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
Research Report
A Comprehensive Scientific Monograph on Somatotropin (DB00052)
Expert Persona: PhD Researcher, Author of Technical Papers
Executive Summary
Somatotropin, or recombinant human growth hormone (rhGH), represents a cornerstone of modern endocrine therapy and a landmark achievement in biotechnology. This monograph provides a comprehensive scientific review of Somatotropin, identified by DrugBank ID DB00052 and CAS Number 12629-01-5. Its history is a compelling narrative of medical progress, evolving from a scarce, high-risk biological extract derived from human cadavers to a safe, pure, and abundantly available therapeutic protein produced via recombinant DNA technology. This transition was critically accelerated by the public health crisis of iatrogenic Creutzfeldt-Jakob disease in the 1980s, which necessitated a safer manufacturing alternative.
The primary physiological role of Somatotropin is the regulation of somatic growth and metabolism. Its mechanism of action is mediated through the Growth Hormone Receptor (GHR), activating the intracellular JAK-STAT signaling pathway. This leads to a cascade of cellular events, most notably the hepatic production of Insulin-like Growth Factor-1 (IGF-1), which mediates the majority of GH's anabolic and growth-promoting effects. Somatotropin exerts pleiotropic effects on metabolism, functioning as a potent nutrient-partitioning agent: it stimulates protein synthesis and lipolysis while inducing a state of relative insulin resistance to conserve glucose.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/25 | Phase 1 | Not yet recruiting | Dr. David Wasserstein | ||
2025/04/15 | Phase 3 | Recruiting | |||
2025/01/31 | Early Phase 1 | Recruiting | |||
2024/10/31 | Phase 2 | Recruiting | |||
2024/06/07 | Phase 4 | Recruiting | Shanghai Zhongshan Hospital | ||
2025/06/24 | Phase 2 | Not yet recruiting | |||
2024/04/09 | Phase 2 | Suspended | |||
2023/11/13 | Phase 1 | Withdrawn | |||
2023/10/26 | Phase 3 | Recruiting | |||
2023/06/12 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novo Nordisk | 0169-7704 | SUBCUTANEOUS | 5 mg in 1.5 mL | 3/9/2020 | |
| Genentech, Inc. | 50242-074 | SUBCUTANEOUS | 10 mg in 2 mL | 12/22/2016 | |
| Novo Nordisk | 0169-7703 | SUBCUTANEOUS | 30 mg in 3 mL | 3/9/2020 | |
| Sandoz Inc | 0781-3001 | SUBCUTANEOUS | 5 mg in 1.5 mL | 6/18/2019 | |
| Novo Nordisk | 0169-7705 | SUBCUTANEOUS | 10 mg in 1.5 mL | 3/9/2020 | |
| Sandoz Inc | 0781-3004 | SUBCUTANEOUS | 10 mg in 1.5 mL | 6/18/2019 | |
| Genentech, Inc. | 50242-075 | SUBCUTANEOUS | 5 mg in 2 mL | 12/22/2016 | |
| Novo Nordisk | 0169-7708 | SUBCUTANEOUS | 15 mg in 1.5 mL | 3/9/2020 | |
| Physicians Total Care, Inc. | 54868-6146 | SUBCUTANEOUS | 5 mg in 1.5 mL | 8/11/2010 | |
| Genentech, Inc. | 50242-076 | SUBCUTANEOUS | 20 mg in 2 mL | 12/22/2016 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/12/2006 | ||
Authorised | 2/15/2001 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SciTropin A Solution for Injection 5 mg/1.5 ml | SIN13607P | INJECTION, SOLUTION | 5mg/1.5mL | 3/6/2009 | |
| NORDITROPIN NORDIFLEX INJECTION 5 mg/1.5 ml | SIN12219P | INJECTION | 5 mg/1.5 ml | 3/5/2003 | |
| ZOMACTON Powder and Solvent for Solution for Injection 4 mg | SIN14362P | INJECTION, POWDER, FOR SOLUTION | 4 mg | 6/10/2013 | |
| Saizen solution for injection 5.83mg/ml (6mg in 1.03ml) | SIN14432P | INJECTION, SOLUTION | 6 mg/1.03 ml | 11/6/2013 | |
