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Home/Compounds/Lonapegsomatropin
Growth hormoneFDA approvedRx required

Lonapegsomatropin

Also known as: Skytrofa · TransCon hGH
Brands: Skytrofa

Once-weekly pegylated prodrug of somatropin that releases unmodified hGH over a week.

A
Grade A
Multiple human RCTs
Human studies25
PubMed citations30
Routesubcutaneous
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

PEGylated prodrug using Ascendis TransCon technology. Cleaves in plasma at physiological pH and temperature to release unmodified hGH over ~7 days.

Evidence summary

25
Human studies
30
PubMed citations
8
Clinical trials
A
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
subcutaneous

Side effects & safety

From the FDA label
Source
abdominal painarthralgiadiarrheanauseapancreatitisvomiting

Terms pulled directly from the referenced source. We don't fabricate frequencies — when a label doesn't publish a percentage, we don't either.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for pediatric growth hormone deficiency (Skytrofa)

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT07221851A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents With Growth Failure or Short Stature Due to Growth Hormone Sufficient Disorders - Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short StatureRecruiting · Phase 3 · Turner Syndrome · n=186NCT06433557A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children With AchondroplasiaActive Not Recruiting · Phase 2 · Achondroplasia · n=22NCT05820672A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)Recruiting · Growth Hormone Deficiency · n=900NCT05775523A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With LonapegsomatropinRecruiting · Growth Hormone Deficiency · n=500NCT05690386New InsiGHTS: A Multicenter, Phase 2, Randomized, Open-label, Active-controlled, Parallel Group Clinical Trial to Investigate the Safety, Tolerability, and Efficacy of Different Dose Levels of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Individuals With Turner SyndromeActive Not Recruiting · Phase 2 · Turner Syndrome · n=48NCT05171855A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone DeficiencyCompleted · Phase 3 · Adult Growth Hormone Deficiency · n=220NCT04615273foresiGHt: A Multicenter, Randomized, Parallel-arm, Placebo-controlled (Double- Blind) and Active-controlled (Open-label) Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone DeficiencyCompleted · Phase 3 · Growth Hormone Deficiency · n=264NCT04326374The Efficacy, Safety and Tolerability of TransCon hGH Administered Weekly Versus Daily hGH in Prepubertal Children With Growth Hormone Deficiency: a Randomized, Open-lable, Active-controlled, Parallel-group Study in ChinaUnknown · Phase 3 · Growth Hormone Deficiency · n=150

Citations

PMID 41758754Ying Y, Wei H et al. · Once-weekly Lonapegsomatropin was Efficacious and Well Tolerated in Chinese Children with Growth Hormone Deficiency: Results from a Phase 3 Randomized Trial.Hormone research in paediatrics (2026)PMID 40049149Maniatis AK, Thornton PS et al. · Children with Growth Hormone Deficiency Treated with Lonapegsomatropin Demonstrated Sustained Height Improvements for up to 6 Years: enliGHten Trial Final Results.Hormone research in paediatrics (2026)HumanPMID 41729595Aimaretti G · Once-Weekly Lonapegsomatropin in Adults With Growth Hormone Deficiency: are we ready to use it?The Journal of clinical endocrinology and metabolism (2026)PMID 41499205Meller LLT, Akkad G et al. · Impact of growth hormone treatment on a 12-year-old female with newly diagnosed panhypopituitarism and distal arthrogryposis.Endocrinology, diabetes & metabolism case reports (2026)PMID 41420532Biller BMK, Gilis-Januszewska A et al. · Efficacy and Safety of Once-Weekly Lonapegsomatropin in Adults With Growth Hormone Deficiency: foresiGHt Trial Results.The Journal of clinical endocrinology and metabolism (2026)PMID 41912009Brue T, Aouchiche K et al. · Facts and news about growth hormone replacement therapy in adults.Annales d'endocrinologie (2026)PMID 41693185Stawerska R · New directions in growth hormone treatment in children.Pediatric endocrinology, diabetes, and metabolism (2026)HumanPMID 40159984Iughetti L, Insalaco A et al. · Long-acting growth hormone in the treatment of children with growth hormone deficiency.Expert review of endocrinology & metabolism (2025)HumanPMID 39810511Rodaro C, Tamaro G et al. · Long-acting growth hormones: innovations in treatment and guidance on patient selection in pediatric growth hormone deficiency.Annals of pediatric endocrinology & metabolism (2025)HumanPMID 40944302Boller E, Raveendran S et al. · Budget impact analysis of skytrofa for the treatment of pediatric growth hormone deficiency in a US health plan.Journal of medical economics (2025)HumanPMID 39843388Coyne E, Muthuvel G et al. · Clinical outcomes of switching to lonapegsomatropin from somatropin for treatment of pediatric growth hormone deficiency.Journal of pediatric endocrinology & metabolism : JPEM (2025)HumanPMID 39777134Hasegawa Y, Ikegawa K et al. · Current understanding and perspectives on growth and long-acting GH therapy in Japan.Clinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology (2025)HumanPMID 40702497Woelfle J, Kreitschmann-Andermahr I et al. · First 100 patients receiving long-acting growth hormone therapy: real-world evaluation from INSIGHTS-GHT registry.Orphanet journal of rare diseases (2025)HumanPMID 40144813Albers N, Cadarette S et al. · Long-Acting Growth Hormone for Pediatric Growth Hormone Deficiency.Journal of the Endocrine Society (2025)HumanPMID 38333899Miller BS, Blair J et al. · Developments in the Management of Growth Hormone Deficiency: Clinical Utility of Somapacitan.Drug design, development and therapy (2024)HumanPMID 34913019Lin Z, Shu AD et al. · Average IGF-1 Prediction for Once-Weekly Lonapegsomatropin in Children With Growth Hormone Deficiency.Journal of the Endocrine Society (2024)HumanPMID 38580693Zhu J, Yuan K et al. · Long-acting growth hormone in the treatment of growth hormone deficiency in children: a systematic literature review and network meta-analysis.Scientific reports (2024)HumanPMID 39261416de Fries Jensen L, Antavalis V et al. · Efficacy and Safety of Somapacitan Relative to Somatrogon and Lonapegsomatropin in Pediatric Growth Hormone Deficiency: Systematic Literature Review and Network Meta-analysis.Advances in therapy (2024)HumanPMID 38112103Velazquez EP, Miller BS et al. · Somatrogon injection for the treatment of pediatric growth hormone deficiency with comparison to other LAGH products.Expert review of endocrinology & metabolism (2024)HumanPMID 37831302Galetaki DM, Merchant N et al. · Novel therapies for growth disorders.European journal of pediatrics (2024)Human

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