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
-

French National Registry of Children Born Small for Gestational Age Treated With Somatropin

First Posted Date
2012-04-16
Last Posted Date
2022-10-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
291
Registration Number
NCT01578135
Locations
🇫🇷

Novo Nordisk Investigational Site, Paris La Défense, France

Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure

First Posted Date
2012-04-13
Last Posted Date
2012-10-18
Lead Sponsor
Federico II University
Target Recruit Count
28
Registration Number
NCT01576861
Locations
🇮🇹

Department of Internal Medicine, Cardiovascular and Immunological Sciences, Napoli, Campania, Italy

Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism

First Posted Date
2012-04-06
Last Posted Date
2015-11-17
Lead Sponsor
Assistance Publique Hopitaux De Marseille
Target Recruit Count
40
Registration Number
NCT01572259
Locations
🇫🇷

Assistance Publique Hopitaux de Marseille, Marseille, France

Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

First Posted Date
2012-03-27
Last Posted Date
2017-02-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
168
Registration Number
NCT01563926
Locations
🇮🇱

Novo Nordisk Investigational Site, Tel - Aviv, Israel

Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients

First Posted Date
2012-03-26
Last Posted Date
2024-02-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
22
Registration Number
NCT01562834
Locations
🇫🇷

Novo Nordisk Investigational Site, Vandoeuvre Les Nancy, France

Safety and Efficacy of Long-term Somatropin Treatment in Adults

First Posted Date
2012-03-05
Last Posted Date
2015-04-29
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
752
Registration Number
NCT01543880

Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658

Phase 3
Completed
Conditions
Interventions
First Posted Date
2012-02-09
Last Posted Date
2023-08-09
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
22
Registration Number
NCT01529944

Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome

Phase 3
Completed
Conditions
Interventions
First Posted Date
2012-02-09
Last Posted Date
2017-01-18
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
24
Registration Number
NCT01529840
Locations
🇸🇪

Novo Nordisk Investigational Site, Göteborg, Sweden

Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome

First Posted Date
2012-01-25
Last Posted Date
2017-01-18
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
65
Registration Number
NCT01518062
Locations
🇳🇱

Novo Nordisk Investigational Site, Alphen a/d Rijn, Netherlands

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