RegulationBreakthrough Therapy (United States), Orphan 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)

Structure/Sequence

Sequence Code 9558060

Source: *****

Clinical Trials associated with Bulevirtide Acetate

NCT07142811

/ RecruitingPhase 2

A Phase 2b Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy Versus Bulevirtide in Participants With Chronic HDV Infection (ECLIPSE 3)

A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection

Start Date05 Aug 2025

Sponsor / Collaborator

Vir Biotechnology, Inc.

NCT07128550

/ RecruitingPhase 3

A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)

This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide

Start Date30 Jul 2025

Sponsor / Collaborator

Vir Biotechnology, Inc.

NCT06504485

/ RecruitingNot ApplicableIIT

Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Association With Disease Outcomes and Response to Bulevirtide Treatment

Pharmacological, single-center, non-profit observational study.
The present study is part of a cooperation project between the SC Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy), the University of Milan, the University of Parma and Rome Tor Vergata, funded under the call for Research Projects of Significant National Interest - 2022 PNRR Call (Prot. P2022WEXP2).
Hepatitis D virus (HDV) is a defective RNA virus, which requires the presence of hepatitis B virus (HBV) to infect liver cells and propagate. To date, the mechanisms underlying the accelerated disease progression in the natural history of Delta hepatitis are poorly understood, as is the course of the HDV-specific immune response (CD4 and CD8 T cells). As in chronic HBV and HCV infections, the outcome of chronic HDV infection appears to be dictated primarily by the host immune response, which represents a key determinant for virus control or persistence. For HBV/HDV coinfection, the role of T cells has not been well defined, as suitable animal models are lacking and so far few HDV-specific T cell epitopes have been precisely mapped, mainly limited to HLA-B alleles.
The study is divided into two substudies (cross-sectional and longitudinal). The primary objective of the cross-sectional study is to calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide. The primary objective of the longitudinal study is the change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment).

Start Date01 Sep 2024

Sponsor / Collaborator

Fondazione IRCCS Ca' Granda

[+1]

100 Clinical Results associated with Bulevirtide Acetate

100 Translational Medicine associated with Bulevirtide Acetate

100 Patents (Medical) associated with Bulevirtide Acetate

213

Literatures (Medical) associated with Bulevirtide Acetate

01 Sep 2025·ZEITSCHRIFT FUR GASTROENTEROLOGIE

Quality of life improves during antiviral therapy with bulevirtide

Article

Author: Mrowietz, Simon Kristian ; Port, Kerstin ; Eichholz, Julia Carolin ; Deterding, Katja ; Wedemeyer, Heiner ; Dinkelborg, Katja ; Dietz-Fricke, Christopher

Abstract:

Hepatitis D virus (HDV) infection is the most severe form of viral hepatitis and has been shown to be associated with reduced quality of life. With the approval of the entry inhibitor bulevirtide, the first specific agent for HDV infection became available. Here, we report data on quality of life (QOL) before and during antiviral therapy with bulevirtide in a single center real-world cohort.We investigated QOL assessed by the Short Form 36 Health Survey (SF-36) in 25 patients undergoing antiviral treatment with bulevirtide. Surveys were completed before the beginning of antiviral therapy and up to week 152 of treatment as a long-term follow up.The study cohort included 7 women (28%) and 18 men (72%) with a median age of 46 years. Liver cirrhosis (defined as liver stiffness measurement ≥ 15.2 kPa) was present in 16 patients (64%) at the start of antiviral treatment. During the course of antiviral treatment with bulevirtide, scores for vitality, mental health and bodily pain significantly improved. The physical component score showed a minimal clinically important increase of ≥ 2.5 points in 10 patients (42%) at week 24 and in 6 patients (30% of patients with full data available) at week 48. The mental component score showed a minimal clinically important increase (≥ 2.5 points compared to baseline) in 10 patients (42%) at week 24 and in 12 patients (60%) at week 48. In the patient cohort with an improvement of physical or mental component scores at week 48, a further improvement beyond week 48 was evident in single cases but not in all patients. Importantly, changes of physical or mental component scores were not associated with virological or biochemical responses.Vitality, mental health and bodily pain improved during BLV treatment. As a sign of the good tolerability of BLV, no significant deteriorations in QOL scores were observed. Findings need to be confirmed and further evaluated in larger cohorts and longer follow-up is needed.

