Efpeglenatide
Efpeglenatide is a long-acting exendin-based GLP-1 receptor agonist originated by Hanmi Pharmaceutical and later developed by Sanofi. Its cardiovascular and renal benefits were shown in the AMPLITUDE-O Phase 3 trial, but Sanofi ended its development program and the drug has not been approved anywhere. Hanmi has continued development toward obesity and diabetes indications. It remains an investigational compound available only through clinical trials.
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Mechanism
In plain terms, efpeglenatide mimics the gut hormone GLP-1, prompting the pancreas to release insulin when blood sugar is high, curbing appetite, and slowing stomach emptying. Technically, it is an exendin-4 analog joined to a long-acting protein carrier that extends its half-life to allow once-weekly dosing, and it activates the GLP-1 receptor to drive glucose-dependent insulin secretion and glucagon suppression.
Regulatory Status by Region
- United States (FDA)Not approved. Efpeglenatide remains an investigational agent with no FDA marketing authorization.
- Australia (TGA)Not registered on the ARTG. Investigational only.
- European Union (EMA)Not authorised. No EMA marketing authorization.
- WADANot listed as a prohibited substance on the WADA Prohibited List (2026). GLP-1 receptor agonists are not classified as prohibited in or out of competition.
Key Studies
- AMPLITUDE-O (Gerstein et al.): cardiovascular and renal outcomes with efpeglenatide in type 2 diabetes (opens in a new tab) (N Engl J Med 2021;385:896-907; DOI 10.1056/NEJMoa2108269; PMID 34215025; NCT03496298)
- AMPLITUDE-O trial registry record (opens in a new tab) (ClinicalTrials.gov NCT03496298; sponsor Sanofi; Phase 3 cardiovascular outcomes trial)
Related Clinical Trials
- Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With SulfonylureaPhase 3 · Terminated
- Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)Phase 3 · Terminated
- Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With MetforminPhase 3 · Terminated
- Effect of Efpeglenatide on Cardiovascular OutcomesPhase 3 · Terminated
- Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and ExercisePhase 3 · Completed
Latest research
- Potential Mediators of Efpeglenatide's Cardiovascular Benefit: An Exploratory Analysis of the AMPLITUDE-O Trial. (opens in a new tab)
Diabetes, obesity & metabolism · Jul 1, 2026
Common Questions
- What is Efpeglenatide?
- Efpeglenatide is an investigational once-weekly injectable GLP-1 receptor agonist. It is not approved by any major regulator. In the Phase 3 AMPLITUDE-O outcomes trial (NEJM 2021), efpeglenatide reduced major adverse cardiovascular and kidney events compared with placebo in people with type 2 diabetes at high cardiovascular risk.
- Is Efpeglenatide approved for medical use?
- Efpeglenatide is investigational: it is being studied in clinical research and is not an approved medicine. United States (FDA): Not approved. Efpeglenatide remains an investigational agent with no FDA marketing authorization. European Union (EMA): Not authorised. No EMA marketing authorization. Australia (TGA): Not registered on the ARTG. Investigational only.
- How does Efpeglenatide work?
- In plain terms, efpeglenatide mimics the gut hormone GLP-1, prompting the pancreas to release insulin when blood sugar is high, curbing appetite, and slowing stomach emptying. Technically, it is an exendin-4 analog joined to a long-acting protein carrier that extends its half-life to allow once-weekly dosing, and it activates the GLP-1 receptor to drive glucose-dependent insulin secretion and glucagon suppression.
- Is Efpeglenatide legal in Australia?
- Efpeglenatide in Australia (TGA): Not registered on the ARTG. Investigational only.
- Is Efpeglenatide banned in sport?
- Efpeglenatide under the World Anti-Doping Agency (WADA) code: Not listed as a prohibited substance on the WADA Prohibited List (2026). GLP-1 receptor agonists are not classified as prohibited in or out of competition.