Somavaratan

Drug Profile

Somavaratan

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: 18 Nov 2016

Price : $50

At a glance

  • Originator 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Somatotropin deficiency

Most Recent Events

  • 07 Nov 2016 Interim efficacy and adverse events data from the combined phase IIa and VISTA trial in Somatropin deficiency released by Versartis
  • 26 Sep 2016 Phase-III clinical trials in Somatotropin deficiency (In children, Treatment-naive) in Japan (SC)
  • 26 Sep 2016 Versartis initiates enrolment in an extension study of J14VR5 trial in Somatotropin deficiency (In children) in Japan
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