Last reviewed · How we verify
Odalasvir 25 mg
Odalasvir inhibits hepatitis C virus NS5A protein to block viral replication and assembly.
Odalasvir 25 mg is a hepatitis C virus (HCV) NS5A inhibitor developed by Janssen Research & Development that was discontinued before FDA approval. The drug was designed to inhibit the NS5A protein, a critical non-structural protein required for HCV replication and virion assembly, and was being evaluated in combination with other direct-acting antivirals (DAAs) including simeprevir and AL-335. Clinical development progressed through Phase 2 trials demonstrating efficacy in chronic hepatitis C patients, with 9 total trials completed or terminated across Phase 1 and Phase 2. The discontinuation reflects the competitive HCV landscape where multiple all-oral, fixed-dose combination regimens with superior efficacy and tolerability profiles (such as sofosbuvir/velpatasvir/voxilaprevir) achieved market dominance, reducing commercial viability for new entrants. Odalasvir never achieved regulatory approval and remains a discontinued development asset with no commercial revenue or market presence.
At a glance
| Generic name | Odalasvir 25 mg |
|---|---|
| Sponsor | Janssen Research & Development, LLC |
| Drug class | Direct-acting antiviral (DAA); NS5A inhibitor |
| Target | Hepatitis C virus NS5A protein |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | discontinued |
Mechanism of action
Odalasvir is a direct-acting antiviral (DAA) that targets the NS5A protein of hepatitis C virus. The NS5A protein is a multifunctional, zinc-binding phosphoprotein essential for HCV RNA replication and the formation of infectious viral particles. By binding to and inhibiting NS5A, odalasvir disrupts the viral replication complex and prevents the assembly and secretion of new HCV virions. This mechanism allows the drug to reduce viral load in infected patients. The drug was developed as part of a combination therapy strategy, where multiple DAAs with different mechanisms (protease inhibitors, polymerase inhibitors, NS5A inhibitors) are used together to maximize efficacy and minimize resistance development.
Approved indications
Pipeline indications
- Chronic hepatitis C virus infection (genotypes 1–6) — Phase 2
Common side effects
Key clinical trials
- A Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir (PHASE1)
- A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants (PHASE1)
- 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)
- 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)
- A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants (PHASE1)
- A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Odalasvir and AL-335 Alone and in Combination With Simeprevir in Participants With Moderately Impaired Hepatic Function (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:
- Odalasvir 25 mg CI brief — competitive landscape report
- Odalasvir 25 mg updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI