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A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)

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Trial Profile

A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2024

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At a glance

  • Drugs Paltusotine (Primary)
  • Indications Acromegaly
  • Focus Registrational; Therapeutic Use
  • Acronyms PATHFNDR-2
  • Sponsors Crinetics Pharmaceuticals

    • Most Recent Events

    • 09 Dec 2024 According to a Crinetics Pharmaceuticals media release,company announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for investigational candidate paltusotine for the treatment and long-term maintenance therapy of acromegaly in adults that included data from the PATHFNDR-1 and PATHFNDR-2 also FDA has set a Prescription Drug User Fee target action date of September 25, 2025, for completing review of the NDA.
    • 12 Nov 2024 According to a Crinetics Pharmaceuticals media release, The submission of our first NDA was a significant milestone in the company history, and we remain on track for the expected launch of our investigational drug paltusotine for acromegaly in 2025, which will be a pivotal event for the company.
    • 26 Sep 2024 According to a Crinetics Pharmaceuticals media release, the company announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for paltusotine, in development for the proposed treatment and long-term maintenance therapy of acromegaly, Crinetics anticipates receiving notification from the FDA on the status of the NDA submission in December

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