NDAORALPELLETSPriority Review
Approved
Jun 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
8/8 — Comprehensive
Priority Review
EPCLUSA (velpatasvir and sofosbuvir) by Gilead Sciences is breast cancer resistance protein inhibitors [moa]. Approved for hepatitis c virus ns5a inhibitor [epc]. First approved in 2021.
Drug data last refreshed 21h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPCLUSA is an oral, fixed-dose combination of velpatasvir (NS5B polymerase inhibitor) and sofosbuvir (nucleotide analog) developed by Gilead Sciences for the treatment of hepatitis C virus (HCV) infection. The combination works by inhibiting viral RNA replication through dual mechanism targeting. Approved in June 2021, it represents a mature direct-acting antiviral therapy option in the HCV treatment landscape, competing within Gilead's own portfolio of HCV antivirals.
$0.9BPart D
8.2 years to LOEMechanism of Action
Breast Cancer Resistance Protein Inhibitors
Pharmacologic Class:
Hepatitis C Virus NS5A Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy
Started Feb 2018
25 enrolled
HIV-1-infectionHepatitis C, ChronicMethadone Dependence+6 more
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
Started Dec 2010
292 enrolled
Chronic Hepatitis C Infection
Why This Matters for Your Career
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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.