Somatrogon
Also known as: hGH-CTP, long-acting growth hormone, MOD-4023, NGENLA, Somatrogon
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Summary
Somatrogon is a recombinant human growth hormone fused with three C‑terminal peptide (CTP) extensions to prolong its half‑life, administered subcutaneously for treatment of growth hormone deficiency in children.
Mechanism of Action
Binds growth hormone receptor, activates JAK2-STAT5 pathway leading to increased IGF-1 synthesis and linear growth.
Routes of Administration
Goals & Uses
- Improved Treatment AdherencePatient ConvenienceModerate
- Adult GHD TreatmentEndocrineLow
- Pediatric Growth Hormone Deficiency TreatmentEndocrine / GrowthHigh
- IGF-1 normalizationBiomarker / Surrogate EndpointHigh
- Pediatric growth hormone deficiencyEndocrineHigh
Contraindications
- Prader-Willi syndrome with obesity/respiratory impairmentGenetic / RespiratoryHigh
- Active malignancyOncologyHighUse caution or avoid depending on agent and context
- Acute critical illnessCritical CareHigh
- Closed epiphysesSkeletalModerate
- Diabetic retinopathyOphthalmologyModerate
- Hypersensitivity to somatrogon or excipientsImmunologicalModerate
Adverse Effects
- EdemaFluid BalanceUncommonSwelling from fluid retention
- HyperglycemiaMetabolicUncommonAbnormally high blood glucose
- Joint stiffnessMusculoskeletalCommon
- Injection site reactionsLocalCommon
- Injection site painLocalCommonPain at the injection site
- HeadacheNeurologicCommonPain in the head or upper neck
- Intracranial hypertensionNeurologicalRare
- Slipped capital femoral epiphysisMusculoskeletalRare
- Arthralgia / myalgiaMusculoskeletalUncommon
- Elevated IGF-1 levelsEndocrine / LaboratoryCommon
Drug Interactions
- CYP450 substrates (e.g., cyclosporine, anticonvulsants)Low
- InsulinModerateMay increase risk of low blood sugar
- GlucocorticoidsModerate
- Oral hypoglycemic agentsModerate
- Insulin / antidiabetic agentsModerate
- Sex hormones (estrogens)Moderate
Population Constraints
- PregnancyReproductive SafetyRelative
- Hepatic impairmentOrgan FunctionRelative
- Renal impairmentOrgan ImpairmentRelative
- Adults with GH deficiencyAdultRelative
- Neonates / infants < 2 yearsPediatricRelative
- Children with growth hormone deficiencyPediatricAbsolute
- AdultsAdult PopulationRelative
Regulatory Status
- European UnionInvestigationalUnder review as of 2024
- United StatesApprovedApproved: Pediatric growth hormone deficiencyFDA approval 2023 (Ngenla)
- United KingdomInvestigationalPending MHRA approval
Approved by Health Canada in 2021, the EMA in 2022, and the FDA in 2023 for pediatric GHD. Marketed as NGENLA by Pfizer. Not approved for adult GHD or other indications as of current data.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Somatrogon?
Somatrogon is a recombinant human growth hormone fused with three C‑terminal peptide (CTP) extensions to prolong its half‑life, administered subcutaneously for treatment of growth hormone deficiency in children.
What is Somatrogon used for?
Somatrogon is educationally associated with: Improved Treatment Adherence, Adult GHD Treatment, Pediatric Growth Hormone Deficiency Treatment, IGF-1 normalization, Pediatric growth hormone deficiency. Educational only — not medical advice.
How is Somatrogon administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Somatrogon?
Reported adverse effects include: Edema, Hyperglycemia, Joint stiffness, Injection site reactions, Injection site pain, Headache, Intracranial hypertension, Slipped capital femoral epiphysis, Arthralgia / myalgia, Elevated IGF-1 levels. This list is not exhaustive — consult a qualified clinician.
Who should avoid Somatrogon?
Recorded contraindications: Prader-Willi syndrome with obesity/respiratory impairment, Active malignancy, Acute critical illness, Closed epiphyses, Diabetic retinopathy, Hypersensitivity to somatrogon or excipients. Consult a qualified clinician before use.