PeptideTrace
ApprovedRecombinant Human Growth Hormone

Somatropin

Genotropin, Humatrope, Norditropin, Nutropin AQ, Saizen, Omnitrope, Zomacton

A

Evidence Grade A — Regulatory approved. 397 published studies. 671 registered clinical trials.

671 trials397 studiesUSEUCA

Licensed Indications

  • Growth Hormone Deficiency
  • Prader-Willi Syndrome
  • Turner Syndrome
  • Chronic Kidney Disease (Pediatric Growth)
  • HIV-Associated Wasting
  • Idiopathic Short Stature
  • Noonan Syndrome
  • SHOX Deficiency
  • Small for Gestational Age

User Experience Reports

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Overview

Somatropin is laboratory-made human growth hormone, identical to what the pituitary gland naturally produces. It is the standard treatment for growth hormone deficiency in children and adults, and is also approved for several other growth-related conditions. Available from multiple manufacturers under many brand names (Genotropin, Humatrope, Norditropin, Omnitrope, and others), it requires daily injections — a burden that newer weekly alternatives are now beginning to address.

Research Activity

397studies
Human 280
Animal 16
In-vitro 12
Reviews 71

397 published studies: 280 human, 16 animal, 12 in-vitro, 71 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
EMA-authorised(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUPrescription medicine (EU centralised authorisation)
CAPrescription drug

Summary

Somatropin has been available since the mid-1980s and is one of the most established peptide therapies. It is sold under numerous brand names including Genotropin, Humatrope, Norditropin, and Omnitrope (the first biosimilar approved in the US, 2006). Approved indications include childhood and adult growth hormone deficiency, Turner syndrome, children born small for gestational age, Prader-Willi syndrome, idiopathic short stature, and short stature from chronic kidney disease.

Daily injection has been the main burden of somatropin therapy, particularly for paediatric patients who may require years of treatment. This has driven the development of once-weekly alternatives (somatrogon and somapacitan), which are gradually changing the treatment landscape. Annual treatment costs remain substantial, and concerns about misuse in anti-ageing and performance enhancement contexts are ongoing.

Mechanism of Action

Growth hormone is one of the body's master hormones, orchestrating growth, metabolism, and body composition throughout life. When the pituitary gland does not produce enough, somatropin replaces it directly. Once injected, it triggers the liver to produce IGF-1 (insulin-like growth factor 1), which is the main driver of growth in children. In adults, growth hormone maintains bone density, muscle mass, and healthy body fat distribution, and supports cardiovascular and metabolic function.

Research Summary

Somatropin has decades of clinical data and is one of the oldest biotechnology products still in widespread use. The biosimilar landscape has expanded significantly since Omnitrope became the first US biosimilar in 2006, improving access and reducing costs. The main practical challenge is the daily injection requirement, particularly for children who may need years of treatment. This has driven the development of once-weekly alternatives (somapacitan and somatrogon), which are gradually changing the treatment landscape. Safety considerations include a theoretical cancer risk related to IGF-1 elevation (large studies are inconclusive), pressure in the brain (intracranial hypertension), and hip joint problems in growing children. Misuse of growth hormone for anti-ageing and athletic performance purposes remains a public health concern.

Clinical Trials

NCT00050921N/ACompleted

Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs

National Institute of Allergy and Infectious Diseases (NIAID)Completion: 2005-03-01
NCT00006143N/ACompleted

Growth Hormone Treatment of Children With HIV-Associated Growth Failure

National Institute of Allergy and Infectious Diseases (NIAID)Completion: 2002-07-01
NCT00003514Phase IIWithdrawn

Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy

Burzynski Research Institute
NCT00005112Phase IIICompleted

Growth Hormone Use in Cystic Fibrosis - a Multicenter Study

National Center for Research Resources (NCRR)
NCT00194961Phase IVTerminated

Effect of Growth Hormone on Leptin, Cytokines and Body Composition of Children With Growth Failure Due to Chronic Kidney Disease

Weill Medical College of Cornell UniversityEndpoint: The primary objective will be to evaluate biochemical/metabolic, and immunologic parameters in relation to body composition.Completion: 2007-12-01
View all 671 trials on ClinicalTrials.gov →

Regulatory Timeline

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Related Compounds

Tesamorelin

Approved
GHRH Analogue

Tesamorelin is marketed as Egrifta SV (approved November 2010) for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. In clinical trials, it reduced visceral fat by approximately 15% compared to a 5% increase with placebo, and this reduction was sustained with continued treatment. Tesamorelin occupies a unique niche — it is the only approved GHRH analogue and the only medication specifically approved for HIV-associated lipodystrophy. Beyond its approved indication, it has attracted research interest for potential effects on liver fat, cognitive function, and peripheral neuropathy. Fat reduction reverses when treatment stops, and it is not approved for general weight loss or body composition purposes.

Somatrogon

Approved
Long-Acting Growth Hormone

Somatrogon is marketed as Ngenla (approved June 2023) for paediatric growth hormone deficiency in children aged 3 years and older. In the pivotal trial, once-weekly somatrogon produced growth rates equivalent to daily somatropin injections (10.1 cm/year versus 9.8 cm/year), confirming that reducing injection frequency does not compromise growth outcomes. Ngenla represents a meaningful advance for paediatric patients and their families, reducing injections from 365 to 52 per year. Treatment adherence has been a persistent challenge with daily growth hormone, and weekly dosing is expected to improve long-term outcomes through better compliance. Somatrogon competes directly with somapacitan (Sogroya), the other approved weekly growth hormone, creating a new generation of less burdensome treatment options.

Sermorelin

Research Compound
GHRH Analogue

Sermorelin was formerly marketed as Geref (Serono) before voluntary withdrawal in 2009. The FDA confirmed the withdrawal was not related to safety or effectiveness. Research suggests it remains one of the most commonly prescribed compounds through US compounding pharmacies, particularly in anti-ageing and hormone optimisation clinics. Research suggests sermorelin's appeal lies in its more physiological approach to growth hormone enhancement compared to direct growth hormone injection — it preserves pulsatile release and feedback regulation. However, clinical evidence for its use in adults outside the original paediatric growth hormone deficiency indication is limited, and its very short half-life requiring daily injection is a practical limitation. Compounding pharmacy formulations are not subject to the same regulatory oversight as FDA-approved products.