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Bemnifosbuvir-Ruzasvir

Phase 3

HEPATITIS C VIRUS CHRONIC INFECTION | Small molecule | Infectious Disease |Atea Pharmaceuticals, Inc.|Last Updated: Jun 29, 2026

Target and mechanism

Molecular targetHCV
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,760

FDA Designations

FAST_TRACK

Clinical trial landscape

Bemnifosbuvir-Ruzasvir · 2 trials · 4 indications

Phase 3 2
NCT07037277C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCVHEPATITIS C VIRUS CHRONIC INFECTION
ACTIVE NOT_RECRUITING880 Analytics
NCT06868264C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCVHEPATITIS C VIRUS CHRONIC INFECTION
ACTIVE NOT_RECRUITING880 Analytics
PHASE3ACTIVE NOT_RECRUITING
C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV
HEPATITIS C VIRUS CHRONIC INFECTIONUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV
HEPATITIS C VIRUS CHRONIC INFECTIONUnlock trial analytics

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 to 85 Years
SexALL
Healthy VolunteersNo
Study Sites107

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:EgyptFranceGermanyGreeceIndiaMalaysiaMoldovaPakistanPolandRomaniaSouth AfricaSouth KoreaSpainThailandTurkey (Türkiye)UkraineVietnamUnited StatesCanada
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Recent Changes (Last 90 Days)

MEDIUMJun 29, 2026NCT07037277Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 29, 2026NCT07037277Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about Bemnifosbuvir-Ruzasvir

What is Bemnifosbuvir-Ruzasvir used for?

Bemnifosbuvir-Ruzasvir (BEM/RZR) is an investigational small molecule being developed for the treatment of chronic hepatitis C virus (HCV) infection. It is currently in Phase 3 clinical development and has received Fast Track designation from the FDA.

What does Bemnifosbuvir-Ruzasvir target?

Bemnifosbuvir-Ruzasvir targets the hepatitis C virus (HCV). It is a small molecule antiviral designed to treat chronic HCV infection by acting on the virus itself.

Who makes Bemnifosbuvir-Ruzasvir?

Bemnifosbuvir-Ruzasvir is being developed by Atea Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol AVIR.

What phase is Bemnifosbuvir-Ruzasvir in?

Bemnifosbuvir-Ruzasvir is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. It has received Fast Track designation for the treatment of chronic hepatitis C virus infection.

What clinical trials is Bemnifosbuvir-Ruzasvir in?

Bemnifosbuvir-Ruzasvir is being studied in two active Phase 3 trials: NCT07037277 (C-Forward) and NCT06868264 (C-BEYOND). Both are active but not recruiting, with 880 participants each, comparing BEM/RZR to sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic HCV.

Is Bemnifosbuvir-Ruzasvir the same as BEM/RZR?

Yes, Bemnifosbuvir-Ruzasvir is also known as BEM/RZR. The combination is referred to by this shortened name in clinical trial documentation and research contexts.