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A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

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Trial Profile

A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 01 Feb 2024

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At a glance

  • Drugs Tasimelteon (Primary)
  • Indications Jet lag
  • Focus Proof of concept; Therapeutic Use
  • Acronyms JET
  • Sponsors Vanda Pharmaceuticals

Most Recent Events

  • 29 Jan 2024 According to a Vanda Pharmaceuticals media release, United States District Court for the District of Columbia orders FDA to resolve Vanda Pharmaceuticals' Jet Lag Hearing Request by March 5, 2024.
  • 29 Jan 2024 According to a Vanda Pharmaceuticals media release, company announced that the United States District Court for the District of Columbia granted Vanda's motion for summary judgment on its claim against the United States Food and Drug Administration (FDA) for unlawfully delaying a hearing on the approvability of Vanda's supplemental new drug application (sNDA) for HETLIOZ to treat jet lag disorder.
  • 08 Nov 2023 According to a Vanda Pharmaceuticals media release, the sNDA for HETLIOZ in insomnia was accepted for filing by the FDA with a PDUFA target action date of March 4, 2024. The company is continuing to pursue FDA approval for HETLIOZ in jet lag disorder.

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