Overview
Entecavir is an oral antiviral drug used in the treatment of hepatitis B infection. It is marketed under the trade name Baraclude (BMS). Entecavir is a guanine analogue that inhibits all three steps in the viral replication process, and the manufacturer claims that it is more efficacious than previous agents used to treat hepatitis B (lamivudine and adefovir). It was approved by the U.S. Food and Drug Administration (FDA) in March 2005.
Indication
For the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Associated Conditions
- Chronic Hepatitis B Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/25 | Phase 2 | Not yet recruiting | |||
2025/05/11 | Phase 3 | Recruiting | Sun Yat-sen University | ||
2023/11/29 | Phase 1 | Active, not recruiting | |||
2023/03/31 | Not Applicable | Active, not recruiting | E-DA Hospital | ||
2023/01/18 | Phase 4 | Completed | First Affiliated Hospital of Zhejiang University | ||
2022/08/10 | Not Applicable | Recruiting | |||
2022/07/12 | Phase 2 | Recruiting | Sun Yat-sen University | ||
2022/07/12 | Not Applicable | Completed | Xiangya Hospital of Central South University | ||
2022/06/21 | N/A | Active, not recruiting | |||
2022/06/21 | Phase 1 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Amneal Pharmaceuticals LLC | 65162-449 | ORAL | 1 mg in 1 1 | 12/19/2023 | |
| YUNG SHIN PHARM. IND. CO., LTD. | 63126-101 | ORAL | 0.5 mg in 1 1 | 11/19/2021 | |
| E.R. Squibb & Sons, L.L.C. | 0003-1611 | ORAL | 0.5 mg in 1 1 | 12/20/2018 | |
| Yaopharma Co., Ltd. | 50771-013 | ORAL | 0.5 mg in 1 1 | 6/8/2025 | |
| NorthStar RxLLC | 16714-717 | ORAL | 0.5 mg in 1 1 | 11/24/2022 | |
| AvKARE | 42291-261 | ORAL | 0.5 mg in 1 1 | 1/9/2024 | |
| Camber Pharmaceuticals, Inc. | 31722-834 | ORAL | 1 mg in 1 1 | 12/24/2019 | |
| E.R. Squibb & Sons, L.L.C. | 0003-1612 | ORAL | 1.0 mg in 1 1 | 12/20/2018 | |
| Yaopharma Co., Ltd. | 50771-014 | ORAL | 1 mg in 1 1 | 6/8/2025 | |
| Camber Pharmaceuticals, Inc. | 31722-833 | ORAL | 0.5 mg in 1 1 | 12/24/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/26/2006 | ||
Authorised | 9/25/2017 | ||
Authorised | 9/18/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ENTEVIR FILM-COATED TABLET 1MG | SIN16034P | TABLET, FILM COATED | 1.00mg | 10/28/2020 | |
| BEATECAVIR FILM COATED TABLET 0.5MG | SIN16620P | TABLET, FILM COATED | 0.5mg | 10/5/2022 | |
| ENTECAVIR SANDOZ FILM-COATED TABLET 0.5MG | SIN15548P | TABLET, FILM COATED | 0.5mg | 9/24/2018 | |
| ALMACAVIR (ENTECAVIR) FILM COATED TABLETS 0.5MG | GENUONE Sciences Inc. | SIN16612P | TABLET, FILM COATED | 0.5mg | 9/23/2022 |
| BARACLUDE TABLET 0.5mg | SIN13165P | TABLET, FILM COATED | 0.5 mg | 1/16/2006 | |
| ENTECAVIR-TEVA FC TABLETS 0.5MG | SIN16092P | TABLET, FILM COATED | 0.5mg | 1/31/2021 | |
| HEPURI F.C. TABLETS 0.5 MG | SIN16090P | TABLET, FILM COATED | 0.5 mg | 1/28/2021 | |
| ENTECAVIR ALVOGEN FILM COATED TABLETS 1 MG | SIN16145P | TABLET, FILM COATED | 1.00mg | 4/6/2021 | |
| TECAVIR FILM COATED TABLETS 0.5 MG | SIN16792P | TABLET, FILM COATED | 0.500 mg | 5/23/2023 | |
| ENTECAVIR ALVOGEN FILM COATED TABLETS 0.5 MG | SIN16146P | TABLET, FILM COATED | 0.5mg | 4/6/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Entecavir Capsules | 国药准字H20130011 | 化学药品 | 胶囊剂 | 1/22/2023 | |
| Entecavir Capsules | 国药准字H20100065 | 化学药品 | 胶囊剂 | 3/2/2020 | |
| Entecavir Capsules | 国药准字H20110172 | 化学药品 | 胶囊剂 | 11/8/2021 | |
| Entecavir Capsules | 国药准字H20130031 | 化学药品 | 胶囊剂 | 11/21/2022 | |
| Entecavir Capsules | 国药准字H20120038 | 化学药品 | 胶囊剂 | 10/12/2021 | |
| Entecavir Dispersible Tablets | 国药准字H20130061 | 化学药品 | 片剂 | 3/5/2023 | |
| Entecavir Dispersible Tablets | 国药准字H20153021 | 化学药品 | 片剂 | 6/15/2020 | |
| Entecavir Dispersible Tablets | 国药准字H20100141 | 化学药品 | 片剂 | 4/23/2020 | |
| Entecavir Dispersible Tablets | 国药准字H20100129 | 化学药品 | 片剂 | 6/15/2020 | |
| Entecavir Dispersible Tablets | 国药准字H20100019 | 化学药品 | 片剂 | 1/15/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ENTAVIR TABLETS 0.5MG | N/A | N/A | N/A | 10/25/2016 | |
| ENTECAVIR LEK SANDOZ TABLETS 0.5MG | N/A | N/A | N/A | 5/18/2018 | |
| HEPAVANCE TABLETS 1MG | N/A | N/A | N/A | 1/24/2017 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ENTECAVIR ML 0.5 mg entecavir (as monohydrate) tablet, blister pack | 259919 | Medicine | A | 7/22/2016 | |
| ENTECAVIR KP 0.5 mg entecavir (as monohydrate) tablet, blister pack | 259918 | Medicine | A | 7/22/2016 | |
| ENTECAVIR KP 0.5mg entecavir (as monohydrate) tablet, bottle | 259916 | Medicine | A | 7/22/2016 | |
| ENTECAVIR ML 1 mg entecavir (as monohydrate) tablet, bottle | 259924 | Medicine | A | 7/22/2016 | |
| ENTECAVIR CW 1 mg entecavir (as monohydrate) tablet, blister pack | 259914 | Medicine | A | 7/22/2016 | |
| ENTECAVIR CH entecavir (as monohydrate) 1 mg film-coated tablet blister pack | 234767 | Medicine | A | 3/8/2016 | |
| ENTECAVIR RM 0.5 mg entecavir (as monohydrate) tablet, bottle | 259929 | Medicine | A | 7/22/2016 | |
| ENTECAVIR VIATRIS entecavir (as monohydrate) 0.5 mg film coated tablets bottle | 220093 | Medicine | A | 4/18/2016 | |
| ENTECAVIR APO entecavir (as monohydrate) 1.0 mg film-coated tablet blister pack | 256492 | Medicine | A | 5/19/2016 | |
| ENTECAVIR RBX entecavir (as monohydrate) 0.5mg film-coated tablet bottle | 256632 | Medicine | A | 5/19/2016 |
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