NDAINHALATIONFOR SOLUTIONPriority Review
Approved
Dec 1985
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
VIRAZOLE (ribavirin) by Bausch + Lomb. Approved for nucleoside analog antiviral [epc]. First approved in 1985.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIRAZOLE (ribavirin) is a nucleoside analog antiviral administered via inhalation solution for the treatment of severe respiratory syncytial virus (RSV) infections, particularly in immunocompromised patients. It works by inhibiting viral nucleic acid synthesis, disrupting the replication machinery of RNA viruses. This inhaled formulation allows direct delivery to the respiratory tract where RSV infection typically occurs.
LOE Approaching
As a decades-old inhaled antiviral approaching loss of exclusivity, the brand team is likely lean and focused on retention strategies rather than growth initiatives.
Mechanism of Action
Pharmacologic Class:
Nucleoside Analog Antiviral
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Pharmacokinetics, Tolerability and Safety of Favipiravir Compared to Ribavirin for the Treatment of Lassa Fever
Started Jul 2021
40 enrolled
Lassa Fever
Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19_#2
Started May 2021
0COVID19
Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers
Started Mar 2021
32 enrolled
Healthy
Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19
Started Feb 2021
51 enrolled
COVID19
The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
Started Nov 2020
17 enrolled
Hepatitis C, Chronic
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.