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 Response in Girls With Turner Syndrome

Phase 4
Completed
Conditions
Interventions
First Posted Date
2012-11-27
Last Posted Date
2017-02-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
31
Registration Number
NCT01734486
Locations
🇫🇷

Novo Nordisk Investigational Site, Vandoeuvre Les Nancy, France

Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

First Posted Date
2012-11-27
Last Posted Date
2017-02-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
57
Registration Number
NCT01734447
Locations
🇫🇷

Novo Nordisk Investigational Site, Paris, France

Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®

Withdrawn
Conditions
Interventions
First Posted Date
2012-11-21
Last Posted Date
2013-02-01
Lead Sponsor
Ferring Pharmaceuticals
Registration Number
NCT01731028

Study of Growth Hormone and Bone in Obesity

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2012-11-09
Last Posted Date
2019-12-17
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
77
Registration Number
NCT01724489
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency

First Posted Date
2012-10-03
Last Posted Date
2017-02-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
7
Registration Number
NCT01698944
Locations
🇬🇷

Novo Nordisk Investigational Site, Athens, Greece

Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

First Posted Date
2012-10-02
Last Posted Date
2017-01-18
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
75
Registration Number
NCT01697644
Locations
🇳🇱

Novo Nordisk Investigational Site, Rotterdam, Netherlands

Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease

First Posted Date
2012-07-23
Last Posted Date
2015-04-13
Lead Sponsor
Columbia University
Registration Number
NCT01647412
Locations
🇺🇸

Columbia University Department of Clinical Genetics, New York, New York, United States

Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

First Posted Date
2012-05-07
Last Posted Date
2020-01-23
Lead Sponsor
OPKO Health, Inc.
Target Recruit Count
56
Registration Number
NCT01592500
Locations
🇸🇰

Children's University Hospital, Kosice, Slovakia

🇬🇷

Children's Hospital "P. A. Kyriakou", Athens, Greece

🇭🇺

Buda Children's Hospital, Budapest, Hungary

and more 1 locations

French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin

First Posted Date
2012-04-19
Last Posted Date
2019-11-12
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
331
Registration Number
NCT01580605
Locations
🇫🇷

Novo Nordisk Investigational Site, Lyon, France

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