Overview
Human growth hormone (HGH), also known as somatotropin, is a peptide hormone that is synthesized and secreted by the somatotropic cells of the anterior pituitary gland. Growth hormone plays an essential role in growth regulation during childhood as well as other basal metabolic functions, muscle and fat mass regulation, blood glucose level regulation, and lipid regulation in both children and adults. Synthesized in a strain of Escherichia coli, recombinant HGH is a polypeptide hormone that contains 191 amino acid residues with a molecular weight of 22 kDa. It has an identical primary protein structure to endogenous human growth hormone. Recombinant HGH has been commercially available since 1985 after its development by Genentech. Somatrem was the first available recombinant HGH and was largely replaced by somatropin, another form of recombinant HGH. Growth hormone therapy is approved for various disorders of growth hormone deficiency, growth failure, or short stature including Turner syndrome, chronic renal insufficiency before transplantation, Prader-Willi syndrome, a history of fetal growth restriction, short stature homeobox (SHOX) haploinsufficiency, Noonan syndrome, idiopathic short stature, and adult- or childhood-onset growth hormone deficiency. Recombinant growth hormone is available as a subcutaneous injection for children and adults under a wide variety of brand names.
Indication
Somatotropin is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone, short stature associated with Turner syndrome, Prader-Willi syndrome (PWS), idiopathic short stature (ISS), short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA). It is indicated for the treatment of growth failure in children associated with chronic kidney disease up to the time of renal transplantation. It is also indicated for adults with adult-onset growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma. It is also used to treat childhood-onset growth hormone deficiency in adults due to congenital, genetic, acquired, or idiopathic causes. Somatotropin is indicated for the treatment of wasting or cachexia in patients with human immunodeficiency virus (HIV) who are receiving antiretroviral therapy to increase lean body mass and body weight and improve physical endurance. Somatotropin is indicated for the treatment of short bowel syndrome in adult patients receiving specialized nutritional support.
Associated Conditions
- Adult Onset Growth Hormone Deficiency
- Cachexia
- Childhood-onset Growth Hormone Deficiency
- Growth Failure
- HIV Wasting Syndrome
- Short Bowel Syndrome (SBS)
- Short Stature
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2007/05/22 | Not Applicable | Completed | |||
2007/05/14 | Phase 1 | UNKNOWN | University of Rostock | ||
2007/05/07 | Phase 1 | Completed | |||
2007/04/10 | Phase 4 | Completed | |||
2007/03/29 | Phase 4 | Completed | |||
2007/03/27 | Phase 3 | Completed | |||
2007/03/08 | Phase 3 | Completed | Children's Mercy Hospital Kansas City | ||
2007/03/05 | N/A | Completed | |||
2007/01/11 | Not Applicable | Completed | Britta E. Hjerrild | ||
2006/12/04 | Phase 3 | Completed |
FDA Drug Approvals
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