A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)

This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).

开始日期2026-02-26

申办/合作机构

Mirum Pharmaceuticals, Inc.

NCT07491848

/ RecruitingN/AIIT

Oral-Periodontal Evaluation and Assessment of Biomarkers in Oral Fluids in Patients With Hepatitis B+D Treated With Bulevirtide

Periodontal disease is a chronic inflammatory condition associated with systemic diseases, highlighting the concept of periodontal medicine. This study aims to investigate the relationship between periodontal inflammation, oral lesions, and hepatitis B+D infection, with or without bulevirtide treatment. Oral-periodontal clinical parameters and targeted inflammatory biomarkers in saliva and gingival crevicular fluid will be evaluated in three groups: patients with hepatitis B+D receiving bulevirtide, patients with hepatitis B+D not receiving bulevirtide, and healthy controls.

开始日期2026-02-15

申办/合作机构

University of Medicine and Pharmacy of Craiova

NCT07142811

/ Active, not recruiting临床2期

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

开始日期2025-08-05

申办/合作机构

Vir Biotechnology, Inc.

100 项与布尔韦肽相关的临床结果

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100 项与布尔韦肽相关的转化医学

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100 项与布尔韦肽相关的专利（医药）

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229

项与布尔韦肽相关的文献（医药）

2026-11-01·COLLOIDS AND SURFACES B-BIOINTERFACES

Liposome formulation of a myristoylated antimicrobial peptide derived from Chionodracine: preparation, physico-chemical characterization and biological activity

Article

作者: Borocci, Stefano ; Ceccacci, Francesca ; Bugli, Francesca ; Massaro, Federica ; Clemente, Mariangela ; Volpe, Antonia ; Toma, Federica ; Pandolfi, Fabiana ; Bombelli, Cecilia ; Porcelli, Fernando ; Taddei, Anna Rita ; Buonocore, Francesco ; Squitieri, Damiano

Second-generation antimicrobial lipopeptides are considered very promising tools to combat the spread of systemic fungal infections caused by fungi multidrug resistance and biofilm-associated infections. The present work reports a study on the lipopeptide Myr-B, derived from myristoylation of the natural antimicrobial peptide Chionodracine. The aim was to exploit its therapeutic potential by developing a suitable procedure for its encapsulation in liposomes, with a view to overcoming its in vivo instability and tendency to aggregation. A systematic investigation allowed to select two optimal liposome formulations, based on dimyristoylphosphatidylcholine, having chains of the same length of the lipopetide, and cholesterol and/or cholesteryl-hemisuccinate. Thin-film hydration and lipid-cake preparation methods were explored, and chemical-physical characterization was integrated with molecular dynamics simulations. The lipid-cake method proved to be the optimal approach, yielding monodisperse, stable liposomes with high encapsulation efficiency. Encapsulation in both liposome formulations markedly enhanced antifungal activity, lowering minimum inhibitory concentrations more than ten-fold against Candida albicans and approximately four-fold against Candida tropicalis compared to free Myr-B. LIVE/DEAD imaging also confirmed a strong reduction in biofilm formation. Liposomes displayed minimal haemolysis, low cytotoxicity toward human fibroblasts, and good in vivo tolerability in Galleria mellonella. Notably, specific interactions between cholesteryl-hemisuccinate and the peptide involved a peculiar liposome structure and a slower release from the liposome. Overall, both Myr-B-loaded liposomes produced by the lipid cake protocol significantly potentiates MYR-B efficacy while maintaining a favourable safety profile. These formulations are not universally applicable to all lipopeptides; however, the underlying criteria presented in this work are.

2026-08-01·JOURNAL OF CLINICAL VIROLOGY

Clinical evaluation of the Altostar HDV RT-PCR Kit 1.5

Article

作者: Bremer, Birgit ; Maasoumy, Benjamin ; Sandmann, Lisa ; Wedemeyer, Heiner ; Eichholz, Julia Carolin

BACKGROUND:

Detection and quantification of hepatitis D virus RNA is essential for diagnosis and treatment of chronic hepatitis D virus (HDV) infection. This study evaluated the diagnostic performance of the Altostar HDV RT-PCR Kit 1.5 in real-world clinical samples with and without treatment with bulevirtide (BLV).

METHODS:

Plasma samples of 40 patients with chronic HDV infection were analyzed with the Altostar HDV RT-PCR Kit 1.5 and compared to the local standard, the RoboGene HDV RNA Quantification Kit 2.0, with additional analyses of corresponding serum and plasma samples and on-treatment samples during BLV therapy.

RESULTS:

HDV RNA levels in plasma samples quantified by both assays showed a significant positive correlation. All samples were quantifiable by Altostar 1.5, whereas two samples were undetectable by Robogene 2.0 During BLV therapy, mean baseline (BL) and follow-up (FU) HDV RNA levels were comparable between the two assays. There was a similar proportion of patients with virological response (Altostar 1.5: 75% [n = 15/20] vs. Robogene 2.0: 70% [n = 14/20]), whereas the proportion of samples with undetectable HDV RNA at FU was considerably higher in measurements with Robogene 1.5 (40% vs. 0%).

CONCLUSIONS:

HDV RNA levels quantified by the Altostar HDV RT-PCR Kit 1.5 were comparable to the local standard. The higher number of detectable samples may reflect increased sensitivity, occasional false-positive results with Altostar 1.5, or the impact of automated extraction in the Robogene workflow. Importantly, treatment response during BLV treatment was not influenced by the type of quantification assay.

2026-07-01·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Correlation of Bile Acid Dynamics to Bulevirtide Response and Disease Severity in Patients With Hepatitis D

Article

作者: Sebesta, Christian ; Thöne, Paul ; Attalla, Patrik ; Balcar, Lorenz ; Mandorfer, Mattias ; Schwarz, Michael ; Gschwantler, Michael ; Hintersteininger, Marlene ; Hartl, Lukas ; Jachs, Mathias ; Trauner, Michael ; Reiberger, Thomas ; Schwabl, Philipp ; Hofer, Benedikt Silvester ; Kramer, Georg

ABSTRACT:

Background:

Bulevirtide (BLV) blocks hepatitis D virus (HDV) entry by targeting the sodium taurocholate co‐transporting polypeptide (NTCP). This study assessed the relationship between bile acid (BA) levels and antiviral response to BLV.

Methods:

Serum BA levels were monitored in HDV‐infected patients pre‐, under, and post BLV treatment. Virologic response (VR) was defined by ≥ 2log 10 decline in HDV‐RNA and discriminated versus virologic non‐response (VNR). Delta BA levels (ΔBA) were calculated and analysed in relation to HDV‐RNA dynamics. Finally, the effect of BLV treatment cessation on BA was investigated.

Results:

Twenty five patients (48% male; advanced chronic liver disease [ACLD]: 92.0%, 17 patients with VR at W48) were included. Median baseline BA levels were significantly higher in patients with ACLD and portal hypertension ( n = 10; 19.2 vs. 5.1 μmol/L; p = 0.015). No difference in median on‐treatment BA levels was detected between patients achieving VR or VNR at W24 (VR: 25.4 vs. VNR: 22.7 μmol/L; p = 1.000) and W48 (VR: 25.4 vs. VNR: 20.8 μmol/L; p = 1.000). Additionally, ΔBA from baseline to W48 did not differ between VR and VNR ( p = 0.534). No significant association between ΔBA and HDV‐RNA dynamics at W48 was detected. After BLV discontinuation, median BA levels significantly dropped to normal ranges (18.9 μmol/L at last on‐BLV assessment to 7.6 μmol/L after discontinuation; p = 0.028). On‐treatment BA levels did neither associate with self‐reported compliance nor with treatment‐related adverse events.

Conclusion:

Bulevirtide increases bile acid levels in most patients, but ΔBA does not predict virologic response or adverse events, nor does it reflect compliance to therapy. Bile acid level monitoring during and following bulevirtide treatment is thus, not advised for clinical practise.

