Ribavirin
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1985
- First approval year
- 1985
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Ribavirin
- Molecular weight
- 244.21
- Structure (SMILES)
- NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
- copegus
- Copegus
- cotronak
- Cotronak
- rebetol
- Rebetol
- ribapak
- Ribapak
- ribasphere
- Ribasphere
- ribavarin
- Ribavarin
- ribavirin
- Ribavirin
- ribavirin biopartners
- Ribavirin biopartners
- Ribavirin mylan (previously ribavirin three rivers)
- ribavirin mylan previously ribavirin three rivers
- ribavirin teva
- Ribavirin teva
- ribavirin teva pharma b v
- Ribavirin teva pharma b.v.
- ribofluranosyl carboxamide
- Ribofluranosyl carboxamide
- viramid
And 5 more, listed on the interactive page.
- 1 beta d ribofuranosyl 1h 1 2 4 triazole 3 carboxamide
- 1-.BETA.-D-RIBOFURANOSYL-1H-1,2,4-TRIAZOLE-3-CARBOXAMIDE
- 1h 1 2 4 triazole 3 carboxamide 1 beta d ribofuranosyl
- 1H-1,2,4-TRIAZOLE-3-CARBOXAMIDE, 1-.BETA.-D-RIBOFURANOSYL-
- Copegus
- COPEGUS
- Copegus (ribavirin)
- COPEGUS (ribavirin)
- Copegus®
- COPEGUS™
- COPEGUS™ 200 mg Tablets
- cotronak
- Cotronak
- Intravenous ribavirin
- nsc 163039
- NSC-163039
- rbv
- RBV
- RBV(24 weeks)
- RBV(48 weeks)
- Rebetol
- REBETOL
- Rebetol (ribavirin)
- Rebetol (Ribavirin)
- Ribasphere
And 70 more, listed on the interactive page.
- CAS registry numbers
- 36791-04-5
- ChEMBL ID
- CHEMBL1643
- InChIKey
- IWUCXVSUMQZMFG-AFCXAGJDSA-N
- PubChem compound IDs
- 37542
- RxNorm IDs (RxCUI)
- 9344
- FDA ingredient codes (UNII)
- 49717AWG6K
- J05AB04
- J05AP01
Sources for recorded values
- Applicant
- BAUSCH
- Approval date
- 31 Dec 1985
- Application number
- NDA018859
- Status
- Withdrawn
- Status date
- 18 Oct 2023
- Authorisation date
- 6 May 1999
- Approved indications
- Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.
- Product number
- EMEA/H/C/000246
- Authorisation holder
- Merck Sharp and Dohme B.V
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Hepatitis C, Chronic
European medicines record
- Patents
- 0
- Designations
- 2
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- ribavirin
- Type
- Synthetic organic
- Drug name stem
- -vir-
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- topical
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- inosine monophosphate dehydrogenase 2
- Gene symbol
- IMPDH2
- Protein identifier
- P12268
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- inosine monophosphate dehydrogenase 1
- Gene symbol
- IMPDH1
- Protein identifier
- P20839
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Inosine-5'-monophosphate dehydrogenase 1 inhibitor
- Action type
- Inhibitor
- Target
- Inosine-5'-monophosphate dehydrogenase 1
- Protein identifier
- P20839
- Mechanism
- RNA inhibitor
- Action type
- Inhibitor
- Target
- RNA
- Mechanism
- RNA-directed RNA polymerase inhibitor
- Action type
- Inhibitor
- Target
- RNA-directed RNA polymerase
- Protein identifier
- O39930
- Mechanism
- Inosine-5'-monophosphate dehydrogenase 1 inhibitor
- Action type
- Inhibitor
- Target
- Inosine-5'-monophosphate dehydrogenase 1
- Mechanism
- RNA-directed RNA polymerase inhibitor
- Action type
- Inhibitor
- Target
- RNA-directed RNA polymerase
- Action type
- Inhibitor
- Gene symbol
- IMPDH2
- Protein identifier
- P12268
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- IMPDH1
- Protein identifier
- P20839
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- NS5B
- Protein identifier
- Q8JXU8
- Organism
- Hepatitis C virus
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Virus Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000763
- Subject identifier
- D014777
- Condition
- HIV Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Fibrosis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001422
- Subject identifier
- D005355
- Condition
- Liver Cirrhosis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001422
- Subject identifier
- D008103
- Condition
- Hepatitis C
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003047
- Subject identifier
- D006526
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004197
- Subject identifier
- D019694
- Condition
- Hepatitis C, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004220
- Subject identifier
- D019698
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004239
- Subject identifier
- D019694
- Condition
- Fibrosis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0006890
- Subject identifier
- D005355
- Condition
- Hemorrhagic Fever with Renal Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007299
- Subject identifier
- D006480
- Condition
- Hepatitis D
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007304
