Is Semaglutide legal in the US?
Yes, FDA approved for type 2 diabetes, weight loss, heart protection and kidney disease in diabetes.
Semaglutide is FDA-approved as Ozempic (weekly injection, type 2 diabetes, 2017; with later indications to reduce cardiovascular events and, since January 2025, kidney disease progression in type 2 diabetes), Rybelsus (daily tablet, type 2 diabetes, 2019), and Wegovy (weekly injection, chronic weight management, 2021; cardiovascular risk reduction in obesity, 2024; MASH with liver fibrosis, 2025; an oral Wegovy tablet, December 2025). Compounded semaglutide is not FDA-approved. 17131415
Not in regulatory terms. Compounded versions are not FDA-approved. The agency does not verify what is in them. Some have used salt forms of semaglutide that have never been tested in humans. The FDA allowed compounding during shortages and has since restricted it. 15
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Citations
- Ozempic (semaglutide) prescribing information, FDA, 2023 accessdata.fda.gov
- Wilding 2021, N Engl J Med: once-weekly semaglutide in adults with overweight or obesity (STEP 1) pubmed.ncbi.nlm.nih.gov
- Lincoff 2023, N Engl J Med: semaglutide and cardiovascular outcomes in obesity without diabetes (SELECT) pubmed.ncbi.nlm.nih.gov
- FrÃas 2021, Lancet Diabetes Endocrinol: higher versus standard dose semaglutide in type 2 diabetes (SUSTAIN FORTE) pubmed.ncbi.nlm.nih.gov
- Diabetol Metab Syndr 2023: systematic review and meta-analysis of subcutaneous semaglutide in type 2 diabetes pubmed.ncbi.nlm.nih.gov
- Rubino 2022, JAMA: semaglutide versus liraglutide for weight loss (STEP 8) pubmed.ncbi.nlm.nih.gov
- Wegovy (semaglutide) prescribing information, DailyMed dailymed.nlm.nih.gov
- Rubino 2021, JAMA: continued semaglutide versus placebo for weight maintenance (STEP 4) pubmed.ncbi.nlm.nih.gov
- Deanfield 2024, Lancet: semaglutide in patients with obesity and heart failure, SELECT prespecified analysis pubmed.ncbi.nlm.nih.gov
- Lincoff 2023, N Engl J Med: SELECT trial (DOI record) doi.org
- Lancet 2025: semaglutide and cardiovascular outcomes by adiposity measures, SELECT prespecified analysis pubmed.ncbi.nlm.nih.gov
- Wilding 2022, Diabetes Obes Metab: weight regain after withdrawal of semaglutide, STEP 1 extension pubmed.ncbi.nlm.nih.gov
- Perkovic 2024, N Engl J Med: effects of semaglutide on chronic kidney disease in type 2 diabetes (FLOW) doi.org
- AJMC 2025: FDA approves semaglutide for MASH with fibrosis ajmc.com
- Healio 2026: FDA approves Wegovy pill, the first oral GLP-1 for obesity healio.com
- Jastreboff 2022, N Engl J Med: tirzepatide once weekly for obesity (SURMOUNT-1) pubmed.ncbi.nlm.nih.gov
- Karagiannis 2024, Diabetologia: tirzepatide versus semaglutide in type 2 diabetes, network meta-analysis pubmed.ncbi.nlm.nih.gov
Reference information only, not medical advice. Drawn from the Semaglutide article, fact-checked against the cited sources. No dosing anywhere on this site.