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Growth

Sermorelin

A compounded fragment of growth-hormone-releasing hormone

Compounded · not FDA-approved · by prescription

Compounded by a licensed pharmacy. Not FDA-approved; FDA has not reviewed compounded medications for safety, effectiveness or quality.

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Consultations are opening state by state.

Important safety information. Compounded sermorelin is not FDA-approved, and FDA has not reviewed it for safety, effectiveness or quality; it may cause injection-site reactions, flushing, headache or dizziness, and hypothyroidism occurred in 6.5% of patients in earlier trials. See safety

Stylised model of the real sequence

Overview.

Sermorelin is not currently FDA-approved, and it has never been approved as a treatment for adults. It is a synthetic 29-amino-acid fragment of human growth-hormone-releasing hormone, identical in sequence to native GHRH(1-29) with an amidated C-terminus. FDA approved it as GEREF in 1990 (a diagnostic test of pituitary GH secretion) and in 1997 (treatment of idiopathic GH deficiency in children with growth failure). EMD Serono discontinued both products in 2008 and FDA withdrew the approvals effective June 18, 2009; in 2013 FDA determined they were not withdrawn for reasons of safety or effectiveness. It is available today only through compounding pharmacies.

Also known as Geref · Geref Diagnostic · Sermorelin acetate

The molecule, decoded.

Sequence

Tyr-Ala-Asp-Ala-Ile-Phe-Thr-Asn-Ser-Tyr-Arg-Lys-Val-Leu-Gly-Gln-Leu-Ser-Ala-Arg-Lys-Leu-Leu-Gln-Asp-Ile-Met-Ser-Arg-NH2

Length
29 residues
Molecular weight
3,357.9 g/mol
Formula
C149H246N44O42S
CAS number
86168-78-7 (free base; acetate salt CAS varies by source)
Half-life
~4-12 minutes (estimates vary by study)
Routes studied
subcutaneous injection
Modifications
None vs. native human GHRH(1-29); C-terminal amidation (shared with native GHRH(1-29)NH2)

How it works.

Binds the GHRH receptor on anterior-pituitary somatotrophs, activating the same Gs/adenylyl-cyclase/cAMP/PKA pathway as endogenous GHRH to stimulate pulsatile GH release. Requires an anatomically and functionally intact pituitary to work, unlike GH itself.

Evidence · Compounded · not FDA-approved · limited adult human data

What the research shows

drug review, pediatric trials1999

Once-daily subcutaneous sermorelin 30 mcg/kg increased height velocity in prepubertal children with idiopathic GH deficiency, with effects sustained over 12 months and, in some children, 36 months of continued treatment.

prepubertal children with idiopathic GH deficiency

Source
FDA approval, withdrawn 20091990

FDA approved GEREF (sermorelin acetate) 0.05 mg/ampule (NDA 19-863) on December 28, 1990 as a diagnostic agent for evaluating the ability of the pituitary somatotroph to secrete GH.

patients undergoing pituitary GH-secretion testing

Source
FDA approval, withdrawn 20091997

FDA approved Geref (sermorelin acetate) for treatment of short stature due to inadequate endogenous GH secretion in children.

children with growth hormone deficiency

Source
FDA determination2013

FDA formally determined that Geref's 2008-2009 market withdrawal was for reasons other than safety or effectiveness, a finding that underpins its continued use as a compounded product.

n/a (regulatory determination)

Source

What to know first.

Based on: a withdrawn FDA label and published trials in children.

Reported side effects

  • injection-site reactions
  • flushing
  • headache
  • dizziness

Cautions

  • requires an intact hypothalamic-pituitary axis to be effective; not useful after pituitary ablation/lesion
  • theoretical caution with active malignancy given GH-axis stimulation
  • hypersensitivity to sermorelin
  • check thyroid function before and during treatment: hypothyroidism occurred in 6.5% of patients in GEREF-era trials and can blunt the response
  • anti-GHRH antibodies developed in a large proportion of treated patients (clinical significance unclear)

Checked 2026-09

Where it stands.

Compounded, by prescription.

When consultations open, a licensed clinician in your state will review your health history and prescribe Sermorelin only if it’s appropriate for you. A licensed U.S. pharmacy will dispense it.

Compounded medications are prepared by a licensed pharmacy for an individual patient. They are not FDA-approved, and FDA has not reviewed them for safety, effectiveness or quality. Not available in Alabama or Mississippi.

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FDA
Not currently FDA-approved. Approved historically (Geref Diagnostic, 1990, diagnostic use; Geref, 1997, pediatric GH-deficiency treatment); manufacturer EMD Serono discontinued production and requested withdrawal of both NDAs in 2008, and FDA withdrew marketing approval effective June 18, 2009. A 2013 FDA determination confirmed the withdrawal was not for safety or effectiveness reasons.
Approved products
  • Geref Diagnostic (FDA, 1990): diagnostic test of pituitary GH secretory capacity
  • Geref (FDA, 1997): treatment of short stature due to inadequate endogenous GH secretion in children with GH deficiency
Compounding
Not on FDA's Category 2 safety-risk list and not in any 503A nomination category. Because GEREF's approvals were withdrawn in 2009 for reasons other than safety or effectiveness (FDA determination, 2013), sermorelin acetate is treated as a component of an FDA-approved drug: FDA's 503B list places sermorelin acetate in Category 1 with the 'component of FDA-approved drugs' designation. There is no current USP monograph for sermorelin acetate (FDA-funded M-CERSI report, 2020). This is a materially different legal basis from never-approved peptides such as CJC-1295 or the GHRPs.
Sport (WADA)
Prohibited at all times under S2 (GHRH and its analogues) of the WADA Prohibited List, naming sermorelin explicitly.
References (2)
  1. PubMed · PMID 18031173
  2. Federal Register

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