Back to discover
Drug

Sofosbuvir

Approved · EMA
Emerging researchLate-stage development
Also known as Epclusa, Harvoni, Ledipasvir-Sofosbuvir, Sofosbuvir-Velpatasvir+3 more

Epclusa, Harvoni, Ledipasvir-Sofosbuvir, Sofosbuvir-Velpatasvir, Sovaldi, Vosevi, S)-Isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4- dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)- (phenoxy)phosphorylamino)propanoate.

RxNorm1484911ChEMBLCHEMBL1259059UNIIWJ6CA3ZU8B
1
Research papers
1
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Atea’s hepatitis C asset matches Gilead’s Epclusa in phase 3 trial

Clinical trial2026-07-28Trial news · Fierce Biotech

An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study

Clinical trial2026-06-29Results expected Q4 2026 · ClinicalTrials.gov

A Phase IV Open-label Multicentre International Pilot Study of 4-week Treatment With Sofosbuvir (400 mg) Plus Glecaprevir/Pibrentasvir (300mg/120mg) in Chronic HCV Treatment naïve Patients With Early Liver Disease

Clinical trial2026-02-01Primary completion · ClinicalTrials.gov

Recall (Class II): VELPATASVIR AND SOFOSBUVIR

Regulatory2025-03-07FDA

A Phase 2 Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of 12 Weeks of Treatment With Simeprevir, Daclatasvir and Sofosbuvir, Followed by a 5-Year Post-treatment Long-term Follow-up, in Treatment-naïve and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease

Clinical trial2025-02-04Results posted · ClinicalTrials.gov

Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy

Clinical trial2024-08-29Terminated · ClinicalTrials.gov

Efficacy and Safety of 8- Versus 12-week Sofosbuvir-ravidasvir Treatment of Non-cirrhotic Chronic Hepatitis C Patients: An Open-label, Randomized, Multicenter Study in Malaysia

Clinical trial2024-03-15Completed · ClinicalTrials.gov

An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3)

Clinical trial2022-05-04Results posted · ClinicalTrials.gov

A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study

Clinical trial2021-11-18Results posted · ClinicalTrials.gov

A Phase II Open-Label Study of Ledipasvir/Sofosbuvir for 12 Weeks in Subjects With Hepatitis B Virus Infection

Clinical trial2021-09-20Results posted · ClinicalTrials.gov

Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial.

Research2016-12-19Hepatology (Baltimore, Md.)

Accelerated approval: Sovaldi (EMA)

Regulatory2014-01-16EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Sofosbuvir
Aliases & brands
EpclusaHarvoniLedipasvir-SofosbuvirSofosbuvir-VelpatasvirSovaldiVoseviS)-Isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4- dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)- (phenoxy)phosphorylamino)propanoate
RxNorm CUI
1484911
ChEMBL ID
CHEMBL1259059
UNII
WJ6CA3ZU8B
Regulatory jurisdictions
fdaema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2014-01-16
Latest approval
2014-01-16
Authorities
FDA · EMA
Total events
2
fdaU.S. Food and Drug Administration· 1 event
2025-03-07RecallSafety
Recall (Class II): VELPATASVIR AND SOFOSBUVIR
Evidence ↗
emaEuropean Medicines Agency· 1 event
2014-01-16Accelerated approval
Accelerated approval: Sovaldi (EMA)
Indication: Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see… Show full indication

Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1. Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

87 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
87
registered trials across all phases
LATEST COMPLETION 2024
1
Active studies
47
Late-stage (III+)
71
Completed
15
Discontinued
PHASE DISTRIBUTIONn = 87
Early Phase 11Phase 16Phase 1 / 21Phase 232Phase 2 / 36Phase 327Phase 412Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase IV Open-label Multicentre International Pilot Study of 4-week Treatment With Sofosbuvir (400 mg) Plus Glecaprevir/Pibrentasvir (300mg/120mg) in Chronic HCV Treatment naïve Patients With Early Liver Disease

Unknown statusPH IVKirby Instituten=302026

Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy

TerminatedPH IVM.D. Anderson Cancer Centern=22024

Study of the Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With and Without Post-hepatitis C Cirrhosis

CompletedPH IVKey trialTanta Universityn=10,0002019

A Phase III, Open Label, Multicentric Clinical Trial of a Single Arm of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotype 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A

WithdrawnPH IVFundacion SEIMC-GESIDA2018

Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon (Hepatitis Eradication Accuracy Trial of Sofosbuvir): An Observational Non-interventional Real Life Trial

CompletedPH IVPharmEvo Pvt Ltdn=5732018

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy and Safety of 8- Versus 12-week Sofosbuvir-ravidasvir Treatment of Non-cirrhotic Chronic Hepatitis C Patients: An Open-label, Randomized, Multicenter Study in Malaysia

CompletedPH II/IIIMuhammad Radzi Abu Hassann=3222024

An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3)

CompletedPH IIIAbbVien=332021

A Phase II Open-Label Study of Ledipasvir/Sofosbuvir for 12 Weeks in Subjects With Hepatitis B Virus Infection

CompletedPH IIUniversity of Maryland, Baltimoren=212021

A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study

CompletedPH IIUniversity of Dundeen=1292020

A Phase Ib/IIa, Single Center, Randomized, Open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability， Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects

CompletedPH I/IISunshine Lake Pharma Co., Ltd.n=242020

Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1

CompletedPH IIR-Pharmn=852020

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Hepatology (Baltimore, Md.)1
Leading researchers
  • Barr E1
  • Dutko FJ1
  • Evans B1
  • Gutierrez JA1
  • Haber B1
  • Howe A1
  • Huang HC1
  • Hwang P1
Leading institutions
free-text, unnormalised
  • Texas Liver Institute1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.