NDAORALSUSPENSIONPriority Review
Approved
Jun 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TEMBEXA (brincidofovir) is an oral antiviral suspension approved by the FDA for treating smallpox. It is a nucleoside analog that inhibits viral DNA polymerase, providing a therapeutic option for orthopoxvirus infections in both pediatric and adult populations.
Peak7.9 years to LOE
Limited commercial signals available; specialty indication with no direct competitors suggests niche market positioning and smaller dedicated team.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
A Phase 1b/2 Study of Intravenous Brincidofovir in Patients With Relapsed or Refractory Lymphoma and Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma
Started Jun 2025
43 enrolled
Relapsed or Refractory Lymphoma Including ENKL
Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults
Started May 2023
44 enrolled
Smallpox
Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation
Started Oct 2022
1 enrolled
BK Virus InfectionNephropathyKidney Transplantation
Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia
Started Dec 2018
0Adenovirus
A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease
Started Sep 2015
5 enrolled
Cytomegalovirus Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.