Somatotropin

Generic Name
Somatotropin
Brand Names
Genotropin, Humatrope, Norditropin, Norditropin Nordiflex, Nutropin, Nutropinaq, Omnitrope, Saizen, Serostim, Zomacton, Zorbtive, NutropinAq
Drug Type
Biotech
Chemical Formula
-
CAS Number
12629-01-5
Unique Ingredient Identifier
NQX9KB6PCL
Background

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
Associated Therapies
-

Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus

First Posted Date
2008-10-29
Last Posted Date
2008-10-29
Lead Sponsor
Göteborg University
Target Recruit Count
40
Registration Number
NCT00781547
Locations
🇸🇪

Centrum for Endocrinology and Metabolism, Sahlgenska University Hospital, Gothenburg, Sweden

Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.

First Posted Date
2008-10-03
Last Posted Date
2019-11-18
Lead Sponsor
University of Pennsylvania
Target Recruit Count
63
Registration Number
NCT00766038
Locations
🇺🇸

University of Texas Southwestern Medical Center, Dallas, Texas, United States

🇺🇸

Center for NeuroSkills, Bakersfield, California, United States

🇺🇸

Baylor University Medical Center, Dallas, Texas, United States

Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2008-08-27
Last Posted Date
2023-09-08
Lead Sponsor
University of Nebraska
Target Recruit Count
5
Registration Number
NCT00742157
Locations
🇺🇸

University of Nebraska Medical Center, Omaha, Nebraska, United States

Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi Syndrome

First Posted Date
2008-06-25
Last Posted Date
2023-11-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
41
Registration Number
NCT00705172

Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors

First Posted Date
2008-05-28
Last Posted Date
2024-07-17
Lead Sponsor
Columbia University
Target Recruit Count
5
Registration Number
NCT00684957
Locations
🇺🇸

Columbia University, College of Physicians and Surgeons, New York, New York, United States

Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2008-03-07
Last Posted Date
2013-03-04
Lead Sponsor
Pfizer
Target Recruit Count
9
Registration Number
NCT00630487
Locations
🇩🇪

Pfizer Investigational Site, Muenchen, Germany

Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

First Posted Date
2008-02-28
Last Posted Date
2012-02-29
Lead Sponsor
Pfizer
Target Recruit Count
23
Registration Number
NCT00625872
Locations
🇩🇪

Pfizer Investigational Site, Muenchen, Germany

Drug Use Investigation of Somatropin for GHD-ADULTS.

First Posted Date
2008-01-28
Last Posted Date
2014-02-06
Lead Sponsor
Pfizer
Target Recruit Count
230
Registration Number
NCT00601419

Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

First Posted Date
2008-01-11
Last Posted Date
2012-11-19
Lead Sponsor
Federico II University
Target Recruit Count
56
Registration Number
NCT00591760
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