DARUNAVIR

Post-LOESM

darunavir

Cipla

ANDAORALTABLET

Approved

Nov 2023

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

3/8 — Basic

Drug data last refreshed 22h ago

$0.0BPart D

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)

NCT05197075Phase 1Completed

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)

NCT05378906Phase 1Completed

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

NCT04718805Phase 1Completed

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

NCT04661397Phase 1Completed

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

NCT04630002Phase 1Completed

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.