Sermorelin

Sermorelin is a 29-amino acid synthetic analog of GHRH. It was FDA-approved for diagnostic evaluation of growth hormone deficiency in children, but discontinued in the US. It stimulates endogenous GH production with normal pulsatile pattern, unlike exogenous GH which causes continuous elevation.

PubMed results: 21 · Human studies: 14 · Animal studies: 14

Ranges reflect protocols studied in published research and animal-model extrapolation. Presented for research purposes only, not a recommendation or instruction for human use.

FDA-approved dosing (discontinued in US). Based on historical data.

• Subcutaneous Injection — standard range 0.5-1 mg, Once daily at bedtime

6-12 minutes (high confidence)

• Stimulation of endogenous pulsatile GH secretion (Strong clinical): As a 29-amino acid GHRH analog, sermorelin has been shown to stimulate pituitary growth hormone release with a more physiologic pulsatile pattern than continuous exogenous GH elevation.
• Diagnostic evaluation of GH axis function (Strong clinical): Sermorelin was FDA-approved for diagnostic evaluation of growth hormone deficiency in children, leveraging its ability to provoke GH release when pituitary secretory capacity is intact.
• Research interest in age-related GH decline and body composition (Limited): Investigational work has explored GHRH-analog stimulation in elderly, obesity, and metabolic research cohorts as a means of supporting endogenous GH axis activity without direct recombinant GH administration.

• Injection site reactions — Mild, Common. Subcutaneous research and clinical use has been associated with local erythema, swelling, or discomfort at the injection site.
• Flushing or transient warmth — Mild, Uncommon. Transient flushing has been reported with GHRH-analog administration, typically mild and self-limited in clinical descriptions.
• Headache — Mild, Uncommon. Headache has been reported among adverse events in GH-axis stimulation research, generally mild when present.

• Active malignancy (Established): GH and IGF-1 pathway stimulation raises concern about promoting neoplastic growth; active cancer is a standard exclusion for GHRH-based research and historical clinical use.
• Absent or severely disrupted pituitary GH secretory capacity (Established): Sermorelin requires intact pituitary somatotroph function to elicit GH release; hypophysectomy or complete pituitary failure precludes the intended pharmacologic response.

Lyophilized (powder): Refrigerated (2-8°C), Up to 24 months. Light sensitive: yes, store dark

Reconstituted (solution): Refrigerated (2-8°C), 4-6 weeks. Solvent: Bacteriostatic water

• NCT00850564 — Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men (NA), status: COMPLETED. Indications: Healthy Volunteers
• NCT00123253 — TH9507 in Patients With HIV-Associated Lipodystrophy (PHASE3), status: COMPLETED. Indications: HIV Infections, Lipodystrophy
• NCT02507245 — Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD), status: COMPLETED. Indications: Growth Hormone Deficiency
• NCT00000380 — Growth Hormone Releasing Hormone (GHRH) Treatment for Age-Related Sleep Disturbances (NA), status: COMPLETED. Indications: Sleep Disorders
• NCT03018886 — Diagnosing Adult Growth Hormone Deficiency (NA), status: COMPLETED. Indications: Growth Hormone Deficiency
• NCT02092779 — Growth Hormone Deficiency and Empty Sella Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study, status: COMPLETED. Indications: Obesity
• NCT00608023 — TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy (PHASE3), status: COMPLETED. Indications: Lipodystrophy, HIV Infections
• NCT01264497 — Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes (PHASE2), status: COMPLETED. Indications: Type 2 Diabetes
• NCT01359488 — VRS-317 in Adult Subjects With Growth Hormone Deficiency (PHASE1), status: COMPLETED. Indications: Growth Hormone Deficiency
• NCT00807365 — Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly (PHASE2), status: TERMINATED. Indications: Elderly
• NCT02196831 — Tesamorelin Effects on Liver Fat and Histology in HIV (NA), status: COMPLETED. Indications: Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
• NCT01897844 — A Two Part Phase 1, Repeated Doses and Continuous Infusion Study With ITF2984 in Healthy Volunteers (PHASE1), status: COMPLETED. Indications: Healthy
• NCT00006073 — Endocrine Studies in Health and Disease, status: TERMINATED. Indications: Endocrine Diseases
• NCT00448747 — Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test. (PHASE3), status: COMPLETED. Indications: Diagnosis of Adult Growth Hormone Deficiency (AGDH)
• NCT01632592 — Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue (NA), status: WITHDRAWN. Indications: Abdominal Obesity
• NCT03226821 — Body Composition and Adipose Tissue in HIV (PHASE4), status: COMPLETED. Indications: HIV Lipodystrophy Syndrome, Growth Hormone Deficiency, Body Composition
• NCT00004332 — Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly, status: COMPLETED. Indications: Acromegaly
• NCT00638287 — Inter-Assay Growth Hormone and IGF-I Variability, status: WITHDRAWN. Indications: Acromegaly, Growth Hormone Deficiency
• NCT06554717 — Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (PHASE2), status: RECRUITING. Indications: HIV-1-infection, Frailty, Impaired Physical Function, Abdominal Obesity, Aging
• NCT00507104 — Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH), status: COMPLETED. Indications: Traumatic Brain Injury, Subarachnoid Hemorrhage, Hypopituitarism