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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
-

Effect of Cytokines on Growth of Children With Chronic Kidney Failure

Phase 4
Suspended
Conditions
Chronic Renal Insufficiency
First Posted Date
2005-09-19
Last Posted Date
2017-11-21
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
50
Registration Number
NCT00194883
Locations
🇺🇸

Weill Medical College of Cornell University, New York, New York, United States

Somatropin Treatment to Final Height in Turner Syndrome

Phase 3
Completed
Conditions
Turner Syndrome
Interventions
First Posted Date
2005-09-19
Last Posted Date
2010-01-27
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
154
Registration Number
NCT00191113
Locations
🇨🇦

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sherbrooke, Quebec, Canada

Effect of Growth Hormone on Leptin, Cytokines and Body Composition of Children With Growth Failure Due to Chronic Kidney Disease

Phase 4
Terminated
Conditions
Chronic Kidney Disease
First Posted Date
2005-09-19
Last Posted Date
2008-03-25
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
15
Registration Number
NCT00194961
Locations
🇺🇸

Weill Medical College of Cornell University, New York, New York, United States

Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency

Phase 3
Completed
Conditions
Adult Growth Hormone Deficiency
First Posted Date
2005-09-19
Last Posted Date
2007-11-06
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
68
Registration Number
NCT00191360
Locations
🇯🇵

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Tokyo, Japan

Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

Phase 3
Completed
Conditions
Growth Hormone Disorder
Adult Growth Hormone Deficiency
First Posted Date
2005-09-16
Last Posted Date
2017-02-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
112
Registration Number
NCT00184743
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

Conditions
Growth Hormone Deficiency
First Posted Date
2005-09-16
Last Posted Date
2005-09-16
Lead Sponsor
University Hospital, Angers
Target Recruit Count
30
Registration Number
NCT00187993
Locations
🇫🇷

UH of Angers, Angers, France

🇫🇷

UH of Brest, Brest, France

🇫🇷

UH of Caen, Caen, France

and more 3 locations

Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)

Phase 3
Completed
Conditions
Foetal Growth Problem
Small for Gestational Age
Interventions
First Posted Date
2005-09-16
Last Posted Date
2017-07-07
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
98
Registration Number
NCT00184717
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years

Phase 3
Completed
Conditions
Foetal Growth Problem
Small for Gestational Age
First Posted Date
2005-09-16
Last Posted Date
2017-01-18
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
78
Registration Number
NCT00184691
Locations
🇪🇸

Novo Nordisk Investigational Site, Sevilla, Spain

Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency

Phase 3
Completed
Conditions
Growth Hormone Disorder
Adult Growth Hormone Deficiency
First Posted Date
2005-09-16
Last Posted Date
2017-01-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
161
Registration Number
NCT00184678
Locations
🇬🇧

Novo Nordisk Investigational Site, London, United Kingdom

Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency

Not Applicable
Completed
Conditions
Growth Hormone Deficiency
Acromegaly
Pituitary Disease
Interventions
First Posted Date
2005-09-16
Last Posted Date
2020-09-02
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
75
Registration Number
NCT00182091
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

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