Sermorelin
updated
Sermorelin is the amidated 29-amino-acid active segment of human growth-hormone-releasing hormone. It has real pediatric and diagnostic human history, but that record does not establish current adult anti-aging, fat-loss, recovery, or sleep benefits.
amidated GHRH(1-29) analogue
- GHRH(1-29)-NH2
- Stimulates pituitary growth-hormone release
- Former US Geref products were withdrawn from sale
- No current FDA-approved sermorelin product identified
What is sermorelin?
Sermorelin is GHRH(1-29)-NH2, the amidated active N-terminal segment of the 44-amino-acid human GHRH hormone. It is not growth hormone, CJC-1295, or a ghrelin-receptor agonist.
It acts at pituitary GHRH receptors and requires a pituitary capable of releasing growth hormone. That physiology makes its response different from directly administering recombinant growth hormone.
Human PK · rapid plasma clearance
Human pharmacokinetic study
Freda PU et al. Journal of Clinical Endocrinology and Metabolism, 1994.
After intravenous GHRH(1-29)-NH2 in healthy volunteers, the reported plasma disappearance half-time was about 4.3 minutes. This supports rapid clearance of the unmodified peptide and does not establish the exposure from current compounded formulations.
- Participants / model
- Healthy adult volunteers
- Treatment
- Intravenous GHRH(1-29)-NH2
- Study design
- Pharmacokinetic and endocrine-response study
What has sermorelin actually shown in people?
Historic studies showed pituitary growth-hormone responses and increased growth velocity in selected children. Growth hormone outperformed GHRH(1-29) in one pediatric comparison. Controlled adult body-composition, recovery, sleep, or longevity outcomes were not identified.
Does the pediatric record prove adult anti-aging benefits?
Children with growth failure, healthy adults in an acute hormone test, and adults seeking body-composition or sleep effects are different populations with different outcomes.
Pediatric study · 110 enrolled
Open-label clinical study
Rochiccioli P et al. Journal of Pediatrics, 1996.
The study enrolled 110 children with growth failure; 86 were evaluable for efficacy. Mean height velocity increased from 4.1 cm/year before treatment to 8.0 cm/year at six months and 7.2 cm/year at 12 months. Without a control group, the study cannot separate treatment, selection, maturation, and measurement effects.
- Participants / model
- Children with growth failure and preserved pituitary responsiveness
- Treatment
- Daily subcutaneous sermorelin
- Follow-up
- 12 months
- Study design
- Multicenter open-label study
Pediatric comparison · GH produced more growth
Randomized comparative study
Thorner MO et al. Journal of Clinical Endocrinology and Metabolism, 1993.
Sixty short prepubertal children were assigned to growth hormone or one of two GHRH(1-29) regimens. Annualized growth was higher with growth hormone, 14.6 cm/year, than with either GHRH schedule, 9.2 and 9.3 cm/year. Antibodies were reported in 39 of 40 GHRH recipients and three had mild injection-site reactions.
- Participants / model
- 60 short prepubertal children
- Treatment
- Growth hormone or subcutaneous GHRH(1-29)
- Follow-up
- Six months
- Study design
- Randomized active-comparator trial
Was sermorelin as effective as growth hormone?
Not in the 60-child comparison. Growth hormone produced more annualized growth over six months. That result is pediatric and does not create an adult treatment comparison.
Pediatric comparison · GH produced more growth
Randomized comparative study
Thorner MO et al. Journal of Clinical Endocrinology and Metabolism, 1993.
Sixty short prepubertal children were assigned to growth hormone or one of two GHRH(1-29) regimens. Annualized growth was higher with growth hormone, 14.6 cm/year, than with either GHRH schedule, 9.2 and 9.3 cm/year. Antibodies were reported in 39 of 40 GHRH recipients and three had mild injection-site reactions.
- Participants / model
- 60 short prepubertal children
- Treatment
- Growth hormone or subcutaneous GHRH(1-29)
- Follow-up
- Six months
- Study design
- Randomized active-comparator trial
Pediatric study · 110 enrolled
Open-label clinical study
Rochiccioli P et al. Journal of Pediatrics, 1996.
The study enrolled 110 children with growth failure; 86 were evaluable for efficacy. Mean height velocity increased from 4.1 cm/year before treatment to 8.0 cm/year at six months and 7.2 cm/year at 12 months. Without a control group, the study cannot separate treatment, selection, maturation, and measurement effects.
