Virazole, Rebetol(ribavirin)
Rebetol, 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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COVID-19
Commercial
Trade Name
FDA
EMA
Virazole (generic drugs available since 2005-10-28, discontinued: Copegus, Rebetol, Ribasphere)
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 RX | 1985-12-31 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| virazole | New Drug Application | 2019-05-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
| human adenovirus infections | EFO_0007434 | D000258 | — |
| respiratory syncytial virus infections | EFO_1001413 | D018357 | — |
| virus diseases | — | D014777 | B34 |
| west nile fever | EFO_0007545 | D014901 | A92.3 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ribavirin, Rebetol, Schering | |||
| 6790837 | 2023-04-05 | DP | |
HCPCS
No data
Clinical
Clinical Trials
736 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 14 | 111 | 107 | 81 | 70 | 370 |
| Hepatitis c | D006526 | B19.2 | 8 | 82 | 63 | 44 | 35 | 219 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 10 | 19 | 9 | 9 | 5 | 49 |
| Hepacivirus | D016174 | — | 17 | 14 | 5 | 7 | 39 | ||
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 1 | 16 | 20 | 2 | 1 | 38 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 5 | 15 | 3 | 2 | 22 |
| Hepatitis b | D006509 | 1 | 4 | 5 | 1 | 4 | 13 | ||
| Hiv | D006678 | O98.7 | 1 | 1 | 2 | 5 | 2 | 11 | |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | 4 | 3 | 1 | 1 | 9 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 3 | — | 3 | 1 | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | 2 | 4 | 2 | — | 1 | 8 | |
| Fibrosis | D005355 | — | 1 | 3 | — | 2 | 6 | ||
| Infections | D007239 | EFO_0000544 | — | 1 | 3 | — | 1 | 5 | |
| Chronic hepatitis | D006521 | K73.9 | — | — | 2 | — | 1 | 3 | |
| Recurrence | D012008 | 1 | 1 | 2 | — | — | 3 | ||
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 2 | 1 | — | 1 | 3 |
| Experimental liver cirrhosis | D008106 | — | 2 | 1 | — | — | 2 | ||
| Respiratory syncytial virus infections | D018357 | EFO_1001413 | — | 1 | 1 | — | — | 2 | |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 1 | — | — | 1 |
| Menopause | D008593 | EFO_0003922 | N95 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | 2 | 4 | — | — | — | 4 | |
| Lassa fever | D007835 | EFO_0007338 | A96.2 | — | 2 | — | — | 1 | 3 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | 2 | — | — | — | 2 |
| Hemorrhagic fever with renal syndrome | D006480 | EFO_0007299 | A98.5 | — | 2 | — | — | — | 2 |
| Pharmacokinetics | D010599 | — | 1 | — | — | — | 1 | ||
| Treatment failure | D017211 | — | 1 | — | — | — | 1 | ||
| Chronic pain | D059350 | HP_0012532 | — | 1 | — | — | — | 1 | |
| Human influenza | D007251 | EFO_0007328 | J11.1 | — | 1 | — | — | — | 1 |
| Hepatocellular carcinoma | D006528 | C22.0 | — | 1 | — | — | — | 1 | |
| Severe dengue | D019595 | A91 | — | 1 | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intravenous substance abuse | D015819 | — | — | — | — | 1 | 1 | ||
| Melanoma | D008545 | — | — | — | — | 1 | 1 | ||
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | 1 | 1 | |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | — | 1 | 1 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | — | — | — | 1 | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 1 | 1 |
| Cognition disorders | D003072 | — | — | — | — | 1 | 1 | ||
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | — | — | 1 | 1 |
| Viral hemorrhagic fevers | D006482 | A99 | — | — | — | — | 1 | 1 | |
| Lichen planus | D008010 | L43 | — | — | — | — | 1 | 1 |
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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 | 3SFU |
| CAS-ID | 36791-04-5 |
| RxCUI | 9344 |
| ChEMBL ID | CHEMBL1643 |
| ChEBI ID | 63580 |
| PubChem CID | 37542 |
| DrugBank | DB00811 |
| UNII ID | 49717AWG6K (ChemIDplus, GSRS) |
Target
Agency Approved
IMPDH2
IMPDH2
IMPDH1
IMPDH1
Organism
Homo sapiens
Gene name
IMPDH2
Gene synonyms
IMPD2
NCBI Gene ID
Protein name
inosine-5'-monophosphate dehydrogenase 2
Protein synonyms
epididymis secretory sperm binding protein, IMP (inosine 5'-monophosphate) dehydrogenase 2, IMP (inosine monophosphate) dehydrogenase 2, IMP dehydrogenase II, IMP oxireductase 2, IMPD 2, IMPDH 2, IMPDH-II, inosine 5' phosphate dehydrogenase 2, inosine monophosphate dehydrogenase type II, Inosine-5'-monophosphate dehydrogenase type II
Uniprot ID
Mouse ortholog
Impdh2 (23918)
inosine-5'-monophosphate dehydrogenase 2 (Q91Z11)
Alternate
No data
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000225949 | IFNL4, 151-152G>A | drug response | 2021-03-24 | 1A |
| VCV000226027 | IFNL3 | drug response | 2021-03-29 | 1B |
| VCV000375658 | IFNL3, 259-126T>C | drug response | 2021-03-24 | 2A |
| VCV000014747 | ITPA, 124+21A>C | drug response | 2021-03-24 | 2B |
| VCV000014746 | ITPA, 94C>A, Pro32Thr | drug response | 2021-03-24 | 2B |
Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Virazole
Adverse Events
Top Adverse Reactions
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391 adverse events reported
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