NDAORALSOLUTIONPriority Review
Approved
Mar 2005
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
21
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BARACLUDE (entecavir) is an oral nucleoside reverse transcriptase inhibitor approved in 2005 for chronic hepatitis B, hepatitis D, and hepatocellular carcinoma. It works by inhibiting HBV reverse transcriptase, reducing viral replication and slowing disease progression. The drug is administered as an oral solution and remains a foundational antiviral therapy in hepatitis B management.
$3MPart D
LOE ApproachingDeclining
Declining Part D spending and approaching loss of exclusivity signal contraction; teams are likely in optimization and transition planning phases rather than growth.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy
Started May 2021
90 enrolled
Chronic Hepatitis B Virus Infection
A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B
Started Jun 2020
122 enrolled
Hepatitis BChronic Hep BHBV
A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B Patients in Combination With Pegylated Interferon alpha2a Alone and With Entecavir
Started May 2020
20 enrolled
Hepatitis B, Chronic
A Study of TQ-A3334 Combined With Entecavir in the Treatment of Chronic Hepatitis B
Started Nov 2019
12 enrolled
Chronic Hepatitis B
An Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Entecavir or Tenofovir in Patients With Chronic Hepatitis b Who Have Received Nucleoside (Acid) Therapy
Started Jul 2019
60 enrolled
Chronic Hepatitis b
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.