232

项与布尔韦肽相关的新闻（医药）

2026-08-07

·新浪财经

医药生物行业点评报告吉利德26Q2：HIV现金流稳健密集收购加码转型、单季计提巨额费用

事件： 2026 年8 月4 日吉利德公布2026 年二季度业绩，Q2 总营收78.0 亿美元（同比+10.0%），主业增长稳健；但受收购相关费用影响，GAAP 口径由盈转亏，Q2 净亏损105 亿美元、每股亏损8.45 美元。　　HIV 核心业务保持稳健增长，治疗与预防双轮驱动。Q2 HIV 业务销售56.9 亿美元（同比+12.0%），仍是吉利德最主要收入来源。（1）治疗端，核心单品比克恩丙诺片（Biktarvy，整合酶抑制剂三合一复方）Q2 销售37.7 亿美元（同比+7.0%），市场份额同比继续提升；（2）预防端，暴露前预防用药（PrEP）Q2 销售首破10 亿美元、同比翻倍，其中恩曲他滨丙酚替诺福韦片（Descovy，核苷类逆转录酶抑制剂复方）用于PrEP 的Q2 销售约8.0 亿美元（同比+60.0%），长效针剂Yeztugo（lenacapavir，衣壳抑制剂）Q2 销售2.3 亿美元、为长效PrEP 新患者首选；（3）受此拉动，公司将全年HIV 销售增速指引由8%上调至9%~10%。　　其他板块新老交替，肝病、肿瘤整体平稳。（1）肝病业务Q2 销售8.77亿美元（同比+10.0%），增长主要来自原发性胆汁性胆管炎（PBC）药物Livdelzi（seladelpar，PPARδ激动剂），Q2 销售1.67 亿美元、同比翻倍以上，另有Hepcludex（bulevirtide，HDV 进入抑制剂）2026 年5 月获FDA 加速批准、为美国首个HDV 治疗药物；（2）肿瘤业务Q2 销售8.73亿美元（同比+3.0%），注射用戈沙妥珠单抗（Trodelvy，TROP2 ADC）Q2 销售4.57 亿美元（同比+26.0%）、获批一线转移性三阴乳腺癌（不限PD-L1 状态），CAR-T 细胞疗法Q2 销售4.17 亿美元（同比-14.0%）、受同类竞争承压；（3）瑞德西韦（Veklury，RNA 聚合酶抑制剂）随新冠住院率下降加速退场，Q2 销售仅0.2 亿美元（同比-81.0%），公司下调其全年销售预期至约3 亿美元。　　转型为核心看点，细胞疗法、ADC 与HIV 长效管线三线推进。公司正通过密集收购与管线推进，从单一HIV 公司向横跨抗病毒、肿瘤、自免的多元化生物制药企业转型。（1）细胞疗法方面，公司2026 年4 月完成对Arcellx 收购、获得anito-cel（BCMA 靶向CAR-T）全部权益，用于四线及以上复发/难治多发性骨髓瘤，公司预计2026 年12 月23 日获美国FDA 批准；（2）ADC 方面，公司2026 年5 月完成对Tubulis 收购、补充下一代ADC 资产，其中GS-8824（NaPi2b 靶向ADC）在铂耐药卵巢癌I 期确认客观缓解率（ORR）达61%、mPFS 11 个月，公司预计最早2027 年进入注册临床；（3）HIV 长效管线方面，与默沙东合作的每周一次口服方案islatravir＋lenacapavir（衣壳抑制剂）两项III 期临床达主要终点、公司预计2027 年上市，另有每日口服的bictegravir（整合酶抑制剂）＋lenacapavir 新方案公司预计2026 年8 月底获美国FDA批准。转型的代价是Q2 季度账面承压，公司在Q2 计提Arcellx、Tubulis、Ouro Medicines 三笔收购产生的在研研发（IPR&D）费用约112 亿美元，导致Q2 GAAP 净亏损约105 亿美元；但该费用属一次性、非现金性质；若剔除上述收购影响，公司Q2 调整后每股收益同比增长约13%，主业盈利能力保持稳健。　　投资建议：吉利德HIV 核心业务延续强劲增长，说明市场对新抗病毒/艾滋病管线仍有需求，建议关注艾迪药业等具备相关新管线的国内企业；同时以吉利德为代表的部分海外药企普遍存在业务转型或管线更新的需求，建议关注国内具备FIC 或BIC 潜力管线的创新药企业。　　风险提示：研发进展不及预期；商业化推进不及预期；海外审批或收益不达预期；国际地缘政治风险。

2026-08-06

·GBIHealth

礼来、诺和诺德等多家MNC发布财报

礼来2026Q2财报：收入增长48% 2026年8月5日，礼来（NYSE：LLY）发布2026年第二季度财务业绩。2026年第二季度，公司收入229.74亿美元，同比增长48%。这主要归因于产品销量增长60%，但部分被实现价格下降13%所抵消。以替尔泊肽（Mounjaro和Zepbound）为首的重点产品（Key Products）营收在第二季度增长至157.0亿美元。免疫学、肿瘤学和神经科学治疗领域的重点产品收入比2025年Q2增长了121%。按市场划分，美国市场收入增长33%至144亿美元，主要受销量增长37%的驱动，部分被实现价格下降3%所抵消。销量增长主要由Zepbound和Mounjaro推动。价格下降主要受Zepbound和Mounjaro影响，但部分被返利和折扣估计值的调整（主要由Trulicity、Zepbound和Mounjaro推动）所抵消。美国以外市场收入增长80%至86.0亿美元，主要受销量大幅增长113%驱动，部分被实现价格下降36%所抵消。海外实现价格下降主要归因于Mounjaro被纳入中国国家医保药品目录（NRDL）。海外销量增长由Mounjaro领跑。欧唐静（Jardiance）在海外市场的收入包含了与勃林格殷格翰（Boehringer Ingelheim）合作相关的2.50亿美元销售里程碑付款。按产品划分，Mounjaro第二季度销售额增长91%至99.0亿美元。该药在美国的销售额增长45%至48.0亿美元，反映出强劲的需求（部分被实现价格下降抵消）；在海外的销售额增长172%至52.0亿美元，主要受销量增长推动。Zepbound第二季度在美国的销售额增长44%至49亿美元，主要由强劲需求推动，部分被实现价格下降所抵消。鉴于核心产品的良好表现，公司将2026全年营收指引上调至850亿至870亿美元，业绩利润率达49.0%~50.5%。诺和诺德2026Q2财报：公司收入121亿美元，中国市场增长13% 2026年8月5日，诺和诺德（NYSE：NVO）发布公司2026年第二季度财务业绩。第二季度，公司净销售额784.88亿丹麦克朗（约121亿美元），同比增长7%（按固定汇率计算，下同）。2026年上半年，公司净销售额1485.51亿丹麦克朗（约229亿美元），同比增长2%。按市场划分，2026年第二季度，美国市场收入408.69亿丹麦克朗，同比增长4%（上半年收入762.54亿丹麦克朗，-4%）；欧洲和加拿大市场收入192.06亿丹麦克朗，同比增长17%（上半年收入371.24亿丹麦克朗，+8%）；新兴市场收入84.13亿丹麦克朗，同比增长5%（上半年收入152.74亿丹麦克朗，-7%）；亚太市场收入50.3亿丹麦克朗，同比下滑6%（上半年收入101.55亿丹麦克朗，+7%）；中国市场收入49.7亿丹麦克朗，同比增长13%（上半年收入97.44亿丹麦克朗，与去年同期持平）。业绩增长主要由司美格鲁肽销售额驱动。第二季度，肥胖症业务收入231.52亿丹麦克朗，同比增长16%，其中减重用司美格鲁肽注射液（Wegovy）销售额194.84亿丹麦克朗，同比增长1%；片剂销售额32.18亿丹麦克朗；GLP-1类降糖业务收入367.84亿丹麦克朗，同比增长2%，其中降糖用司美格鲁肽注射液（Ozempic）销售额313.75亿丹麦克朗，同比增长5%；Wegovy片剂和Rybelsus销售额52.28亿丹麦克朗，同比下滑4%。出于业务组合调整，诺和诺德终止了monlunabant的开发。该药是一种实验性化合物，靶向1型大麻素受体（CB1受体），2023年诺和诺德斥资11亿美元收购拿大生物技术公司Inversago Pharma获得该药。试验发现，该药较高剂量时减重效果有限，且出现轻中度神经精神副作用。吉利德2026Q2财报：收入增长10%至78亿美元 2026年8月5日，吉利德科学公司（Nasdaq: GILD）公布2026年第二季度财务业绩。报告期内，公司总收入达78亿美元，同比增长10%。产品销售额为76亿美元，同比增长8%。剔除Veklury（瑞德西韦）后，产品销售额增长10%，主要得益于HIV产品、拓达维（戈沙妥珠单抗）和Livdelzi（司拉德帕）的销售增长，但部分被细胞治疗产品和丙型肝炎（HCV）产品的销售下降所抵消。 2026年第二季度，吉利德的HIV产品销售额同比增长12%，达57亿美元。其中，必妥维（Biktarvy）销售额增长7%至38亿美元；达可挥（Descovy）销售额大幅增长48%至9.67亿美元。肝脏疾病产品组合销售额增长10%至8.77亿美元，主要由于Livdelzi、慢性乙型肝炎（HBV）产品及Hepcludex需求的增加，但部分被HCV产品销售额下降所抵消。细胞治疗产品销售额下降14%至4.17亿美元，其中奕凯达（阿基仑赛）销售额下降12%至3.46亿美元，Tecartus（布瑞基奥仑赛）销售额下降24%至7000万美元，主要受竞争压力影响。瑞德西韦销售额锐减81%至2300万美元，主要因COVID-19相关住院率持续走低。TROP2 ADC药物拓达维实现销售额4.57亿美元，同比增长26%，受需求增加所驱动。安斯泰来2026财年第一季度财报：收入增长26.7% 2026年8月5日，安斯泰来（TSE：4503）公布2026财年第一季度财务业绩，公司收入6409.14亿日元（约40.66亿美元），同比增长26.7%。战略品牌（Padcev，Izervay，Vyloy，Veozah，Xospata）销售收入1603亿日元，同比增长43.2%。按市场划分，第一季度美国市场收入2888亿日元，同比增长28.5%；日本市场收入796亿日元，同比增长15.5%；成熟市场（欧洲、加拿大等）收入1522亿日元，同比增长18.2%；中国市场（中国大陆和香港）收入321亿日元，同比增长8.9%；其他市场收入854亿日元，同比增长60.5%。公司预计，2026财年收入将达22200亿日元，同比增长3.8%；核心营业利润4600亿日元，同比增长8.4%。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ olivia.xu@generalbiologic.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

