NDAORALTABLET
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
6/8 — Strong
SYMTUZA (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) by Johnson & Johnson is hiv protease inhibitors [moa]. Approved for protease inhibitor [epc]. First approved in 2018.
Drug data last refreshed 8h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYMTUZA is a once-daily oral fixed-dose combination containing darunavir (protease inhibitor), cobicistat (CYP3A inhibitor), emtricitabine, and tenofovir alafenamide for the treatment of HIV-1 infection. It works by inhibiting cytochrome P450 3A enzymes and viral protease to suppress viral replication. This single-tablet regimen is designed for treatment-naive and treatment-experienced adult patients with HIV-1.
$0.469BPart D
PeakStable
11.9 years to LOEEstablished peak-cycle product generating $469M in Part D spending with 93,533 annual claims, indicating stable mature market position and stable team sizing.
Mechanism of Action
HIV Protease Inhibitors
Pharmacologic Class:
Protease Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain
Started Mar 2023
30 enrolled
HIV InfectionsObesity
Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)
Started Sep 2021
75 enrolled
HIV-1-infection
Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)
Started Sep 2019
1 enrolled
Human Immunodeficiency Virus
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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.