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An Open-Label Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

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Trial Profile

An Open-Label Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 15 May 2024

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At a glance

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

    • Most Recent Events

    • 09 May 2024 According to an Insmed media release, the company has received the necessary regulatory approvals in 10 of 17 countries where the study is taking place to amend the protocol to allow for an increase in the maximum dose of TPIP from 640 µg to up to 1,280 µg, once a day, in the open label extension study for certain PAH patients based on investigator decision.
    • 22 Feb 2024 According to an Insmed media release, company has submitted a protocol amendment to the FDA and other regulatory authorities for the open-label extension of the Phase 2 PAH study. This amendment, if approved, would allow investigators to continue to increase the dose of TPIP up to a maximum of 1,280 micrograms once daily.
    • 15 Sep 2022 Status changed from active, no longer recruiting to discontinued.

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