NDAORALTABLETPriority Review
Approved
Oct 2001
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 7h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIREAD (tenofovir disoproxil fumarate) is an oral nucleotide reverse transcriptase inhibitor approved in 2001 for the treatment of HIV-1 infection and chronic hepatitis B. It works by inhibiting viral reverse transcriptase, preventing viral replication in infected cells. The drug is a foundational antiretroviral therapy widely used in combination regimens.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (60/100), signaling potential team restructuring and shift toward managed decline or transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)
Started Jul 2025
200 enrolled
Chronic Hepatitis B Infection
A Study of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) and MK-8527 in Healthy Participants
Started Feb 2025
20 enrolled
Healthy
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
Started Dec 2023
181 enrolled
Pre-Exposure Prophylaxis of HIV Infection
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
Started Nov 2023
253 enrolled
Pre-Exposure Prophylaxis of HIV Infection
Switching From Tenofovir Disoproxil Fumarate to Besifovir Dipivoxil Maleate
Started May 2019
152 enrolled
Hepatitis BBesifovir Dipivoxil MaleateTenofovir Disoproxil Fumarate
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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.