Peptide dossier, updated Nov 1, 2026
Sermorelin
Sermorelin acetate, a 29-amino-acid fragment of growth hormone-releasing hormone (GHRH). Brand name GEREF. A lab-made version of the first 29 amino acids of the brain hormone that tells the pituitary to release growth hormone. FDA approved it under the brand GEREF; Drugs@FDA lists the products as discontinued. FDA determined in 2013 that GEREF was not withdrawn for safety or effectiveness reasons. This page lays out what each source actually says.
See all 8 verified records for Sermorelin on the Records page
In plain terms
Approved for: GEREF (sermorelin acetate) injection was FDA-approved. Drugs@FDA lists both applications as discontinued. A 1999 review describes uses in diagnosing growth hormone deficiency and in treating some children with idiopathic growth hormone deficiency.
What it is: A lab-made copy of the first 29 amino acids of GHRH, the brain hormone that prompts the pituitary gland to release growth hormone.
What it is said to do, and by whom:
- FDA, 2013: determined that GEREF was not withdrawn from sale for reasons of safety or effectiveness. This allows FDA to approve generic applications; it is not an approval.
- Reviewers, 1999: a one-dose test of growth hormone reserve, and, in limited data, a daily injection that raised height velocity in some prepubertal children.
- We did not collect sellers’ claims for this compound.
How strong the evidence is: Approved and studied in the past for diagnosis and for some children with growth hormone deficiency. We found no current FDA-approved product, and the adult use that is promoted online is not an approved use.
FDA approvals
Dates are from Drugs@FDA through the openFDA API. We did not read the GEREF labels: a DailyMed search for GEREF and sermorelin returned no labels.
| Brand | Application | Original approval | Status |
|---|---|---|---|
| GEREF 0.05 mg per ampule | Drugs@FDA NDA019863 | Dec 28, 1990 | Discontinued, per Drugs@FDA. The 2013 Federal Register notice says EMD Serono told FDA in July 2008 it was discontinuing this product and asked in Dec 2008 to withdraw the application. |
| GEREF 0.5 mg and 1.0 mg per vial | Drugs@FDA NDA020443 | Sep 26, 1997 | Discontinued, per Drugs@FDA. The notice says EMD Serono told FDA on Dec 2, 2008 it was discontinuing this product and asked to withdraw the application. |
FDA statements
Two FDA documents are the basis for this section.
What they say
- Federal Register, Mar 4, 2013. FDA determined that GEREF (sermorelin acetate) injection, 0.5 mg and 1.0 mg base per vial, and 0.05 mg base per ampule, were not withdrawn from sale for reasons of safety or effectiveness. The notice says EMD Serono notified FDA in 2008 that the products were being discontinued, and that FDA reviewed the evidence, including postmarketing adverse events, before concluding they were not withdrawn for safety or effectiveness. It says this allows FDA to approve abbreviated applications if all other requirements are met. Federal Register notice
- Safety-risk page. We read the page on Nov 1, 2026 and did not find sermorelin among the listed substances. FDA page
What we did not find
- The notice does not give EMD Serono’s business reason for discontinuing. It says FDA also evaluated the literature and possible postmarketing adverse events and found no safety or effectiveness reason.
- We found no current Drugs@FDA product, and no generic application. We searched openFDA’s copy by active ingredient, not FDA’s own site.
Published research
PubMed returns 25 results for sermorelin in the title or abstract as of Nov 1, 2026. Several are recent reviews and doping-detection papers. ClinicalTrials.gov returns 27 studies for the term, many labelled growth hormone-releasing hormone in general; we did not open each to confirm sermorelin.
What the papers show
- Review, 1999. Describes sermorelin as the shortest synthetic peptide with full GHRH activity. A 1 microgram/kg intravenous dose is a rapid, relatively specific test for growth hormone deficiency. Limited data suggest a daily bedtime injection can treat some prepubertal children with idiopathic deficiency. A normal response does not exclude deficiency of hypothalamic origin. BioDrugs PubMed
- Review, 2006. Title asks whether sermorelin is a better approach to managing adult-onset growth hormone insufficiency. We did not read the abstract. Clin Interv Aging PubMed
- Doping detection, 2021. Advances in detecting synthetic GHRH analogues. Drug Test Anal PubMed
- Reviews, 2026. Recent reviews of peptide therapies in sports medicine and orthopaedics list it among peptides discussed. Titles only. Sports Med PubMed J Am Acad Orthop Surg PubMed
Read with care
- The evidence base is older: the main clinical review is from 1999.
- We read one abstract in full and the rest by title.
- We did not verify any adult-use claims; we found no FDA-approved adult use.
Timeline
Newest first. Every entry links to the document it comes from.
- Government or registry record
- Journal
- Oct 30, 2026RegulatoryHHS publishes draft policy pausing enforcement on six peptides; Sermorelin is not one of them
The draft policy’s appendix names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. The policy is a draft and not FDA approval. We read the appendix through a text extraction.
- July 23–24, 2026RegulatoryFDA advisory committee meets on seven peptides; Sermorelin is not among them
The committee recommended six of the seven, all nonbinding. FDA’s notice of the meeting does not list Sermorelin.
- Jan 1, 2026Anti-dopingWADA’s 2026 Prohibited List names sermorelin in S2.2.4
The list names it among GHRH analogues. We read WADA’s own file through a text extraction.
- Mar 4, 2013RegulatoryFDA determines GEREF was not withdrawn from sale for safety or effectiveness reasons
The notice allows FDA to approve generic applications if other requirements are met.
- Dec 2, 2008RegulatoryEMD Serono tells FDA it is discontinuing GEREF vials and asks to withdraw NDA 20-443
A July 11, 2008 letter covered the ampule product, and a Dec 12, 2008 letter asked to withdraw NDA 19-863. Per the 2013 notice.
- Sep 26, 1997ApprovalFDA approves GEREF (NDA 020443)
Original approval date per Drugs@FDA. Listed as discontinued.
- Dec 28, 1990ApprovalFDA approves GEREF (NDA 019863)
Original approval date per Drugs@FDA. Listed as discontinued.
Still not covered
Left off rather than guessed:
- HHS policy: we read the draft policy appendix through a text extraction, not as the original PDF layout. It names six covered peptides and not sermorelin.
- FDA review: we found no FDA briefing document or advisory committee evaluation for sermorelin. FDA’s notice for the July meeting does not name it.
- GEREF labels: not read. The approved indications on this page come from a 1999 review, not the labels.
- Why GEREF was discontinued: the 2013 notice says only that the sponsor discontinued it. The company’s reason is not stated.
- Compounding status: we did not research how FDA treats compounded sermorelin; it is not on the safety-risk page we read.
- Warning letters: we found none that name sermorelin. Absence is not proven.
- Patents and SEC filings: not researched for this dossier.
- Seller claims and independent lab reports: how gray-market product is marketed versus what testing finds. We have not collected testing data.
- Unread items: full text of most papers; EU and other non-US regulators and registries; WADA lists for years other than 2026; FDA warning letters beyond those listed, which rest on web searches.