Hormone · FDA Approved
Lonapegsomatropin (Skytrofa)
FDA-approved
01 · Overview
Lonapegsomatropin is a long-acting prodrug of somatropin in which growth hormone is transiently linked to a polyethylene glycol carrier through a cleavable linker, releasing unmodified growth hormone after administration (PMID 34272849). The carrier extends circulating time and enables once-weekly dosing.
This transient conjugation strategy differs from permanent modifications because the active molecule released is native growth hormone.
02 · Research summary & key findings
In the 52-week phase 3 heiGHt trial of 161 treatment-naive prepubertal children with growth hormone deficiency, once-weekly lonapegsomatropin produced an annualized height velocity of 11.2 cm per year versus 10.3 cm per year with daily somatropin, meeting non-inferiority and also showing superiority (PMID 34272849). Adverse events, tolerability, immunogenicity, and bone age progression were similar between groups (PMID 34272849). The FDA approved lonapegsomatropin in August 2021 for children aged one year and older weighing at least 11.5 kg with growth hormone deficiency.
03 · Regulatory status
Lonapegsomatropin (Skytrofa) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Lonapegsomatropin (Skytrofa) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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04 · Administration routes
- Subcutaneous injection
References
- [1]Weekly Lonapegsomatropin in Treatment-Naïve Children With Growth Hormone Deficiency: The Phase 3 heiGHt Trial J Clin Endocrinol Metab, 2021. PMID 34272849
Primary literature
- PubMed: "Lonapegsomatropin"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Lonapegsomatropin"
Registered interventional and observational studies, including status and phase.
- PubChem: "Lonapegsomatropin"
Chemical structure, molecular properties, and bioactivity data.
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