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
-

The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature

Not Applicable
Withdrawn
Conditions
Interventions
First Posted Date
2013-10-28
Last Posted Date
2018-08-17
Lead Sponsor
Maimonides Medical Center
Registration Number
NCT01970800
Locations
🇺🇸

Maimonides Medical Center, Brooklyn, New York, United States

Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

First Posted Date
2013-09-23
Last Posted Date
2017-01-19
Lead Sponsor
Ascendis Pharma A/S
Target Recruit Count
53
Registration Number
NCT01947907
Locations
🇺🇦

Kharkiv National Medical University, Kharkiv, Ukraine

🇺🇦

Institute of Endocrinology and Metabolism, Kiev, Ukraine

🇺🇦

Donetsk Regional Children Clinical Hospital, Donetsk, Ukraine

and more 33 locations

Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-08-23
Last Posted Date
2020-08-10
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
51
Registration Number
NCT01927861
Locations
🇯🇵

Novo Nordisk Investigational Site, Zentsuji, Kagawa, Japan

Assessment Of Gh-Igf-1 Axis In Children With Chronic Myelogenous Leukemia (CML) In Remission

First Posted Date
2013-07-17
Last Posted Date
2013-07-17
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Target Recruit Count
20
Registration Number
NCT01901666
Locations
🇮🇳

Postgraduate Institute of Medical Education and Research, Chandigarh, UT, India

Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"

Completed
Conditions
Interventions
First Posted Date
2013-07-12
Last Posted Date
2023-09-25
Lead Sponsor
Pfizer
Target Recruit Count
482
Registration Number
NCT01897766

Retrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age

First Posted Date
2013-07-12
Last Posted Date
2014-01-20
Lead Sponsor
Pfizer
Target Recruit Count
264
Registration Number
NCT01897753
Locations
🇪🇸

Hospital Virgen de la Arrixaca, El Palmar, Murcia, Spain

🇪🇸

H.Marqués de Valdecilla, Santander, Cantabria, Spain

🇪🇸

H. Germans Trias i Pujol, Badalona, Barcelona, Spain

and more 9 locations

Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old

Phase 4
Completed
Conditions
Interventions
First Posted Date
2013-05-15
Last Posted Date
2014-09-03
Lead Sponsor
Universidade Federal do Rio de Janeiro
Target Recruit Count
13
Registration Number
NCT01853566
Locations
🇧🇷

Hospital Universitário Clementino Fraga Filho - UFRJ, Rio de Janeiro, Brazil

Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency

First Posted Date
2013-03-14
Last Posted Date
2021-12-10
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
52
Registration Number
NCT01811576
Locations
🇬🇷

Teva Investigational Site 63044, Athens, Greece

🇸🇰

Teva Investigational Site 62022, Bratislava, Slovakia

🇸🇮

Teva Investigational Site 64016, Ljubljana, Slovenia

and more 20 locations

Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-01-29
Last Posted Date
2017-06-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
54
Registration Number
NCT01778023
Locations
🇰🇷

Novo Nordisk Investigational Site, Suwon, Korea, Republic of

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