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
-

Three Times Weekly (TIW) Growth Hormone Therapy in Children on Hemodialysis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2009-07-22
Last Posted Date
2015-05-05
Lead Sponsor
Nationwide Children's Hospital
Target Recruit Count
3
Registration Number
NCT00943995
Locations
🇺🇸

Children's Healthcare of Atlanta at Egleston, Atlanta, Georgia, United States

🇺🇸

Children's Memorial Hermann Hospital-TMC, Houston, Texas, United States

🇺🇸

Texas Children's Hospital, Houston, Texas, United States

and more 2 locations

A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

First Posted Date
2009-07-10
Last Posted Date
2017-02-08
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
31
Registration Number
NCT00936403
Locations
🇬🇧

Novo Nordisk Investigational Site, Cambridge, United Kingdom

A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin

First Posted Date
2009-07-02
Last Posted Date
2017-02-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
86
Registration Number
NCT00931476
Locations
🇺🇸

Novo Nordisk Investigational Site, Honolulu, Hawaii, United States

A Study of Zomacton in Children With Growth Hormone Deficiency

Phase 3
Completed
Conditions
Interventions
First Posted Date
2009-04-20
Last Posted Date
2012-07-17
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
165
Registration Number
NCT00884000
Locations
🇭🇺

University of Szeged, Szeged, Hungary

🇭🇺

Petz Country Teaching Hospital, Gyor, Hungary

🇮🇳

TOTALL Diabetes Hormone Institute, Indore, India

and more 40 locations

A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height

Phase 4
Active, not recruiting
Conditions
Interventions
First Posted Date
2009-02-11
Last Posted Date
2023-07-28
Lead Sponsor
Belgian Study Group for Pediatric Endocrinology
Target Recruit Count
44
Registration Number
NCT00840944
Locations
🇧🇪

CHU ND-des Bruyères, Liege, Belgium

🇧🇪

Antwerp University Hospital, Edegem, Antwerpen, Belgium

🇧🇪

Kinderziekenhuis UZ Brussel, Brussel, Belgium

and more 3 locations

Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency

Phase 2
Conditions
Interventions
First Posted Date
2009-02-05
Last Posted Date
2009-05-07
Lead Sponsor
Altus Pharmaceuticals
Target Recruit Count
36
Registration Number
NCT00837863
Locations
🇺🇸

Children's Hospital Medical Centre, Cincinnati, Ohio, United States

🇺🇸

UMass Memorial Medical Center, Worcester, Massachusetts, United States

🇺🇸

Schneider Children's Hospital, New Hyde Park, New York, United States

and more 8 locations

Effects of Short-term Growth Hormone in HIV-infected Patients

First Posted Date
2008-11-21
Last Posted Date
2014-01-08
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
25
Registration Number
NCT00795210
Locations
🇺🇸

MGH, Boston, Massachusetts, United States

Long Term Use of Somatropin in Patients Small for Gestational Age

Completed
Conditions
Interventions
First Posted Date
2008-11-19
Last Posted Date
2014-02-06
Lead Sponsor
Pfizer
Target Recruit Count
920
Registration Number
NCT00793325

Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects

First Posted Date
2008-11-10
Last Posted Date
2017-01-18
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
153
Registration Number
NCT00787878
Locations
🇳🇱

Novo Nordisk Investigational Site, Rotterdam, Netherlands

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