NDAORALPELLETSPriority Review
Approved
Jun 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
7/8 — 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 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPCLUSA is an oral, fixed-dose combination of velpatasvir (NS5A inhibitor) and sofosbuvir (nucleotide polymerase inhibitor) approved for hepatitis C virus (HCV) treatment. It works by inhibiting viral proteins essential for HCV replication, enabling a cure-all-comers approach across all HCV genotypes. The drug represents a cornerstone of pan-genotypic HCV therapy.
$877MPart D
PeakStable
dominant in HCV fixed-dose combination market
8.0 years to LOEPeak-cycle product with strong market position; commercial teams are optimizing market penetration and managing mature franchise operations.
Mechanism 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 (1)
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
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.