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Bemnifosbuvir-Ruzasvir
Bemnifosbuvir is a nucleoside analog that inhibits hepatitis C virus (HCV) RNA-dependent RNA polymerase, while ruzasvir is an NS5A inhibitor that blocks viral protein function and replication.
Bemnifosbuvir is a nucleoside analog that inhibits hepatitis C virus (HCV) RNA-dependent RNA polymerase, while ruzasvir is an NS5A inhibitor that blocks viral protein function and replication. Used for Chronic hepatitis C virus (HCV) infection, genotype 1-6.
At a glance
| Generic name | Bemnifosbuvir-Ruzasvir |
|---|---|
| Also known as | (BEM/RZR) |
| Sponsor | Atea Pharmaceuticals, Inc. |
| Drug class | Direct-acting antiviral (DAA) combination; nucleoside polymerase inhibitor + NS5A inhibitor |
| Target | HCV NS5B RNA-dependent RNA polymerase; HCV NS5A protein |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
This is a fixed-dose combination targeting two distinct steps of the HCV replication cycle. Bemnifosbuvir acts as a chain terminator in viral RNA synthesis by inhibiting the NS5B polymerase, while ruzasvir prevents the proper functioning of the NS5A protein, which is essential for viral replication and assembly. Together, they provide complementary antiviral activity against HCV.
Approved indications
- Chronic hepatitis C virus (HCV) infection, genotype 1-6
Common side effects
- Headache
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV (PHASE3)
- Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone (PHASE1)
- Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG) (PHASE1)
- C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV (PHASE3)
- A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV (PHASE2)
- Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function (PHASE1)
- Drug-drug Interaction Study of Omeprazole and Bemnifosbuvir/Ruzasvir (PHASE1)
- Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Digoxin and Rosuvastatin (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bemnifosbuvir-Ruzasvir CI brief — competitive landscape report
- Bemnifosbuvir-Ruzasvir updates RSS · CI watch RSS
- Atea Pharmaceuticals, Inc. portfolio CI