2026-08-05

·Business Wire

CPC Scientific Announces U.S. FDA Pre-License Inspection (PLI) Successfully Completed at Its Hangzhou cGMP Manufacturing Facility for Hepcludex® API, Establishing a Proven Track Record Under the Stringent BLA Pathway

ROCKLIN, Calif. & HANGZHOU, China--(BUSINESS WIRE)--CPC Scientific Inc., a premier peptide and oligonucleotide-focused Contract Research, Development, and Manufacturing Organization (CRDMO) and a wholly owned subsidiary of Medtide Inc. (HKEX: 3880.HK), today announced that Chinese Peptide Company, its current Good Manufacturing Practice (cGMP) manufacturing facility, located in Hangzhou, China, has successfully completed a Pre-License Inspection (PLI) conducted by the U.S. Food and Drug Administration (FDA). "As the commercial API supplier for this pioneering therapy, we are immensely proud to witness and support this historic medical advancement that may potentially alter the treatment landscape for patients with chronic HDV." The rigorous onsite audit, conducted from January 26 to February 3, 2026, comprehensively evaluated the facility's commercial manufacturing operations for the complex, fully synthetic long-chain peptide active pharmaceutical ingredient (API) of Hepcludex® (bulevirtide-gmod) 8.5 mg for injection, which received accelerated approval from the U.S. FDA on May 22, 2026, as the first and only approved treatment for chronic hepatitis delta virus (HDV) infection in the United States. With a sequence exceeding 40 amino acids, the commercial-scale manufacturing of the Hepcludex® API is long and complex. Under current FDA regulatory frameworks, synthetic peptides of this length are classified as biologics, mandating significantly more rigorous controls compared to traditional small-molecule peptide NDAs. About Chronic HDV and the Unmet Medical Need Hepatitis delta virus (HDV) infection occurs exclusively as a co-infection in individuals living with the hepatitis B virus (HBV). Chronic HDV is clinically recognized as the most severe and rapidly progressive form of viral hepatitis. Compared with HBV infection alone, HDV co-infection accelerates the disease progression, carrying a markedly higher risk of rapid progression toward severe liver fibrosis (scarring), cirrhosis, liver failure, liver cancer, and mortality. In the United States, studies in general populations estimate that HDV affects between 2% and 4% of individuals with chronic HBV, representing approximately 40,000 to 80,000 people living with this devastating condition. Due to historically low screening rates and limited clinical pathways, patients face the immense complexity of managing two distinct viral liver diseases simultaneously. Prior to the accelerated approval of Hepcludex® (bulevirtide-gmod), there were no FDA-approved therapies available, leaving a critical gap in care. The landmark approval of Hepcludex® addresses this profound unmet medical need, marking a historic milestone that has the potential to fundamentally alter the clinical course of HDV for patients in the United States. Management Commentary “Following the landmark U.S. FDA accelerated approval of Hepcludex®, CPC Scientific extends our warmest and most sincere congratulations to our strategic partner, Gilead Sciences,” said Dr. Shawn Lee, Chairman of both CPC Scientific and Chinese Peptide Company. “As the commercial API supplier for this pioneering therapy, we are immensely proud to witness and support this historic medical advancement that may potentially alter the treatment landscape for patients with chronic HDV. “The successful completion of this rigorous FDA Pre-License Inspection stands as a proud milestone for our team, serving as a testament to our manufacturing capability and quality standards forged over 25 years. “This milestone, combined with our consistent track record of supporting multi-regional filings for this program, further solidifies CPC Scientific’s position as an indispensable, strategic technical partner for the industry’s most sophisticated long-chain peptide programs. “Looking ahead, this validation carries significant strategic weight beyond the program itself. Early-stage discovery pipelines in GLP-1 and obesity are increasingly exploring next-generation candidates featuring longer-chain architectures, often around or beyond 40 amino acids. We are uniquely positioned to leverage this BLA-grade validated capability to support global partners pursuing commercial regulatory filings for this new class of molecules.” About CPC Scientific CPC Scientific is a premier global Contract Research, Development, and Manufacturing Organization (CRDMO) specializing in synthetic peptides and oligonucleotides for the biopharmaceutical industry. Headquartered in Rocklin, California, CPC Scientific serves as the primary international corporate vehicle and strategic of Medtide Inc. (HKEX: 3880.HK), driving seamless global business operations and delivering access to an integrated infrastructure backed by nearly 25 years of technical excellence. The company supports pharmaceutical and biotechnology innovators through the most critical phases of drug development, with a particular focus on late-phase development, large-scale manufacturing, and commercial production. Backed by metric-ton scale cGMP manufacturing, CPC Scientific operates world-class, cGMP-compliant commercial production facilities, including its core manufacturing asset in Hangzhou, China, which has successfully completed rigorous regulatory inspections conducted by multiple regulatory authorities and quality organizations, including the U.S. FDA, NMPA, TGA, and EMA, underscoring the company’s consistent compliance with international quality and manufacturing standards. To further strengthen global supply chain resilience and meet evolving market demands, CPC Scientific is actively expanding its global footprint with the development of a localized, state-of-the-art GMP manufacturing facility in the United States. Learn more at: www.cpcscientific.com

上市批准加速审批寡核苷酸临床研究

100 项与布尔韦肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11878	布尔韦肽	J05A	DB15248

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
病毒感染	加拿大	Gilead Sciences Canada, Inc.	2025-08-01
慢性丁型肝炎	欧盟	Gilead Sciences Ireland UC	2020-07-31
慢性丁型肝炎	冰岛	Gilead Sciences Ireland UC	2020-07-31
慢性丁型肝炎	列支敦士登	Gilead Sciences Ireland UC	2020-07-31
慢性丁型肝炎	挪威	Gilead Sciences Ireland UC	2020-07-31

