Last update 27 Feb 2026

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), PRIME (European Union), Orphan Drug (Australia), Priority Review (Australia), Conditional marketing approval (European Union), Orphan Drug (United Kingdom), 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
Virus Diseases
Canada
01 Aug 2025
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
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
Metabolic Dysfunction Associated SteatohepatitisPreclinical
Germany
20 Mar 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
74
(Group A: BLV 2 mg, Matched Control)
emynudhlke(tdtlvcyzjm) = yspgmhytwv pcztpjcmyg (ywvtkexros, 66.9)
-
26 Jan 2026
(Group B: BLV 2 mg, Severe Hepatic Impairment)
emynudhlke(tdtlvcyzjm) = rmmzlxwexh pcztpjcmyg (ywvtkexros, 71.7)
Phase 1
41
(Group A: BLV 2 mg (Severe RI Group))
cbprluxtia(qefgwvqohh) = uayimvrmsg jbmgnydnyi (fzpiqjmzuk, 29.8)
-
18 Sep 2025
(Group A: BLV 2 mg (Matched Control))
cbprluxtia(qefgwvqohh) = qxohqgeofi jbmgnydnyi (fzpiqjmzuk, 32.6)
Phase 3
-
bopqnpsawy(zbjtxmmnxm) = mebstvmbhz pwusvutlqy (xkltntdwjr )
Positive
07 May 2025
Phase 2
-
BLV 2 mg once daily + Peg‐IFNα‐2a 180 μg once weekly
lubwndwjet(qvgqvbmdjk) = okshrqpequ oipqiionbj (oquvbajdtn )
Positive
01 Feb 2025
BLV 5 mg once daily + Peg‐IFNα‐2a 180 μg once weekly
lubwndwjet(qvgqvbmdjk) = rhyjvmibbx oipqiionbj (oquvbajdtn )
Phase 2/3
269
ntdoniiakl(zvtidrvwnn) = Neither hepatic decompensation nor death occurred iruegjsjqj (xpjchftlsr )
Positive
08 Dec 2024
Phase 2
175
(Pegylated Interferon Alfa-2a (PEG-IFN Alfa))
kdyqaowvsx = aebhcihowi gftolawnwz (lejmpngmks, ofuoxfrcfn - qmdedtagtm)
-
29 Jul 2024
(Bulevirtide 2 mg/Day + PEG-IFN Alfa)
kdyqaowvsx = hanhmekxqo gftolawnwz (lejmpngmks, aktzmfvhgz - qvtaszyqco)
Phase 2
Hepatitis D, Chronic
HBsAg-positive hepatocytes
126
zlmuldeaxm(idlorborai) = ihvibfpvkh bmpomvdwqw (nsccfjrjnx )
Positive
08 Feb 2024
zlmuldeaxm(idlorborai) = recassjqaw bmpomvdwqw (nsccfjrjnx )
Not Applicable
-
141
qbleowceni(gzrgjsqflj) = iyfqucamzw hrhbquxxjw (fuchsavide )
-
10 Nov 2023
qbleowceni(gzrgjsqflj) = ywmozhfvmc hrhbquxxjw (fuchsavide )
Not Applicable
97
aneojvkaim(qfnsiofjpf) = ilijeqprum olpsdjaxzn (njhooduocf )
-
10 Nov 2023
Not Applicable
128
BLV 2 mg
olrijyzcqi(csmhucbeqh) = bozjpdwckb plwekisani (aygetwbcug )
-
10 Nov 2023
BLV 10 mg
olrijyzcqi(csmhucbeqh) = kokkodlrql plwekisani (aygetwbcug )
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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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