Virazole, Rebetol(ribavirin)
Cotronak, Rebetol, Ribavirin, Virazole (ribavirin) is a small molecule pharmaceutical. Ribavirin was first approved as Virazole on 1985-12-31. It is used to treat chronic hepatitis c, human adenovirus infections, respiratory syncytial virus infections, virus diseases, and west nile fever in the USA. It has been approved in Europe to treat chronic hepatitis c. The pharmaceutical is active against inosine-5'-monophosphate dehydrogenase 2 and inosine-5'-monophosphate dehydrogenase 1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Ribavirin (discontinued: Copegus, Rebetol, Ribasphere, Ribavirin, Virazole)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ribavirin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VIRAZOLE | Bausch Health Companies | N-018859 DISCN | 1985-12-31 | 1 products, RLD |
| REBETOL | Merck & Co | N-020903 DISCN | 1998-06-03 | 2 products |
| COPEGUS | Roche | N-021511 DISCN | 2002-12-03 | 2 products, RLD |
| REBETOL | Merck & Co | N-021546 DISCN | 2003-07-29 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ribavirin | ANDA | 2024-02-06 |
Indications
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Agency Specific
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Patent Expiration
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Clinical
Clinical Trials
1121 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis c | D006526 | — | B19.2 | 2 | 17 | 22 | 39 | 24 | 103 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 2 | 23 | 18 | 36 | 24 | 103 |
| Hepatitis | D006505 | — | K75.9 | 1 | 14 | 20 | 37 | 23 | 95 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | 13 | 18 | 36 | 23 | 91 |
| Chronic hepatitis | D006521 | — | K73.9 | — | 2 | 7 | 6 | 3 | 18 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | 6 | 1 | 1 | 10 |
| Coinfection | D060085 | — | — | — | — | 2 | 1 | 1 | 4 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | 1 | 1 | 2 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | — | 1 | — | 1 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | 2 | — | 2 | 4 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | — | 3 | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 2 | — | — | 3 |
| Hepatitis b | D006509 | — | — | — | — | 1 | — | 1 | 2 |
| Communicable diseases | D003141 | — | — | — | 1 | 1 | — | — | 2 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
| Fibrosis | D005355 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | 1 | — | — | — | 3 |
| Treatment failure | D017211 | — | — | — | 1 | — | — | — | 1 |
| Depression | D003863 | — | F33.9 | — | 1 | — | — | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | — | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | — | — | — | 1 |
| Chronic hepatitis d | D019701 | — | — | — | 1 | — | — | — | 1 |
| Hepatitis d | D003699 | EFO_0007304 | — | — | 1 | — | — | — | 1 |
| Hepacivirus | D016174 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv | D006678 | — | O98.7 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ribavirin |
| INN | ribavirin |
| Description | Ribavirin is a white powder and exists in two polymorphic forms. Ribavirin is a 1-ribosyltriazole that is the 1-ribofuranosyl derivative of 1,2,4-triazole-3-carboxamide. A synthetic guanosine analogue, it is an inhibitor of HCV polymerase and possesses a broad spectrum of activity against DNA and RNA viruses. It has a role as an antimetabolite, an antiviral agent, an antiinfective agent and an EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor. It is a 1-ribosyltriazole, an aromatic amide and a monocarboxylic acid amide. Ribavirin is a synthetic nucleoside analog of ribofuranose with activity against hepatitis C virus and other RNA viruses. Ribavirin is incorporated into viral RNA, thereby inhibiting viral RNA synthesis, inducing viral genome mutations, and inhibiting normal viral replication. |
| Classification | Small molecule |
| Drug class | antivirals |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1 |
Identifiers
| PDB | — |
| CAS-ID | 36791-04-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1643 |
| ChEBI ID | 63580 |
| PubChem CID | 37542 |
| DrugBank | DB00811 |
| UNII ID | 49717AWG6K (ChemIDplus, GSRS) |
Target
Agency Approved
IMPDH1
IMPDH1
Organism
Homo sapiens
Gene name
IMPDH1
Gene synonyms
IMPD1
NCBI Gene ID
Protein name
inosine-5'-monophosphate dehydrogenase 1
Protein synonyms
IMP (inosine 5'-monophosphate) dehydrogenase 1, IMP (inosine monophosphate) dehydrogenase 1, IMPD 1, IMPDH 1, IMPDH-I
Uniprot ID
Mouse ortholog
Impdh1 (23917)
inosine-5'-monophosphate dehydrogenase 1 (P50096)
Alternate
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Variants
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Financial
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Estimated US medical usage
Ribavirin
Total medical expenditures per year (USD, in millions)
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Safety
Black-box Warning
Black-box warning for: Ribavirin
Adverse Events
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92,361 adverse events reported
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