Last reviewed 2026-04-20 · How we verify

Tembexa (BRINCIDOFOVIR)

Tembexa works by inhibiting the replication of viruses.

At a glance

Mechanism of action

Brincidofovir is an antiviral drug against variola (smallpox) virus [see Microbiology ( 12.4 )] .

Approved indications

• human smallpox disease
• diseases other than human smallpox disease

Boxed warnings

• 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 )] .

Common side effects

• Diarrhea
• Nausea
• Vomiting
• Abdominal pain
• ALT increased
• Dyspepsia
• Enteritis
• Frequent bowel movements
• Bowel movement irregularity
• Defecation urgency
• Fecal incontinence
• Abdominal discomfort

Drug interactions

• OATP1B1 and 1B3 inhibitors
• OATP1B1 and 1B3 inhibitors
• Claritromycin
• Cyclosporine
• Erythromycin
• Gemfibrozil
• HIV and HCV protease inhibitors
• Rifampin
• Live smallpox vaccine (vaccinia virus)
• Replication-defective smallpox vaccine (modified vaccinia virus Ankara)

Key clinical trials

• A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT (PHASE3)
• 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 (PHASE1,PHASE2)
• Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults (PHASE1)
• Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation (PHASE2)
• A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection (PHASE2)
• Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects (PHASE1)
• Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease
• CMX001 in Post-transplant Patients With BK Virus Viruria (PHASE1,PHASE2)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.