NDAORALTABLETPriority Review
Approved
Jun 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
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 2016.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPCLUSA is an oral fixed-dose combination tablet containing velpatasvir and sofosbuvir, developed by Gilead Sciences and approved in June 2016. It is a nucleotide analog NS5B polymerase inhibitor that works through RNA replicase inhibition to treat hepatitis C virus (HCV) infection. The combination addresses the need for pan-genotypic, direct-acting antiviral therapy with high efficacy across HCV genotypes. As a foundational DAA regimen, it established a treatment paradigm shift from interferon-based therapy to all-oral, short-duration HCV cure.
$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 (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.