HGH / Somatropin

Somatropin is recombinant human growth hormone, structurally identical to pituitary-derived GH. FDA-approved since 1987 for GH deficiency in children and adults, Turner syndrome, chronic kidney disease, Prader-Willi syndrome, and HIV-associated wasting. It is a 191-amino acid protein.

PubMed results: 45 · Human studies: 31 · Animal studies: 32

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

Dosing highly individualized based on indication and response

• Subcutaneous Injection — standard range 0.4-0.6 mg/day, Daily

2-3 hours (SC) (high confidence)

• Replacement therapy in growth hormone deficiency (Strong clinical): Recombinant somatropin is structurally identical to pituitary GH and has extensive clinical evidence supporting its use in pediatric and adult GH deficiency since FDA approval in 1987.
• Growth and body composition endpoints in approved indications (Strong clinical): Clinical programs have demonstrated benefits on linear growth and body composition in conditions including Turner syndrome, chronic kidney disease, Prader-Willi syndrome, and small-for-gestational-age cohorts under labeled indications.
• HIV-associated wasting research and labeled support (Strong clinical): Somatropin has been studied and labeled for HIV-associated wasting, with clinical data showing improvements in lean body mass in this population under medical supervision.

• Fluid retention and peripheral edema — Mild, Common. GH-related sodium and water retention commonly presents as mild edema, joint stiffness, or carpal tunnel–like symptoms, often dose-related in clinical practice.
• Hyperglycemia and insulin resistance — Moderate, Common. Growth hormone antagonizes insulin action; clinical use requires attention to glycemic control, particularly in adults and individuals with diabetes risk factors.
• Arthralgia and myalgia — Mild, Common. Joint and muscle discomfort are frequently reported adverse events with recombinant GH therapy and often improve with dose adjustment in clinical settings.

• Active malignancy (Established): GH and IGF-1 can stimulate cell proliferation; active cancer is a labeled contraindication for somatropin outside specific oncology research contexts.
• Acute critical illness after open-heart or abdominal surgery, multiple trauma, or acute respiratory failure (Established): Increased mortality was observed in critically ill non-GH-deficient adults receiving high-dose GH in clinical trials; labeling contraindicates use in these acute settings.

Lyophilized (powder): Refrigerated (2-8°C), Up to manufacturer-labeled shelf life (typically until expiration when refrigerated unopened). Light sensitive: yes, store dark

Reconstituted (solution): Refrigerated (2-8°C), Per product labeling (commonly up to 14–28 days for multi-dose vials after reconstitution). Solvent: Bacteriostatic water

• NCT02946606 — A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9 (PHASE2), status: COMPLETED. Indications: Adult Growth Hormone Deficiency
• NCT02349152 — Remifentanil and Glycemic Response in Cardiac Surgery (PHASE4), status: COMPLETED. Indications: Heart Diseases, Hyperglycemia
• NCT04277364 — Effects of Phosphatidic Acid on Strength and Hypertrophy (NA), status: UNKNOWN. Indications: Hypertrophy, Muscle Strength
• NCT05250063 — Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial (OraGrowtH213) (PHASE2), status: COMPLETED. Indications: Growth Hormone Deficiency
• NCT00537914 — Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA) (PHASE4), status: COMPLETED. Indications: Small for Gestational Age
• NCT01467193 — The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids., status: COMPLETED. Indications: Ectopic Lipids, Insulin Sensitivity, Aerobic Exercise, Fat Load, Growth Hormone Deficiency
• NCT02418975 — Pre-operative Very Low-calorie Protein-based Versus Hypocaloric Enteral Nutrition (NA), status: UNKNOWN. Indications: Perioperative/Postoperative Complications
• NCT00191165 — Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency (PHASE3), status: COMPLETED. Indications: Growth Hormone Deficiency
• NCT00600886 — Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly (PHASE3), status: COMPLETED. Indications: Acromegaly
• NCT00171730 — An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly (PHASE2), status: COMPLETED. Indications: Acromegaly
• NCT01934270 — Growth Hormone Secretion Following the Anaerobic Exercise (NA), status: UNKNOWN. Indications: Short Stature, Obesity, Childhood
• NCT00453245 — Molecular Basis of the Growth Axis in Short Stature, status: COMPLETED. Indications: Growth Hormone Deficiency
• NCT06970457 — The Interaction of Body Composition, Sex Hormones and Exercise in Men (NA), status: RECRUITING. Indications: Normal-weight Obesity
• NCT00082628 — Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients (PHASE3), status: COMPLETED. Indications: HIV Infections, Lipodystrophy
• NCT03281889 — Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation (NA), status: ACTIVE_NOT_RECRUITING. Indications: Brain Tumor
• NCT06297473 — Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors. (NA), status: ENROLLING_BY_INVITATION. Indications: Non-Functional Pituitary Adenoma
• NCT06803589 — Growth Hormone for the Treatment of Gastroparesis (EARLY_PHASE1), status: RECRUITING. Indications: Gastroparesis
• NCT00209235 — Albright Hereditary Osteodystrophy: Natural History, Growth, and Cognitive/Behavioral Assessments (NA), status: RECRUITING. Indications: Pseudohypoparathyroidism Type 1A, Albright Hereditary Osteodystrophy, Pseudopseudohypoparathyroidism
• NCT00102817 — Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children (PHASE3), status: COMPLETED. Indications: Growth Hormone Disorder, Pituitary Dwarfism
• NCT02814240 — Hepatic Steatosis and Pituitary Gland Failure, Evaluation by Nuclear Magnetic Resonance (NMR) Imaging (NA), status: COMPLETED. Indications: Hepatic Steatosis, Pituitary Gland Failure