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
Phase of Trial: Phase III
Latest Information Update: 11 Dec 2017
At a glance
- Drugs Tecovirimat (Primary)
- Indications Orthopoxvirus infections; Smallpox
- Focus Adverse reactions; Registrational
- Sponsors SIGA Technologies
- 11 Dec 2017 According to a SIGA Technologies media release, company has submitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the oral formulation of TPOXX (tecovirimat) on 8th December 2017 and expects to receive information from FDA in Feb 2018.
- 02 Mar 2017 Status changed from active, no longer recruiting to completed.
- 29 Aug 2016 According to a SIGA Technologies media release, the company anticipates submitting the complete New Drug Application (NDA) for TPOXX™ to the FDA by the end of 2017 and will seek an expedited review of its submission.