An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

Trial Profile

An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2018

At a glance

  • Drugs Tecovirimat (Primary)
  • Indications Orthopoxvirus infections; Smallpox
  • Focus Adverse reactions; Registrational
  • Sponsors SIGA Technologies
  • Most Recent Events

    • 13 Jul 2018 According to a SIGA Technologies media release,, the U.S. Food and Drug Administration (FDA) has approved oral TPOXX (tecovirimat) for the treatment of smallpox to mitigate the impact of a potential outbreak.
    • 05 Jul 2018 According to a SIGA Technologies media release, data from this trial will be published in New England Journal of Medicine.
    • 01 May 2018 According to a SIGA Technologies media release, company announced a favorable outcome of the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee meeting on oral TPOXX.
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