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: 08 Mar 2017
At a glance
- Drugs Tecovirimat (Primary)
- Indications Orthopoxvirus infections; Smallpox
- Focus Adverse reactions; Registrational
- Sponsors SIGA Technologies
- 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.
- 29 Aug 2016 According to a SIGA media release, enrollment and dosing in the final cohort of this trial has been completed.