How to Reconstitute Sermorelin for Travel and Transport Without Losing Potency
At a glance
- Regulatory status / no FDA-approved sermorelin since 2009 [1]
- Products sold now / compounded; not reviewed by FDA for safety, effectiveness or quality [2]
- Official instructions / no current FDA-approved sermorelin label exists to set reconstitution, storage or beyond-use rules [1]
- Molecule / 29-amino-acid GHRH analogue, not growth hormone [3]
- Doses used in studies / 30 micrograms/kg once daily in children; 0.5 or 1 mg twice daily for 14 days in older men, not recommended doses [4][5]
- Sport status / prohibited at all times, WADA section S2.2.4 [6]
- Bringing it into the US / importing an unapproved drug is illegal in most circumstances [7]
Why there is no standard sermorelin travel protocol
Geref came in two FDA-approved forms: a 0.05 mg/ampule product (NDA 019863) for testing the pituitary's ability to release growth hormone, and 0.5 mg and 1 mg vials (NDA 020443) for treating idiopathic growth hormone deficiency in children [1]. The manufacturer discontinued both in 2008 and asked FDA to withdraw the applications; approval ended on June 18, 2009 [1]. In March 2013 FDA determined that Geref had not been withdrawn for reasons of safety or effectiveness [1].
Sermorelin sold in the US today is compounded. Compounded drugs are not FDA-approved: FDA does not review their safety, effectiveness or quality before they are marketed [2].
What is documented about the molecule
Sermorelin is a 29-amino-acid analogue of human growth hormone-releasing hormone and the shortest synthetic peptide with GHRH's full biological activity; it prompts the pituitary to release growth hormone and is not growth hormone itself [3]. In healthy men given GHRH(1-29)-NH2 intravenously, the peptide was eliminated quickly while growth hormone levels stayed raised for about 3 hours [8].
No sermorelin product is approved, and the doses that have been studied are not recommended doses. In a 1-year open-label trial, 110 previously untreated children with growth hormone deficiency received 30 micrograms/kg subcutaneously at bedtime; among the 86 evaluable, mean height velocity rose from 4.1 cm/yr at baseline to 8.0 cm/yr at 6 months and 7.2 cm/yr at 12 months, and 74% were good responders at 6 months [4]. In a much smaller physiology study, 10 healthy older men took 0.5 mg or 1 mg subcutaneously twice daily for 14 days; at the higher dose, 24-hour growth hormone and IGF-I rose to levels not significantly different from those of 9 young men [5].
Travel rules that are documented
WADA's 2026 Prohibited List names sermorelin in S2.2.4 (growth hormone releasing factors, GHRH and its analogues), prohibited at all times in and out of competition and classed as a non-Specified Substance; it is also named in the 2027 List [6][9].
For entry into the United States, FDA's personal importation guidance says it is illegal in most circumstances for individuals to import drugs, and a drug approved abroad but unapproved in the US is illegal to import [7]. For a serious condition, FDA staff may consider a more permissive decision in defined situations, generally for no more than a three-month supply, when the consumer affirms in writing that the product is for personal use and provides the name and address of a US-licensed doctor responsible for treatment, or evidence that treatment began abroad [7]. Compounded sermorelin is not an FDA-approved drug [2].
Frequently asked questions
How do you reconstitute sermorelin?
How long does reconstituted sermorelin last?
What dose of sermorelin has actually been studied?
Is sermorelin the same as growth hormone?
Can I carry sermorelin into the United States?
References
- Federal Register :: Request Access. Federal Register :: Request Access
- Official web page. Official web page
- 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. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency
- Thorner M, Rochiccioli P, Colle M, Lanes R, Grunt J, Galazka A, et al. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group. J Clin Endocrinol Metab. 1996;81(3):1189-96. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group
- Corpas E, Harman SM, Piñeyro MA, Roberson R, Blackman MR. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men. J Clin Endocrinol Metab. 1992;75(2):530-5. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men
- World Anti-Doping Agency. World Anti-Doping Agency
- Personal Importation | FDA. Personal Importation | FDA
- Wilton P, Chardet Y, Danielson K, Widlund L, Gunnarsson R. 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. Pharmacokinetics of growth hormone-releasing hormone(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects after intravenous or intranasal administration
- World Anti-Doping Agency. World Anti-Doping Agency