Brincidofovir sodiumProduct ingredient for Brincidofovir

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^7,3 - this lipid conjugate improves drug delivery to the target cells and significantly reduces the nephrotoxicity typically associated with cidofovir therapy.^3,4 Due to its formulation as a pro-drug brincidofovir also carries a greater bioavailability than cidofovir,^5,3 allowing for oral administration rather than intravenous. Cidofovir itself has broad antiviral activity against several DNA viruses,³ 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 2021.⁸ 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,⁹ 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.

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