Somatropin pegol
Also known as: ACP-011, Lonapegsomatropin, Lonapegsomatropin-tcgd, PEG‑somatropin, SKYTROFA, TransCon hGH, VRS‑317
Source Somatropin pegol at Peptiology
Save 10% with code PEPTI-BOSSRABBIT-10
Affiliate link: we earn a commission on purchases made through this link, at no extra cost to you.
Tapping Shop Now & Save 10% copies your 10% off code PEPTI-BOSSRABBIT-10 to your clipboard. Paste it at the Peptiology checkout to claim the discount.
Summary
Somatropin pegol (trade name Lonapegsomatropin, brand SKYTROFA) is a long-acting PEGylated recombinant human growth hormone designed for once-weekly subcutaneous administration. It was developed to replace the daily injections required by conventional somatropin. The PEG moiety is cleaved in vivo to release the active somatropin molecule.
Mechanism of Action
Binds to growth hormone receptors on target cells, activating the JAK2-STAT5 signaling pathway, leading to IGF-1 production in the liver and peripheral tissues, thereby promoting growth, anabolism, and metabolic regulation. PEGylation extends the half-life compared to native somatropin.
Routes of Administration
Goals & Uses
- Improved IGF‑1 levelsBiomarkerHigh
- Growth hormone deficiency (adults)EndocrineModerate
- Growth hormone deficiency (children)EndocrineModerate
- Adult growth hormone deficiency (investigational)EndocrinologyModerate
- IGF-1 normalizationBiomarker / Surrogate EndpointHigh
- Turner syndrome (investigational)Rare Disease / GrowthLow
- Treatment of pediatric growth hormone deficiencyEndocrinology / GrowthHigh
- Improved treatment adherence via once-weekly dosingPatient Convenience / AdherenceHigh
Contraindications
- Active malignancyOncologyHighUse caution or avoid depending on agent and context
- Acute critical illnessCritical CareHigh
- Known hypersensitivity to somatropin or PEGAllergyHigh
- Hypersensitivity to somatropin or PEG componentsAllergy / ImmunologyHigh
- PregnancyPopulationModeratePotential fetal risk or insufficient safety data
- Diabetic retinopathyOphthalmologyModerate
- Active proliferative or severe non-proliferative diabetic retinopathyOphthalmologyHigh
- Closed epiphyses (for growth promotion)EndocrinologyModerate
- Prader-Willi syndrome with obesity or respiratory impairmentGenetic DisorderHigh
Adverse Effects
- EdemaFluid BalanceUncommonSwelling from fluid retention
- Peripheral edemaFluid BalanceUncommonSwelling of the arms or legs
- HyperglycemiaMetabolicUncommonAbnormally high blood glucose
- Injection site reactionsLocalCommon
- Intracranial hypertensionNeurologicalRare
- IGF-1 elevation above normal rangeEndocrine / MetabolicCommon
- ArthralgiaMusculoskeletalUncommonJoint pain
- Arthralgia / myalgiaMusculoskeletalUncommon
- Glucose intolerance / hyperglycemiaMetabolic / EndocrineUncommon
Drug Interactions
- InsulinModerateMay increase risk of low blood sugar
- GlucocorticoidsModerate
- Insulin / Oral antidiabeticsModerate
- CYP450 substrates (narrow therapeutic index)Low
- Sex hormones (estrogens)Moderate
- Oral estrogenLow
Population Constraints
- Neonates and infants under 1 yearPediatricRelative
- PregnancyReproductive SafetyRelative
- Adults with GH deficiencyAdultRelative
- Patients with active cancerOncologicalAbsolute
- Patients with diabetes mellitusMetabolicRelative
- Patients with History of MalignancyOncologyRelative
- Hypothyroidism (untreated)EndocrineRelative
- Pediatric patients with open epiphysesAgeRelative
Regulatory Status
- European UnionInvestigationalEMA review pending; clinical development continues.
- United StatesInvestigationalPhase III trials ongoing; not FDA‑approved.
- United KingdomInvestigationalMHRA has granted clinical trial authorization only.
No regulatory approval in US, EU, or UK as of 2024; undergoing Phase III clinical trials.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Somatropin pegol?
Somatropin pegol (trade name Lonapegsomatropin, brand SKYTROFA) is a long-acting PEGylated recombinant human growth hormone designed for once-weekly subcutaneous administration. It was developed to replace the daily injections required by conventional somatropin. The PEG moiety is cleaved in vivo to release the active somatropin molecule.
What is Somatropin pegol used for?
Somatropin pegol is educationally associated with: Improved IGF‑1 levels, Growth hormone deficiency (adults), Growth hormone deficiency (children), Adult growth hormone deficiency (investigational), IGF-1 normalization, Turner syndrome (investigational), Treatment of pediatric growth hormone deficiency, Improved treatment adherence via once-weekly dosing. Educational only — not medical advice.
How is Somatropin pegol administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Somatropin pegol?
Reported adverse effects include: Edema, Peripheral edema, Hyperglycemia, Injection site reactions, Intracranial hypertension, IGF-1 elevation above normal range, Arthralgia, Arthralgia / myalgia, Glucose intolerance / hyperglycemia. This list is not exhaustive — consult a qualified clinician.
Who should avoid Somatropin pegol?
Recorded contraindications: Active malignancy, Acute critical illness, Known hypersensitivity to somatropin or PEG, Hypersensitivity to somatropin or PEG components, Pregnancy, Diabetic retinopathy, Active proliferative or severe non-proliferative diabetic retinopathy, Closed epiphyses (for growth promotion), Prader-Willi syndrome with obesity or respiratory impairment. Consult a qualified clinician before use.