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Somapacitan - Novo Nordisk

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: 10 May 2021

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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

  • Registered Somatotropin deficiency

Most Recent Events

  • 31 Mar 2021 Registered for Somatotropin deficiency in European Union, Iceland, Norway, Liechtenstein (SC)
  • 20 Mar 2021 Updated efficacy and safety data from the phase II REAL 3 trial in Somatotropin deficiency presented at the 103rd Annual Meeting of the Endocrine Society (ENDO-2021)
  • 29 Jan 2021 The Committee for Medicinal Products for Human Use of the European Medicines Agency adopts a positive opinion and recommends granting marketing authorization of somapacitan for Somatotropin deficiency
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