No sermorelin product is FDA-approved and on the US market today (checked Nov 4, 2026). FDA approved sermorelin under the brand name Geref, held by EMD Serono, on December 28, 1990 (NDA 19-863) and September 26, 1997 (NDA 20-443). EMD Serono discontinued both products, and FDA withdrew approval of both NDAs effective June 18, 2009 [S1]. In 2013, FDA formally found that Geref was not withdrawn for reasons of safety or effectiveness [S1]. Sermorelin does not appear on FDA's current 503A category lists of nominated bulk substances (list updated May 14, 2026) [S2]. Whether a substance may be used in compounding depends on FDA's 503A criteria; this page does not say whether any pharmacy can or cannot compound sermorelin. Compounded drugs are not FDA-approved.
Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.
FDA status
Not approved
Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.
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Evidence tier
Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 4/5. 328 PubMed citations indexed.
Synthetic 29-aa GHRH analog binding pituitary GHRH receptors to stimulate pulsatile endogenous GH secretion while preserving hypothalamic-pituitary feedback.
What the literature studies
Growth Hormone Stimulation
Evidence tier
Human RCT
Compounding record
Status not verified
| Item | Status | Source, date checked |
|---|---|---|
| FDA-approved product on the market | None | [S1], Nov 4 2026 |
| Geref (EMD Serono) | NDA 19-863 (0.05 mg/amp) approved Dec 28 1990; NDA 20-443 (0.5 and 1.0 mg/vial) approved Sep 26 1997; discontinued, NDA approvals withdrawn effective Jun 18 2009 (74 FR 23407) | [S1] 78 FR 14095 |
| 2013 FDA finding | Not withdrawn for safety or effectiveness; FDA may approve ANDAs referencing Geref if all other requirements are met | [S1] 78 FR 14095, Mar 4 2013 |
| 503A bulks categories 1/2/3 | Not listed | [S2] FDA list updated May 14 2026, checked Nov 4 2026 |
| HHS draft peptide policy (proposed, not final) | Not among the six peptides in Appendix A | HHS draft policy, Appendix A |
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Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.
Sermorelin is a GHRH(1-29) analog that was FDA-approved as Geref for pediatric GH deficiency and for diagnostic GH testing, then withdrawn from the market for business reasons - not safety - and is no longer an approved marketed product in the US.
Synthetic growth hormone-releasing hormone fragment GHRH(1-29)-NH2 (sermorelin acetate), formerly sold as Geref (EMD Serono) [R1].
Not central; human pediatric and adult pharmacologic studies exist.
Historical labeled risks for GHRH products included injection-site reactions and the usual caveats of stimulating the GH/IGF-1 axis (glucose effects, fluid retention, theoretical neoplasm concerns in susceptible patients). Long-term safety for off-label adult "wellness" use is not established. Gray-market vials: identity, purity and sterility unverified.
No pending FDA reapproval of Geref identified. Watch FDA interim peptide compounding policy (RIN 0910-ZD94) for any related GHRH analogs [OIRA].
Last checked 2026-10-27
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