Brincidofovir

Generic Name: Brincidofovir

Brand Names: Tembexa

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₅₂N_₃O_₇P

CAS Number: 444805-28-1

Unique Ingredient Identifier: 6794O900AX

Background: Brincidofovir is an oral antiviral drug used in the treatment of human smallpox infections. It is a lipid conjugate pro-drug of the acyclic nucleotide analogue cidofovir - this lipid conjugate improves drug delivery to the target cells and significantly reduces the nephrotoxicity typically associated with cidofovir therapy. Due to its formulation as a pro-drug brincidofovir also carries a greater bioavailability than cidofovir, allowing for oral administration rather than intravenous. Cidofovir itself has broad antiviral activity against several DNA viruses, resulting in brincidofovir being investigated for the prevention and treatment of cytomegalovirus (CMV), BK Virus (BKV), adenoviruses (AdV), and Epstein-Barr virus (EBV), amongst others.

Brincidofovir, developed by Chimerix under the brand name Tembexa, was approved by the FDA for the treatment of smallpox infection in June 2021. As smallpox has been eradicated, the efficacy of Tembexa was assessed in animals infected with viruses closely related to variola. The approval was granted under the agency’s Animal Rule, which allows for a drug to be approved based on the results of well-controlled animal studies when human trials would be unethical or infeasible.

Indication: Brincidofovir is indicated for the treatment of human smallpox disease in adult and pediatric patients.

Associated Conditions: Variola Major (Smallpox)

Clinical Trials

A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus

Phase 3

Terminated

Conditions: Cytomegalovirus Disease
Kidney Transplant Infection

Interventions: Drug: Valganciclovir
Drug: Brincidofovir

First Posted Date: 2015-05-12

Last Posted Date: 2021-07-16

Lead Sponsor: Chimerix

Target Recruit Count: 6

Registration Number: NCT02439957

Locations: 🇺🇸
Yale New Haven Hospital, New Haven, Connecticut, United States
🇺🇸
University of Colorado Hospital/Health Science Center, Aurora, Colorado, United States
🇺🇸
St. Vincent Medical Center, Los Angeles, California, United States

A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304

Terminated

Conditions: Adenovirus

Interventions: Drug: Brincidofovir

First Posted Date: 2015-04-17

Last Posted Date: 2017-01-09

Lead Sponsor: Chimerix

Target Recruit Count: 100

Registration Number: NCT02420080

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸
Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
🇺🇸
Emory University, Atlanta, Georgia, United States

and more 19 locations

An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease

Phase 2

Withdrawn

Conditions: Ebola Virus

Interventions: Drug: CMX001

First Posted Date: 2014-10-22

Last Posted Date: 2015-02-02

Lead Sponsor: Chimerix

Registration Number: NCT02271347

The Chimerix CMX001 Registry

Terminated

Conditions: Outcomes
Survival Rates

Interventions: Drug: CMX001

First Posted Date: 2014-06-19

Last Posted Date: 2019-05-17

Lead Sponsor: Chimerix

Target Recruit Count: 550

Registration Number: NCT02167685

Locations: 🇺🇸
Children's Hospital of LA, Los Angeles, California, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Winship Cancer Institute Emory University, Atlanta, Georgia, United States

and more 48 locations

Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection

Phase 3

Completed

Conditions: Adenovirus Infection

Interventions: Drug: Brincidofovir

First Posted Date: 2014-03-14

Last Posted Date: 2021-08-13

Lead Sponsor: Chimerix

Target Recruit Count: 201

Registration Number: NCT02087306

Locations: 🇺🇸
Children's Hospital, New Orleans, Louisiana, United States
🇺🇸
Children's National Health System, Washington, District of Columbia, United States
🇺🇸
Montifore Medical Center, Bronx, New York, United States

and more 30 locations

A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients

Phase 3

Completed

Conditions: CMV

Interventions: Other: Placebo
Drug: Brincidofovir

First Posted Date: 2013-01-16

Last Posted Date: 2021-07-21

Lead Sponsor: Chimerix

Target Recruit Count: 452

Registration Number: NCT01769170

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
The Universit of Iowa, Iowa City, Iowa, United States
🇺🇸
University of California, San Diego-Moores Cancer Center, La Jolla, California, United States

and more 40 locations

Phase 2 Study to Evaluate Brincidofovir for the Prevention of Adenovirus Disease

Phase 2

Completed

Conditions: Adenovirus Disease

Interventions: Drug: Brincidofovir
Other: Placebo

First Posted Date: 2010-11-16

Last Posted Date: 2021-07-21

Lead Sponsor: Chimerix

Target Recruit Count: 52

Registration Number: NCT01241344

Locations: 🇺🇸
St. Louis Children's Hosptial, Saint Louis, Missouri, United States
🇺🇸
Harvard-Children's Hospital Boston, Boston, Massachusetts, United States
🇺🇸
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

and more 27 locations

Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses

Phase 3

Completed

Conditions: Double-stranded DNA Virus

Interventions: Drug: Brincidofovir

First Posted Date: 2010-06-14

Last Posted Date: 2021-08-12

Lead Sponsor: Chimerix

Target Recruit Count: 210

Registration Number: NCT01143181

Locations: 🇺🇸
Children's Hospital of LA, Los Angeles, California, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 34 locations

Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients

Phase 2

Completed

Conditions: Cytomegalovirus Infection

Interventions: Drug: Placebo
Drug: Brincidofovir

First Posted Date: 2009-07-20

Last Posted Date: 2021-07-16

Lead Sponsor: Chimerix

Target Recruit Count: 239

Registration Number: NCT00942305

Locations: 🇺🇸
UCLA Medical Center, Los Angeles, California, United States
🇺🇸
Winship Cancer Institute at Emory University, Atlanta, Georgia, United States
🇺🇸
UT Southwestern Medical Center at Dallas, Dallas, Texas, United States

and more 23 locations

CMX001 in Post-transplant Patients With BK Virus Viruria

Phase 1

Completed

Conditions: Viruria

Interventions: Drug: Placebo
Drug: Brincidofovir

First Posted Date: 2008-11-19

Last Posted Date: 2021-08-16

Lead Sponsor: Chimerix

Target Recruit Count: 29

Registration Number: NCT00793598

Locations: 🇺🇸
Tulane Center for Abdominal Transplant, New Orleans, Louisiana, United States
🇺🇸
Mt. Sinai Medical Center, New York, New York, United States
🇺🇸
UNC Kidney Center, Chapel Hill, North Carolina, United States

and more 12 locations

Drug Development Updates

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