A Prospective Cohort Study on ETV+Ommaya Reservoir for Preventing persistent postoperative hydrocephalus for High-Grade Posterior Fossa Brain Tumors in Children

Start Date25 Feb 2025

Sponsor / Collaborator

Zhujiang Hospital of Southern Medical University

KCT0009610

/ Not yet recruitingPhase 4IIT

A single-arm, open-label study evaluating safety and efficacy of switching treatment to Enped tab (entecavir) in patients with chronic hepatitis B treated with Baraclude tab (ETV)

Start Date12 Aug 2024

Sponsor / Collaborator

GangNeung Asan Hospital

NCT06296147

/ RecruitingNot ApplicableIIT

A Randomized, Controlled Trial: Impact on Patient Experience in Patients Assigned to Virtual Reality Headset; Aromatherapy Patch; Virtual Reality + Aromatherapy; or Standard of Care for Transperineal Prostate Biopsy

The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group.

Start Date20 May 2024

Sponsor / Collaborator

University of Pittsburgh

100 Clinical Results associated with Entecavir

100 Translational Medicine associated with Entecavir

100 Patents (Medical) associated with Entecavir

5,345

Literatures (Medical) associated with Entecavir

01 Dec 2025·CHILDS NERVOUS SYSTEM

Clinical and radiologic criteria to predict endoscopic third ventriculostomy success in non-communicating pediatric hydrocephalus

Article

Author: Pennacchietti, Valentina ; Thomale, Ulrich-W ; Tietze, Anna ; Cohrs, Gesa ; Tatoshvili, Davit ; Schaumann, Andreas ; Schulz, Matthias

Abstract:

Objective:

Endoscopic third ventriculocisternostomy (ETV) became the relevant treatment option for non-communicating pediatric hydrocephalus. ETV success was predicted in relation to age, diagnosis, and previous shunt implantation. Radiological factors are usually taken for indication decision-making. The aim of this study is to investigate radiological signs of non-communicating hydrocephalus for ETV success in a single-center retrospective analysis.

Patients and methods:

ETV interventions were collected from a 10-year period (2010–2019) from our institution. Clinical patient characteristics such as prematurity, age, diagnosis, and previous shunt treatment and follow-up in terms of possible shunt implantation or revision surgeries were investigated. Radiological data was retrieved from the in-house PACS system to analyze preoperative signs for noncommunicating hydrocephalus such as ventricular size, pressure gradients at the third ventricle, and any signs of obstruction from internal towards external cerebral spinal fluid communication. Fisher’s test was used to demonstrate the significance of each individual predictor. A multivariable model was built using the backward elimination method with multiple logistic regression.

Results:

From 136 ETV interventions, 95 met the inclusion criteria (age < 18 years; > 6-month follow-up; MR image data availability, treatment goal for shunt independence). In chi-square statistical evaluation of single parameters age > 6 months (OR 32.5; 95% CI 4.8–364), ventricular width (FOHR < 0.56; OR 6.1; 95% CI 2.2–16.3) and non-post-hemorrhagic hydrocephalus as underlying diagnosis (OR 13.1; 95% CI 1.9–163) showed significant increased odds ratio for shunt independence during follow-up. Logistic regression analysis for multiple parameters showed age > 6 months (OR 29.3; 95% CI 4.1–606) together with outward bulged lamina terminalis (OR 4.6; 95% CI 1.2–19.6), smaller FOHR (continuous parameter; OR 2.83 × 10−5; 95% CI 4.7 × 10−9–0.045), and non-4th-ventricular-outlet obstruction (4thVOO; OR 0.31; 95% CI 0.09–1.02) as significant factors for ETV success.

Conclusion:

ETV has become a relevant treatment for non-communicating hydrocephalus, with typical MR image characteristics. Analyzing radiological markers as predictors for success smaller ventricular width and outward displaced lamina terminalis was relevant in combination with age > 6 months. Since the analysis is based on single-center experience, a larger cohort of patients with a multi-center approach should further investigate the combined clinical and radiological criteria.

