Sermorelin
Also known as: Sermorelin acetate, Geref
Sermorelin is currently approved product discontinued from marketing for fda-approved drug product.
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A growth hormone-releasing hormone analog. Geref (sermorelin acetate) was FDA approved but is discontinued from marketing per Drugs@FDA. It remains a component of a previously approved drug.
Current status
FDA-approved drug product: Approved product discontinued from marketing; 503B outsourcing-facility compounding: Component of FDA-approved drug (Category 1**)
| Activity | Status | As of | Jurisdiction | Qualification | Sources |
|---|---|---|---|---|---|
| FDA-approved drug product | Approved product discontinued from marketing | Dec 10, 2024 | United States federal | Geref (sermorelin acetate) was approved in 1990 but is listed as discontinued from marketing in Drugs@FDA. No currently marketed FDA-approved sermorelin product was identified. | |
| 503B outsourcing-facility compounding | Component of FDA-approved drug (Category 1**) | Mar 21, 2025 | United States federal | Sermorelin acetate appears in FDA's 503B Category 1 list marked as a component of an FDA-approved drug. Other 503B conditions, including the 'not essentially a copy' restriction, still apply. |
What this means
- ✓ FDA-approved drug product: Approved product discontinued from marketing. Geref (sermorelin acetate) was approved in 1990 but is listed as discontinued from marketing in Drugs@FDA. No currently marketed FDA-approved sermorelin product was identified.
- ✓ 503B outsourcing-facility compounding: Component of FDA-approved drug (Category 1**). Sermorelin acetate appears in FDA's 503B Category 1 list marked as a component of an FDA-approved drug. Other 503B conditions, including the 'not essentially a copy' restriction, still apply.
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 sermorelin products
enforcement action recordedXcel Research warning letter states sermorelin products marketed online are unapproved new drugs.
Geref approved
finalFDA approved Geref (sermorelin acetate) for evaluating pituitary growth hormone reserve.
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 Warning Letter to Xcel Research LLC
U.S. Food and Drug Administration, CDER Office of Compliance · Warning letter · 694608