Entecavir: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Entecavir appears in the FDA drug-label database. Marketed as Entecavir.
- Boxed warning
- The FDA label for Entecavir carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Entecavir tablets are a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. ( 1 )
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Failed Impurity/Degradation Specifications — Zydus Pharmaceuticals (USA) Inc | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-09-04 |
| Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity — Zydus Pharmaceuticals (USA) Inc | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-09-24 |
| Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point. — Hetero USA Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2017-07-20 |
| Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity — Zydus Pharmaceuticals (USA) Inc | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-09-24 |
| Failed Impurity/Degradation Specifications — Zydus Pharmaceuticals (USA) Inc | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-09-04 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Hepatitis B · Entecavir for Hepatitis B | 4 |
| Acute-On-Chronic Liver Failure | 1 |
| Gastrointestinal Cancers | 1 |
| Hepatitis B Virus (HBV) | 1 |
| Lung Transplant Recipient | 1 |
| Viral Hepatitis | 1 |
Recruiting trials involving Entecavir
- Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors
- Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers
- Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B
- Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF
Common questions
Is Entecavir FDA-approved?
Yes, marketed as Entecavir. Its FDA label carries a boxed warning.
How many recruiting trials involve Entecavir?
4 recruiting trials across 6 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.