Galidesivir (BCX4430) is a broad-spectrum antiviral in advanced development for the treatment of viruses that pose a threat to health and national security, including SARS-CoV-2 (the cause of COVID-19), Ebola, Marburg, Yellow Fever and Zika viruses.
BioCryst is developing galidesivir in collaboration with U.S. government agencies and other institutions. In September 2013, NIAID contracted with BioCryst for the development of galidesivir as a treatment for Marburg virus disease and potentially for other filoviruses, including Ebola virus.
Galidesivir is an adenosine nucleoside analog that acts to block viral RNA polymerase. RNA polymerase plays a crucial role in the viral replication process, including transcription and replication of the virus genome. Nucleoside RNA polymerase inhibitors, such as galidesivir, are metabolized to the active triphosphate (nucleotide) form by cellular kinases. The drug nucleotide binds to the viral enzyme active site and becomes incorporated into the growing viral RNA strand, leading to premature chain termination.
Phase 1 clinical safety and pharmacokinetics trials have been completed by both intravenous and intramuscular routes of administration in healthy subjects. In animal studies, galidesivir has demonstrated antiviral activity against a variety of serious pathogens.
Galidesivir is investigational and has not been deemed safe and effective by the FDA