established. [3] Weight and blood sugar are biomarkers; see biomarker changes vs meaningful outcomes.
Off-label and investigational questions
Using an approved drug for a use not on its label is called off-label; FDA says it has not determined the drug is safe and effective for that use. [7] One example: two large phase 3 trials gave oral semaglutide to 3,808 people with early Alzheimer's disease for up to 156 weeks. It did not slow progression (change in the dementia rating score was similar to placebo), and the trials were stopped for negative outcome. Label: no good evidence of benefit for that use. The trials were funded by the manufacturer. [8] See approved, off-label and investigational use.Professional care and compounded copies
Semaglutide is prescription-only. The labels ask clinicians to watch kidney function in people with vomiting or diarrhea and to monitor people with a history of diabetic retinopathy. [1] Do not start, stop or change a medicine without your prescriber. FDA warns that compounded and other unapproved semaglutide versions are not reviewed for safety, effectiveness or quality, and has received reports of dosing errors. [9] See compounded and unapproved GLP-1 products and GLP-1 medicines overview. Report side effects through reporting adverse events.Frequently asked questions
Are Ozempic and Wegovy the same drug?
Both contain semaglutide, but they are separate products with different approved uses in the US: Ozempic for type 2 diabetes and related heart and kidney outcomes, Wegovy for weight, heart risk and a liver condition. [1][3]
Is semaglutide a peptide or a protein?
The labels call it a GLP-1 analogue whose backbone is made in yeast. [1] The length boundary between peptide and protein is not universal; see peptides vs proteins.
Does semaglutide treat Alzheimer's disease?
Not in the trials reported so far. Two phase 3 trials of oral semaglutide found no slowing of early Alzheimer's disease. [8]
What do regulators say about copies sold online or by compounders?
FDA says unapproved versions do not go through its safety, effectiveness and quality review and lists red flags such as claims of being the same as the approved drug. [9]
Can I use this page to decide on treatment?
No. It summarizes labels and trials for education. Talk with your prescriber or a pharmacist; see talking with a health professional.
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
Brands, forms and approved uses
| Brand and form | US (FDA label) | EU (EMA page) |
|---|---|---|
| Ozempic injection | Type 2 diabetes blood sugar control; fewer major heart events in type 2 diabetes with heart disease; fewer kidney and heart outcomes in type 2 diabetes with chronic kidney disease [1] | Type 2 diabetes in adults [2] |
| Wegovy injection | Weight reduction and maintenance in adults and children 12 and older with obesity, or adults with overweight plus a weight-related condition; fewer major heart events in adults with heart disease and obesity or overweight; a liver condition (MASH) under accelerated approval [3] | Weight management in adults and in adolescents 12 and older with obesity and body weight above 60 kg [4] |
| Rybelsus tablets | Type 2 diabetes blood sugar control; fewer major heart events in type 2 diabetes at high risk [5] | Type 2 diabetes in adults [6] |
| Ozempic tablets and Wegovy tablets | Covered by the US labels that also list Rybelsus and Wegovy; indications as above [5][3] | Not verified |
The US tablet label says Rybelsus and Ozempic tablets "are not substitutable on a mg-to-mg basis", a reminder that strengths do not carry across products. [5] The tablets contain an absorption enhancer called SNAC, which helps a peptide survive the stomach; see oral peptide medicines. [5] Wegovy's label says it should not be combined with other semaglutide products or any other GLP-1 receptor agonist. [3]
Main safety information from the labels
- Boxed warning. In rodents semaglutide caused thyroid C-cell tumors; whether it does in humans is unknown. It must not be used by people with a personal or family history of medullary thyroid carcinoma or the genetic condition MEN 2. [1]
- Common effects. Nausea, vomiting, diarrhea, abdominal pain and constipation, mostly during dose increases. [1] Stomach and bowel reactions were reported in 32.7% to 36.4% on Ozempic versus 15.3% on placebo in pooled trials. [1]
- Serious warnings. Pancreatitis, gallbladder disease, kidney injury from dehydration, severe stomach problems (not recommended with severe gastroparesis), serious allergic reactions, and a higher chance of low blood sugar when used with insulin or sulfonylureas. [1]
- Eyes. In a 2-year trial, diabetic retinopathy complications were 3.0% on Ozempic versus 1.8% on placebo. [1]
- Surgery. Pulmonary aspiration (stomach contents entering the lungs) has been reported in people on GLP-1 drugs having elective surgery under anesthesia or deep sedation, so patients are told to tell their clinicians about planned procedures. [1]
- Pregnancy. The Ozempic label says to stop at least 2 months before a planned pregnancy because of the long washout. [1] The Wegovy label says weight loss offers no benefit in pregnancy and may cause fetal harm. [3] See pregnancy and breastfeeding.
- Children. Ozempic and the tablets have not been established in children; Wegovy injection is labeled from age 12. [1][5][3]
- Mood. The US Wegovy label's suicidal behavior and ideation section was removed in 02/2026. [3]
References
- Ozempic (semaglutide) injection prescribing information, Novo Nordisk, DailyMed listing dated 2026-06-10. Source. Read 2026-10-22.
- Ozempic EPAR overview, European Medicines Agency. Source. Read 2026-10-22.
- Wegovy (semaglutide) injection and tablets prescribing information, Novo Nordisk, DailyMed listing dated 2026-06-30. Source. Read 2026-10-22.
- Wegovy EPAR product page, European Medicines Agency. Source. Read 2026-10-22.
- Rybelsus and Ozempic (semaglutide) tablets prescribing information, Novo Nordisk, DailyMed listing dated 2026-08-19. Source. Read 2026-10-22.
- Rybelsus EPAR product page, European Medicines Agency. Source. Read 2026-10-22.
- Understanding Unapproved Use of Approved Drugs "Off Label", U.S. Food and Drug Administration. Source. Read 2026-10-22.
- Cummings JL et al. Efficacy and safety of oral semaglutide 14 mg in early-stage symptomatic Alzheimer's disease (evoke and evoke+): two phase 3 randomised placebo-controlled trials. Lancet 2026;407:2167-2179. PMID 41865758. Source. Read 2026-10-22.
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, U.S. Food and Drug Administration. Source. Read 2026-10-22.