01 Sep 2025·MICROBIAL PATHOGENESIS

Update on the management of HDV infection: current events and perspectives

Review

Author: Ametrano, Luigi ; Di Fusco, Antonio ; Gentile, Ivan ; Iuliano, Antonio ; D'Agostino, Alessia ; Buonomo, Antonio Riccardo ; Pinchera, Biagio ; Trucillo, Emilia ; Esposito, Nunzia

HDV infection has long been, and continues to be, a significant challenge. Chronic liver disease related to HDV is one of the most aggressive forms of liver disease, carrying a high risk of progression to cirrhosis and decompensated liver disease. Although an estimated 12 to 72 million people worldwide have been exposed to HDV, the prevalence of HDV-related conditions is believed to be underreported, and further epidemiological studies are needed to better understand its scope. In this context, screening for anti-HDV in all HBsAg-positive individuals could help identify undiagnosed cases of HDV, regardless of known risk factors. While certain groups are at higher risk for HDV infection, more than half of individuals with HDV infection have no identifiable risk factors. Simultaneously, the risk factors for severe disease progression remain poorly defined, although persistent and/or high viral load, along with elevated cytolysis indices, appear to be linked to a more severe disease prognosis. Once HDV infection is diagnosed, treatment becomes necessary, especially given the limited therapeutic options available. Until recently, interferon-α was the only treatment option, but it came with challenges, including poor tolerability and suboptimal virological response rates. In July 2020, the European Medicines Agency (EMA) approved Bulevirtide, a new drug for the treatment of HDV. Bulevirtide not only offered a novel therapeutic option for HDV but also marked a milestone in the history of HDV treatment. However, while this new drug represents a significant advance, there are still several aspects that need further clarification and exploration.

01 Aug 2025·Liver International

Comparative Efficacy of Treatment Regimens for Chronic Hepatitis D Virus Infection: A Systematic Review and Network Meta‐Analysis

Review

Author: Mylona, Evangelia K. ; Shehadeh, Fadi ; Kalligeros, Markos ; Bakaloudi, Dimitra Rafailia ; Noureddin, Mazen ; Mylonakis, Eleftherios ; Dellis, Charilaos ; Ouranos, Konstantinos

ABSTRACT:

Background and Aims:

Treatment of chronic hepatitis delta virus (HDV) infection with pegylated interferon‐alpha (PEG‐IFN‐alpha) is associated with variable and often poor treatment responses. Recently, bulevirtide was approved for chronic HDV infection with promising results.

Methods:

We conducted a pairwise network meta‐analysis of five treatment regimens—bulevirtide, bulevirtide plus PEG‐IFN‐alpha, PEG‐IFN‐alpha, lonafarnib and lonafarnib plus PEG‐IFN‐alpha—by reviewing randomised studies in PubMed, EMBASE and Web of Science. A control group receiving no treatment or nucleos(t)ide analogs alone was included. Primary outcomes were virological response (undetectable HDV RNA or ≥ 2 log10 IU/mL decrease from baseline), biochemical response (ALT normalisation) and combined response (defined as fulfilment of both virological and biochemical responses), measured at end of treatment and 24 weeks post‐treatment. Odds ratios (ORs) with 95% confidence intervals (CIs) were used for analysis.

Results:

Data from 934 patients in 6 randomised studies showed that, at the end of treatment, bulevirtide plus PEG‐IFN‐alpha combination therapy was more likely to achieve virological response compared to PEG‐IFN‐alpha (OR, 8.39; 95% CI: 3.46, 20.37) and bulevirtide (OR, 6.31; 95% CI: 3.17, 12.59). Bulevirtide 10 mg plus PEG‐IFN‐alpha combination therapy was more likely to achieve virological response compared to bulevirtide 2 mg plus PEG‐IFN‐alpha combination therapy at the end of treatment (OR, 2.43; 95% CI: 1.16, 5.09). Bulevirtide 10 mg (OR, 4.43; 95% CI: 1.17, 16.83) and bulevirtide 2 mg (OR, 10.95; 95% CI: 2.51, 47.74) were more likely to achieve biochemical response compared to PEG‐IFN‐alpha at the end of treatment, but bulevirtide plus PEG‐IFN‐alpha combination therapy was not (OR, 3.24; 95% CI: 0.84, 12.50). At 24 weeks post‐treatment, bulevirtide plus PEG‐IFN‐alpha combination therapy was more likely to result in virological response compared to PEG‐IFN‐alpha (OR, 3.69; 95% CI: 1.05, 12.98) and bulevirtide (OR, 2.79; 95% CI: 1.13, 6.92), as well as biochemical response compared to PEG‐IFN‐alpha (OR, 3.23; 95% CI: 1.38, 7.56). Bulevirtide plus PEG‐IFN‐alpha combination therapy was more likely to result in combined response compared to PEG‐IFN‐alpha (OR, 6.06; 95% CI: 2.03, 18.05) and bulevirtide (OR, 4.67; 95% CI: 2.21, 9.85) at the end of treatment. At 24 weeks post‐treatment, neither bulevirtide monotherapy nor bulevirtide plus PEG‐IFN‐alpha combination therapies at various doses were more likely to achieve combined response compared to PEG‐IFN‐alpha.

