Baraclude(entecavir)
Baraclude (entecavir) is a small molecule pharmaceutical. Entecavir was first approved as Baraclude on 2005-03-29. It is used to treat chronic hepatitis b and hepatitis b in the USA. It has been approved in Europe to treat chronic hepatitis b and hepatitis b.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Baraclude, Entecavir (discontinued: Entecavir)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Entecavir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BARACLUDE | Bristol Myers Squibb | N-021797 RX | 2005-03-29 | 2 products, RLD, RS |
| BARACLUDE | Bristol Myers Squibb | N-021798 RX | 2005-03-29 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| baraclude | New Drug Application | 2024-05-09 |
| entecavir | ANDA | 2025-06-08 |
| entecavir entecavir | ANDA | 2025-01-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hepatitis b | — | D006509 | — |
| chronic hepatitis b | EFO_0004239 | D019694 | B18.1 |
Agency Specific
FDA
EMA
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Patent Expiration
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Clinical
Clinical Trials
319 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 b | D006509 | — | — | 24 | 70 | 32 | 80 | 73 | 271 |
| Hepatitis | D006505 | — | K75.9 | 21 | 66 | 27 | 66 | 59 | 230 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 27 | 64 | 22 | 67 | 55 | 225 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 19 | 56 | 21 | 58 | 48 | 195 |
| Chronic hepatitis | D006521 | — | K73.9 | 9 | 32 | 13 | 31 | 27 | 107 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | 6 | 3 | 9 | 7 | 25 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 2 | 3 | 5 | 9 | 18 |
| Fibrosis | D005355 | — | — | 1 | 4 | 2 | 7 | 5 | 18 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 1 | 2 | 4 | 9 | 17 |
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | 2 | 4 | 4 | 12 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute-on-chronic liver failure | D065290 | — | — | — | 1 | 1 | — | 3 | 5 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | — | — | 1 | — | 3 | 4 |
| Hepatic insufficiency | D048550 | — | — | 1 | 1 | 1 | — | 2 | 4 |
| B-cell lymphoma | D016393 | — | — | — | 1 | 1 | — | — | 2 |
| Chronic disease | D002908 | — | — | — | — | 1 | — | 1 | 2 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | — | 1 | — | — | 1 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | 1 | — | — | 1 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | 1 | — | — | 1 |
| Spondylitis | D013166 | — | M46.9 | — | — | 1 | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis d | D003699 | EFO_0007304 | — | — | 2 | — | — | 1 | 3 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | — | — | 1 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | 1 | 2 |
| Chronic hepatitis d | D019701 | — | — | — | 1 | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | 1 | 3 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Self efficacy | D020377 | — | — | — | — | — | — | 2 | 2 |
| Disease progression | D018450 | — | — | — | — | — | — | 2 | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | — | — | — | 1 | 1 |
| Sustained virologic response | D000072230 | — | — | — | — | — | — | 1 | 1 |
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | — | — | 1 | 1 |
| Prognosis | D011379 | — | — | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 1 | 1 |
| Necrosis | D009336 | — | — | — | — | — | — | 1 | 1 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 1 | 1 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Entecavir |
| INN | entecavir |
| Description | Entecavir (anhydrous) is guanine substituted at the 9 position by a 4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl group. A synthetic analogue of 2'-deoxyguanosine, it is a nucleoside reverse transcriptase inhibitor with selective antiviral activity against hepatitis B virus. Entecavir is phosphorylated intracellularly to the active triphosphate form, which competes with deoxyguanosine triphosphate, the natural substrate of hepatitis B virus reverse transcriptase, inhibiting every stage of the enzyme's activity, although it has no activity against HIV. It is used for the treatment of chronic hepatitis B. It has a role as an EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor and an antiviral drug. It is a member of 2-aminopurines, an oxopurine, a primary alcohol and a secondary alcohol. |
| Classification | Small molecule |
| Drug class | antivirals: carbocyclic nucleosides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=C1[C@@H](n2cnc3c(=O)[nH]c(N)nc32)C[C@H](O)[C@H]1CO |
Identifiers
| PDB | — |
| CAS-ID | 142217-69-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL713 |
| ChEBI ID | 473990 |
| PubChem CID | 135398508 |
| DrugBank | DB00442 |
| UNII ID | NNU2O4609D (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Baraclude – Bristol Myers Squibb
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Estimated US medical usage
Entecavir
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
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Safety
Black-box Warning
Black-box warning for: Baraclude, Entecavir, Entecavir entecavir
Adverse Events
Top Adverse Reactions
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7,125 adverse events reported
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