NDAORALPELLETSPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
5/8 — Partial
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 2019.
Drug data last refreshed 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOVALDI (sofosbuvir) is an oral nucleotide analog NS5B polymerase inhibitor that directly targets hepatitis C virus replication. It is a foundational HCV cure therapy administered as pellets via oral route. The drug works by inhibiting the viral RNA replicase enzyme essential for HCV genome synthesis.
Peak4.8 years to LOE
SOVALDI occupies a mature peak-lifecycle position within Gilead's dominant HCV portfolio, with minimal standalone spending ($2M) suggesting it functions as a component therapy rather than a primary franchise driver.
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.