| GENOTROPIN FOR INJECTION 16 iu (5.3 mg) /ml | SIN05273P | INJECTION, POWDER, FOR SOLUTION | 5.3 mg/ml | 12/24/1990 | |
| NORDITROPIN NORDIFLEX INJECTION 10 mg/1.5 ml | SIN12215P | INJECTION | 10 mg/1.5 ml | 3/5/2003 | |
| Saizen solution for injection 8.00mg/ml (12mg in 1.50ml) | SIN14425P | INJECTION, SOLUTION | 12 mg/1.50 ml | 11/6/2013 | |
| Saizen solution for injection 8.00mg/ml (20mg in 2.50ml) | SIN14433P | INJECTION, SOLUTION | 20 mg/2.5 ml | 11/6/2013 | |
| SciTropin A Solution for Injection 10 mg/1.5 ml | SIN13608P | INJECTION, SOLUTION | 10 mg/1.5mL | 3/6/2009 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SAIZEN LIQUID SOLUTION FOR INJECTION 20MG/2.5ML | N/A | N/A | N/A | 12/21/2012 | |
| SCITROPIN A SOLUTION FOR INJ 5MG/1.5ML (15IU) | N/A | N/A | N/A | 9/28/2009 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| GENOTROPIN | 02401819 | Powder For Solution - Subcutaneous | 1.6 MG / SYR | 9/18/2013 | |
| GENOTROPIN | 02401789 | Powder For Solution - Subcutaneous | 1 MG / SYR | 9/18/2013 | |
| OMNITROPE | 02325071 | Solution - Subcutaneous | 10 MG / 1.5 ML | 4/20/2009 | |
| OMNITROPE | 02325055 | Kit
,
Powder For Solution - Subcutaneous | 5.8 MG / VIAL | N/A | |
| NORDITROPIN NORDIFLEX | Novo Nordisk Canada Inc | 02334860 | Solution - Subcutaneous | 10 MG / 1.5 ML | 8/15/2014 |
| GENOTROPIN | 02401835 | Powder For Solution - Subcutaneous | 2 MG / SYR | 9/18/2013 | |
| HUMATROPE | eli lilly canada inc | 02243078 | Liquid
,
Powder For Solution - Intramuscular
,
Subcutaneous | 12 MG | 8/28/2001 |
| SAIZEN | emd serono, a division of emd inc., canada | 02350130 | Solution - Subcutaneous | 8 MG / ML | 12/2/2010 |
| GENOTROPIN | 02401797 | Powder For Solution - Subcutaneous | 1.2 MG / SYR | 9/18/2013 | |
| OMNITROPE | 02459647 | Solution - Subcutaneous | 15 MG / 1.5 ML | 8/14/2017 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| GENOTONORM MINIQUICK 0,4 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | Pfizer S.L. | 61814 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
| HUMATROPE 6 mg POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | 60421 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| GENOTONORM MINIQUICK 1,6 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | Pfizer S.L. | 61820 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
| SAIZEN 8 MG/ML SOLUCION INYECTABLE EN CARTUCHOS | Merck S.L. | 73843 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
| GENOTONORM MINIQUICK 1,8 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | Pfizer S.L. | 61821 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
| NORDITROPIN NORDIFLEX 10 MG/1,5 ML SOLUCION INYECTABLE EN PLUMA PRECARGADA | 85644 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Uso Hospitalario | Commercialized | |
| NUTROPINAQ 10 mg/2 ml (30 UI), SOLUCION INYECTABLE | 00164003 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| GENOTONORM MINIQUICK 0,2 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | Pfizer S.L. | 61813 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
| NUTROPINAQ 10 mg/2 ml (30 UI), SOLUCION INYECTABLE | 00164004 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| OMNITROPE 5 MG/1,5 ML SOLUCION INYECTABLE EN CARTUCHO | 06332005 | SOLUCIÓN INYECTABLE EN CARTUCHO | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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