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
丁型肝炎	临床3期	-	Gilead Sciences, Inc.	-
丁型肝炎	临床3期	-	Atos SE	-
慢性乙型肝炎	临床2期	俄罗斯	Hepatera LLC	2016-04-01
慢性丙型肝炎	临床2期	-	Hepatera LLC	2014-02-13
乙型肝炎	临床2期	-	Atos SE	-
胆汁性肝硬化	临床前	德国	MYR GmbH	2018-04-04
血脂障碍	临床前	德国	MYR GmbH	2018-03-24
代谢功能障碍相关脂肪性肝炎	临床前	德国	MYR GmbH	2018-03-20

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03852719 (MYR301, Pubmed \| J Hepatol)	临床3期	慢性丁型肝炎	150	Bulevirtide 2 mg/day	壓膚積鬱齋選餘願簾遞(鹽餘廠淵蓋夢製積醖觸) = 艱淵範壓蓋簾網醖範壓壓簾夢構鹹築齋壓遞壓 (願齋憲衊膚膚襯構鹹糧 ) 更多	积极	2026-04-01
				Bulevirtide 10 mg/day	壓膚積鬱齋選餘願簾遞(鹽餘廠淵蓋夢製積醖觸) = 鏇艱願窪鑰網遞遞餘鏇壓簾夢構鹹築齋壓遞壓 (願齋憲衊膚膚襯構鹹糧 ) 更多
NCT05765344 (CTgov)	临床1期	肝功能不全	74	Bulevirtide (Group A: BLV 2 mg, Matched Control)	願蓋選觸選遞艱餘構淵(遞製顧膚願網壓襯鬱淵) = 窪餘廠鹹膚窪襯襯憲積淵衊鏇範憲齋願積廠遞 (構獵願鑰鬱遞築膚蓋選, 66.9) 更多	-	2026-01-26
				Bulevirtide (Group B: BLV 2 mg, Severe Hepatic Impairment)	願蓋選觸選遞艱餘構淵(遞製顧膚願網壓襯鬱淵) = 夢鬱蓋糧觸膚製構繭鏇淵衊鏇範憲齋願積廠遞 (構獵願鑰鬱遞築膚蓋選, 71.7) 更多
NCT05760300 (CTgov)	临床1期	慢性丁型肝炎	41	Bulevirtide (BLV) (Group A: BLV 2 mg (Severe RI Group))	選鑰鏇積窪壓齋簾簾鹽(窪夢鹽艱鬱鑰觸襯壓鹽) = 淵鹹積鹹蓋網獵艱鹽鏇齋選餘網積網鑰鏇醖網 (襯淵製夢壓餘鹽夢壓鹽, 29.8) 更多	-	2025-09-18
				Bulevirtide (BLV) (Group A: BLV 2 mg (Matched Control))	選鑰鏇積窪壓齋簾簾鹽(窪夢鹽艱鬱鑰觸襯壓鹽) = 膚遞鏇艱鹹遞鹽壓壓鏇齋選餘網積網鑰鏇醖網 (襯淵製夢壓餘鹽夢壓鹽, 32.6) 更多
NCT03852719 (MYR301, Company_Website) 人工标引	临床3期	丁型肝炎	-	Bulevirtide	願鏇顧繭遞製獵蓋廠範(選製觸鬱廠廠鏇廠衊鹽) = 夢鏇齋廠衊構廠齋鑰壓夢鑰選艱醖簾顧築襯糧 (膚膚蓋繭鹽選夢醖鹹選 ) 更多	积极	2025-05-07
NCT02888106 (Pubmed \| Liver Int)	临床2期	慢性丁型肝炎	-	BLV 2 mg once daily + Peg‐IFNα‐2a 180 μg once weekly	網糧蓋鑰鬱構積衊選衊(獵獵顧鹹範鏇鹹憲夢齋) = 鏇製築鑰積廠積鹽糧獵淵衊鹽願膚衊餘積蓋淵 (齋蓋襯憲淵艱鹽餘簾網 )	积极	2025-02-01
