Research information only, not medical advice. Sermorelin is a synthetic 29-amino-acid GHRH analogue (GRF 1-29 amide) that stimulates the anterior pituitary to release growth hormone. It was formerly FDA-approved (Geref, NDA 020443) for short stature due to pediatric growth hormone deficiency, with a separate Geref Diagnostic formulation approved as a diagnostic agent for adult GHD. Both products were withdrawn from the U.S. market in 2008 as a business decision after the active ingredient was no longer manufactured — not for reasons of safety or efficacy. No FDA-approved sermorelin product is currently marketed in the United States; sermorelin in clinical use today is supplied by compounding pharmacies. It is not an FDA-approved therapy for anti-aging, body composition, or adult wellness indications.
Sermorelin at a glance
The evidence base consists of controlled clinical studies in pediatric growth hormone deficiency that supported the former Geref FDA approval, showing increased growth velocity. In that pediatric registration program, the most common treatment-related adverse effect was a self-limited, transient injection-site reaction (pain, redness, and/or swelling) in roughly 16% of patients. These data are summarized in a published review (Prakash & Goa, PMC2699646). The provided sources document no controlled efficacy data for anti-aging, body composition, or adult wellness uses, for which sermorelin currently has no marketed FDA-approved product and is used via compounding.
See how we grade evidence for the methodology behind this page.
Evidence profile
59 studies- Human trial 2 · 3%
- Review 16 · 27%
- Animal 4 · 7%
- In-vitro 8 · 14%
- Unknown 29 · 49%
The longer the green, the stronger the human evidence. For most research peptides the bar is dominated by animal and in-vitro work, which is a signal to read every claim carefully.
Regulatory status
Clinical trials
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Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances
- NCT00004332 COMPLETED
Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly
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TH9507 in Patients With HIV-Associated Lipodystrophy
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SMART: Somatotrophics, Memory, and Aging Research Trial
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Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing
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TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
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Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese
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Adult Growth Hormone Deficiency and Cardiovascular Risk
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The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure
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Effects of Short-term Growth Hormone in HIV-infected Patients
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Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
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Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
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Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
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Effects of Growth Hormone Releasing Hormone in HIV
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VRS-317 in Adult Subjects With Growth Hormone Deficiency
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Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
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Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue
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Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
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Tesamorelin Effects on Liver Fat and Histology in HIV
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Estradiol-Receptor Blockade in Older Men and Women
- NCT02507245 COMPLETED
Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD)
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The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
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Dehydroepiandrosterone Versus Growth Hormone in Women Undergoing ICSI With Expected Poor Ovarian Response
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Diagnosing Adult Growth Hormone Deficiency
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Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers
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Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
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Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
Indexed research
Sorted by evidence level, strongest first.
- Human trial 2017Growth Hormone Secretagogue Treatment in Hypogonadal Men Raises Serum Insulin-Like Growth Factor-1 Levels
This retrospective study found that treatment with growth hormone secretagogues (GHRP-2, GHRP-6, and sermorelin) significantly increased serum IGF-1 levels in hypogonadal men on testosterone therapy.
- Human trial 2025Development of smart samplers and their comparison to dried serum spots for the analysis of growth hormone releasing hormone analogs using LC HRMS/MS
This study compares dried serum spots and smart samplers for detecting GHRH analogs in human serum using LC HRMS/MS, demonstrating improved reproducibility and sensitivity with smart samplers.
- Review 2026A new era of doping? Use of peptide and peptide-analog drugs in recreational and professional sport and bodybuilding: a critical review
- Review 2026Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
- Review 2026Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions
- Review 2020Beyond the androgen receptor: the role of growth hormone secretagogues in the modern management of body composition in hypogonadal males
- Review 2009Clinical review: Is lack of recombinant growth hormone (GH)-releasing hormone in the United States a setback or time to consider glucagon testing for adult GH deficiency?
- Review 2026Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
This narrative review examines the pharmacological mechanisms, safety, and regulatory status of approved and unapproved peptide therapies for musculoskeletal injuries and athletic performance, highlighting the scarcity of human safety data for unapproved compounds.
- Review 2025Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
This review discusses the pharmacological mechanisms, safety, and regulatory status of approved and unapproved peptide therapies used for musculoskeletal injuries and athletic performance, highlighting the lack of rigorous human safety data for unapproved compounds.
- Review 2026The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration
This narrative review examines the clinical evidence and safety concerns of performance-enhancing peptides that modulate the GH-IGF1 axis, comparing regulatory-grade data with common self-administration practices.
+ 49 more studies indexed for Sermorelin.
Frequently asked questions
- Is Sermorelin approved for human use?
- Sermorelin is a synthetic 29-amino-acid GHRH analogue (GRF 1-29 amide) that stimulates the anterior pituitary to release growth hormone. It was formerly FDA-approved (Geref, NDA 020443) for short stature due to pediatric growth hormone deficiency, with a separate Geref Diagnostic formulation approved as a diagnostic agent for adult GHD. Both products were withdrawn from the U.S. market in 2008 as a business decision after the active ingredient was no longer manufactured — not for reasons of safety or efficacy. No FDA-approved sermorelin product is currently marketed in the United States; sermorelin in clinical use today is supplied by compounding pharmacies. It is not an FDA-approved therapy for anti-aging, body composition, or adult wellness indications.
- What does the research on Sermorelin show?
- The evidence base consists of controlled clinical studies in pediatric growth hormone deficiency that supported the former Geref FDA approval, showing increased growth velocity. In that pediatric registration program, the most common treatment-related adverse effect was a self-limited, transient injection-site reaction (pain, redness, and/or swelling) in roughly 16% of patients. These data are summarized in a published review (Prakash & Goa, PMC2699646). The provided sources document no controlled efficacy data for anti-aging, body composition, or adult wellness uses, for which sermorelin currently has no marketed FDA-approved product and is used via compounding.