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Tesamorelin - Theratechnologies

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Drug Profile

Tesamorelin - Theratechnologies

Alternative Names: EGRIFTA; EGRIFTA MDVTM; EGRIFTA SV; F4; F8; Tesamorelin acetate; TH-9507; ThGRF 1-44

Latest Information Update: 13 Dec 2024

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At a glance

  • Originator Theratechnologies
  • Developer National Heart, Lung and Blood Institute; National Institute on Aging; Theratechnologies
  • Class Antidementias; Hepatoprotectants; Pituitary hormone releasing hormones; Sleep disorder therapies
  • 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.

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes - Non-alcoholic steatohepatitis

Highest Development Phases

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

Most Recent Events

  • 10 Dec 2024 The US FDA sets PDUFA date of 25/03/2025 for sBLA review for F8 formulation of tesamorelin
  • 26 Nov 2024 Theratechnologies anticipates approval of tesamorelin by the end of March 2025
  • 26 Nov 2024 Theratechnologies completes a Type A meeting with the US FDA for the F8 formulation of tesamorelin sBLA

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