Treats human smallpox disease. Sold as Tembexa. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Brincidofovir (sold as Tembexa), first approved Jun 4, 2021, with 0 new uses approved and 0 published complete response letters.
| Intravenous Brincidofovir as an Antiviral for Treatment of Progressive Multifocal Leukoencephalopathy: A Pilot StudyProgressive Multifocal Leukoencephalopathy · National Institute of Neurological Disorders and Stroke (NINDS) | Phase 2 | Recruiting | Apr 6, 2026 |
| A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCTAdenovirus Infections · SymBio Pharmaceuticals | Phase 3 | Recruiting | Feb 4, 2026 |
| Jun 4, 2021 | TembexaNDA 214460 · New active ingredient | Emergent Biodefense | 1 | Marketed |
| Jun 4, 2021 | TembexaNDA 214461 · New active ingredient | Emergent Biodefense | 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
