NDAORALTABLET
Approved
Aug 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
PIFELTRO (doravirine) by Merck & Co. is non-nucleoside reverse transcriptase inhibitors [moa]. First approved in 2018.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PIFELTRO (doravirine) is an oral non-nucleoside reverse transcriptase inhibitor (NNRTI) approved by the FDA in August 2018 for HIV-1 treatment. It works by inhibiting HIV reverse transcriptase, blocking the virus's ability to replicate. Doravirine is indicated for treatment-experienced and treatment-naïve HIV-1 patients as part of combination antiretroviral therapy.
$0.071BPart D
Peak6.2 years to LOEProduct is in peak lifecycle stage with $71M in Part D spending and stable claim volume, indicating an established but potentially plateauing market presence with likely stable commercial team size.
Mechanism of Action
Non-Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.