Last reviewed · How we verify
Placebo matching BMS-790052
BMS-790052 is a direct-acting antiviral agent that inhibits hepatitis C virus (HCV) NS5A protein, blocking viral replication.
BMS-790052 is a direct-acting antiviral agent that inhibits hepatitis C virus (HCV) NS5A protein, blocking viral replication. Used for Chronic hepatitis C virus infection (genotype 1).
At a glance
| Generic name | Placebo matching BMS-790052 |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | NS5A inhibitor |
| Target | HCV NS5A protein |
| Modality | Small molecule |
| Therapeutic area | Virology/Hepatology |
| Phase | Phase 3 |
Mechanism of action
BMS-790052 targets the NS5A protein of hepatitis C virus, which is essential for viral RNA replication and assembly. By inhibiting NS5A, the drug prevents HCV from multiplying in infected hepatocytes. This mechanism allows for high barrier to resistance when combined with other direct-acting antivirals in combination therapy regimens.
Approved indications
- Chronic hepatitis C virus infection (genotype 1)
Common side effects
- Headache
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects: Part A: Safety and Efficacy of INX-08189 With Peg IFN Alfa-2a and Ribavirin. Part B: INX-08189 in Interferon Free Treatment With Daclatasvir and/or Ribavirin (PHASE2)
- A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects (PHASE2)
- Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C (PHASE3)
- Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3 (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)
- Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |