Product Description
Entecavir is used to treat chronic (long-term) hepatitis B infection (swelling of the liver caused by a virus) in adults and children 2 years of age and older who have liver damage. Entecavir is in a class of medications called nucleoside analogs. It works by decreasing the amount of hepatitis B virus (HBV) in the body. Entecavir does not cure HBV and may not prevent complications of chronic hepatitis B such as cirrhosis of the liver or liver cancer. Entecavir does not prevent the spread of HBV to other people (Sourced from: https://medlineplus.gov/druginfo/meds/a605028.html)
Mechanisms of Action: Nucleoside Polymerase Inhibitor, HBV-NART Inhibitor, NRT Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Bristol-Myers Squibb
Company Location: Eastern America
Company CEO: Giovanni Caforio
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, Bulgaria, Canada, Chile, China, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 12
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Hepatitis B, Chronic
Phase 2: Abdominal Pain|Chronic Pain|Flank Pain|Hepatitis A|Herpesviridae Infections|Liver Cirrhosis
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04288310 |
CR108679 | P2 |
Recruiting |
Hepatitis B, Chronic|Hepatitis A|Herpesviridae Infections |
2022-01-31 |
2020-02-29 |
Primary Endpoints|Treatments |
|
NCT05391360 |
HEC160208-HBV-101 | P1 |
Completed |
Hepatitis B, Chronic|Hepatitis A |
2023-01-17 |
44% |
2023-04-13 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT07295873 |
KDN-F351-202505 | P1 |
Not yet recruiting |
Hepatitis B, Chronic|Liver Cirrhosis |
2026-06-30 |
50% |
2025-12-23 |
|
CTR20211478 |
CTR20211478 | P2 |
Completed |
Hepatitis B, Chronic |
2024-07-19 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Trial Status |
|
CTR20201678 |
CTR20201678 | P2 |
Completed |
Hepatitis B, Chronic |
2024-07-19 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
CTR20182060 |
CTR20182060 | P2 |
Completed |
Hepatitis B, Chronic |
2023-09-14 |
2025-04-29 |
Primary Completion Date|Start Date|Study Completion Date |
|
CTR20160135 |
CTR20160135 | P2 |
Recruiting |
Chronic Pain|Abdominal Pain|Hepatitis B, Chronic|Flank Pain |
None |
2025-04-29 |
Patient Enrollment|Treatments|Trial Status |
|
CTR20231809 |
CTR20231809 | P2 |
Recruiting |
Hepatitis B, Chronic|Liver Cirrhosis |
None |
2025-06-22 |
Patient Enrollment|Treatments |
|
CTR20192316 |
CTR20192316 | P2 |
Active, not recruiting |
Hepatitis B, Chronic |
None |
2025-04-29 |
Patient Enrollment |
|
CTR20210513 |
CTR20210513 | P3 |
Recruiting |
Hepatitis B, Chronic |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
CTR20212114 |
CTR20212114 | P1 |
Completed |
Hepatitis B, Chronic |
2023-01-17 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20221976 |
CTR20221976 | P2 |
Completed |
Hepatitis B, Chronic |
2025-04-18 |
2025-11-23 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |