Hormones & metabolism Growth hormone
Somatropin (rhGH)
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- Also known as
- rhGH
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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Key takeaway
Somatropin is recombinant human growth hormone, a laboratory-made copy of the pituitary hormone, sold under several brands including Genotropin, Norditropin, and Omnitrope. It replaces missing growth hormone in children and adults and treats several conditions of short stature and wasting. It has been FDA-approved in the U.S. since the late 1980s and is given as a daily subcutaneous injection.
At a glance
- What it is
- Recombinant human growth hormone (an identical copy of the natural 191-amino-acid hormone)
- Approved for
- Growth hormone deficiency, Turner syndrome, Prader-Willi syndrome, and several other causes of short stature or wasting
- Key fact
- Recombinant growth hormone replaced cadaver-derived hormone after that older source was linked to a fatal brain disease
- Route
- Subcutaneous injection, usually daily
- Evidence strength
- FDA approved
Summary
Somatropin is lab-made human growth hormone, FDA-approved since the late 1980s. Learn its approved uses, how it works, and the safety considerations involved.
What is somatropin?
Somatropin is recombinant human growth hormone, made by inserting the human growth hormone gene into cells so they produce a protein identical to the body's own 191-amino-acid hormone. It is sold under brand names including Genotropin, Norditropin, Omnitrope, and Zomacton. Nutropin was discontinued in the U.S. at the end of 2024, and Humatrope is being withdrawn at the end of 2026. (Some newer long-acting products, such as lonapegsomatropin and somatrogon, are distinct engineered molecules rather than plain somatropin.)
The history of somatropin
Growth hormone therapy has a sobering history that shaped modern practice. Before recombinant technology, growth hormone could only be extracted from the pituitary glands of human cadavers, and supply was scarce. In 1985 that program was halted after cadaver-derived growth hormone was linked to cases of Creutzfeldt-Jakob disease, a fatal neurodegenerative illness transmitted through contaminated pituitary material. Recombinant human growth hormone, first approved shortly afterward, removed that risk by producing the hormone in the laboratory, and it has been the standard ever since.
How does somatropin work?
Somatropin binds growth hormone receptors on cells throughout the body and stimulates the liver and peripheral tissues to produce insulin-like growth factor 1 (IGF-1). IGF-1 and growth hormone together drive linear bone growth at the growth plates in children, promote protein building, encourage the breakdown of fat, and influence carbohydrate metabolism. Because it is identical to the natural hormone, it reproduces the full range of growth hormone's effects.
In children who do not make enough growth hormone, or who have conditions such as Turner or Prader-Willi syndrome, replacement increases growth velocity and adult height; in adults with deficiency, it improves body composition and metabolic measures. The hormone is cleared quickly, which is why standard somatropin is injected daily, and dosing is adjusted to growth response and IGF-1 levels.
Is it FDA-approved?
Editor’s note
Status: Yes. Recombinant human growth hormone products have been FDA-approved since the late 1980s, beginning with Humatrope in 1987, and many brands have followed. The approved indications vary by product but are extensive, covering pediatric and adult growth hormone deficiency and several specific syndromes.
Category: FDA-approved · Primary body area: Hormones & metabolism
Yes. Recombinant human growth hormone products have been FDA-approved since the late 1980s, beginning with Humatrope in 1987, and many brands have followed. The approved indications vary by product but are extensive, covering pediatric and adult growth hormone deficiency and several specific syndromes.
What is somatropin prescribed for?
Somatropin is prescribed for growth hormone deficiency in children and adults, and for short stature associated with:
- Turner syndrome
- Prader-Willi syndrome
- Chronic kidney disease
- Noonan syndrome
- SHOX deficiency
- Being born small for gestational age
- Idiopathic short stature
Some products are also approved for HIV-associated wasting.
What are the side effects?
Common side effects vary by product and include:
- Injection-site reactions
- Joint and muscle aches
- Swelling from fluid retention
- Headache
More serious considerations include:
- Reduced insulin sensitivity and higher blood sugar
- A specific caution against use in people who are acutely critically ill, where growth hormone increased mortality in studies
- In Prader-Willi syndrome with severe obesity or breathing problems, reports of sudden death, so breathing is assessed before and during treatment
- Increased pressure around the brain, slipped hip growth plate, and worsening scoliosis in children
- Growth of existing tumors, pancreatitis, and serious allergic reactions
Sources: FDA prescribing information for somatropin products (Genotropin, Norditropin, and others); manufacturer discontinuation notices for Nutropin and Humatrope; historical accounts of the shift from cadaver-derived to recombinant growth hormone. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
approved (PDF)
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