
Available as a once-weekly injection. Wegovy is also available as an FDA-approved once-daily oral tablet for adults.
Dual‑hormone; once‑weekly injection
Not FDA‑approved
GLP-1 receptor agonists mimic the gut hormone GLP-1, improving insulin secretion and slowing gastric emptying—effects that also reduce appetite and caloric intake. After years as type 2 diabetes drugs, they were studied and then authorized for chronic weight management in people with obesity or overweight plus a comorbidity. The first GLP-1 approved specifically for chronic weight management was liraglutide 3 mg (Saxenda) in Dec 2014. Source
Saxenda® (liraglutide), Wegovy® (semaglutide), and Zepbound® (tirzepatide) are FDA-approved for chronic weight management in eligible patients. Saxenda is approved for adults and certain adolescents age 12 and older. Wegovy is approved for chronic weight management and is available as an injection and, for adults, an oral tablet. Zepbound is approved for chronic weight management in adults. Eligibility and approved uses vary by product, so patients should review the prescribing information with a licensed health care professional.
Wegovy and Ozempic both contain semaglutide, but they are FDA-approved for different uses and have different labeling. Wegovy is approved for chronic weight management and certain other indications, and is available as both an injection and an oral tablet. Ozempic is approved for type 2 diabetes and certain cardiovascular and kidney-related indications. Zepbound and Mounjaro both contain tirzepatide: Zepbound is approved for chronic weight management and moderate-to-severe obstructive sleep apnea in adults with obesity, while Mounjaro is approved to improve blood sugar control in adults and pediatric patients age 10 years and older with type 2 diabetes.
Yes, for certain patients and specific FDA-approved products. Wegovy is approved to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight. These benefits are tied to specific FDA-approved indications, so patients should discuss whether they qualify with a licensed health care professional.
The FDA has approved Saxenda and Wegovy for certain adolescents age 12 and older with obesity.
Compounded GLP-1 medicines are not FDA-approved, but they may be legally prepared in limited circumstances when a patient’s medical needs cannot be met by an available FDA-approved drug. “Research-use only” products sold online for human use are different and should not be treated as legitimate prescription medicines. Avoid products from unverified sellers, and obtain prescription GLP-1 medicines through a licensed health care professional and an appropriately licensed pharmacy.
Dec 2024:
FDA re-evaluated its earlier decision and determined that the tirzepatide injection shortage was resolved. Temporary enforcement-discretion periods were provided for certain compounders to reduce treatment disruption.
Feb 2025:
FDA determined that the semaglutide injection shortage was resolved and provided temporary enforcement-discretion periods for certain compounders.
Feb–May 2025:
FDA’s temporary enforcement-discretion periods ended in stages. For tirzepatide, all temporary enforcement-discretion periods had ended by March 19, 2025. For semaglutide, they had ended by May 22, 2025.
Sept 2025:
FDA launched a “Green List” import alert to help prevent GLP-1 active pharmaceutical ingredients with potential quality concerns from unverified foreign sources from entering the U.S. supply chain, while allowing imports from compliant manufacturers.
March 2026:
FDA issued warning letters to 30 telehealth companies over false or misleading marketing of compounded GLP-1 products.
April 2026:
FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List after finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.
May 31, 2026:
FDA reported receiving 990 adverse-event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide.
July 2026:
CMS launched the Medicare GLP-1 Bridge, providing eligible Medicare Part D beneficiaries access to certain GLP-1 medications for weight management with a $50 monthly copay. The program runs through December 31, 2027.
July 2026:
The Senate HELP Committee advanced the bipartisan SAFE Drugs Act of 2026 (S. 3794) by a 17–5 vote. The bill would strengthen transparency and reporting requirements for compounded medications, including serious adverse-event reporting and clearer labeling. On July 27, 2026, the bill was reported to the Senate and placed on the Senate Legislative Calendar under General Orders, Calendar No. 524. It has not yet passed the full Senate.
Compounded GLP-1 medicines are not FDA-approved and may only be prepared under specific legal conditions. In April 2026, FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List after finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.
Bulk API from unverified foreign suppliers can be detained at the border; products labeled “research use only/not for human use” are not appropriate for patients.
Salt forms such as semaglutide sodium or semaglutide acetate are different active ingredients from the semaglutide used in FDA-approved medicines. FDA has said it is not aware of a lawful basis for using these salt forms in compounded drugs and has raised concerns about their safety and effectiveness.