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A Phase 1, Single-center, Open-label, Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder (TrIP) in Healthy Normal Volunteers

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Trial Profile

A Phase 1, Single-center, Open-label, Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder (TrIP) in Healthy Normal Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 27 May 2022

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At a glance

  • Drugs Treprostinil (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Adverse reactions
  • Sponsors MannKind Corporation

Most Recent Events

  • 24 May 2022 According to a MannKind Corporation media release, the company celebrated that the U.S. Food and Drug Administration (FDA) has approved United Therapeutics DPI™ (treprostinil) inhalation powder for the treatment of patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • 24 Feb 2022 According to a MannKind Corporation media release, the U.S FDA issued an information request to United Therapeutics Corporation earlier this month regarding the NDA for Tyvaso DPI, requesting additional information regarding the pulmonary safety of Tyvaso DPI related to a pending Citizen Petition. United Therapeutics promptly responded to the agency's request. As FDA consider response to be major amendment to NDA, thereby has extended review deadline of pending NDA to May 2022.
  • 18 Oct 2021 According to an United Therapeutics Corporation media release, Tyvaso DPI can receive approval by the summer of 2022 or earlier.

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