PIFELTRO (doravirine)
Pifeltro treats HIV-1 infection in adults and pediatric patients weighing at least 35 kg. It is used for individuals who have not previously taken antiretroviral therapy or as a replacement for those currently on a stable, successful regimen with low viral levels. This medication helps patients maintain viral suppression when used in combination with other antiretroviral agents, provided there is no history of treatment failure or resistance to the drug.
How PIFELTRO Works
Pifeltro works by acting as a non-nucleoside analog reverse transcriptase inhibitor against the HIV-1 virus. As an antiretroviral agent, it targets the viral replication process to help control the infection.
Details
- Status
- Prescription
- First Approved
- 2018-08-30
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
PIFELTRO Approval History
What PIFELTRO Treats
1 indicationsPIFELTRO 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
PIFELTRO Competitive Set
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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 PIFELTRO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 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 |
| NCT06719570 | 8591A-055 MK-8591A-055, CA42943 | Ph 1 | completed | A Study of Doravirine and Islatravir as a Single Entity or Combination Therapy and the Effect of Food in Healthy Adult Participants (MK-8591A-055) |
| 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.
PIFELTRO FDA Label Details
Indications & Usage
FDA Label (PDF)PIFELTRO is indicated for the treatment of HIV-1 Infection.
PIFELTRO Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for PIFELTRO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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.