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dasabuvir 8 weeks
dasabuvir 8 weeks is a HCV NS5B polymerase inhibitor Small molecule drug developed by Hepa C. It is currently in Phase 2 development. Also known as: exviera.
Dasabuvir inhibits the HCV NS5B RNA-dependent RNA polymerase, blocking viral RNA replication.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | dasabuvir 8 weeks |
|---|---|
| Also known as | exviera |
| Sponsor | Hepa C |
| Drug class | HCV NS5B polymerase inhibitor |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
Dasabuvir binds to a non-nucleoside site on the HCV NS5B polymerase, causing a conformational change that prevents the enzyme from synthesizing viral RNA. This direct-acting antiviral mechanism stops HCV replication without requiring host immune activation.
Approved indications
Common side effects
Key clinical trials
- Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P (PHASE3)
- A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects (PHASE2, PHASE3)
- A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults (PHASE3)
- A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV) (PHASE2)
- Pilot HCV Direct Acting Antiviral Therapy and Metabolism (PHASE4)
- The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France
- A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before (PHASE3)
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:
- dasabuvir 8 weeks CI brief — competitive landscape report
- dasabuvir 8 weeks updates RSS · CI watch RSS
- Hepa C portfolio CI
Frequently asked questions about dasabuvir 8 weeks
What is dasabuvir 8 weeks?
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Is dasabuvir 8 weeks also known as anything else?
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Related
- Drug class: All HCV NS5B polymerase inhibitor drugs
- Manufacturer: Hepa C — full pipeline
- Also known as: exviera
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing