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 cytochrome p450 3a inhibitors [moa]. Approved for cytochrome p450 3a inhibitor [epc]. First approved in 2018.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYMTUZA is a once-daily, four-component fixed-dose combination tablet containing darunavir (protease inhibitor), cobicistat (cytochrome P450 3A inhibitor), emtricitabine (nucleoside reverse transcriptase inhibitor), and tenofovir alafenamide (nucleotide reverse transcriptase inhibitor). Approved in July 2018, it is indicated for HIV-1 treatment in treatment-experienced and treatment-naïve adult patients. The product functions as a complete antiretroviral regimen requiring no additional HIV medications, with cobicistat serving as a pharmacokinetic booster to enhance darunavir exposure. SYMTUZA represents a convenient single-tablet, once-daily formulation in the competitive HIV treatment landscape.
$0.5BPart D
12.2 years to LOEMechanism of Action
Cytochrome P450 3A Inhibitors
Pharmacologic Class:
Cytochrome P450 3A 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.