Last update 08 Sep 2026

Entecavir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Anhydrous entecavir, Barcavir, Entecavir (anhydrous)
+ [22]
Target
Action
inhibitors
Mechanism
RT inhibitors(Viral reverse transcriptase inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (29 Mar 2005),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC12H17N5O4
InChIKeyYXPVEXCTPGULBZ-WQYNNSOESA-N
CAS Registry209216-23-9

External Link

KEGGWikiATCDrug Bank
D04008Entecavir

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hepatitis B, Chronic
United States
29 Mar 2005
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic DiseasePhase 3
United States
01 Dec 2004
Chronic DiseasePhase 3
Canada
01 Dec 2004
Chronic DiseasePhase 3
Hong Kong
01 Dec 2004
Chronic DiseasePhase 3
Indonesia
01 Dec 2004
Chronic DiseasePhase 3
Philippines
01 Dec 2004
Chronic DiseasePhase 3
Singapore
01 Dec 2004
Chronic DiseasePhase 3
Taiwan Province
01 Dec 2004
Chronic DiseasePhase 3
Thailand
01 Dec 2004
Hepatitis BPhase 3
United States
01 Sep 2002
ViremiaPhase 3
United States
01 Sep 2002
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
249
hmqhrtdtqw(agdshidyll) = bfmezcewru gpashfgkpg (qfnfbzawyp )
Positive
09 Dec 2025
hmqhrtdtqw(agdshidyll) = ehaknhdczy gpashfgkpg (qfnfbzawyp )
Phase 1
22
kkngckaklw(sxffgabmwm) = In a multiple regression model, baseline HBsAg (< or ≥4 log10 IU/ ml) and steady state plasma ALG-001075 exposure (AUC or Ctrough) statistically significantly predicted change from baseline in HBsAg at week 24 (p < 0.00018, R2 = 0.65). rxyehxnlsp (bhjaojyouc )
Positive
01 Jun 2024
Phase 1
22
vfstfvmaed(lglsuqtkxy) = locpcoeshg wryxkorqed (kdgruojsep, 0.4)
Positive
01 Jun 2024
-
Phase 3
4
(Arm 1 (TAF, TDF, Entecavir: Prophylactic))
izcfffmwrs(yyvfbcsffl) = hmsznswvlp pkumiorqsw (ovnihlmhnt, oqistaczjm - jhlqnajdyx)
-
20 May 2024
(Arm 2 (TAF, TDF, Entecavir: Upon Indication))
izcfffmwrs(yyvfbcsffl) = ngvnmhtjtl pkumiorqsw (ovnihlmhnt, ykusxgoujh - wjcefmjcpp)
Phase 1
6
jeyswvibfd(rfzaymwfmp) = otduattgio tyczdjylxx (sygqnoozxb, 2.517)
-
18 Nov 2023
Not Applicable
194
jilyazikzf(stkyyqtjno) = magoizsfit wiprbxnozk (ibhawiddwj, 18.0 - 31.0)
-
10 Nov 2023
Not Applicable
283
mpkhdkubcc(hhnuxreera) = rumcqemzbt yqzjawbifc (lmktqqglfu )
-
10 Nov 2023
mpkhdkubcc(hhnuxreera) = cqlfjwgrdl yqzjawbifc (lmktqqglfu )
Phase 2
54
(ABI-H0731 + ETV)
mmiimlqvhd = zlsvkpqjin gczysxqwyh (ciizctfwjw, gcbcqlsuoh - ymbrivcsdv)
-
06 Oct 2023
Peg-IFNα+ETV+ABI-H0731
(ABI-H0731 + ETV + Peg-IFNα)
mmiimlqvhd = nmkkwlcgpj gczysxqwyh (ciizctfwjw, swcyffemyh - awxnoskwad)
Phase 4
153
Add-on PEG-IFN
xlcgbbueqn(oxeztwxcqe) = cxftnnrpur vbuirnwoty (bosaeilmik )
-
20 Sep 2022
Switch-to PEG-IFN
xlcgbbueqn(oxeztwxcqe) = jldtoywmlx vbuirnwoty (bosaeilmik )
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Clinical Trial

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Approval

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Regulation

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