01 May 2025·EJSO

Benefits of entecavir therapy in HBV-related hepatocellular carcinoma patients with compensated cirrhosis after hepatectomy: A ten-year retrospective cohort study

Article

Author: Liu, Jian ; Wu, Yeye ; Dai, Chun ; Yuan, Tao ; Yu, Yongjin ; Zhu, Bin ; Fu, Xiaohui ; Shi, Xintong ; Bai, Shilei ; Yu, Wenlong ; Li, Jun ; Wang, Kui ; Lin, Jianbo ; Cui, Longjiu

INTRODUCTION:

Data on the impact of antiviral therapy(AVT) on the long-term outcomes of hepatitis B virus(HBV)-related hepatocellular carcinoma(HCC) patients with historically-proved cirrhosis after hepatectomy are limited. We aimed to determine the effect of AVT on resected HCC in the background of HBV-related cirrhosis.

MATERIALS AND METHODS:

A total of 1396 patients with HBV-related cirrhotic HCC undergoing curative resection were categorized into AVT and no-AVT groups retrospectively. Recurrence rates were compared, especially according to the initiation time of AVT, virological response, and low HBV levels. Early and late recurrence was stratified by 2 years postoperatively.

RESULTS:

The 1-, 3-, 5- and 10-year recurrence rates in AVT group(n = 432) were lower than those in no-AVT group(n = 964, 26 %, 49 %, 65 % and 76 % vs. 29 %, 69 %, 87 % and 92 %,p < 0.001). AVT was an independent factor for late, but not early, recurrence(p < 0.001). The late recurrence rates were similar between patients with only postoperative AVT and those with both pre-and postoperative AVT(p = 0.772). In the AVT group, the late recurrence rates in patients with persistent virological response(PVR) were lower than those in patients with low detectable viral levels(LDV, p = 0.003). Logistic regression analysis showed that the time to virological response(p < 0.001) and HBeAg positivity(p < 0.001) were independently associated with LDV. Patients with spontaneous or treatment-induced undetectable HBV showed the lowest and similar late recurrence rates(p = 0.796). Results were similar in multiple sensitivity analyses.

CONCLUSION:

Long-term AVT, regardless of preoperative or postoperative initiation, reduced post-resection late recurrence in patients with HCC and cirrhosis, especially in those with PVR.

01 May 2025·ANTIVIRAL RESEARCH

Mechanism of entecavir-induced reduction of HBV DNA integration

Article

Author: Mak, Lung-Yi ; Wong, Danny Ka-Ho ; Ma, Hoi Tang ; Yuen, Man-Fung ; Wong, Ka Yan ; Seto, Wai-Kay ; Chow, Ning

Nucleos(t)ide analogues (NUC) treatment can reduce the extent of HBV DNA integration in chronic hepatitis B (CHB) patients. However, the mechanism by which NUC reduces HBV integration is unclear. This study investigated the effects of entecavir (ETV), one of the commonly used NUC, on cells with HBV integration. Full genome-length HBV DNA was inserted into HepG2 cell genome using the sleeping beauty transposon system. The resulting cells, named HepG2/SB/HBV, was subjected to ETV treatment. In ETV-treated HepG2/SB/HBV, intracellular HBV DNA was reduced by 2-fold. When treated with ETV, HepG2/SB/HBV had an impaired cell survival (25% reduction in cell proliferation rate when compared with untreated cells; p = 0.043). The median integration frequency in untreated HepG2/SB/HBV was 16 integration sites per 10⁵ cells, which was reduced to 14.8 integration sites per 10⁵ cells when treated with ETV. Analysis of the expression of apoptosis and mitosis markers showed that ETV-treated HepG2/SB/HBV had a reduced expression of mitosis markers phospho-cell division control-2 (p-cdc-2) and phospho-histone H3 (p-histone H3), but that of the apoptotic markers [Poly-ADP-ribose-polymerase] (PARP) and caspase-3 were not affected. In conclusion, ETV suppressed cell proliferation of hepatoma cells with HBV integration via interference of mitosis and reduced expression of p-histone H3, thereby reducing the number of HBV-integrated hepatocytes. This may be the mechanism by which HBV integration is reduced in CHB patients who received ETV therapy.

