GH 191AA (Somatropin)

Ten publications are cited, from 2008 to 2025. Two are phase 3 trials in children with growth hormone deficiency, published in 2021 and 2022, in which somatropin was the comparator for the long-acting agents somatrogon and lonapegsomatropin. Three are reviews: a 2025 meta-analysis comparing long-acting pegylated growth hormone with conventional preparations in children, a 2008 meta-analysis in children born small for gestational age, and a 2025 bibliometric analysis of research on idiopathic short stature. Four are cohort or registry studies, covering the international KIGS database, Italian adults with growth hormone deficiency, girls with central precocious puberty and short-statured children profiled for metabolic factors. The tenth is a 2025 pharmacovigilance and Mendelian randomisation study.

The heiGHt trial measured annualised height velocity, and both phase 3 trials reported similar safety and tolerability in their somatropin and long-acting arms. KIGS, which its authors describe as the largest and longest-running international database of children given recombinant growth hormone, reported gains in short-term and adult height across growth hormone deficiency and other diagnoses. The 2008 meta-analysis reported a consistent dose-response relationship for catch-up growth in children born small for gestational age, and the 2025 metabolic study linked growth response to insulin resistance, hyperinsulinaemia, free T3 and HDL. The Italian study was descriptive, setting out diagnoses and prescribing in a large adult cohort. The pharmacovigilance study found a statistical association between recombinant growth hormone and brain neoplasm reports in US, Japanese and Canadian adverse-event databases, and its Mendelian randomisation analysis suggested the link may be causal.

The trials were designed to evaluate the long-acting agents, with somatropin as the benchmark, and enrolled children only. The registry, cohort and pharmacovigilance findings are observational, and the brain neoplasm signal rests on adverse-event reports and genetic inference rather than a controlled comparison. Only one citation is specific to adults, and it describes prescribing rather than outcomes.