Macimorelin

Drug Profile

Macimorelin

Alternative Names: AEZS-130; ARD-07; D-87575; EP-01572; EP-1572; JMV-1843; Macimorelin acetate; Macrilen; Solorel

Latest Information Update: 03 Jul 2017

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At a glance

  • Originator AEterna Zentaris Inc
  • Class Amides; Carboxylic acids; Indoles; Oligopeptides; Small molecules
  • Mechanism of Action Ghrelin 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
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Somatotropin deficiency
  • Phase II Cachexia

Most Recent Events

  • 18 Jul 2017 FDA assigns PDUFA action date of 30/12/2017 for macimorelin for Somatotropin deficiency
  • 30 Jun 2017 AEterna Zentaris re-submits NDA with the US FDA for Somatotropin deficiency (In adults, Diagnosis)
  • 05 Apr 2017 Updated efficacy and adverse event data from a phase III trial in Somatotropin deficiency presented at the 99th Annual Meeting of the Endocrine Society
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