News (Medical) associated with Entecavir

31 Mar 2025

·www.globenewswire.com

Gyre Therapeutics Announces Publication of Protocol for Phase 3 Trial Evaluating F351 for CHB-Associated Liver Fibrosis in Journal of Clinical and Translational Hepatology

March 27, 2025 -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced the publication of the manuscript titled “Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial” in the Journal of Clinical and Translational Hepatology. This publication details the full protocol for the pivotal Phase 3 trial to support the use of hydronidone in Chinese patients with liver fibrosis associated with chronic hepatitis B (“CHB”). The published protocol outlines patient inclusion criteria, randomization and blinding processes, key assessments, and the statistical analysis plan. The randomized, double-blind, placebo-controlled, multicenter Phase 3 trial (NCT05115942) completed the enrollment of 248 patients across 44 clinical research hospitals in the People’s Republic of China (“PRC”) in October 2024. Patients were randomized 1:1 to receive either F351 or placebo in addition to entecavir antiviral basic therapy for CHB. The primary endpoint is a decrease in liver fibrosis (as measured by the Ishak Scoring System) by at least one stage after 52 weeks of treatment relative to baseline. The PRC’s National Medical Products Administration (“NMPA”) designated F351 as a “Breakthrough Therapy” in 2021. Gyre expects to report topline results from this Phase 3 trial in the second quarter of 2025. F351 is a next-generation anti-fibrotic compound and a structural analogue of Pirfenidone, the first approved treatment for idiopathic pulmonary fibrosis (“IPF”) in Japan, the European Union, the United States and the PRC. F351's dual mechanism has been shown to inhibit in vitro p38γ kinase activity and TGF-β1-driven collagen overproduction—both key drivers of liver fibrosis. F351 specifically targets hepatic stellate cells (“HSCs”), which are central to the progression of fibrosis. In preclinical studies, it has shown strong anti-proliferative and anti-fibrotic effects on HSCs. These effects have been validated across multiple in vivo models of liver fibrosis, including CCl4-induced liver fibrosis in mice, DMN- and HSA-induced liver fibrosis in rats, and a mouse model of MASH fibrosis (a form of MASH with fibrosis) induced by CCl4 plus a Western high-fat diet. Together, these results highlight F351’s potential as a differentiated treatment for liver fibrosis, with a unique mechanism and strong preclinical and clinical evidence supporting its advancement into later-stage development. Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to readout topline data by Q2 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, DKD, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.). Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company's experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230. The content above comes from the network. if any infringement, please contact us to modify.

Breakthrough TherapyDrug ApprovalClinical Result

06 Feb 2025

·medcitynews.com

Denali’s Data in Rare Enzyme Deficiency Keep It on Pace to Seek Speedy FDA Approval - MedCity News