- Subject identifier
- D003699
- Condition
- Influenza, Human
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007328
- Subject identifier
- D007251
- Condition
- Encephalitis, Japanese
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007332
- Subject identifier
- D004672
- Condition
- Lassa Fever
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007338
- Subject identifier
- D007835
- Condition
- Respiratory Syncytial Virus Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001413
- Subject identifier
- D018357
- Condition
- Thrombocytopenia
- Highest recorded phase
- 2
- Condition identifier
- HP:0001873
- Subject identifier
- D013921
- Condition
- Hepatitis
- Highest recorded phase
- 3
- Condition identifier
- HP:0012115
- Subject identifier
- D006505
- Condition
- Depressive Disorder
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0002050
- Subject identifier
- D003866
- Condition
- Diabetes Mellitus, Type 1
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005147
- Subject identifier
- D003922
- Condition
- Breast Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition identifier
- EFO_0000222
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000694
- Condition identifier
- EFO_0000763
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001422
- Condition identifier
- EFO_0003047
- Condition identifier
- EFO_0004197
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004220
- Condition identifier
- EFO_0004239
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004952
- Highest recorded phase
- 3
- Condition identifier
- EFO_0006859
- Condition identifier
- EFO_0006890
- Condition identifier
- EFO_0006890
- Highest recorded phase
- 4
- Condition identifier
- EFO_0007296
- Condition identifier
- EFO_0007299
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007332
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007338
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007949
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008496
- Condition identifier
- EFO_0008496
- Highest recorded phase
- 3
- Condition identifier
- EFO_0010702
- Condition identifier
- EFO_1001413
- Highest recorded phase
- 3
- Condition identifier
- HP_0000855
- Highest recorded phase
- 2
- Condition identifier
- HP_0001394
- Highest recorded phase
- 3
And 41 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Warning
- Black Box Warning
- Effect
- dermatological toxicity
- Warning
- Black Box Warning
- Effect
- hematological toxicity
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- dermatological toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- hematological toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Country
- United States
- Event
- anaemia
- Reports
- 5,817
- Reporting signal score
- 8,987.05
- Event
- ascites
- Reports
- 710
- Reporting signal score
- 996.529
- Event
- asthenia
- Reports
- 1,712
- Reporting signal score
- 529.874
- Event
- blood bilirubin increased
- Reports
- 632
- Reporting signal score
- 738.161
- Event
- decreased appetite
- Reports
- 1,399
- Reporting signal score
- 835.818
- Event
- depression
- Reports
- 1,635
- Reporting signal score
- 1,113.55
- Event
- dysgeusia
- Reports
- 765
- Reporting signal score
- 784.5
- Event
- fatigue
- Reports
- 3,380
- Reporting signal score
- 1,124.95
- Event
- haemoglobin decreased
- Reports
- 2,002
- Reporting signal score
- 2,192.69
- Event
- hepatic cirrhosis
- Reports
- 481
- Reporting signal score
- 779.631
- Event
- hepatic encephalopathy
- Reports
- 341
- Reporting signal score
- 567.204
- Event
- hepatic failure
- Reports
- 612
- Reporting signal score
- 1,004.77
- Event
- hepatitis c
- Reports
- 2,000
- Reporting signal score
- 5,791.26
- Event
- hepatocellular carcinoma
- Reports
- 726
- Reporting signal score
- 1,806.42
- Event
- hyperbilirubinaemia
- Reports
- 432
- Reporting signal score
- 726.005
- Event
- hyperuricaemia
- Reports
- 247
- Reporting signal score
- 506.003
- Event
- influenza like illness
- Reports
- 944
- Reporting signal score
- 892.629
- Event
- insomnia
- Reports
- 1,517
- Reporting signal score
- 891.861
- Event
- leukopenia
- Reports
- 816
- Reporting signal score
- 670.068
- Event
- nausea
- Reports
- 2,889
- Reporting signal score
- 487.879
- Event
- neutropenia
- Reports
- 1,152
- Reporting signal score
- 469.056
- Event
- neutrophil count decreased
- Reports
- 826
- Reporting signal score
- 939.65
- Event
- pancytopenia
- Reports
- 907
- Reporting signal score
- 855.694
- Event
- platelet count decreased
- Reports
- 1,716
- Reporting signal score
- 1,733.85
- Event
- pruritus
- Reports
- 1,704
- Reporting signal score
- 779.224
And 9 more, listed on the interactive page.
