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DCV/ASV/BMS-791325
DCV/ASV/BMS-791325 is a Direct-acting antiviral combination (NS5A inhibitor + NS3 protease inhibitor + NS5B polymerase inhibitor) Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 3 development for Chronic hepatitis C virus infection (genotype 1-6). Also known as: Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325.
This is a three-drug combination of direct-acting antivirals (DCV, ASV, and BMS-791325) that inhibit hepatitis C virus NS5A, NS3 protease, and NS5B polymerase respectively to block viral replication.
DCV/ASV/BMS-791325 is a small molecule combination treatment that has been studied in clinical trials for Hepatitis C Infection, Hepatitis C Virus Genotype 4 Infection, and Hepatitis C. This combination treatment has been investigated in a study on its pharmacokinetic effects in healthy volunteers, specifically in relation to the selective serotonin reuptake inhibitors escitalopram and sertraline.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Bristol-Myers Squibb is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | DCV/ASV/BMS-791325 |
|---|---|
| Also known as | Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325 |
| Sponsor | Bristol-Myers Squibb |
| Drug class | Direct-acting antiviral combination (NS5A inhibitor + NS3 protease inhibitor + NS5B polymerase inhibitor) |
| Target | HCV NS5A, NS3/4A protease, NS5B polymerase |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | Phase 3 |
Mechanism of action
DCV (daclatasvir) inhibits the NS5A protein, ASV (asunaprevir) inhibits the NS3/4A serine protease, and BMS-791325 inhibits the NS5B RNA-dependent RNA polymerase. Together, these three agents target multiple steps of the hepatitis C viral lifecycle, preventing viral replication and clearance of infection. This pan-genotypic combination was designed to achieve high cure rates across different HCV genotypes with a short treatment duration.
Approved indications
- Chronic hepatitis C virus infection (genotype 1-6)
Common side effects
- Headache
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (PHASE3)
- Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study) (PHASE2)
- Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV (PHASE2)
- Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications (PHASE2)
- Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus (NA)
- Pilot Study to Assess Efficacy and Safety of a Triple Therapy With Asunaprevir, Daclatasvir, and BMS-791325 in HCV Genotype 4-infected Patients After Failure of Pegylated Interferon-Ribavirin Regimen (PHASE2)
- UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects (PHASE3)
- UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis (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:
- DCV/ASV/BMS-791325 CI brief — competitive landscape report
- DCV/ASV/BMS-791325 updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about DCV/ASV/BMS-791325
What is DCV/ASV/BMS-791325?
How does DCV/ASV/BMS-791325 work?
What is DCV/ASV/BMS-791325 used for?
Who makes DCV/ASV/BMS-791325?
Is DCV/ASV/BMS-791325 also known as anything else?
What drug class is DCV/ASV/BMS-791325 in?
What development phase is DCV/ASV/BMS-791325 in?
What are the side effects of DCV/ASV/BMS-791325?
What does DCV/ASV/BMS-791325 target?
Related
- Drug class: All Direct-acting antiviral combination (NS5A inhibitor + NS3 protease inhibitor + NS5B polymerase inhibitor) drugs
- Target: All drugs targeting HCV NS5A, NS3/4A protease, NS5B polymerase
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Therapeutic area: All drugs in Virology / Hepatology
- Indication: Drugs for Chronic hepatitis C virus infection (genotype 1-6)
- Also known as: Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing