IDVYNSO (doravirine)
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 and Clinical Studies ].
Details
- Status
- Prescription
- First Approved
- 2026-04-20
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET
IDVYNSO Approval History
What IDVYNSO Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04375800 | 1439-066 MK-1439-066, 2019-003955-13 | Ph 2 | recruiting | Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066) |
| NCT04900974 results posted | 20-0052 | Ph 1 | completed | Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women |
| NCT05630638 DoraDO | UoL001707 | Ph 4 | recruiting | Doravirine Dose Optimisation in Pregnancy |
| NCT02275780 DRIVE-FORWARD results posted | 1439-018 MK-1439-018, 2014-001127-69 | Ph 3 | completed | Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018) |
| NCT03894124 results posted | CRF001 2019-000978-33 | Ph 1 | completed | Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers |
| NCT04689737 results posted | Dora-HD | Ph 4 | completed | Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD) |
| NCT04892654 DORDOL | CW004 2020-003928-17 | Ph 3 | recruiting | Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch |
| NCT03272347 results posted | 8591-011 2017-000437-32 | Ph 2 | completed | Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) |
| NCT04097925 results posted | DORAGEN 2018-003921-27 | Ph 2 | completed | Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals |
| NCT04079452 results posted | DORACeNeS 2018-003915-24 | Ph 3 | completed | Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals |
| NCT01632345 results posted | 1439-007 MK-1439-007, 2012-001573-93 | Ph 2 | completed | A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007) |
| NCT02715700 results posted | 1439-045 MK-1439-045 | Ph 1 | completed | Effects of Doravirine (MK-1439) on Methadone Pharmacokinetics in Methadone-Maintained Participants (MK-1439-045) |
| NCT01466985 results posted | 1439-005 2011-003508-19, MK-1439-005 | Ph 1 | completed | A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005) |
| NCT02641067 results posted | 1439-051 MK-1439-051 | Ph 1 | completed | A Study Evaluating the Pharmacokinetics of Doravirine (MK-1439) in Participants With Severe Renal Impairment (MK-1439-051) |
| NCT02089659 results posted | 1439-019 MK-1439-019 | Ph 1 | completed | A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IDVYNSO FDA Label Details
Indications & Usage
FDA Label (PDF)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 and Clinical Studies ]. IDVYNSO is a two-drug combination of doravirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), and islatravir, a nucleoside analo...
IDVYNSO Patents & Exclusivity
Exclusivity
Track IDVYNSO with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.