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Bemnifosbuvir-Ruzasvir

Phase 3

HEPATITIS C VIRUS CHRONIC INFECTION | Small molecule | Infectious Disease |Atea Pharmaceuticals, Inc.|Last Updated: Apr 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment1,760
FDA Designations
FAST_TRACK
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07037277C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCVPHASE3 RECRUITING 880Jun 2, 2025Mar 1, 2027Apr 13, 2026106 France, Germany +14
NCT06868264C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCVPHASE3 ACTIVE NOT_RECRUITING 880Apr 7, 2025Dec 1, 2026Dec 5, 2025105 United States, Canada
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Study Endpoints
Primary Endpoints
Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at week 24
Day 1 through Week 24
Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.
Day 1 through Week 24
Secondary Endpoints
Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs
Day 1 through 12 weeks after the end of treatment
Proportion of subjects experiencing virologic failure as measured by HCV RNA RT-qPCR
Day 1 through Week 24
Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs.
Day 1 through 12 weeks after the end of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bemnifosbuvir - Ruzasvir (BEM/RZR)EXPERIMENTAL -
Sofosbuvir-Velpatasvir (SOF/VEL)ACTIVE_COMPARATOR -
Bemnifosbuvir-Ruzasvir (BEM/RZR)EXPERIMENTAL -
Interventions
NameTypeDescription
Bemnifosbuvir-RuzasvirDRUGBEM/RZR Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 8 weeks (in those without cirrhosis) or 12 weeks (in those with compensated cirrhosis)
Sofosbuvir-VelpatasvirDRUGSOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks
Bemnifosbuvir-Ruzasvir (BEM/RZR)DRUGBEM/RZR Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 8 weeks (in those without cirrhosis) or 12 weeks (in those with compensated cirrhosis)
Sofosbuvir-Velpatasvir (SOF/VEL)DRUGSOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites106

Key Inclusion Criteria: * Use of adequate contraception for females of childbearing potential * Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approved or experimental DAA for HCV) * Documented medical history compatible with chronic HCV * Either no liver cirrhosis or wi...

Countries:FranceGermanyGreeceIndiaMalaysiaMoldovaPakistanPolandRomaniaSouth AfricaSouth KoreaSpainThailandTurkey (Türkiye)UkraineVietnamUnited StatesCanada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07037277primaryCompletionDate: changed
LOWMay 26, 2026NCT06868264primaryCompletionDate: changed
LOWMay 24, 2026NCT07037277studyFirstPostDate: changed
LOWMay 24, 2026NCT06868264studyFirstPostDate: changed