Conclusions:

Bulevirtide plus PEG‐IFN‐alpha combination therapy was superior in achieving virological response, both in magnitude and duration, compared to bulevirtide or PEG‐IFN‐alpha monotherapies in patients with chronic HDV infection.

News (Medical) associated with Bulevirtide Acetate

04 Sep 2025

·www.globenewswire.com

Bluejay Therapeutics Enrolls First Patient in AZURE-2 Global Phase 3 Clinical Trial Evaluating Brelovitug (BJT-778) Compared to Hepcludex® (Bulevirtide) for Chronic Hepatitis D

AZURE-2 evaluates the efficacy and safety of brelovitug as a monotherapy compared head-to-head with Hepcludex (bulevirtide) Enrollment in AZURE-1, a global pivotal clinical trial evaluating the efficacy and safety of brelovitug compared to delayed treatment, continues on track REDWOOD CITY, Calif., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases, today announced that it has enrolled the first patient in its AZURE-2 global clinical trial evaluating brelovitug (also known as BJT-778) compared to Hepcludex® (bulevirtide) for the treatment of chronic hepatitis D (CHD). The phase 3 clinical trial is part of the global registrational program for brelovitug. AZURE-2 is a randomized, controlled study evaluating brelovitug monotherapy (300 mg subcutaneous injection self-administered by participants weekly at home) compared with Hepcludex (bulevirtide) in adults with CHD. The primary endpoint is the proportion of participants who achieve a composite response at week 48, defined as undetectable hepatitis D virus RNA together with normalization of alanine aminotransferase (ALT). Elevated ALT levels are a marker of liver cell inflammation, which drives the development of liver cirrhosis and liver cancer. “Chronic hepatitis D is the most severe form of viral hepatitis, yet it remains underserved, with limited or no approved treatment options in most countries,” said Nancy Shulman, M.D., Chief Medical Officer of Bluejay Therapeutics. “The primary endpoints of the AZURE-1 and AZURE-2 trials include a composite measure of viral response and ALT normalization. Evidence from large cohort studies in hepatitis B has shown an association between delayed ALT normalization and increased risk of liver disease progression and liver cancer.1” “Bluejay continues to swiftly advance our registrational program for brelovitug in CHD,” said Keting Chu, M.D., Ph.D., Founder, Chief Executive Officer and Chairman of Bluejay Therapeutics. “We are proud to support the patients and providers in need of new hope.” AZURE-1 (NCT06907290), which was initiated in March 2025, is enrolling in the United States and other countries around the world. The AZURE-1 trial is powered to detect superiority of brelovitug treatment compared with delayed treatment. About Brelovitug (also known as BJT-778)Brelovitug is an investigational, highly potent, pan-genotypic, fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets the surface antigen (anti-HBsAg) on both the hepatitis D virus (HDV) and the hepatitis B virus (HBV). Brelovitug is designed to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles, which gives brelovitug a potentially advantageous safety profile and makes it a potentially efficacious treatment for chronic hepatitis D (CHD), a condition with urgent unmet medical need. In addition, brelovitug has shown immunomodulatory functions in chronic hepatitis B (CHB) patients, which may help to reconstitute antiviral immunity and contribute to functional cure for CHB when combined with other agents. In January 2025, brelovitug received FDA Breakthrough Therapy designation for the treatment of CHD. It has also received PRIME and Orphan designations from the European Medicines Agency. Bluejay Therapeutics owns the worldwide rights to brelovitug. About Chronic Hepatitis D (CHD) CHD, a coinfection that occurs in some people infected with the hepatitis B virus, is the most severe form of viral hepatitis due to the potential for rapid progression to liver cirrhosis, liver cancer and liver-related death. CHD affects approximately 7 million people globally. It is estimated that more than 50% of individuals with CHD will die of liver-related causes within 10 years of diagnosis. There are currently no approved treatments for CHD in the United States and most countries worldwide. About Bluejay TherapeuticsBluejay Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing potentially life-changing therapeutics for serious viral and liver diseases. The company is currently investigating brelovitug for the treatment of chronic hepatitis D (CHD) and chronic hepatitis B (CHB) viral infections. Additionally, Bluejay is advancing several innovative programs with the goal of developing a combination regimen to achieve a functional cure for chronic hepatitis B, including a proprietary TLR9 agonist (cavrotolimod) and a liver-targeted HBV transcript inhibitor (BJT-628). The company is also investigating BJT-188, a preclinical liver-targeted fatty acid synthase (FASN) inhibitor, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). For more information on Bluejay Therapeutics, please visit the company’s website at www.bluejaytx.com or follow the company on LinkedIn. Contact: Dan Boyle Orangefiery media@orangefiery.com 818-209-1692 1 https://pubmed.ncbi.nlm.nih.gov/31895708/

