NDAORALTABLET
Approved
Aug 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
PIFELTRO (doravirine) by Merck & Co. is non-nucleoside reverse transcriptase inhibitors [moa]. Approved for hiv-1 infection. First approved in 2018.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PIFELTRO (doravirine) is an oral non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Merck & Co. and approved by the FDA on August 30, 2018. It is indicated for the treatment of human immunodeficiency virus 1 (HIV-1) infection in treatment-naïve and treatment-experienced adult patients. The drug works by inhibiting HIV-1 reverse transcriptase, blocking viral replication. As a once-daily NNRTI option, it provides an alternative to other antiretroviral classes in combination therapy regimens for HIV management.
$0.1BPart D
6.3 years to LOEMechanism of Action
Non-Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Indications (1)
Clinical Trials (20)
Efficacy and Safety of Doravirine in the Rapid Initiation
Started Jul 2026
100 enrolled
HIV-1-infection
A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061)
Started Sep 2025
12 enrolled
Healthy
Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully
Started Apr 2025
408 enrolled
HIV-1-infection
DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection
Started Jan 2025
610 enrolled
HIV-1-infection
Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV
Started Mar 2024
26 enrolled
HIV I InfectionCardiovascular Risk FactorLipid Metabolism Disorders
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.