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Entecavir · Baraclude, ETV

Small molecule · Inhibitor of hepatitis B virus reverse transcriptase · developed by Bristol Myers Squibb

Approved FDA, Mar 2005
6 Registered trials

What is Entecavir?

Entecavir is a deoxyguanosine nucleoside analogue that is phosphorylated to its triphosphate form, which competes with deoxyguanosine triphosphate and inhibits the hepatitis B virus reverse transcriptase. It is used in the treatment of chronic hepatitis B virus infection.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Baraclude, ETV, BMS-200475-01, SQ-34676
Drug type
Small molecule
Targets
hepatitis B virus reverse transcriptase
Mechanism
Inhibitor of hepatitis B virus reverse transcriptase
Pathways
HBV reverse transcription, HBV DNA synthesis
Therapy area
Infectious disease
Developer
Bristol Myers Squibb
In trials of
ASMB
FDA status
Approved as Baraclude (March 29, 2005), NDA021797 · FDA label
UNII
5968Y6H45M

✅ FDA-approved uses

From the indications section of the FDA label (version of Nov 6, 2019). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT04820686 Phase 2 Chronic Hepatitis B Terminated ASMB
NCT04781647 Phase 2 Chronic Hepatitis B Terminated ASMB
NCT04398134 Phase 2 Chronic Hepatitis B Terminated ASMB
NCT03577171 Phase 2 Chronic Hepatitis B Completed ASMB
NCT03576066 Phase 2 Chronic Hepatitis B Completed ASMB
NCT03109730 Phase 1/2 Chronic Hepatitis B Completed ASMB

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Chronic Hepatitis B

Sources

Updated Oct 11, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.