Doravirine: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Doravirine appears in the FDA drug-label database. Marketed as PIFELTRO.

Drug class

Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor (FDA established pharmacologic class)

Mechanism of action

Non-Nucleoside Reverse Transcriptase Inhibitors (as stated on the FDA label)

FDA-approved use

PIFELTRO ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history; OR to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine [see Clinical Studies (14) ] . PIFELTRO, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine. ( 1 )

FDA label via openFDA