Treats human smallpox disease. Sold as Tpoxx. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 2 applications for Tecovirimat (sold as Tpoxx), first approved Jul 13, 2018, with 2 new uses approved and 0 published complete response letters.
| Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus DiseaseMonkeypox, Mpox · ANRS, Emerging Infectious Diseases | Phase 3 | Active, not recruiting | Oct 28, 2022 |
| Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOSSmallpox · SIGA Technologies | Phase 2 | Active, not recruiting | Jul 12, 2021 |
| Jul 13, 2018 | TpoxxNDA 208627 · New molecular entity | Siga Technologies | 3 | Marketed |
| May 18, 2022 | TpoxxNDA 214518 · New dosage form | Siga Technologies | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