- NCT00000699
- NCT00000733
- NCT00000772
- NCT00000833
- NCT00001015
- NCT00122616
- NCT00296972
- NCT00982553
- NCT02006745
- NCT00001729
- NCT00001854
- NCT00006164
- NCT00028093
- NCT00039871
- NCT00062816
- NCT00077636
- NCT00077649
- NCT00081770
- NCT00084279
- NCT00087568
- NCT00087594
- NCT00087607
- NCT00087633
- NCT00087646
- NCT00093093
And 401 more, listed on the interactive page.
- Dose
- 20 mg/mL
- Route
- Inhalation
- How often
- 12-18 hours per day for 3 to 7 days
- Discard solution after 24 hours or when low
- Do not mix with other aerosolized medications
- Hydrogen bond acceptors
- 8
- Hydrogen bond donors
- 4
- Polar surface area
- 143.72
- Calculated partition coefficient (ALogP)
- -3.01
- Calculated partition coefficient (XLogP)
- -1.8
- Prodrug
- Yes
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 3
- Heavy atoms
- 17
- Molecular formula
- C8H12N4O5
- Monoisotopic mass
- 244.08076950
- Natural product
- Yes
- 65862-207
- 65862-290
- 68682-019
- Recorded assays
- 7,756
- Active assays
- 343
- Confirmatory
- Other
- Screening
- Summary
- Antimetabolites
- Antiviral Agents
Oral bioavailability
- Median
- 64
- Mean
- 64
- Minimum
- 64
- Maximum
- 64
- Unit
- %
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- F
Related records
Trials (1,949)
- 1.Comparison of the Analgesic Effect of Remifentanil Group and Different Dose Groups of Oliceridine in Postoperative Patients Undergoing Cardiac Surgery 2.Exploring the Hemodynamic Effects of Analgesic Regimens With Different Doses of Oliceridine After Cardiac Surgery
- 12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
- 12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF
- 14 vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response
- 24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C
- 36 Weeks Short-Term Optimization Treatment of Glucocorticosteroid in the Patients With Chronic Recurrent DILI
- 48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection
- 480 STUDY: Phase 2b Study of Locteron Plus Ribavirin to Treat Hepatitis C Virus (HCV)
- 5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
- 5-HTP and Creatine for Depression R33 Phase
- A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
- A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
- A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
- A Clinical Study of Mesenchymal Stem Cell Exosomes Nebulizer for the Treatment of ARDS
- A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors
- A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)
- A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis
- A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
- A Clinical Trial of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotypes 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A
- A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Approved for (3)
In development for (20)
- Acute myeloid leukemia Phase 2
- Breast cancer Phase 1
- Chronic hepatitis B virus infection Phase 3
- COVID-19 Phase 3
- Depressive disorder Phase 3
- Hemorrhagic fever Phase 2
- Hemorrhagic fever-renal syndrome Phase 2
- Hepatitis Phase 3
- Hepatitis B virus infection Phase 3
- Hepatitis C virus infection Phase 3
- Hepatitis D virus infection Phase 2
- HIV infectious disease Phase 3
- Influenza Phase 2
- Japanese encephalitis Phase 2
- Lassa fever Phase 2
- Neoplasm Phase 1
- Respiratory syncytial virus infectious disease Phase 3
- Severe acute respiratory syndrome Phase 3
- Thrombocytopenia Phase 2
- Type 1 diabetes mellitus Phase 2
Other linked conditions (3)
- Hantavirus pulmonary syndrome
- Head and neck cancer
- Viral hemorrhagic fever
Targets (1)
- IMPDH1 Inosine-5'-monophosphate dehydrogenase 1 inhibitor