Breakthrough TherapyPhase 3Orphan Drug

07 Aug 2025

·endpoints.news

Gilead says it 'hit the ground running' on its long-acting HIV shot launch

The launch of Gilead’s groundbreaking HIV prevention shot is progressing “well ahead of our expectations,” the company’s chief commercial officer said Thursday. Yeztugo, the first-ever twice-yearly prevention shot available in the US, was approved in June for pre-exposure prophylaxis (PrEP) in adults and adolescents. The first prescription was written hours after the approval, and the first injection was administered within days, Gilead chief commercial officer Johanna Mercier told investors on the company’s second-quarter earnings call. “The team has been executing what I consider to be the best-planned commercial launch I have seen to date,” she said, adding later that Gilead “hit the ground running.” Yeztugo is also known as lenacapavir, which was first approved by the FDA in 2022 as Sunlenca for the treatment of HIV. Other options for prevention include ViiV Healthcare’s shot Apretude, which is administered every two months, or daily pills for PrEP. In an effort to differentiate Yeztugo, Gilead has positioned the injection as a more convenient option that could drive stronger patient adherence. The company declined to provide exact figures on the number of Yeztugo prescriptions written or the number of doses administered so far. But Mercier said on the call that Gilead is “extremely pleased with the feedback from both clinicians and consumers, as well as the progress of our early discussions with payers.” Gilead’s HIV product sales increased 7% in the second quarter, compared to the same period in 2024, reaching $5.1 billion. That includes a 35% sales spike for Descovy, a tablet that can be used for HIV prevention and in combination with other medicines to treat the virus. Biktarvy, Gilead’s other oral treatment for HIV, saw a 9% sales increase. The company now expects HIV sales to grow about 3% in 2025, as opposed to prior expectations of flat year-over-year revenue, partly driven by strong sales of Biktarvy and Descovy. CFO Andrew Dickinson said Gilead isn’t updating its assumptions for Yeztugo revenue in the second half of 2025 “at this time,” despite being “very encouraged by the launch dynamics” so far. Gilead raised its full-year sales guidance to $28.3 billion to $28.7 billion, slightly up from prior expectations of $28.2 billion to $28.6 billion. That takes into account lowered expectations for the company’s Covid-19 antiviral Veklury, as the company reports lower rates of Covid-related hospitalizations. Elsewhere in its news release, Gilead reported a $190 million impairment charge related to assets from its $1.7 billion acquisition of MYR in 2020. Hepcludex, MYR’s hepatitis delta virus treatment approved in Europe, was at the center of the buyout. However, the FDA rejected the drug in 2022 over “manufacture and delivery” concerns, Gilead said at the time. It now has a biologics license application pending, according to Gilead’s second-quarter earnings slides . When asked for more details, a Gilead spokesperson said the partial impairment charge was “related to the changing competitive dynamics in indications Hepcludex is being developed for.”

Drug ApprovalAcquisition

07 Aug 2025

·pipelinereview.com

Vir Biotechnology Successfully Initiates all Trials in ECLIPSE Registrational Program for Chronic Hepatitis Delta

SAN FRANCISCO, CA, USA I August 06, 2025 I Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the enrollment of the first participant in ECLIPSE 3. All three trials in the Company’s registrational ECLIPSE program for chronic hepatitis delta (CHD) have now been initiated. ECLIPSE 3 is a Phase 2b trial designed to compare the combination of tobevibart and elebsiran to bulevirtide treatment in patients with CHD. ECLIPSE 3 will provide important supportive data to help establish access and reimbursement in key markets. “We believe our registrational ECLIPSE program will validate the potential of our combination of tobevibart and elebsiran to establish a new standard of care in both newly diagnosed and previously treated patients with chronic hepatitis delta.” Share “People living with chronic hepatitis delta urgently need new options to treat their disease,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “With the strong foundation of our previous data and the proven expertise of our team, we believe our registrational ECLIPSE program will validate the potential of our combination of tobevibart and elebsiran to establish a new standard of care in both newly diagnosed and previously treated patients with chronic hepatitis delta.” “We are encouraged by the high rates of viral suppression demonstrated by the combination of tobevibart and elebsiran in our Phase 2 SOLSTICE study,” said Mark Eisner, M.D., M.P.H., Chief Medical Officer, Vir Biotechnology. “Taken together, our ECLIPSE trials are designed to demonstrate the potential of our tobevibart and elebsiran combination therapy, including breadth of response and dosing convenience. These are key aspects for improving patients’ quality of life and supporting long-term treatment adherence in real-world settings.” CHD is an area of significant unmet medical need, with no approved treatments in the U.S. and limited options globally. CHD is the most severe form of chronic viral hepatitis, 1 with people living with the disease rapidly progressing to cirrhosis, liver failure 2 and liver-related death. 1 The objective of therapy is to eliminate the virus. Tobevibart in combination with elebsiran offers the potential to achieve this by tackling the viral lifecycle through multiple mechanisms. The potential of the combination of tobevibart and elebsiran has been recognized by Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration (FDA), along with Priority Medicines (PRIME) and orphan drug status from the European Medicines Agency (EMA). These designations support the expedited development of treatments for serious diseases where there is a significant unmet medical need. About the ECLIPSE Registrational Program ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 ( NCT06903338 ) is a Phase 3 trial evaluating the safety and efficacy of tobevibart in combination with elebsiran compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 is a Phase 3 trial that will evaluate the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies, and both trials are currently recruiting. ECLIPSE 3 is a Phase 2b head-to-head trial to evaluate tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets. ECLIPSE 3 plans to enroll participants who have never received bulevirtide for the treatment of CHD. Participants will be randomized 2:1 to receive the combination of tobevibart and elebsiran or bulevirtide. The primary endpoint in ECLIPSE 3 measures hepatitis delta virus (HDV) RNA at the lower limit of quantification target not detected, HDV RNA TND (defined as HDV RNA = 0 IU/mL), at Week 48. About Tobevibart and Elebsiran Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. References: 1 WHO Hepatitis Delta Factsheet – Hepatitis D (who.int) , accessed July 2025 2 CDC What is Hepatitis D – FAQ | CDC , accessed July 2025 SOURCE: Vir Biotechnology

Phase 2Orphan DrugFast TrackPhase 3Breakthrough Therapy

100 Deals associated with Bulevirtide Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D11878	Bulevirtide Acetate	J05A	DB15248