- Participants / model
- Children with growth failure and preserved pituitary responsiveness
- Treatment
- Daily subcutaneous sermorelin
- Follow-up
- 12 months
- Study design
- Multicenter open-label study
Pediatric comparison · GH produced more growth
Randomized comparative study
Thorner MO et al. Journal of Clinical Endocrinology and Metabolism, 1993.
Sixty short prepubertal children were assigned to growth hormone or one of two GHRH(1-29) regimens. Annualized growth was higher with growth hormone, 14.6 cm/year, than with either GHRH schedule, 9.2 and 9.3 cm/year. Antibodies were reported in 39 of 40 GHRH recipients and three had mild injection-site reactions.
- Participants / model
- 60 short prepubertal children
- Treatment
- Growth hormone or subcutaneous GHRH(1-29)
- Follow-up
- Six months
- Study design
- Randomized active-comparator trial
Human PK · rapid plasma clearance
Human pharmacokinetic study
Freda PU et al. Journal of Clinical Endocrinology and Metabolism, 1994.
After intravenous GHRH(1-29)-NH2 in healthy volunteers, the reported plasma disappearance half-time was about 4.3 minutes. This supports rapid clearance of the unmodified peptide and does not establish the exposure from current compounded formulations.
- Participants / model
- Healthy adult volunteers
- Treatment
- Intravenous GHRH(1-29)-NH2
- Study design
- Pharmacokinetic and endocrine-response study
How does it change the growth-hormone axis?
Sermorelin can provoke pituitary growth-hormone release and raise downstream IGF-1 when the axis is responsive. Human studies measured those hormones and pediatric growth, not improved adult recovery, sleep, cognition, fat loss, or lifespan.
The peptide clears rapidly after intravenous administration. Claims that a modern formulation has a particular half-life or sustained clinical effect need formulation-specific pharmacokinetic data.
Human PK · rapid plasma clearance
Human pharmacokinetic study
Freda PU et al. Journal of Clinical Endocrinology and Metabolism, 1994.
After intravenous GHRH(1-29)-NH2 in healthy volunteers, the reported plasma disappearance half-time was about 4.3 minutes. This supports rapid clearance of the unmodified peptide and does not establish the exposure from current compounded formulations.
- Participants / model
- Healthy adult volunteers
- Treatment
- Intravenous GHRH(1-29)-NH2
- Study design
- Pharmacokinetic and endocrine-response study
Pediatric study · 110 enrolled
Open-label clinical study
Rochiccioli P et al. Journal of Pediatrics, 1996.
The study enrolled 110 children with growth failure; 86 were evaluable for efficacy. Mean height velocity increased from 4.1 cm/year before treatment to 8.0 cm/year at six months and 7.2 cm/year at 12 months. Without a control group, the study cannot separate treatment, selection, maturation, and measurement effects.
- Participants / model
- Children with growth failure and preserved pituitary responsiveness
- Treatment
- Daily subcutaneous sermorelin
- Follow-up
- 12 months
- Study design
- Multicenter open-label study
What safety information exists?
Pediatric studies provide some administered-human experience, including frequent antibody detection and mild injection-site reactions in one trial. Adult repeated-use safety, immune effects, glucose effects, interactions, pregnancy, and current compounded-product quality remain incompletely characterized.
- Immune response: antibodies were reported in 39 of 40 GHRH recipients in the six-month comparison.
- Endocrine response: excess or mistimed GH and IGF-1 exposure may matter in people with glucose dysregulation, pituitary disease, or active malignancy, but current off-label regimens are not well characterized.
- Product quality: compounded or research-market material is not interchangeable with historic Geref trial product.
Pediatric comparison · GH produced more growth
Randomized comparative study
Thorner MO et al. Journal of Clinical Endocrinology and Metabolism, 1993.
Sixty short prepubertal children were assigned to growth hormone or one of two GHRH(1-29) regimens. Annualized growth was higher with growth hormone, 14.6 cm/year, than with either GHRH schedule, 9.2 and 9.3 cm/year. Antibodies were reported in 39 of 40 GHRH recipients and three had mild injection-site reactions.
- Participants / model
- 60 short prepubertal children
- Treatment
- Growth hormone or subcutaneous GHRH(1-29)
- Follow-up
- Six months
- Study design
- Randomized active-comparator trial
Pediatric study · 110 enrolled
Open-label clinical study
Rochiccioli P et al. Journal of Pediatrics, 1996.
The study enrolled 110 children with growth failure; 86 were evaluable for efficacy. Mean height velocity increased from 4.1 cm/year before treatment to 8.0 cm/year at six months and 7.2 cm/year at 12 months. Without a control group, the study cannot separate treatment, selection, maturation, and measurement effects.
