Is Efpeglenatide legal in the US?
No, not in the US. It is not FDA approved, though Korea approved it for weight loss in 2026.
Not approved by the FDA. Efpeglenatide is a once-weekly GLP-1 receptor agonist developed by Hanmi Pharmaceutical; Sanofi licensed it, ran a phase 3 program in type 2 diabetes, and returned the rights in 2020 before any filing. South Korea's Ministry of Food and Drug Safety approved it on October 7, 2026 for chronic weight management in adults with obesity or overweight who do not have diabetes, and no US marketing application has been reported.
No. It completed a phase 3 program. But Sanofi returned the rights to Hanmi in 2020, and no US application was filed. South Korea approved it on October 7, 2026 for weight management in adults without diabetes. 24
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Citations
- StatPearls: glucagon-like peptide-1 receptor agonists ncbi.nlm.nih.gov
- Gerstein 2021, NEJM: cardiovascular and renal outcomes with efpeglenatide in type 2 diabetes (AMPLITUDE-O) doi.org
- Lam 2021, Circulation: efpeglenatide and clinical outcomes with and without concomitant SGLT2 inhibitor use doi.org
- South Korea MFDS: efpeglenatide (Efe) approval notice, October 2026 mfds.go.kr
Reference information only, not medical advice. Drawn from the Efpeglenatide article, fact-checked against the cited sources. No dosing anywhere on this site.