Growth hormone
Somatrem
An early recombinant growth-hormone product with pediatric growth studies and a withdrawn US product application; it is distinct from somatropin.
Historical pediatric studies; limited samples and changing trial groups constrain interpretation
Also known as: Protropin · methionyl human growth hormone
Practical use
Evidence interpretation and clinical context
- Check historical status
- Distinguish a formerly approved product from a currently available one.
- Read the unit of time
- Annualized height velocity is not height gained during a shorter follow-up.
- Track changing trial groups
- Later outcomes cannot be treated as a clean continuation of the original randomized comparison.
Protropin somatrem identity and immunogenicity-development report
Historical US approval and withdrawal — primary or official source
Overview
Somatrem was an early recombinant human growth hormone, historically sold as Protropin. It is the methionyl form of the hormone, distinct from somatropin. Historical growth studies should be read as evidence for the studied product and condition.
Risks and limitations
The small historical reports cannot define uncommon or long-term harms. In the Turner-syndrome trial, skeletal maturation advanced alongside growth, and an androgen-containing combination produced mild virilization. That combination is a study detail, not a treatment recommendation.
How to read this
Pediatric growth velocity measures the speed of linear growth. An annualized rate calculated from six months does not mean that much height was gained during those six months.
Research explained
Results from the first 2 years of a clinical trial with recombinant DNA-derived human growth hormone (somatrem) in Turner's syndrome.
Who was studied
70 girls with Turner syndrome entered a multicenter study with untreated, somatrem, oxandrolone and combination groups.
What was found
Active groups grew faster during the first year than their pretreatment rates and the control group. Growth and IGF-1 effects persisted in later follow-up.
What it cannot establish
Several groups changed treatment after the initial period, complicating later comparisons. Bone-age advancement and predicted height do not establish attained adult height.
Read the original studyAccelerated growth following treatment of children with chronic renal failure with recombinant human growth hormone (somatrem): a preliminary report.
Who was studied
Five young boys with chronic renal failure and growth retardation followed for six months.
What was found
Mean annualized height velocity rose from 4.94 to 10.08 cm/year.
What it cannot establish
This was a tiny uncontrolled preliminary report. The annualized number is not the measured height gained in six months, and long-term benefit was unresolved.
Read the original studyHistorical US approval and withdrawal
FDA’s withdrawn-biologics list records Protropin’s initial approval in 1985 and a 2006 withdrawal-of-approval notice. Its historical approval should not be represented as a current marketed US product.
Supporting sourceWhy the product name matters
The cited Turner trial explicitly studied somatrem. Later findings for other growth-hormone products need their own product and population context.
Supporting sourceClaims versus findings
Incorrect unit interpretation
The renal study showed children gained ten centimeters in six months.
The paper reported an annualized velocity of about ten centimeters per year after six months of observation.
Check the evidenceCommon questions
Did the Turner report establish a final-height benefit?
It reported growth velocity and evaluated predicted height. That differs from measuring final adult height.
SourceSources
Protropin somatrem identity and immunogenicity-development report
Historical US approval and withdrawal — primary or official source
Sources checked 2026-10-01.
General education; not a personal treatment plan.