Somapacitan

Summary

Somapacitan (Sogroya) is a once-weekly subcutaneous long-acting growth hormone analog developed by Novo Nordisk. It is approved for growth hormone deficiency in adults and children. Its extended half-life is achieved through reversible albumin binding via an attached fatty acid linker, distinguishing it from daily recombinant hGH.

Mechanism of Action

Somapacitan is a reversible albumin-binding growth hormone derivative. It binds to and activates the growth hormone receptor, stimulating IGF-1 production and downstream anabolic and metabolic effects. The albumin-binding fatty acid chain prolongs its half-life, enabling once-weekly dosing.

Routes of Administration

Goals & Uses

• Improvement of quality of life in GHDPatient Reported OutcomesModerate
• Treatment of adult growth hormone deficiency (AGHD)Endocrinology / Hormone ReplacementHigh
• Treatment of pediatric growth hormone deficiencyEndocrinology / GrowthHigh
• Improvement of body composition (lean mass / fat mass)Metabolic / Body CompositionHigh

Contraindications

• Active malignancyOncologyHighUse caution or avoid depending on agent and context
• Acute critical illnessCritical CareHigh
• Closed epiphyses with Prader-Willi syndrome and obesity/respiratory impairmentGenetic/RespiratoryHigh
• Diabetic retinopathyOphthalmologyHigh
• Hypersensitivity to somapacitan or excipientsAllergy / ImmunologyHigh

Adverse Effects

• Peripheral edemaFluid BalanceCommonSwelling of the arms or legs
• Injection site reactionsLocalCommon
• HeadacheNeurologicCommonPain in the head or upper neck
• Intracranial hypertensionNeurologicalRare
• Hyperglycemia / insulin resistanceMetabolic / EndocrineUncommon
• Arthralgia / myalgiaMusculoskeletalCommon

Drug Interactions

• GlucocorticoidsModerate
• Cytochrome P450-metabolized drugs (e.g., cyclosporine, sex steroids, anticonvulsants)Low
• Insulin / Oral antidiabeticsModerate
• Oral estrogenModerate

Population Constraints

• PregnancyReproductive SafetyRelative
• History of malignancyOncologyRelative
• Diabetes mellitusMetabolicRelative
• Pediatric patients < 2 yearsAgeRelative

Regulatory Status

• European UnionApprovedApproved: Adult growth hormone deficiency, Pediatric growth hormone deficiencyEMA approved Sogroya; approved for both adult and pediatric GHD.
• United StatesApprovedApproved: Adult growth hormone deficiency, Pediatric growth hormone deficiency (≥2.5 years)FDA approved Sogroya for AGHD in August 2020; pediatric indication added in June 2021.
• United KingdomApprovedApproved: Adult growth hormone deficiency, Pediatric growth hormone deficiencyApproved via MHRA post-Brexit regulatory pathway.

Approved by FDA in August 2020 for adult growth hormone deficiency; pediatric indication approved by FDA in 2021. Also approved in the EU and other jurisdictions.

Evidence & Sources

No sources recorded yet.