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Somapacitan - Novo Nordisk

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Drug Profile

Somapacitan - Novo Nordisk

Alternative Names: Albumin-binding somatropin - Novo Nordisk; Growth hormone derivative - Novo Nordisk; Long-acting growth hormone - Novo Nordisk; Long-acting somatropin - Novo Nordisk; NN 8640; NNC-0195-0092; Sogroya; Somatropin derivative - Novo Nordisk; Somatropin long acting - Novo Nordisk

Latest Information Update: 19 May 2025

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At a glance

  • Originator Novo Nordisk
  • Class Growth hormones; Hormonal replacements; Tetrazoles
  • Mechanism of Action Somatotropin receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Somatotropin deficiency
  • New Molecular Entity No

Highest Development Phases

  • Marketed Somatotropin deficiency

Most Recent Events

  • 12 May 2025 Novo Nordisk submits regulatory application for Somapacitan for Children born small for gestational age (SGA), children with Noonan syndrome (NS), and children with idiopathic short stature (ISS) in the European Union (EU)
  • 12 May 2025 Efficacy and adverse event data from the phase III REAL8 trial in Somatotropin deficiency released by Novo Nordisk
  • 30 Apr 2025 Preregistration for Somatotropin deficiency (In children, In adolescents) in USA (SC)

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