DELSTRIGO (doravirine)
Delstrigo is a combination medication that treats HIV-1 infection in adults and pediatric patients weighing at least 35 kg. It serves as a complete regimen for individuals who have not previously used antiretroviral therapy or for those who are switching from a stable, successful treatment plan. This option helps patients maintain viral suppression when they have no known resistance to the specific drugs included in the tablet.
How DELSTRIGO Works
This medication works by combining three different antiretroviral agents: doravirine, lamivudine, and tenofovir disoproxil fumarate. These components target the virus using both non-nucleoside and nucleoside analogue reverse transcriptase inhibitors. By interfering with the reverse transcriptase enzyme, the combination helps stop the virus from multiplying within the body.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-08-30
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
DELSTRIGO Approval History
What DELSTRIGO Treats
1 indicationsDELSTRIGO is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
DELSTRIGO Boxed Warning
POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B (HBV) have been reported in people with concomitant HIV-1 and HBV who have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue DELSTRIGO. If appropriate, initiation of anti-hepatit...
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B (HBV) have been reported in people with concomitant HIV-1 and HBV who have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue DELSTRIGO. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.2) ] . WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B (HBV) have been reported in people with concomitant HIV-1 and HBV who have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), two of the components of DELSTRIGO. Closely monitor hepatic function in these patients. If appropriate, initiation of anti-hepatitis B therapy may be warranted. ( 5.2 )
DELSTRIGO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DELSTRIGO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
17 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 |
| NCT04233372 DORAVIPEP results posted | DORAVIPEP 2019-004140-30 | Ph 4 | completed | Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study |
| NCT05924438 Opti-DOR | EZ-JW-033 DOH-27-052023-5232 | Ph 3 | active not recruiting | A Randomised, Phase 3 Non-inferiority Study of DOR/3TC/TDF Compared to DTG/TAF/FTC in Participants Infected With HIV-1 Starting First-line Antiretroviral Therapy |
| 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.
DELSTRIGO FDA Label Details
Indications & Usage
FDA Label (PDF)DELSTRIGO is indicated for the treatment of HIV-1 Infection.
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B (HBV) have been reported in people with concomitant HIV-1 and HBV who have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Hepatic function should be ...
Pro Intelligence Preview
Deep insights for DELSTRIGO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 5 active patents
Trial Analysis
- • 17 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment