Efpeglenatide
A long-acting exendin-based GLP-1 receptor agonist linked to an Fc carrier.
- Evidence grade
- BModerate Human Evidence
Moderate Human Evidence
- Regulatory status
- Investigational
No US FDA approval was identified; phase 3 human research exists, and current availability or development requires separate verification.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- October 27, 2026
Overview
A long-acting exendin-based GLP-1 receptor agonist linked to an Fc carrier.
No US FDA approval was identified; phase 3 human research exists, and current availability or development requires separate verification.
Substantial phase 3 evidence is not FDA approval. Sponsor termination of a trial record should not automatically be described as a safety stop.
Why It's Being Studied
- Type 2 diabetes
- Cardiovascular and renal outcomes
Mechanism of Action
It activates GLP-1 receptors with prolonged exposure to influence glucose-dependent insulin and metabolic signalling.
It activates GLP-1 receptors with prolonged exposure to influence glucose-dependent insulin and metabolic signalling. Substantial phase 3 evidence is not FDA approval. Sponsor termination of a trial record should not automatically be described as a safety stop.
From molecular target to clinical evidence
Tap each stage to see what happens.
Background: Clinical Peptide Medicines
Clinical peptide medicines include endocrine treatments, antimicrobial drugs, receptor blockers and targeted diagnostic or cancer agents. They do not share one mechanism or one set of indications.
An approval belongs to a specific medicine and indication. A diagnostic tracer, an antibiotic and a hormone are not interchangeable wellness products; read each profile's own mechanism and prescribing source.
Research Areas & Routes Studied
- Type 2 diabetes
- Cardiovascular and renal outcomes
- Subcutaneous clinical research
Evidence Summary
AMPLITUDE-O studied 4,076 high-risk adults with type 2 diabetes and found fewer major cardiovascular and renal composite events.
Higher tiers carry more weight. Filled tiers have evidence for Efpeglenatide; tap to read it.
- AMPLITUDE-O studied 4,076 high-risk adults with type 2 diabetes and found fewer major cardiovascular and renal composite events.
1 cited sources.
- Randomised controlled trial1
Human clinical evidence
- AMPLITUDE-O studied 4,076 high-risk adults with type 2 diabetes and found fewer major cardiovascular and renal composite events.
Reported Adverse Events in Research
- Gastrointestinal adverse effects were more frequent; clinical safety applies to the studied population.
Limitations of Current Evidence
- Substantial phase 3 evidence is not FDA approval. Sponsor termination of a trial record should not automatically be described as a safety stop.
- Findings apply to the product, route and population studied; they do not establish benefits or safety for unrelated wellness uses or research-vial products.
How to Read This Research
- Is this a single molecule or a family of medicines?
- Is the use diagnostic, therapeutic or investigational?
- Does the quoted outcome match the exact product, formulation and population?
- Use the compound-specific mechanism above; this diagram describes drug development, not a shared biological pathway.
- Historical approval, present availability and off-label use are distinct questions.
- For radiopharmaceuticals and hospital medicines, specialist handling is part of the treatment context.
- Indication
- The condition and population for which a medicine is approved.
- Antagonist
- A compound that blocks activity at a receptor.
- Radiopharmaceutical
- A medicine containing a radioactive isotope for imaging or treatment.
Compare With Other Compounds
| Efpeglenatide | Trofinetide | |
|---|---|---|
| Evidence grade | B — Moderate Human Evidence | B — Moderate Human Evidence |
| Regulatory status | Investigational | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Subcutaneous clinical research | Oral approved medicine |
| Cited sources | 1 | 2 |
Frequently Asked Questions
Research References
- Randomised controlled trial
Efpeglenatide — randomised controlled trial