← All approvals · Infections & vaccines · 2026
Idvynso (doravirine and islatravir)
The FDA approved Idvynso (doravirine and islatravir) on April 20, 2026 to treat HIV-1 infection (as a complete regimen) in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.
- Brand name
- Idvynso
- Generic name
- doravirine and islatravir
- FDA approval date
- April 20, 2026
- Approved use (FDA wording)
- To treat HIV-1 infection (as a complete regimen) in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine
- Company
- Msd
- Application
- NDA216964
- Dosage form / route
- TABLET · ORAL
- Drug class (EPC)
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- Boxed warning on label
- Not listed
- Category on this site
- Infections & vaccines
Indications and usage, from the FDA label
IDVYNSO™ is indicated as a complete two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine [see Microbiology (12.4) and Clinical Studies (14) ]. IDVYNSO is a two-drug combination of doravirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), and islatravir, a nucleoside analog reverse transcriptase inhibitor (NRTI), and is indicated as a complete regimen for the…