Virazole
(Ribavirin)ApprovedSmall molecule
Ribavirin is an antiviral medication used to treat certain viral infections, most commonly hepatitis C (often combined with other drugs) and severe respiratory syncytial virus (RSV) infection in hospitalized patients.[2] Virazole is currently approved and in use across 22 indications[4].[1]
Virazole is one of 438 small molecule programs targeting HIV infection. It is currently in Approved.
22
Indications
517
Total Trials
2
Active Trials
437
Competitors
4
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 22 indications
Competition
Competitive Landscape
332 competitors in Treatment
#DrugCompanyPhaseTrials
1Virazole
CConrado Roberto Hoffmann Filho
Approved
Biltricide
BayerPreclinical
Minipress
PfizerPreclinical
Levulan
Sun Pharmaceutical Industries, Inc.Preclinical
Lamprene
NovartisPreclinical
Emtriva
GileadPreclinical
Foscavir
CClinigen, Inc.
Preclinical
Hivid
CConrado Roberto Hoffmann Filho
Preclinical
Intuniv
PPromius Pharma, LLC
Preclinical
Reminyl
WWim Janssens
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Chronic Hepatitis71 trials
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Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV)
Completed·—·Phase 2/3·NCT01276756·100 enrolled
Observational Cohort Study of Clinical Outcomes After Antiviral Therapy for Chronic Hepatitis C
Unknown status·—··NCT04071353·1,000 enrolled
High-Dose Ribavirin and Peginterferon to Treat Chronic Hepatitis C Genotype 1
Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00735969·21 enrolled
Hepatitis C50 trials
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Timing and Duration of Acute Hepatitis C Treatment
Completed·—·Phase 4·NCT00241618·180 enrolled
Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C
Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 3·NCT00122616·52 enrolled
Hepatitis C Antiviral Resistance in African-Americans
Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00038974·401 enrolled
Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT01443923·4 enrolled
Escitalopram for the Prevention of PEGASYS-associated Depression in Hepatitis C Virus-infected Patients
Completed·—·Phase 3·NCT00136318·208 enrolled
Treatment of Hepatitis C in Hemophilic Patients With HIV
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00055341·22 enrolled
Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00018031·36 enrolled
Treatment10 trials
Show 7 more trials
Efficacy and Safety4 trials
Show 1 more trial
HCV3 trials
Response Modifier (Arabinoxylan Rice Bran/MGN-3/Biobran) With Interferon-Alpha for HCV
Completed·—·Phase 2·NCT02690103·37 enrolled
45 more indications
HIV3 trials
Zidovudine Levels in HIV Infected Patients Being Treated for HCV
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00059358·16 enrolled
Safety and Efficacy3 trials
Liver Transplant2 trials
Hepatocellular Carcinoma2 trials
Randomized2 trials
Chronic Hepatitis C Virus Infection2 trials
Lassa fever2 trials
Hepatitis C Virus Infection2 trials
Combination Therapy2 trials
A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000833·20 enrolled
COVID-192 trials
Induction Therapy2 trials
Insulin resistance2 trials
Liver Disease1 trial
Metastatic Melanoma1 trial
Interaction1 trial
Herpangina1 trial
Effect of Recombinant Human Interferon α-2b Spray on Herpangina
Completed·—·Phase 4·NCT03266601·668 enrolled
Oral1 trial
Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease
Completed·—·Phase 4·NCT02328651·24 enrolled
Cirrhosis1 trial
Hepatitis E Virus Infection1 trial
HCV Infection1 trial
HIV-11 trial
Children1 trial
Immunodeficiency1 trial
Hemorrhage1 trial
Pneumonia1 trial
Hepatitis1 trial
A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus
Unknown status·—·Phase 2·NCT01698723·40 enrolled
Age1 trial
Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure
Completed·—·N/A·NCT03549832·40 enrolled
Solid Tumour1 trial
Monotherapy1 trial
Prospective1 trial
Mantle Cell Lymphoma1 trial
Respiratory Syncytial Virus1 trial
Unspecified4 trials
12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF
Terminated·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT02605304·7 enrolled
Show 1 more trial
Regulatory
FDA Approval Timeline[5]
Dec 31, 1985
VIRAZOLE
NDA NDA018859
Jun 3, 1998
REBETOL
NDA NDA020903
Dec 3, 2002
COPEGUS
NDA NDA021511
Jul 29, 2003
REBETOL
NDA NDA021546
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Virazole drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Ribavirin. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Inosine-5'-Monophosphate Dehydrogenase 1 Inhibitor; RNA-Directed RNA Polymerase Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- CConrado Roberto Hoffmann Filho