Lonapegsomatropin (Skytrofa)
Overview
Lonapegsomatropin is a long-acting prodrug of somatropin created through site-specific PEGylation that releases active growth hormone after administration. The PEG moiety extends circulating half-life and enables once-weekly dosing for pediatric growth hormone deficiency. This represents a transient modification strategy in which the PEG is cleaved to yield native growth hormone.
Key Research Findings
The Phase 3 enliGHten trial published in Lancet Child & Adolescent Health in 2021 demonstrated non-inferiority to daily somatropin in improving annualized height velocity in children with growth hormone deficiency. FDA approval was granted in August 2021 for pediatric patients aged one year and older. Safety and efficacy profiles were comparable to conventional daily somatropin formulations.
Subcutaneous injection
FDA Approved
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