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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIA Study of FSD201 (Ultramicronized PEA) + Standard of Care (SOC) Vs SOC in the Treatment of Hospitalized Patients With COVID-19

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIA Study of FSD201 (Ultramicronized PEA) + Standard of Care (SOC) Vs SOC in the Treatment of Hospitalized Patients With COVID-19

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 28 Jul 2023

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At a glance

  • Drugs Palmitoylethanolamide (Primary)
  • Indications COVID 2019 infections; Inflammation
  • Focus Proof of concept; Therapeutic Use
  • Sponsors FSD Pharma

Most Recent Events

  • 17 Jul 2023 According to a FSD Pharma media release, the Arbitration Panel Finds that Syneos Health (NASDAQ: SYNH) Failed to Use Commercially Reasonable Efforts in Conducting its Trial for FSD 201. Syneos Health had not enrolled a single patient in seven months. By mid May 2021, over nine months into the trial, Syneos Health had enrolled fewer than 50 patients. The enrollment deadline, which had already been extended once, was 6/15/21.
  • 24 Aug 2021 According to a FSD Pharma media release, there are potential commercial opportunities for FSD-201, specifically the treatment of COVID-19 by FSD-201 is unlikely to be commercially viable. Based on this information, the Company has elected to terminate the current Phase 2 clinical study in order to concentrate its resources on more commercially viable opportunities.
  • 24 Aug 2021 Status changed from recruiting to discontinued, according to a FSD Pharma media release.

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