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foresiGHt: A Multicenter, Randomized, Parallel-arm, Placebo-controlled (Double- Blind) and Active-controlled (Open-label) Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

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Trial Profile

foresiGHt: A Multicenter, Randomized, Parallel-arm, Placebo-controlled (Double- Blind) and Active-controlled (Open-label) Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jan 2025

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At a glance

  • Drugs Lonapegsomatropin (Primary) ; Somatropin
  • Indications Somatotropin deficiency
  • Focus Registrational; Therapeutic Use
  • Acronyms foresiGHt
  • Sponsors Ascendis Pharma

    • Most Recent Events

    • 12 Jan 2025 According to an Ascendis Pharma media release, company is planning to submit an Investigational New Drug (IND) application or similar for a basket trial evaluating TransCon hGH in additional indications.
    • 12 Jan 2025 According to an Ascendis Pharma media release, commercial launch of SKYTROFA planned in the fourth quarter of 2025.
    • 12 Dec 2024 According to an Ascendis Pharma media release, the company announced that the U.S. Food & Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) in adult growth hormone deficiency (GHD) for TransCon hGH. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025.

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