Last reviewed · How we verify
Odalasvir 75 mg
Odalasvir 75 mg is a Direct-acting antiviral (DAA); NS5A inhibitor Small molecule drug developed by Janssen Research & Development, LLC. It is currently in discontinued development.
Odalasvir inhibits hepatitis C virus NS5A protein to block viral replication and assembly.
Odalasvir 75 mg is being studied in clinical trials for its pharmacokinetic interaction with other medications, including in patients with hepatic impairment and those with chronic hepatitis C. The exact indications for Odalasvir 75 mg are not specified in the provided facts, but it is being investigated in combination with simeprevir for a pharmacokinetic interaction study.
At a glance
| Generic name | Odalasvir 75 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. NS5A is a multifunctional, zinc-binding phosphoprotein that plays critical roles in HCV RNA replication, virion assembly, and host cell interactions. By binding to and inhibiting NS5A, odalasvir disrupts the viral replication complex, preventing the virus from making copies of itself and assembling infectious particles. This mechanism is distinct from protease inhibitors (which block viral protein processing) and polymerase inhibitors (which block RNA synthesis), allowing odalasvir to be combined with drugs targeting other viral proteins for enhanced antiviral activity. The drug was developed as part of a multi-DAA combination strategy to achieve high cure rates in hepatitis C patients across different viral genotypes.
Approved indications
Pipeline indications
- Chronic hepatitis C (genotype 1) — Phase 2
- Chronic hepatitis C (treatment-naïve and treatment-experienced) — Phase 2
- Chronic hepatitis C (Japanese population) — Phase 2
Common side effects
Drug interactions
- Simeprevir
- AL-335
Key clinical trials
- Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants (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 75 mg CI brief — competitive landscape report
- Odalasvir 75 mg updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Odalasvir 75 mg
What is Odalasvir 75 mg?
How does Odalasvir 75 mg work?
Who makes Odalasvir 75 mg?
What drug class is Odalasvir 75 mg in?
What development phase is Odalasvir 75 mg in?
What does Odalasvir 75 mg target?
Related
- Drug class: All Direct-acting antiviral (DAA); NS5A inhibitor drugs
- Target: All drugs targeting Hepatitis C virus NS5A protein
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Therapeutic area: All drugs in Infectious Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing