EPCLUSA (sofosbuvir)
EPCLUSA is indicated for the treatment of Hepatitis C.
How EPCLUSA Works
EPCLUSA consists of two direct-acting antiviral agents, sofosbuvir and velpatasvir, which target specific stages of the hepatitis C virus lifecycle. Sofosbuvir is a nucleotide analog that inhibits the NS5B polymerase, an enzyme the virus requires to replicate its genetic material. Velpatasvir targets the NS5A protein, which is essential for both viral replication and the assembly of new virus particles. By inhibiting these two distinct proteins, the medication prevents the hepatitis C virus from multiplying.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-06-28
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET, PELLETS
EPCLUSA Approval History
What EPCLUSA Treats
1 indicationsEPCLUSA is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hepatitis C
EPCLUSA Boxed Warning
RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfect...
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated [see Warnings and Precautions (5.1) ] . WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV See full prescribing information for complete boxed warning. Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 )
EPCLUSA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to EPCLUSA
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
69 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03520660 | 180091 18-DK-0091 | Ph 4 | active not recruiting | People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents |
| NCT02771405 FRI-STC | 4/2016 | Ph 3 | completed | Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC |
| NCT04075916 THINKER-NEXT | 10067385 U01DK126654 | Ph 2 | completed | A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients |
| NCT03383419 TROJAN-C | 018-009 | Ph 2 | recruiting | Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients |
| NCT02262728 results posted | CR105028 TMC435HPC2010 | Ph 2 | completed | An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease |
| NCT05717400 results posted | 2022-0844 NCI-2023-00828 | Ph 4 | terminated | Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy |
| NCT02992457 | Asem Elfert | Ph 4 | completed | Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection |
| NCT02596880 SD100 | 94-02-159-30278 | Ph 3 | completed | Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics |
| NCT03724149 SHELTER results posted | 829397 | Ph 1, Ph 2 | completed | Transplanting Hepatitis C Lungs Into Negative Lung Recipients |
| NCT03377478 | STUDY19030435 | Ph 1 | completed | Expanding the Pool in Lung Transplantation |
| NCT04246723 | CJ05013053 | Ph 2 | completed | Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 |
| NCT02939989 MAGELLAN-3 results posted | M15-942 2016-002491-26 | Ph 3 | completed | Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study |
| NCT03706898 | HIV-VM1500-07 | Ph 1 | completed | Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs |
| NCT02640157 ENDURANCE-3 results posted | M13-594 2015-002272-24 | Ph 3 | completed | A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection |
| NCT02292719 Quartz II/III results posted | M14-567 2014-003147-35 | Ph 2 | completed | A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection |
| NCT03480932 results posted | R01DA026727 R01DA026727 | Ph 2, Ph 3 | completed | Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C] |
| NCT03487848 results posted | AI444-423 2017-003338-94 | Ph 2 | terminated | Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection |
| NCT02541409 C-DOT results posted | R01DA02672 R01DA026727 | Ph 2 | completed | Directly Observed Therapy for HCV in Chennai, India |
| NCT03883698 | 2018-167-IMP-107 CTRI/2019/03/018011 | Ph 3 | completed | Safety of Sofosbuvir in People With Advanced Kidney Failure |
| NCT02133131 results posted | 5172-074 | Ph 2 | completed | Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074) |
| NCT02825212 results posted | GCO 15-2282 IN-US-337-1716 | Ph 2, Ph 3 | completed | Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia |
| NCT02175966 FOURward results posted | AI443-131 | Ph 2 | completed | Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study) |
| NCT02468648 results posted | 150143 15-DK-0143 | Ph 2 | completed | Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816 |
| NCT03207399 results posted | Pro00074361 | Ph 4 | terminated | Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment |
| NCT02601573 results posted | 5172-083 2015-003187-37, MK-5172-083 | Ph 2 | completed | Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083) |
| NCT03995485 KW-136_III | KYGL-2017-001 CTR20171654 | Ph 3 | completed | KW-136 With Sofosbuvir for Chinese Adults With Chronic Hepatitis C |
| NCT03282474 | HepNet-SofE 2017-000403-24 | Ph 2 | completed | HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE) |
| NCT02717949 Optimal results posted | 042015-086 | Ph 4 | terminated | Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study |
| NCT02358044 results posted | 5172-077 2014-003836-38 | Ph 3 | completed | Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077) |
| NCT02804386 HEATS | PE/ZOVAL/2016/08 | Ph 4 | completed | Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon |
| NCT02781649 EXPANDER-1 results posted | IRB00089751 | Ph 4 | completed | Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients |
| NCT02214420 results posted | PJPIIS-01-14 | Ph 4 | completed | SMV + SOF With/Without RBV for IFN-II Patients With CHC |
| NCT03105349 C-RESCUE | GESIDA 9516 | Ph 4 | withdrawn | A Clinical Trial of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotypes 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A |
| NCT02705534 SL50 | 94-04-37-31023 | Ph 3 | completed | Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 |
| NCT02128217 SWIFT-C results posted | ACTG A5327 UM1AI068636 | Ph 1 | completed | Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection |
| NCT02473211 | H&H_SOF plus DCV treatment | Ph 2, Ph 3 | completed | SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients |
| NCT02021643 results posted | GS-US-334-0115 | Ph 3 | completed | Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection |
| NCT03416491 KW-136_II | BJKY-2016-006 CTR20170073 | Ph 2 | completed | Safety and Efficacy of KW-136 and Sofosbuvir for Treatment of Chronic Hepatitis C |
| NCT02356562 results posted | M14-224 | Ph 2 | completed | A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection |
| NCT02405013 TAC | ANRS 12311 TAC | Ph 2 | completed | Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa |
| NCT02647632 | ANRS HC34 REVENGE | Ph 2 | completed | Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir |
| NCT01805882 results posted | 130066 13-I-0066 | Ph 2 | completed | Combination Therapy for Chronic Hepatitis C Infection |
| NCT02768961 JAILFREE-C | JCG-SOFLDP-2015-01 | Ph 4 | completed | Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C) |
| NCT02032875 ALLY 1 results posted | AI444-215 | Ph 3 | completed | Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant |
| NCT02319031 results posted | AI444-326 | Ph 3 | completed | Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis |
| NCT02250807 results posted | CR105429 TMC435HPC3021, 2014-003446-27 | Ph 3 | completed | Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection |
| NCT02165189 GALAXY | CR104281 TMC435HPC2009 | Ph 2 | completed | An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant |
| NCT02074514 results posted | GS-US-334-0116 | Ph 3 | completed | Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection |
| NCT02278419 | CR104970 TMC435HPC2014 | Ph 2 | completed | An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection |
| NCT02485080 | 33431 | Ph 4 | withdrawn | Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1 |
Showing 50 of 69 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EPCLUSA FDA Label Details
Indications & Usage
FDA Label (PDF)EPCLUSA is indicated for the treatment of Hepatitis C.
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing...
EPCLUSA Patents & Exclusivity
Patents (32 active)
Exclusivity
Pro Intelligence Preview
Deep insights for EPCLUSA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 232 active patents
Trial Analysis
- • 72 total trials
- • Stage: Declining
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment