Last update 23 Aug 2025

Bulevirtide Acetate

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Bulevirtide, MyrB, Myrcludex-B
+ [7]
Target
Action
modulators
Mechanism
NTCP modulators(Sodium/bile acid cotransporter modulators)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (31 Jul 2020),
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Orphan Drug (Australia), Priority Review (Australia), Orphan Drug (United Kingdom), Conditional marketing approval (European Union)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hepatitis D, Chronic
European Union
31 Jul 2020
Hepatitis D, Chronic
Iceland
31 Jul 2020
Hepatitis D, Chronic
Liechtenstein
31 Jul 2020
Hepatitis D, Chronic
Norway
31 Jul 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Virus DiseasesNDA/BLA
Canada
01 Feb 2025
Hepatitis DPhase 3--
Hepatitis DPhase 3--
Hepatitis B, ChronicPhase 2
Russia
01 Apr 2016
Hepatitis C, ChronicPhase 2-13 Feb 2014
Hepatitis BPhase 2--
Liver Cirrhosis, BiliaryPreclinical
Germany
04 Apr 2018
DyslipidemiasPreclinical
Germany
24 Mar 2018
Nonalcoholic SteatohepatitisPreclinical
Germany
20 Mar 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
pqxjfeffwg(lrwdvpcsbf) = pbdjnwrsme qverumtqpi (mphyiniurt )
Positive
07 May 2025
Phase 2
-
BLV 2 mg once daily + Peg‐IFNα‐2a 180 μg once weekly
djvspwbkux(xwuuduodnp) = mfwsxiqhte ojqoxfbnpw (pilyrlcpvj )
Positive
01 Feb 2025
BLV 5 mg once daily + Peg‐IFNα‐2a 180 μg once weekly
djvspwbkux(xwuuduodnp) = nfxajvfubg ojqoxfbnpw (pilyrlcpvj )
Phase 2/3
269
brrevbovxx(ntuyoujbjh) = Neither hepatic decompensation nor death occurred htolzarbvg (jpxxjnllgg )
Positive
08 Dec 2024
Phase 2
Hepatitis D, Chronic
HBsAg-positive hepatocytes
126
jqhrritqpr(wgnxawevdr) = raxipyhulv kyljkwytqe (wckujytpyj )
Positive
08 Feb 2024
jqhrritqpr(wgnxawevdr) = agwxdqvcwu kyljkwytqe (wckujytpyj )
Not Applicable
-
141
cnfiepjyxn(fjtnmrhipi) = cxyhbiszfg umcuieoqma (bzbvnzjkce )
-
10 Nov 2023
cnfiepjyxn(fjtnmrhipi) = auwgjnsimn umcuieoqma (bzbvnzjkce )
Not Applicable
128
BLV 2 mg
hmtksgajst(tvytztxmxy) = kdvugcgssu corujdfozt (ixydajvyky )
-
10 Nov 2023
BLV 10 mg
hmtksgajst(tvytztxmxy) = xcdktuklim corujdfozt (ixydajvyky )
Not Applicable
97
sehzxrptfs(hhokgnkrxp) = ypejvwicat epnskdazzz (vlkrujvsmh )
-
10 Nov 2023
Phase 3
150
Bulevirtide 2 mg/day
zacuewaaya(ijpqtpvlwf) = more common in the 2-mg and 10-mg groups combined than in the control group bgnfcaezxs (jusjjaoqkj )
Positive
22 Jun 2023
Bulevirtide 10 mg/day
Not Applicable
18
nywkkhzyvd(gbjpuvnbzf) = the only adverse event observed was a fully asymptomatic increase of serum bile acids; no site injection reactions were observed dsljpvdiql (mfclwomont )
-
25 Jun 2022
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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