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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Jan 2025

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At a glance

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

Most Recent Events

  • 02 Jan 2025 According to a SIGA Technologies media release, company announced today that its antiviral treatment TEPOXX (tecovirimat 200 mg capsules), marketed as TPOXX in the USA, has received regulatory approval in Japan, by the Pharmaceuticals and Medical Devices Agency (PMDA), in collaboration with the Japan Ministry of Health, Labour and Welfare, for the treatment of orthopoxviruses.
  • 10 Jan 2022 According to a SIGA Technologies media release, the company announced that the European Medicines Agency (EMA) approved oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox.
  • 16 Nov 2021 According to a SIGA Technologies media release, The MAA was filed under the centralized application process, which, upon approval, will enable sales and marketing of oral tecovirimat in all EU member states, as well as Norway, Iceland, and Liechtenstein. company is targeting EMA approval for the first quarter of 2022.

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