				BLV 5 mg once daily + Peg‐IFNα‐2a 180 μg once weekly	網糧蓋鑰鬱構積衊選衊(獵獵顧鹹範鏇鹹憲夢齋) = 鏇網繭蓋艱築蓋齋餘築淵衊鹽願膚衊餘積蓋淵 (齋蓋襯憲淵艱鹽餘簾網 )
NCT03852433 \| NCT02888106 \| NCT03852719 (MYR301;MYR203;MYR204, Pubmed \| Liver Int)	临床2/3期	慢性丁型肝炎	269	Bulevirtide 2 mg	鬱鬱範艱製衊鏇網醖遞(範壓鏇鬱鬱觸窪觸糧壓) = Neither hepatic decompensation nor death occurred 網糧範艱壓繭鬱觸醖願 (範願顧鏇鏇顧願淵壓觸 ) 更多	积极	2024-12-08
				Bulevirtide 10 mg
NCT03852433 (CTgov)	临床2期	慢性丁型肝炎	175	Peginterferon Alfa-2a (PEG-IFN alfa) (Pegylated Interferon Alfa-2a (PEG-IFN Alfa))	淵襯淵襯襯淵繭鏇醖構 = 顧襯膚醖構繭壓鬱顧範蓋衊簾鹽網蓋壓鹽襯艱 (顧積積鏇壓蓋襯衊繭憲, 構築窪蓋鹽衊簾築壓觸 ~ 獵構鬱蓋餘淵窪範壓範) 更多	-	2024-07-29
				Peginterferon Alfa-2a (PEG-IFN alfa)+Bulevirtide (Bulevirtide 2 mg/Day + PEG-IFN Alfa)	淵襯淵襯襯淵繭鏇醖構 = 網鏇製淵積醖網鏇鏇艱蓋衊簾鹽網蓋壓鹽襯艱 (顧積積鏇壓蓋襯衊繭憲, 餘簾繭製窪鏇鏇鹹築廠 ~ 顧糧顧齋築廠簾壓淵鑰) 更多
NCT03546621 \| NCT02888106 \| NCT03852719 (MYR301, Pubmed) 人工标引	临床2期	慢性丁型肝炎 HBsAg-positive hepatocytes	126	Bulevirtide 2 mg/day	鏇齋製選鬱遞構鹹遞願(糧網憲壓糧艱艱範鑰糧) = 壓積鏇膚餘鏇製蓋鏇製鏇衊膚鑰願繭顧鑰淵夢 (製艱鬱醖鏇蓋範鬱觸醖 ) 更多	积极	2024-02-08
				Bulevirtide 5 mg/day	鏇齋製選鬱遞構鹹遞願(糧網憲壓糧艱艱範鑰糧) = 鬱製餘膚觸餘獵鏇醖醖鏇衊膚鑰願繭顧鑰淵夢 (製艱鬱醖鏇蓋範鬱觸醖 )
AASLD2023	N/A	-	141	Bulevirtide 2mg	鹹簾遞夢鹽鹹觸餘廠齋(顧餘遞繭衊艱衊廠構積) = 鬱餘鹹鏇製齋鑰醖獵齋壓鏇製窪顧簾範鹹製夢 (衊製鑰鹽遞鑰餘齋範簾 ) 更多	-	2023-11-10
				Bulevirtide 10mg	鹹簾遞夢鹽鹹觸餘廠齋(顧餘遞繭衊艱衊廠構積) = 鏇鑰糧夢齋獵鬱衊夢網壓鏇製窪顧簾範鹹製夢 (衊製鑰鹽遞鑰餘齋範簾 ) 更多
AASLD2023	N/A	冠状动脉疾病	128	BLV 2 mg	築襯鹽襯網網繭蓋鬱願(餘願淵鑰鏇製蓋積鹹壓) = 餘獵淵壓鏇憲積廠鹽鹹醖艱鑰醖壓願構積願獵 (齋衊鏇鑰簾網築襯鹽襯 ) 更多	-	2023-11-10
				BLV 10 mg	築襯鹽襯網網繭蓋鬱願(餘願淵鑰鏇製蓋積鹹壓) = 積繭廠憲選廠壓鏇鬱糧醖艱鑰醖壓願構積願獵 (齋衊鏇鑰簾網築襯鹽襯 ) 更多