Hormones & metabolism Long-acting GLP-1 agonist
Efpeglenatide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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Key takeaway
Efpeglenatide is an investigational long-acting GLP-1 receptor agonist, originally developed by Hanmi Pharmaceutical, given as a once-weekly injection for type 2 diabetes and cardiovascular risk. In a large Phase 3 outcomes trial it reduced major cardiovascular events in people with type 2 diabetes. As of 2026, it has not reached approval in major markets.
At a glance
- FDA status
- Investigational peptide, not approved by the FDA or EMA
- What it is
- Long-acting GLP-1 receptor agonist given as a once-weekly injection
- Research
- A large Phase 3 cardiovascular outcomes trial (AMPLITUDE-O) reported positive results
- Development
- Rights returned to Hanmi, which has pursued regional licensing
- Evidence strength
- Deep research
Summary
Efpeglenatide is an investigational once-weekly GLP-1 receptor agonist. Learn how it works, what the AMPLITUDE-O trial found, and why it is not yet approved.
What is efpeglenatide?
Efpeglenatide is an experimental GLP-1 receptor agonist built on an exendin-based peptide with a half-life-extension technology that allows once-weekly injection. It was developed by Hanmi Pharmaceutical and was previously licensed to Sanofi, which later returned the rights. It has been studied for type 2 diabetes and cardiovascular and kidney risk, and it is investigational, not approved in major markets.
How does it work?
Efpeglenatide activates the GLP-1 receptor, the same incretin target as drugs such as semaglutide and dulaglutide. Activation of the receptor:
- Enhances glucose-dependent insulin secretion
- Suppresses glucagon
- Slows gastric emptying
- Reduces appetite
In people with type 2 diabetes these effects lower blood sugar and body weight, and GLP-1 agonists as a class have also shown cardiovascular benefits. This describes the mechanism, separate from the trial outcomes below.
Is it FDA-approved?
Safety note
Status: Investigational peptide, not approved by the FDA or EMA
Category: In clinical trials · Primary body area: Hormones & metabolism
No. Efpeglenatide is investigational and not approved by the FDA or EMA. After Sanofi returned development rights, Hanmi took the program back in-house and has pursued regional licensing arrangements, but no major-market approval exists.
What does the research show?
Editor’s note
Evidence strength: Deep research (1 human · 0 animal/cell studies)
It has a large, positive, peer-reviewed Phase 3 cardiovascular outcomes trial plus supportive glycemic data, though it is not approved in major markets.
The key evidence is a large cardiovascular outcomes trial. According to PubMed, the Phase 3 AMPLITUDE-O trial enrolled over 4,000 adults with type 2 diabetes who had cardiovascular or kidney disease. The table summarizes what it and a follow-up analysis reported:
| Endpoint | Finding |
|---|---|
| Major adverse cardiovascular events | Occurred less often with efpeglenatide than placebo (hazard ratio 0.73) |
| Composite kidney outcome | Reduced with efpeglenatide |
| Benefit by SGLT2 inhibitor use | A prespecified analysis found the benefit was consistent regardless of whether participants were already taking an SGLT2 inhibitor |
These are positive, peer-reviewed Phase 3 results, although the program has not reached approval.
Sources: the AMPLITUDE-O trial (Gerstein et al., New England Journal of Medicine, 2021, DOI: 10.1056/NEJMoa2108269) and a prespecified subgroup analysis (Lam et al., Circulation, 2021, DOI: 10.1161/CIRCULATIONAHA.121.057934), both indexed on PubMed. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
1 registered human trial on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
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