SoluneFit

Peptide library

Sermorelin

Withdrawn Evidence grade B — human randomised trials, not approved for that use Updated 2026-10-20

This page describes published research and public regulatory records. It is not medical advice. SoluneFit does not sell, supply, or recommend any compound. The SoluneFit app includes a private, on-device tracker for people who want a record of what they and their clinician have already decided — the app neither suggests compounds nor doses.

Also known as: Geref, sermorelin acetate, GHRH(1-29)-NH2, GRF(1-29).

Regulatory status

Previously approved: Geref diagnostic (NDA 19-863, 1990) and Geref for idiopathic GH deficiency in children (NDA 20-443, 1997) [1][2]. EMD Serono discontinued both in 2008 and FDA withdrew the approvals effective 18 Jun 2009; in 2013 FDA determined they were not withdrawn for safety or effectiveness reasons [3]. Sermorelin is not on any of FDA's 503A bulk-substance category lists (May 2026) [8]; the legal basis for current 503A compounding (e.g. as a component of a previously approved drug) is UNVERIFIED — no FDA statement found. FDA has cited sermorelin in warning letters to 'research' peptide sellers (Dec 2024) [9].

What it is

GHRH analogue (the first 29 amino acids of human growth hormone-releasing hormone, amidated).

The active 29-amino-acid fragment of natural GHRH. It was FDA-approved as Geref, first as a diagnostic test of pituitary GH reserve and later for idiopathic GH deficiency in children, and was discontinued by the maker in 2008. Today it circulates as a compounded or research-market product.

What the published research shows

Approved in the US on limited, largely uncontrolled paediatric data (12-36 months of growth in some prepubertal children with idiopathic GHD); well established as an IV diagnostic. No trials support adult anti-ageing use.

Published human studies and reports (these describe trial populations, not SoluneFit claims):

  • Idiopathic GH deficiency in prepubertal children (Geref; review of trials): 30 µg/kg once daily SC at bedtime; height velocity rose significantly and was sustained over 12 months, with limited data to 36 months. Height-velocity gains were smaller than with daily somatropin 30 µg/kg.
  • Diagnostic test of pituitary GH reserve (Geref diagnostic): Single IV dose of 1 µg/kg; a normal response does not rule out hypothalamic GH deficiency.
  • Healthy men, IV vs intranasal (Wilton 1993): 30 men aged 19-43; maximal GH release at 1-2 µg/kg IV; nasal bioavailability only 3-5 %, with about 50 µg/kg intranasally matching 1 µg/kg IV.

Mechanism, as reported

Binds the GHRH receptor on pituitary somatotrophs and releases growth hormone in the normal pulsatile way. It is cleaved quickly in blood by dipeptidyl peptidase, so each dose acts briefly.

Practical record

  • Elimination half-life: 0.25 h (confidence: low). UNVERIFIED for sermorelin itself: the Geref label (source of the app's 10-20 min) is no longer available from FDA. Primary data show GHRH(1-29)-NH2 is 'rapidly eliminated' after IV injection with GH raised for about 3 h (Wilton 1993), and full-length GRH(1-44) has an IV half-life of 6.8 min in humans. The app's 15 min is kept as a placeholder pending a label copy.
  • Studied routes: subcutaneous, intravenous.
  • Typical supply: Geref: 0.05 mg/ampule (diagnostic) and 0.5 / 1.0 mg vials (treatment), all discontinued [1][2]. Now sold as compounded or research-market lyophilised vials.

Safety signals on record

  • Reported adverse events: Transient facial flushing and injection-site pain were the most common reported effects; single IV and daily SC doses were otherwise well tolerated in the paediatric studies.
  • Contraindications: Geref label contraindications UNVERIFIED (label not available from FDA).
  • Interactions: None documented in the sources found.
  • Notes: WADA Prohibited List 2026 (in force 1 Jan 2026), S2.2.4 names sermorelin among 'GHRH and its analogues', prohibited at all times (in and out of competition), non-specified. Geref's withdrawal was a business decision, not a safety one (FDA 2013), but no current FDA-approved sermorelin product exists, so compounded product quality is not FDA-reviewed.

Sources

  1. Drugs@FDA: NDA 019863 GEREF (sermorelin acetate) 0.05 mg base/amp — approved 28 Dec 1990, discontinued (1990)
  2. Drugs@FDA: NDA 020443 GEREF (sermorelin acetate) 0.5 mg and 1 mg base/vial — approved 26 Sep 1997, discontinued (1997)
  3. FDA. Determination That GEREF (Sermorelin Acetate) Injection ... Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register, 4 Mar 2013 (FR Doc 2013-04827) (2013)
  4. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs 1999;12(2):139-57 (1999)
  5. Wilton P et al. Pharmacokinetics of growth hormone-releasing hormone(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects after intravenous or intranasal administration. Acta Paediatr Suppl 1993;388:10-5 (1993)
  6. Frohman LA et al. Rapid enzymatic degradation of growth hormone-releasing hormone by plasma in vitro and in vivo to a biologically inactive product cleaved at the NH2 terminus. J Clin Invest 1986;78(4):906-13 (1986)
  7. World Anti-Doping Agency. The 2026 Prohibited List (International Standard), in force 1 January 2026 — section S2.2.4 Growth hormone releasing factors (S2.2.4 text checked against a mirrored copy of this PDF; wada-ama.org blocked automated download) (2025)
  8. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (categories 1-3, updated 14 May 2026) (2026)
  9. FDA Warning Letter to Xcel Research LLC (sermorelin among products), 10 Dec 2024 (2024)

General wellness education, not medical advice. Unapproved compounds have no established dosing, purity standard, or safety profile.

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