GX H9

Drug Profile

GX H9

Alternative Names: GX-H9; hGH-hyFc; HL 2356; HyTropin; Long-acting human growth hormone - Genexine; Somatropin long-acting - Genexine/Handok

Latest Information Update: 10 May 2018

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At a glance

  • Originator Genexine
  • Developer Genexine; Handok Inc
  • 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 II Somatotropin deficiency

Most Recent Events

  • 01 May 2018 Genexine announces intention to submit IND to the US FDA for a phase III trial in Somatotropin deficiency (SC)
  • 18 Mar 2018 Efficacy and adverse event data from a phase II trial in Somatotropin deficiency presented at the 100th Annual Meeting of the Endocrine Society (ENDO-2018)
  • 20 Apr 2017 Genexine completes a phase II trial in Somatotropin deficiency (In adults) in Germany, Slovakia, Hungary, Poland, South Korea, Sweden and Greece (EudraCT2014-002698-13)
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