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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
-

Efficacy on Height in SGA Children Treated With Growth Hormone

Phase 3
Completed
Conditions
Foetal Growth Problem
Small for Gestational Age
First Posted Date
2005-09-16
Last Posted Date
2017-01-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
151
Registration Number
NCT00184756
Locations
🇸🇪

Novo Nordisk Investigational Site, Örebro, Sweden

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

Phase 3
Completed
Conditions
Adult Growth Hormone Deficiency
Growth Hormone Disorder
First Posted Date
2005-09-16
Last Posted Date
2016-11-17
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
86
Registration Number
NCT00184730
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency (CRI) and Growth Retardation.

Phase 4
Completed
Conditions
Chronic Renal Insufficiency
Chronic Kidney Disease
First Posted Date
2005-09-16
Last Posted Date
2017-02-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
16
Registration Number
NCT00184769
Locations
🇪🇸

Novo Nordisk Investigational Site, Zaragoza, Spain

HORMA: Hormonal Regulators of Muscle and Metabolism in Aging

Phase 2
Completed
Conditions
Frailty
Muscle Weakness
Sarcopenia
First Posted Date
2005-09-16
Last Posted Date
2009-06-02
Lead Sponsor
National Institute on Aging (NIA)
Target Recruit Count
108
Registration Number
NCT00183040
Locations
🇺🇸

Tufts University, Boston, Massachusetts, United States

🇺🇸

Washington University School of Medicine, St. Louis, Missouri, United States

Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease

Phase 2
Completed
Conditions
End-Stage Renal Disease
Chronic Kidney Disease
First Posted Date
2005-09-16
Last Posted Date
2017-01-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
140
Registration Number
NCT00184652
Locations
🇬🇧

Novo Nordisk Investigational Site, Swansea, United Kingdom

Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy

Phase 3
Terminated
Conditions
Endocrine System Diseases
Interventions
First Posted Date
2005-09-15
Last Posted Date
2012-12-04
Lead Sponsor
Pfizer
Target Recruit Count
21
Registration Number
NCT00174291
Locations
🇫🇷

Pfizer Investigational Site, Paris, France

Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy

Phase 3
Terminated
Conditions
Endocrine System Diseases
Interventions
First Posted Date
2005-09-15
Last Posted Date
2012-12-04
Lead Sponsor
Pfizer
Target Recruit Count
30
Registration Number
NCT00174187
Locations
🇫🇷

Pfizer Investigational Site, Paris, France

Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome

Phase 3
Completed
Conditions
Short Bowel Syndrome
First Posted Date
2005-09-15
Last Posted Date
2008-10-31
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
14
Registration Number
NCT00169637
Locations
🇫🇷

Alain LACHAUX, Lyon, France

Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

Phase 3
Completed
Conditions
Growth Hormone Deficiency
Growth Retardation
First Posted Date
2005-09-15
Last Posted Date
2008-08-05
Lead Sponsor
Pfizer
Target Recruit Count
14
Registration Number
NCT00174278
Locations
🇫🇷

Pfizer Investigational Site, Paris, France

Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

Phase 2
Completed
Conditions
Infant, Very Low Birth Weight
Growth Hormone Therapy
Interventions
Drug: Somatropin
Other: Control Arm
First Posted Date
2005-09-15
Last Posted Date
2017-04-05
Lead Sponsor
Pfizer
Target Recruit Count
33
Registration Number
NCT00174460
Locations
🇩🇪

Pfizer Investigational Site, Tuebingen, Germany

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