Efpeglenatide
Efpeglenatide is an investigational weekly GLP-1 receptor agonist with positive Phase 3 cardiovascular and kidney findings. Those trial results have not produced a major-market approval in the reported development history.
Quick Facts
An extended-duration exendin-based agonist
Hanmi Pharmaceutical developed efpeglenatide using an exendin-based peptide and half-life-extension technology for once-weekly injection. Sanofi previously licensed the program and later returned the rights. Development has addressed type 2 diabetes and cardiovascular/renal risk.
GLP-1 receptor activity
The GLP-1 pathway supports glucose-dependent insulin secretion, suppresses glucagon, slows gastric emptying and reduces appetite. These actions can lower glucose and weight in type 2 diabetes. Similarity of target to semaglutide or dulaglutide does not erase differences in the particular molecule, trial and approval status.
Supporting references: GLP-1 receptor.
Sources: [1]
AMPLITUDE-O cardiovascular evidence
Phase 3 AMPLITUDE-O enrolled more than 4,000 adults with type 2 diabetes and cardiovascular or kidney disease. Major adverse cardiovascular events were less frequent than placebo, with hazard ratio 0.73, and a composite kidney outcome was also reduced. A prespecified follow-up analysis found benefit consistent whether or not participants were already using an SGLT2 inhibitor. These are favorable peer-reviewed clinical outcomes, separate from the receptor mechanism.
Supporting references: AMPLITUDE-O; analysis.
Investigational development status
Efpeglenatide is not FDA- or EMA-approved in the reported account. After rights returned from Sanofi, Hanmi resumed in-house development and pursued regional licensing. Positive Phase 3 data and commercial arrangements are not an approval or a marketed treatment label.
References and further reading
This reference draws on Superpower’s Peptide Library and the research linked below. Peptide Dossier’s editorial team adapted and integrated the material on .
- ncbi.nlm.nih.govGLP-1 receptor activityCited in: GLP-1 receptor activity
- 10.1056/NEJMoa2108269AMPLITUDE-O cardiovascular evidenceCited in: AMPLITUDE-O cardiovascular evidence
- 10.1161/CIRCULATIONAHA.121.057934AMPLITUDE-O cardiovascular evidenceCited in: AMPLITUDE-O cardiovascular evidence
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Disclaimer: This article is for informational and educational purposes only. It is not intended as medical advice. The information presented is based on published research and should not be used as a substitute for professional medical guidance. Always consult a qualified healthcare provider before starting any peptide protocol. Some peptides discussed may not be approved for human use by the FDA or equivalent regulatory bodies.