How to Reconstitute Sermorelin for Travel and Transport Without Losing Potency
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Sermorelin travel rules: no approved label to follow
Key numbers
- 30 micrograms/kgDose given to children with growth hormone deficiency in a trial; not a recommended doseSource: pubmed.ncbi.nlm.nih.gov, as cited Nov 7, 2026
- 0.5 mg or 1 mgDoses given twice daily for 14 days to healthy older men in a small study; not recommended dosesSource: pubmed.ncbi.nlm.nih.gov, as cited Nov 7, 2026
- 3 hoursHow long growth hormone stayed raised after intravenous GHRH(1-29)-NH2 in healthy menSource: pubmed.ncbi.nlm.nih.gov, as cited Nov 7, 2026
From the public record
Registered clinical studies of sermorelin
ClinicalTrials.gov lists 27 registered studies that name sermorelin as an intervention as of 2026-11-11. Of these, 1 are recruiting, 21 are completed and 4 are phase 3 studies.
| Measure | Value |
|---|---|
| Registered studies | 27 |
| Recruiting now | 1 |
| Not yet recruiting | 0 |
| Completed | 21 |
| Terminated, withdrawn or suspended | 4 |
| Phase 3 (including phase 2/3) | 4 |
| Phase 2 (including phase 1/2) | 7 |
| Phase 1 | 5 |
How this was calculated
Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.
Studies whose intervention field matches sermorelin, any condition, any country, all statuses
A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.
From the public record
Published papers mentioning sermorelin
PubMed indexes 25 papers that mention sermorelin in the title or abstract, 14 of them published from 2016 to 2025. The count for 2025 is 1 and for 2024 is 1.
| Measure | Value | Note |
|---|---|---|
| Papers indexed, all years | 25 | |
| Published 2016 to 2025 | 14 | |
| Published in 2025 | 1 | |
| Published in 2024 | 1 | |
| Busiest year since 2016 | 2023 | 3 papers |
How this was calculated
Ran a PubMed title and abstract search for the exact name variants shown and recorded the count for each publication year. No filtering by study type or quality.
PubMed records with 'sermorelin' in the title or abstract, all article types and species
A paper that mentions a compound is not evidence that it works or is safe in people. Counts include animal, cell, review and opinion papers.
From the public record
Patents and generic approvals for sermorelin
The FDA Orange Book lists 0 approved generic applications for sermorelin across 3 listed products. No unexpired patents are listed for it.
| Measure | Value |
|---|---|
| Brand-name applications (NDA) | 2 |
| Approved generic applications (ANDA) | 0 |
| Listed patents not yet expired | 0 |
| Earliest approval date on file | 1990-12-28 |
| Products not marked discontinued | 0 of 3 |
How this was calculated
Selected Orange Book products whose only active ingredient is this substance, then counted applications by type and the distinct patents and exclusivities listed against them. Expired patents are left out.
All single-ingredient sermorelin products in the Orange Book, every brand and strength, files dated 2026-10-09
An approved generic or an expired patent does not show that a generic is on sale. Launch timing also depends on litigation, settlements and supply. Biologics and compounded products are not in the Orange Book.
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].
Check what you know
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Questions worth asking
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?
Reader questions
What people actually ask
Short answers drawn from the sources this article cites.
Does sermorelin really work?
Not established by FDA review. No FDA-approved sermorelin product exists today, and compounded sermorelin is not reviewed by FDA for safety, effectiveness or quality. In a 1-year open-label trial of 110 children with growth hormone deficiency, mean height velocity rose from 4.1 cm/yr at baseline to 8.0 cm/yr at 6 months, but the doses studied are not recommended doses.
How long will sermorelin last unrefrigerated?
No documented time limit exists. No current FDA-approved sermorelin label sets a beyond-use period for reconstituted sermorelin, so there is no established figure for how long it lasts unrefrigerated. Compounded sermorelin is not reviewed by FDA for safety, effectiveness or quality.
References
Show all 9 referencesHide references
- Federal Register :: Request Access.
- 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.
- 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.
- 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.
- World Anti-Doping Agency.
- 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.
- World Anti-Doping Agency.