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: 09 Mar 2017

Price : $50

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
  • 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
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Somatotropin deficiency
  • Phase II Cachexia

Most Recent Events

  • 09 Mar 2017 The Pediatric Committee of the European Medicines Agency agrees to Aeterna Zentaris to postpone its Pediatric Investigation Plan (PIP) until it files an MAA for Macimorelin for the treatment of somatotropin-deficiency in adults
  • 07 Mar 2017 The Pediatric Committee of the European Medicines Agency accepts Aeterna Zentaris's Pediatric Investigation Plan for Macimorelin
  • 01 Nov 2016 Aeterna Zentaris completes phase III trial in Somatotropin deficiency (Diagnosis, In adults) in USA, Austria, France, Germany, Italy, Poland, Serbia, Spain, and the UK (NCT02558829)
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