Confirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (ITT)

Trial Profile

Confirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (ITT)

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Macimorelin (Primary) ; Insulin
  • Indications Somatotropin deficiency
  • Focus Diagnostic use; Registrational
  • Sponsors AEterna Zentaris Inc
  • Most Recent Events

    • 10 Aug 2017 According to an Aeterna Zentaris media release, the Company announced on June 30, 2017 that an NDA seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD) was resubmitted to the US FDA. On July 18, 2017, the Company announced that the NDA had been accepted as a complete response to the FDA's November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017.
    • 10 Jun 2017 Biomarkers information updated
    • 04 Apr 2017 Results presented at The 99th Annual Meeting of the Endocrine Society
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