NDAORALTABLETPriority Review
Approved
Dec 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
SOVALDI (sofosbuvir) by Gilead Sciences is rna replicase inhibitors [moa]. Approved for hepatitis c virus nucleotide analog ns5b polymerase inhibitor [epc]. First approved in 2013.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOVALDI (sofosbuvir) is an oral nucleotide analog NS5B polymerase inhibitor that blocks hepatitis C virus replication. It is a small-molecule antiviral approved in 2013 and has become a cornerstone of direct-acting antiviral (DAA) regimens for HCV cure. The drug works by inhibiting the viral RNA replicase enzyme essential for HCV replication.
$2MPart D
Peak5.1 years to LOEProduct is in peak lifecycle stage with established market position; commercial teams remain focused on maintaining share in a mature HCV treatment market with 5+ years of patent protection remaining.
Mechanism of Action
RNA Replicase Inhibitors
Pharmacologic Class:
Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Started Apr 2022
100 enrolled
Hepatitis C, ChronicPregnancy; Infection
Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir
Started Oct 2020
11 enrolled
Hepatitis C, Chronic
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
Started Jan 2020
87 enrolled
Hepatitis C Virus Infection
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
Started Oct 2019
37 enrolled
Hepatitis C Virus Infection
Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir
Started May 2019
20 enrolled
Hepatitis CAcute Hepatitis C
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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.