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A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients

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Trial Profile

A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Aug 2024

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At a glance

  • Drugs Treprostinil (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Adverse reactions; Registrational
  • Acronyms INSPIRE
  • Sponsors Liquidia Technologies

    • Most Recent Events

    • 22 Aug 2024 According to a Liquidia Technologies media release, company announced that it has filed litigation in the U.S. District Court of the District of Columbia that challenges the recent decision by the USFDA to grant 3 year new clinical investigation exclusivity (NCI exclusivity) to Tyvaso DPI, As a result of the FDAs award of NCI exclusivity to Tyvaso DPI, the final approval of YUTREPIA inhalation powder is currently delayed until after the expiration of the exclusivity on May 23, 2025.
    • 19 Aug 2024 According to a Liquidia Technologies media release, Final Approval of YUTREPIA for PAH and PH-ILD may occur after expiration of 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025.
    • 19 Aug 2024 According to a Liquidia Technologies media release, FDA's tentative approval is based upon all information submitted in the NDA, including the status of good manufacturing practices of the facilities used in the manufacture and testing of YUTREPIA.

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