- Participants / model
- Children with growth failure and preserved pituitary responsiveness
- Treatment
- Daily subcutaneous sermorelin
- Follow-up
- 12 months
- Study design
- Multicenter open-label study
Is sermorelin currently FDA approved?
No current FDA-approved sermorelin product was identified. Historic Geref products were withdrawn from sale; FDA later determined that the withdrawal was not for safety or effectiveness, which permits certain abbreviated applications but provides no current approval or adult-wellness indication.
Does “not withdrawn for safety or effectiveness” mean approved today?
The cited record explains why an old listed product left the market. It does not establish that a seller’s product is approved, equivalent, or supported for a new indication.
Federal Register · withdrawal was not for safety or effectiveness
FDA legal determination
US Food and Drug Administration. Federal Register, 22 November 2013.
FDA determined that Geref sermorelin acetate injection products were not withdrawn from sale for reasons of safety or effectiveness. That finding permits certain abbreviated applications; it does not mean a current product is approved, marketed, or clinically validated for adult wellness.
- Study design
- Agency withdrawal determination
Federal Register · withdrawal was not for safety or effectiveness
FDA legal determination
US Food and Drug Administration. Federal Register, 22 November 2013.
FDA determined that Geref sermorelin acetate injection products were not withdrawn from sale for reasons of safety or effectiveness. That finding permits certain abbreviated applications; it does not mean a current product is approved, marketed, or clinically validated for adult wellness.
- Study design
- Agency withdrawal determination
WADA 2026 · GHRH analogues
Sports rule
World Anti-Doping Agency, effective 1 January 2026.
Growth-hormone-releasing factors and their analogues are prohibited under S2 for athletes covered by the Code.
- Study design
- Binding sport rule for covered athletes
Studies and sources
Pediatric study · 110 enrolled
Open-label clinical study
Rochiccioli P et al. Journal of Pediatrics, 1996.
The study enrolled 110 children with growth failure; 86 were evaluable for efficacy. Mean height velocity increased from 4.1 cm/year before treatment to 8.0 cm/year at six months and 7.2 cm/year at 12 months. Without a control group, the study cannot separate treatment, selection, maturation, and measurement effects.
- Participants / model
- Children with growth failure and preserved pituitary responsiveness
- Treatment
- Daily subcutaneous sermorelin
- Follow-up
- 12 months
- Study design
- Multicenter open-label study
Pediatric comparison · GH produced more growth
Randomized comparative study
Thorner MO et al. Journal of Clinical Endocrinology and Metabolism, 1993.
Sixty short prepubertal children were assigned to growth hormone or one of two GHRH(1-29) regimens. Annualized growth was higher with growth hormone, 14.6 cm/year, than with either GHRH schedule, 9.2 and 9.3 cm/year. Antibodies were reported in 39 of 40 GHRH recipients and three had mild injection-site reactions.
- Participants / model
- 60 short prepubertal children
- Treatment
- Growth hormone or subcutaneous GHRH(1-29)
- Follow-up
- Six months
- Study design
- Randomized active-comparator trial
Human PK · rapid plasma clearance
Human pharmacokinetic study
Freda PU et al. Journal of Clinical Endocrinology and Metabolism, 1994.
After intravenous GHRH(1-29)-NH2 in healthy volunteers, the reported plasma disappearance half-time was about 4.3 minutes. This supports rapid clearance of the unmodified peptide and does not establish the exposure from current compounded formulations.
- Participants / model
- Healthy adult volunteers
- Treatment
- Intravenous GHRH(1-29)-NH2
- Study design
- Pharmacokinetic and endocrine-response study
Federal Register · withdrawal was not for safety or effectiveness
FDA legal determination
US Food and Drug Administration. Federal Register, 22 November 2013.
FDA determined that Geref sermorelin acetate injection products were not withdrawn from sale for reasons of safety or effectiveness. That finding permits certain abbreviated applications; it does not mean a current product is approved, marketed, or clinically validated for adult wellness.
- Study design
- Agency withdrawal determination
WADA 2026 · GHRH analogues
Sports rule
World Anti-Doping Agency, effective 1 January 2026.
Growth-hormone-releasing factors and their analogues are prohibited under S2 for athletes covered by the Code.
- Study design
- Binding sport rule for covered athletes
Why is Sermorelin in B tier?
The B grade reflects pediatric growth studies, diagnostic hormone responses, and human pharmacokinetics. Historic products were withdrawn, and controlled adult wellness outcomes have not been established.