A
TL;DR
Semaglutide has the broadest and strongest human evidence base among GLP-1 receptor agonists currently approved for weight management and type 2 diabetes. The STEP clinical trial program, comprising multiple large phase 3 randomized controlled trials, demonstrated clinically meaningful weight loss in adults with…
Key Takeaways
- Grade A: assigned from the published evidence rubric, not popularity.
- FDA Approved: Approved as Ozempic (subcutaneous injection, type 2 diabetes), Wegovy (subcutaneous injection 2.4 mg and oral 25 mg tablet, chronic weight management and cardiovascular risk reduction in obesity), and Rybelsus (oral tablet, type 2 diabetes).
- Compounding: FDA-approved; brand and generic forms available. Mass compounding from bulk API by 503A and 503B facilities was permitted during a declared shortage; the semaglutide shortage was resolved by FDA in February 2025 and enforcement grace periods for compounders ended by May 2025. As of June 2026, mass compounding of semaglutide injection is prohibited; FDA proposed in April 2026 to formally exclude semaglutide from the 503B Bulks List. Narrow 503A exceptions may apply for documented patient-specific clinical need.
Safety & Risks
The full profile separates established adverse effects, regulatory warnings, and unknowns in the available human evidence.