Last reviewed 2026-04-19 · How we verify

ODV 25 mg

Odalasvir inhibits hepatitis C virus NS5A protein to block viral replication and assembly.

ODV 25 mg (odalasvir) is a hepatitis C virus NS5A inhibitor developed by Janssen Research & Development that was discontinued before FDA approval. The drug was designed to inhibit the NS5A protein, a critical regulator of HCV replication and virion assembly, and was evaluated in combination with other direct-acting antivirals (simeprevir and AL-335) in Phase 2 clinical trials enrolling 559 patients with chronic hepatitis C. Clinical development was halted despite completion of Phase 2 efficacy and safety studies, likely due to competitive pressures from other all-oral HCV regimens that achieved superior efficacy profiles or simpler dosing schedules. The discontinuation reflects the rapidly evolving HCV treatment landscape where multiple first-in-class and best-in-class combination therapies achieved market dominance, reducing commercial viability for late-stage entrants. No approved indications, revenue, or commercial data exist for this discontinued asset.

At a glance

Mechanism of action

Odalasvir is a direct-acting antiviral (DAA) that targets the NS5A protein of hepatitis C virus (HCV). The NS5A protein is a multifunctional regulator essential for HCV RNA replication and the assembly and secretion of infectious viral particles. By binding to and inhibiting NS5A, odalasvir disrupts both the early replication phase and the later stages of virion production, effectively suppressing viral load in infected patients. The drug was designed to be used as part of combination therapy with other DAAs (such as simeprevir, a protease inhibitor, and AL-335, a nucleotide polymerase inhibitor) to achieve high barrier to resistance and improved efficacy across diverse HCV genotypes.

Approved indications

No approved indications tracked.

Pipeline indications

• Chronic Hepatitis C (genotypes 1–6) — Phase 2

Common side effects

No common side effects on file.

Drug interactions

• Simeprevir
• AL-335

Key clinical trials

• A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants (PHASE1)
• Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy (PHASE4)
• Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection (PHASE2)
• A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive (PHASE2)
• A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir (PHASE2)
• A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD (PHASE3)
• Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD) (PHASE3)
• Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC) (PHASE1)

Primary sources

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