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Tesamorelin - Theratechnologies

Drug Profile

Tesamorelin - Theratechnologies

Alternative Names: EGRIFTA; F4; Tesamorelin acetate; TH-9507; ThGRF 1-44

Latest Information Update: 09 Nov 2018

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At a glance

  • Originator Theratechnologies
  • Developer National Heart, Lung and Blood Institute; National Institute on Aging; Theratechnologies
  • Class Pituitary hormone releasing hormones
  • Mechanism of Action Growth hormone releasing factor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Lipodystrophy
  • Phase II Mild cognitive impairment; Non-alcoholic steatohepatitis
  • Discontinued Insomnia; Lipid metabolism disorders; Muscular atrophy

Most Recent Events

  • 05 Nov 2018 The US FDA approves single-vial formulation of tesamorelin for treatment of Lipodystrophy in
  • 05 Sep 2018 The US FDA sets PDUFA date of 03/11/2018 for sNDA review for single-vial formulation of tesamorelin
  • 03 Jul 2018 Theratechnologies files sNDA for single-vial formulation of tesamorelin for Lipodystrophy in USA
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