Retatrutide
Also known as: LY3437943, RETA
Retatrutide is currently not an approved drug / investigational for fda-approved drug product.
Not legal or medical advice.
This page is for informational purposes only. Always verify the current official source or consult a qualified professional before making compliance, prescribing, purchasing, or clinical decisions. Read full disclaimer.
A triple agonist of GIP, GLP-1, and glucagon receptors. It is an investigational drug and is not a component of any FDA-approved product.
Current status
FDA-approved drug product: Not an approved drug / investigational; 503A/503B compounding: No compounding pathway
| Activity | Status | As of | Jurisdiction | Qualification | Sources |
|---|---|---|---|---|---|
| FDA-approved drug product | Not an approved drug / investigational | Dec 10, 2024 | United States federal | No FDA-approved application is in effect for retatrutide. It is being studied in Phase 3 clinical trials. | |
| 503A/503B compounding | No compounding pathway | Dec 10, 2024 | United States federal | Retatrutide is not on the 503A or 503B bulk lists and is not a component of an FDA-approved drug. |
What this means
- ✓ FDA-approved drug product: Not an approved drug / investigational. No FDA-approved application is in effect for retatrutide. It is being studied in Phase 3 clinical trials.
- ✓ 503A/503B compounding: No compounding pathway. Retatrutide is not on the 503A or 503B bulk lists and is not a component of an FDA-approved drug.
What this does not mean
- ✗ Status in one jurisdiction does not automatically apply elsewhere.
- ✗ An approved active ingredient is not the same as an approved finished product.
- ✗ “Research use” labeling does not make an unapproved drug lawful for human use.
Timeline
FDA warning letter cites retatrutide products
enforcement action recordedFDA warned Xcel Research that retatrutide products marketed online were unapproved new drugs.
Controlling sources
- FDA Warning Letter to Xcel Research LLC
U.S. Food and Drug Administration, CDER Office of Compliance · Warning letter · 694608