NDAORALSOLUTIONPriority Review
Approved
Jul 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
REBETOL (ribavirin) by Merck & Co. is mechanism of action in cell cultures the inhibitory activity of ribavirin for respiratory syncytial virus (rsv) is selective. First approved in 2003.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REBETOL (ribavirin) is an oral antiviral nucleoside analogue indicated for chronic hepatitis C, typically used in combination with interferon-based regimens. It inhibits viral replication through an unknown mechanism believed to involve disruption of cellular metabolites. The drug has demonstrated broad-spectrum antiviral activity against RSV, influenza, and herpes simplex virus in vitro, though clinical significance remains unclear.
LOE Approaching
Declining
As LOE approaches, REBETOL team is entering managed-decline phase with reduced headcount and focus on existing patient maintenance rather than growth initiatives.
Mechanism of Action
Mechanism of Action In cell cultures the inhibitory activity of ribavirin for respiratory syncytial virus (RSV) is selective. The mechanism of action is unknown. Reversal of the in vitro antiviral activity by guanosine or xanthosine suggests ribavirin may act as an analogue of these cellular…
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
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
Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever
Started Mar 2019
2 enrolled
Lassa Fever
Different Ribavirin Dosages and Different Duration of Treatment in Combination With PegInterferon in Patients With Genotype 2 and 3 (WRITE)
Started Dec 2018
1,150 enrolled
Chronic Hepatitis
Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation
Started Mar 2017
60 enrolled
Chronic Hepatitis C
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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.