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
-

Novel Interventions in HIV-1 Infection

First Posted Date
2010-05-26
Last Posted Date
2013-09-04
Lead Sponsor
Imperial College London
Target Recruit Count
12
Registration Number
NCT01130376
Locations
🇬🇧

St. Stephen's AIDS Trust, London, United Kingdom

Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing

First Posted Date
2010-04-27
Last Posted Date
2019-01-11
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
227
Registration Number
NCT01110928
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency

First Posted Date
2010-04-22
Last Posted Date
2015-01-08
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
387
Registration Number
NCT01109017

A Prospective Observational Study of Effect of Somatropin on Growth Hormone Deficient Adults

First Posted Date
2010-03-17
Last Posted Date
2014-04-21
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
10673
Registration Number
NCT01088399

A Pharmaco-epidemiological Study of Short Patients Born Small for Gestational Age (SGA), Treated With Saizen® (Recombinant Somatropin)

First Posted Date
2010-03-08
Last Posted Date
2016-02-12
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
150
Registration Number
NCT01082354
Locations
🇫🇷

Merck Serono Investigational Site, Vesoul, France

Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)

First Posted Date
2009-11-10
Last Posted Date
2010-06-08
Lead Sponsor
Ascendis Pharma A/S
Target Recruit Count
44
Registration Number
NCT01010425

An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)

First Posted Date
2009-11-09
Last Posted Date
2017-04-12
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
22960
Registration Number
NCT01009905
Locations
🇺🇸

Novo Nordisk Investigational Site, Plainsboro, New Jersey, United States

The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons

First Posted Date
2009-09-01
Last Posted Date
2009-09-01
Lead Sponsor
Herlev Hospital
Target Recruit Count
12
Registration Number
NCT00969644
Locations
🇩🇰

Department of Endocrinology J 106, Herlev Hospital, Herlev, Denmark

Observational Prospective Study on Patients Treated With Norditropin®

First Posted Date
2009-08-17
Last Posted Date
2017-10-12
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
21249
Registration Number
NCT00960128
Locations
🇬🇧

Novo Nordisk Investigational Site, Crawley, United Kingdom

Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

First Posted Date
2009-08-12
Last Posted Date
2018-06-29
Lead Sponsor
The University of Texas Medical Branch, Galveston
Target Recruit Count
15
Registration Number
NCT00957671
Locations
🇺🇸

The University of Texas Medical Branch at Galveston, Galveston, Texas, United States

🇺🇸

Transitional Learning Center, Galveston, Texas, United States

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