NDAORALTABLETPriority Review
Approved
Jun 2006
Lifecycle
LOE Approaching
Competitive Pressure
40/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREZISTA (darunavir) is an oral protease inhibitor approved in 2006 for the treatment of HIV-1 infection in treatment-experienced and treatment-naïve patients. It works by inhibiting HIV protease, preventing viral replication and reducing viral load in infected individuals. The drug is administered orally as a tablet and is typically used in combination antiretroviral therapy.
LOE Approaching9mo to LOE
Product is approaching loss of exclusivity in mid-2027, signaling potential team downsizing and shift to defensive strategies focused on market retention.
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 to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children
Started Aug 2022
15 enrolled
Human Immunodeficiency Virus (HIV)
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants
Started Jun 2022
32 enrolled
Healthy
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions
Started Jan 2021
22 enrolled
Healthy
A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents
Started Jan 2021
37 enrolled
Healthy
Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)
Started Oct 2020
54 enrolled
HIV Infections
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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.