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
-

Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients

Phase 3
Completed
Conditions
Interventions
First Posted Date
2007-12-10
Last Posted Date
2007-12-11
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
112
Registration Number
NCT00570011
Locations
🇺🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Indianapolis, Indiana, United States

Metabolic Studies- Interactions Between GH and Insulin in GHDA

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2007-12-06
Last Posted Date
2013-01-21
Lead Sponsor
University of Aarhus
Target Recruit Count
8
Registration Number
NCT00568568
Locations
🇩🇰

Department M (endocrinology and diabets), Aarhus, Denmark

Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

First Posted Date
2007-12-04
Last Posted Date
2017-02-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
176
Registration Number
NCT00567385
Locations
🇹🇷

Novo Nordisk Investigational Site, Altunizade-Istanbul, Turkey

Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age

First Posted Date
2007-11-14
Last Posted Date
2017-02-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
160
Registration Number
NCT00557336
Locations
🇪🇸

Novo Nordisk Investigational Site, Zaragoza, Spain

Pilot Study of Growth Hormon to Treat SMA Typ II and III

Phase 2
Completed
Conditions
Interventions
First Posted Date
2007-09-21
Last Posted Date
2013-12-18
Lead Sponsor
University Hospital Freiburg
Target Recruit Count
20
Registration Number
NCT00533221
Locations
🇩🇪

Charité, Department of Neurpaediatrics, Berlin, Germany

🇩🇪

von Haunersches Kinderspital, Munich, Bavaria, Germany

🇩🇪

University Children'S Hospital, Kiel, Schleswig-Holstein, Germany

Growth and Metabolic Response to GH and GnRHa Treatment Versus GH Alone in Boys Born SGA.

First Posted Date
2007-08-30
Last Posted Date
2010-07-14
Lead Sponsor
Rabin Medical Center
Target Recruit Count
17
Registration Number
NCT00522743
Locations
🇮🇱

Schnider children medical center, Petach-Tikva, Israel

Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction

First Posted Date
2007-08-23
Last Posted Date
2015-11-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
5
Registration Number
NCT00519844

Growth Hormone Deficiency in Adults (GHDA)

First Posted Date
2007-08-22
Last Posted Date
2017-02-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
121
Registration Number
NCT00519558
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Low Dose Growth Hormone in Obese PCOS Women

Not Applicable
Withdrawn
Conditions
Interventions
First Posted Date
2007-08-21
Last Posted Date
2013-02-20
Lead Sponsor
Oregon Health and Science University
Registration Number
NCT00518635
Locations
🇺🇸

Oregon Health and Science University, Portland, Oregon, United States

Growth Hormone Signaling in Vivo in Humans

First Posted Date
2007-08-07
Last Posted Date
2007-08-07
Lead Sponsor
University of Aarhus
Target Recruit Count
8
Registration Number
NCT00512473
Locations
🇩🇰

Medical Research Laboratories, Aarhus, Denmark

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