Ipamorelin
Also known as: Ipamorelin acetate, NNC 26-0091
Ipamorelin is currently not an approved drug 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 synthetic pentapeptide growth hormone secretagogue. No USAN or USP/NF monograph; not a component of an FDA-approved drug.
Current status
FDA-approved drug product: Not an approved drug; 503A pharmacy compounding: Not on 503A bulk list; 503B outsourcing-facility compounding: Ipamorelin acetate in Category 2 — significant safety risk
| Activity | Status | As of | Jurisdiction | Qualification | Sources |
|---|---|---|---|---|---|
| FDA-approved drug product | Not an approved drug | Oct 29, 2024 | United States federal | No FDA-approved application is in effect for ipamorelin. | |
| 503A pharmacy compounding | Not on 503A bulk list | Oct 29, 2024 | United States federal | FDA's advisory committee reviewed ipamorelin-related bulk substances in October 2024 and recommended against placing them on the 503A bulk list. Nominations were withdrawn. | |
| 503B outsourcing-facility compounding | Ipamorelin acetate in Category 2 — significant safety risk | Mar 21, 2025 | United States federal | FDA placed ipamorelin acetate in 503B Category 2. It is not on the 503B bulk list for lawful compounding. |
What this means
- ✓ FDA-approved drug product: Not an approved drug. No FDA-approved application is in effect for ipamorelin.
- ✓ 503A pharmacy compounding: Not on 503A bulk list. FDA's advisory committee reviewed ipamorelin-related bulk substances in October 2024 and recommended against placing them on the 503A bulk list. Nominations were withdrawn.
- ✓ 503B outsourcing-facility compounding: Ipamorelin acetate in Category 2 — significant safety risk. FDA placed ipamorelin acetate in 503B Category 2. It is not on the 503B bulk list for lawful compounding.
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
PCAC reviews ipamorelin
advisoryAdvisory committee discussed ipamorelin-related bulk substances; FDA recommended against inclusion on the 503A bulk list.
Controlling sources
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503B
U.S. Food and Drug Administration · Agency list · FDA-2015-N-0030
- FDA Briefing Document: Ipamorelin-Related Bulk Drug Substances (PCAC October 2024)
U.S. Food and Drug Administration · Advisory committee briefing