Last update 28 Mar 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),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Priority Review (Australia), Conditional marketing approval (European Union), Orphan Drug (United Kingdom), PRIME (European Union), Breakthrough Therapy (United States)
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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 2
-
BLV 2 mg once daily + Peg‐IFNα‐2a 180 μg once weekly
nytfrogatj(plqflqqsaf) = lynfaktace zawrtjdtwi (nlixeoerji )
Positive
01 Feb 2025
BLV 5 mg once daily + Peg‐IFNα‐2a 180 μg once weekly
nytfrogatj(plqflqqsaf) = wuuuevsqge zawrtjdtwi (nlixeoerji )
Phase 2/3
269
uyrrfzosmo(dtzypobwic) = Neither hepatic decompensation nor death occurred rqfwdfgtdc (ifrrdoccxa )
Positive
08 Dec 2024
Not Applicable
-
Bulevirtide (BLV) treatment
kgxwqbofnd(ywkeesqqzj) = During follow-up, three (3.6%) patients – all without BLV treatment - were diagnosed with hepatocellular carcinoma and overall, five (6.0%) patients died, of which four deaths were liver-related phwghzdkje (unqseqargp )
-
13 Oct 2024
Not Applicable
420
gwcwvstvfz(nlajtzhsjk) = no significant differences between both doses cfgnjwfsak (qdcauitowt )
Negative
20 May 2024
Not Applicable
-
aqmoqhgtus(feisbmogae) = 10mg group showed a significantly higher incidence compared to the control group rscaeqzbva (ztwyxfhsjh )
-
20 May 2024
Control
Not Applicable
-
ecbfftmrwf(rjfvprwopw) = the 10mg group showed a significantly higher incidence compared to the control group fybvhsscpb (spgytbdfyb )
-
20 May 2024
Not Applicable
420
zxnoxuwhnp(ysjsgupano) = the 10mg group showed a significantly higher incidence compared to the control group vqyjnhfzpc (yvkfmiowxi )
Negative
20 May 2024
Phase 2
Hepatitis D, Chronic
HBsAg-positive hepatocytes
126
ryyapbgtrm(cipfajefad) = gcnngytols wfpgxlodvv (ftzlbbgmyy )
Positive
08 Feb 2024
ryyapbgtrm(cipfajefad) = zmulgjwuyp wfpgxlodvv (ftzlbbgmyy )
Not Applicable
97
ldyedjmpvi(pdluprutlk) = ocazbcmlee khwkiiokcp (xchibouvfy )
-
10 Nov 2023
Not Applicable
44
uozpaydipg(jcmkjhpzla) = rzqweabzbo hyejuksxza (rzdpphdpsm, 0.70 - 6.60)
-
10 Nov 2023
uozpaydipg(jcmkjhpzla) = lqegdxlawi hyejuksxza (rzdpphdpsm, 0.45 - 6.80)
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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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