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
-

Use of Somatropin in Turner Syndrome

Phase 3
Completed
Conditions
Interventions
First Posted Date
2012-01-25
Last Posted Date
2017-02-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
57
Registration Number
NCT01518036
Locations
🇬🇧

Novo Nordisk Investigational Site, Crawley, United Kingdom

Special Survey for Long Term Application

Completed
Conditions
Interventions
First Posted Date
2012-01-24
Last Posted Date
2017-02-27
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
395
Registration Number
NCT01516229
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers

Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2012-01-19
Last Posted Date
2013-09-16
Lead Sponsor
Novo Nordisk A/S
Registration Number
NCT01512095

Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis

First Posted Date
2011-12-30
Last Posted Date
2017-01-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
21
Registration Number
NCT01502137
Locations
🇩🇪

Novo Nordisk Investigational Site, München, Germany

Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

First Posted Date
2011-12-30
Last Posted Date
2017-02-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
78
Registration Number
NCT01502124
Locations
🇺🇸

Novo Nordisk Investigational Site, Seattle, Washington, United States

Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.

First Posted Date
2011-12-19
Last Posted Date
2012-09-25
Lead Sponsor
Azidus Brasil
Target Recruit Count
32
Registration Number
NCT01494779
Locations
🇧🇷

LAL Clínica Pesquisa e Desenvolvimento Ltda, Valinhos, São Paulo, Brazil

Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-09-26
Last Posted Date
2012-10-16
Lead Sponsor
HanAll BioPharma Co., Ltd.
Target Recruit Count
40
Registration Number
NCT01440686
Locations
🇰🇷

Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute, Seoul, Korea, Republic of

A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin

Completed
Conditions
Interventions
First Posted Date
2011-09-16
Last Posted Date
2017-05-05
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
81
Registration Number
NCT01435629
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers

First Posted Date
2011-07-25
Last Posted Date
2017-02-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
30
Registration Number
NCT01401244
Locations
🇺🇸

Novo Nordisk Investigational Site, Evansville, Indiana, United States

rHGH and Intestinal Permeability in Intestinal Failure

First Posted Date
2011-06-27
Last Posted Date
2016-02-08
Lead Sponsor
Northwestern University
Target Recruit Count
15
Registration Number
NCT01380366
Locations
🇺🇸

Northwestern Memorial Hospital, Chicago, Illinois, United States

© Copyright 2024. All Rights Reserved by MedPath