Anamorelin

Drug Profile

Anamorelin

Alternative Names: Adlumiz; Anamorelin HCl; Anamorelin hydrochloride; ONO-7643; RC-1291; ST-1291

Latest Information Update: 26 Sep 2017

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At a glance

  • Originator Novo Nordisk
  • Developer Helsinn Therapeutics; Ono Pharmaceutical
  • Class Appetite stimulants; Piperidines; 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Anorexia; Cachexia
  • Phase II Fatigue

Most Recent Events

  • 15 Sep 2017 Committee for Medicinal Products for Human Use (CHMP) recommends the refusal of the marketing authorisation for anamorelin for Anorexia and Cachexia in European Union as the benefits of anamorelin do not outweigh the potential risks
  • 23 Jun 2017 Hensinn Birex Pharmaceuticals requests for re-examination of the CHMP negative opinion for anamorelin
  • 19 May 2017 CHMP adopts negative opinion for approval of anamorelin for Anorexia and Cachexia in European Union
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