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Virus Diseases	Canada	Gilead Sciences Canada, Inc.	01 Aug 2025
Hepatitis D, Chronic	European Union	Gilead Sciences Ireland UC	31 Jul 2020
Hepatitis D, Chronic	Iceland	Gilead Sciences Ireland UC	31 Jul 2020
Hepatitis D, Chronic	Liechtenstein	Gilead Sciences Ireland UC	31 Jul 2020
Hepatitis D, Chronic	Norway	Gilead Sciences Ireland UC	31 Jul 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis D	Phase 3	-	Gilead Sciences, Inc.	-
Hepatitis D	Phase 3	-	Atos SE	-
Hepatitis B, Chronic	Phase 2	Russia	Hepatera LLC	01 Apr 2016
Hepatitis C, Chronic	Phase 2	-	Hepatera LLC	13 Feb 2014
Hepatitis B	Phase 2	-	Atos SE	-
Liver Cirrhosis, Biliary	Preclinical	Germany	MYR GmbH	04 Apr 2018
Dyslipidemias	Preclinical	Germany	MYR GmbH	24 Mar 2018
Nonalcoholic Steatohepatitis	Preclinical	Germany	MYR GmbH	20 Mar 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05760300 (CTgov)	Phase 1	Hepatitis D, Chronic	41	Bulevirtide (BLV) (Group A: BLV 2 mg (Severe RI Group))	giouemmdox(mutykxfupp) = zmamnxkjlt dmljqlxjdy (uezcdrtegw, 29.8) View more	-	18 Sep 2025
				Bulevirtide (BLV) (Group A: BLV 2 mg (Matched Control))	giouemmdox(mutykxfupp) = kcficzvful dmljqlxjdy (uezcdrtegw, 32.6) View more
NCT03852719 (MYR301, Company_Website) Manual	Phase 3	Hepatitis D	-	Bulevirtide	vbdusouryl(kwshelpebc) = imbmpngdad ldjhrpukaj (vcbdthzfcs ) View more	Positive	07 May 2025
NCT02888106 (Pubmed \| Liver Int)	Phase 2	Hepatitis D, Chronic	-	BLV 2 mg once daily + Peg‐IFNα‐2a 180 μg once weekly	fqqdlztioy(anbzkvkezv) = evhlurvyay iknuzznxvo (fxiprifern )	Positive	01 Feb 2025
				BLV 5 mg once daily + Peg‐IFNα‐2a 180 μg once weekly	fqqdlztioy(anbzkvkezv) = efqurravtu iknuzznxvo (fxiprifern )
NCT03852433 \| NCT02888106 \| NCT03852719 (MYR301;MYR203;MYR204, Pubmed \| Liver Int)	Phase 2/3	Hepatitis D, Chronic	269	Bulevirtide 2 mg	vpeovselto(mmxlxcteeb) = Neither hepatic decompensation nor death occurred eqadzwhhih (izcqpziyst ) View more	Positive	08 Dec 2024
				Bulevirtide 10 mg
NCT03546621 \| NCT02888106 \| NCT03852719 (MYR301, Pubmed) Manual	Phase 2	Hepatitis D, Chronic HBsAg-positive hepatocytes	126	Bulevirtide 2 mg/day	awwwyxaesi(fogutcoigz) = hmwlxkwvgh zwssemwczh (mhugcawflf ) View more	Positive	08 Feb 2024
				Bulevirtide 5 mg/day	awwwyxaesi(fogutcoigz) = enydrnnsax zwssemwczh (mhugcawflf )
AASLD2023	Not Applicable	-	141	Bulevirtide 2mg	zgcmbiglws(zuudoihmqo) = zvayxdinof rfosuukumm (ibbwbzzlrd ) View more	-	10 Nov 2023
				Bulevirtide 10mg	zgcmbiglws(zuudoihmqo) = ypjoqihcpo rfosuukumm (ibbwbzzlrd ) View more
AASLD2023	Not Applicable	Coronary Disease	128	BLV 2 mg	subntxdtcx(xgaenfobox) = nczmrwjrou dspevgaevn (bajfjcdnpn ) View more	-	10 Nov 2023
				BLV 10 mg	subntxdtcx(xgaenfobox) = djnqiybkli dspevgaevn (bajfjcdnpn ) View more
NCT05962307 (HEP4Di, AASLD2023)	Not Applicable	Hepatitis D	97	Bulevirtide 2 mg/day	bofwpukkzb(hcstzesrxp) = rispygdvuw jwdpqganai (sjyyhczlnr ) View more	-	10 Nov 2023
NCT05928000 \| NCT03852719 (MYR 301, Pubmed)	Phase 3	Hepatitis D, Chronic	150	Bulevirtide 2 mg/day	xoelusdapj(iihpflhmxu) = more common in the 2-mg and 10-mg groups combined than in the control group osjuckwfyf (kzhejokgzq ) View more	Positive	22 Jun 2023
				Bulevirtide 10 mg/day

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