TEMBEXA (brincidofovir)
TEMBEXA is indicated for the treatment of Smallpox.
How TEMBEXA Works
Brincidofovir is a lipid conjugate prodrug of the nucleotide analog cidofovir. It is designed to effectively deliver the drug into cells, where it is converted into cidofovir diphosphate. This active metabolite acts as an orthopoxvirus DNA polymerase inhibitor, competitively inhibiting viral DNA synthesis and preventing the variola virus from replicating its genetic material, thereby halting viral spread.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-06-04
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET, SUSPENSION
TEMBEXA Approval History
What TEMBEXA Treats
1 indicationsTEMBEXA is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Smallpox
TEMBEXA Boxed Warning
INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease [see Warnings and Precautions ( 5.1 )] . WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION See full prescribing information for complete boxed warning. An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to pl...
WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease [see Warnings and Precautions ( 5.1 )] . WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION See full prescribing information for complete boxed warning. An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease [see Warnings and Precautions ( 5.1 )] .
TEMBEXA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TEMBEXA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07511049 | 10002635 002635-N | Ph 2 | recruiting | Intravenous Brincidofovir as an Antiviral for Treatment of Progressive Multifocal Leukoencephalopathy: A Pilot Study |
| NCT07387367 ENOVIA | BCV-PA02 | Ph 3 | recruiting | A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT |
| NCT06761677 | BCV-NL01 | Ph 1, Ph 2 | suspended | 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 |
| NCT05935917 BCV-001 | EBS-BCV-001 | Ph 1 | completed | Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults |
| NCT05511779 | BCV-BN01 | Ph 2 | terminated | Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation |
| NCT00793598 results posted | CMX001-104 | Ph 1, Ph 2 | completed | CMX001 in Post-transplant Patients With BK Virus Viruria |
| NCT02087306 results posted | CMX001-304 | Ph 3 | completed | Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection |
| NCT01143181 results posted | CMX001-350 | Ph 3 | completed | Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses |
| NCT01769170 results posted | CMX001-301 | Ph 3 | completed | A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients |
| NCT01241344 results posted | CMX001-202 | Ph 2 | completed | Phase 2 Study to Evaluate Brincidofovir for the Prevention of Adenovirus Disease |
| NCT03532035 | CMX001-211 | Ph 2 | withdrawn | Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia |
| NCT00942305 results posted | CMX001-201 | Ph 2 | completed | Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients |
| NCT02439970 SUSTAIN results posted | CMX001-303 | Ph 3 | terminated | A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease |
| NCT02439957 results posted | CMX001-307 | Ph 3 | terminated | A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus |
| NCT03339401 AdAPT results posted | CMX001-999 | Ph 2 | terminated | The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation |
| NCT04268966 BCV EBOV | CMX001-206 | Ph 2 | withdrawn | An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TEMBEXA FDA Label Details
Indications & Usage
FDA Label (PDF)TEMBEXA is indicated for the treatment of Smallpox.
WARNING: INCREASED RISK FOR MORTALITY WHEN USED FOR LONGER DURATION An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease [see Warnings and Precautions ( 5.1 )] . WARNING...
TEMBEXA Patents & Exclusivity
Patents (5 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TEMBEXA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 6 active patents
Trial Analysis
- • 16 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment