Somavaratan - Versartis

Drug Profile

Somavaratan - Versartis

Alternative Names: hGH-rPEG - Versartis; hGH-XTEN; Human growth hormone-XTEN - Amunix; Recombinant human growth hormone long-acting - Versartis; Somatropin long-acting - Versartis; VRS-317

Latest Information Update: 23 Mar 2018

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At a glance

  • Originator Versartis
  • Developer Teijin Pharma; Versartis
  • Class Growth hormones; Hormonal replacements; Recombinant fusion proteins
  • 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 Yes

Highest Development Phases

  • Phase III Somatotropin deficiency

Most Recent Events

  • 07 Mar 2018 Versartis terminates the phase II/III VISTA extension trial as the primary endpoint of non-inferiority to daily therapy in the paediatric phase III study was not achieved for Somatotropin deficiency (In children) in USA, Belgium, Poland, Sweden (SC) (NCT02068521)
  • 09 Jan 2018 Teijin terminates its exclusive license and supply agreement with Versartis for development and marketing of Somavaratan in Japan
  • 09 Jan 2018 Versartis terminates the phase II/III VISTA trial in Somatotropin deficiency
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