Brincidofovir

Generic Name
Brincidofovir
Brand Names
Tembexa
Drug Type
Small Molecule
Chemical Formula
C27H52N3O7P
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-dr...

Indication

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

Associated Conditions
Variola Major (Smallpox)
Associated Therapies
-

Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults

Phase 1
Completed
Conditions
Interventions
First Posted Date
2023-07-07
Last Posted Date
2024-05-01
Lead Sponsor
Emergent BioSolutions
Target Recruit Count
44
Registration Number
NCT05935917
Locations
🇺🇸

Altasciences, Overland Park, Kansas, United States

Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation

First Posted Date
2022-08-23
Last Posted Date
2024-12-04
Lead Sponsor
SymBio Pharmaceuticals
Target Recruit Count
1
Registration Number
NCT05511779
Locations
🇯🇵

Research Site, Tokyo, Japan

An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2020-02-13
Last Posted Date
2020-02-26
Lead Sponsor
Chimerix
Registration Number
NCT04268966

Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2018-05-22
Last Posted Date
2021-07-21
Lead Sponsor
Chimerix
Registration Number
NCT03532035
Locations
🇺🇸

Brigham and Womens Hospital, Boston, Massachusetts, United States

🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

University of Chigago, Chicago, Illinois, United States

and more 5 locations

The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2017-11-13
Last Posted Date
2021-01-25
Lead Sponsor
Chimerix
Target Recruit Count
29
Registration Number
NCT03339401
Locations
🇺🇸

Joseph M. Sanzari Childrens Hospital-Regional Cancer Care, Hackensack, New Jersey, United States

🇵🇱

Uniwerstytecki Azpital Kliniczny we Wroclawiu, Wrocław, Dolnoslaskie, Poland

🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

and more 33 locations

Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

Conditions
First Posted Date
2015-11-04
Last Posted Date
2022-03-14
Lead Sponsor
Chimerix
Registration Number
NCT02596997
Locations
🇺🇸

UCLA Medical Center, Los Angeles, California, United States

🇺🇸

University of Arkansas Medical Center, Little Rock, Arkansas, United States

🇺🇸

Methodist University Hospital-BMT program west clinic, Memphis, Tennessee, United States

and more 43 locations

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

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

First Posted Date
2015-05-12
Last Posted Date
2021-07-16
Lead Sponsor
Chimerix
Target Recruit Count
5
Registration Number
NCT02439970
Locations
🇺🇸

St. Vincent Medical Center, Los Angeles, California, United States

🇺🇸

University of Colorado Hospital/Health Science Center, Aurora, Colorado, United States

🇺🇸

Yale New Haven Hospital, New Haven, Connecticut, 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
Interventions
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

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

Phase 3
Completed
Conditions
Interventions
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
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