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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
319 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 |
Show 29 more
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 |
Show 4 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Baraclude – Bristol Myers Squibb
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Entecavir
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 8,969 documents
View more details
Safety
Black-box Warning
Black-box warning for: Baraclude, Entecavir, Entecavir entecavir
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
7,125 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use