A Denali Therapeutics drug for the rare enzyme deficiency Hunter syndrome is still in pivotal testing, but the company has guidance from the FDA on a pathway to get this therapy to the market sooner. Denali now has additional data from an earlier study that will be the main component of an application seeking accelerated approval. The updated Phase 1/2 data, presented Thursday during the WORLDSymposium conference in San Diego, continue to show benefit for patients, some of whom have received the experimental therapy, tividenofusp alfa, for nearly four years. South San Francisco-based Denali reiterated that it plans to file a biologics license application with the FDA early this year. In Hunter syndrome, genetic mutations lead to deficiency of iduronate-2-sulfatase (IDS), an enzyme key to the function of lysosomes, a component of cells that breaks down material. Lacking IDS leads to a buildup of glycosaminoglycans (GAGs), a type of sugar. GAG buildup in lysosomes leads to organ dysfunction, joint stiffness, hearing loss, neurocognitive symptoms and impaired development. In severe cases, Hunter syndrome patients can die in their teens. sponsored content, Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech Standard treatment for Hunter syndrome is weekly infusions of IDS enzymes. While these engineered enzymes help, they don’t cross the blood-brain barrier so they can’t address the cognitive and behavioral symptoms of the disease. Denali’s solution is to get IDS enzymes into the brain. Tividenofusp alfa is a fusion protein made with Denali’s Enzyme TransportVehicle technology, or ETV. The drug, administered as a once-weekly infusion, uses ETV to target transferrin, a receptor on the blood-brain barrier whose role is to transport iron from the blood into cells. The Denali drug binds to transferrin, which then transports the IDS enzyme cargo across the blood brain-barrier. Denali is part of a group of biotechs targeting transferrin as a way to deliver drugs into the brain. The open-label Phase 1/2 clinical trial for tividenofusp alfa enrolled 47 pediatric participants, both those who had previously received enzyme replacement therapy and those who had not. The study’s main goal is assessing safety; results so far show the therapy continues to be safe and well tolerated. Secondary goals include measuring for heparan sulfate (HS) in cerebrospinal fluid and urine. HS, a component of GAGs, accumulates in the tissues of Hunter syndrome patients. Trial results show that by week 24, 93% of study participants achieved HS levels in their cerebrospinal fluid that were within normal ranges. That percentage continued to increase with longer duration of treatment. All three patients who have reached 201 weeks have HS levels within normal ranges. In addition, the results show lowering of neurofilament light (NfL), a protein that indicates neuronal damage. Improvement on these biological indicators appears to translating to improvement on the symptoms of the disease. The latest results show improvement on measures of hearing and cognition. sponsored content, Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient Last September, Denali announced the FDA agreed that measuring for HS in cerebrospinal fluid may be used as a surrogate endpoint supporting accelerated approval of tividenofusp alfa in Hunter syndrome. Denali said its application will include both preclinical and clinical measures of this biomarker. The submission will also include measures for NfL. In a note sent to investors, William Blair analyst Sarah Schram noted that the data are early and in a limited number of patients, but the results so far appear to be translating to clinical benefit. She added that normalization on multiple markers of Hunter’s syndrome reinforce the Denali therapy’s potential to become a best-in-class treatment option for the disease. “While additional patient data at extended follow-ups will be needed to continue building this profile, the data is important as it illustrates potential for significant broad symptom benefit and potential for a single weekly treatment option for patients across the Hunter syndrome spectrum,” Schram said. A brain-penetrating fusion protein is already available to Hunter syndrome patients in Japan. This JCR Pharmaceuticals drug, marketed as Izcargo, also leverages the transferrin receptor to transport an engineered version of IDS into the brain. Japanese authorities approved this once-weekly infused therapy in 2021. Ashiya, Japan-based JCR is conducting a global Phase 3 test that could support an FDA submission. Takeda Pharmaceutical holds an exclusive option to commercialize the JCR therapy in the U.S. following completion of the pivotal test. Under a separate agreement, the pharmaceutical giant secured rights to commercialize JCR’s Hunter syndrome treatment in the rest of the world, excluding Japan and certain Asian countries. Takeda already has a presence in the Hunter syndrome market with Elaprase, an enzyme replacement therapy that came from its acquisition of Shire. At the WORLDSymposium, JCR presented a retrospective case study in nine patients after four years. Two died due to the progression of their disease. In the remaining seven, 71% showed increased muscle strength and 42% showed improved motor skills. Furthermore, 57% of participants showed cognitive and gait improvement. Meanwhile, Regenxbio is gearing up to bring Hunter syndrome patients the option of a one-time treatment. The company’s gene therapy, RGX-121, delivers to cells of the central nervous system a functioning version of the gene that codes for IDS. In RGX-121’s pivotal test, Regenxbio reported a statistically significant 86% reduction of HS levels in cerebrospinal fluid. In the third quarter of 2024, Regenxbio began a rolling biologics license application seeking accelerated approval. The company expects this application will be complete in the first quarter of this year. Regenxbio has a commercialization partner for its Hunter syndrome gene therapy as well as RGX-111, a gene therapy for the enzyme deficiency known as Hurler syndrome. Per deal terms announced in January, Nippon Shinyaku will commercialize both therapies in the U.S. and certain Asian countries. The Kyoto, Japan-based company agreed to pay Regenxbio $110 million up front; another $700 million is tied to the achievement of milestones. Public domain image by Flickr user SciTechTrend

Clinical ResultPhase 3License out/inAcquisition

08 Jan 2025

·www.echemi.com

80 batches of drugs recalled urgently! A major decision by the National Medical Products Administration

Recently, the National Medical Products Administration announced an important decision to stop the production, sale, and use of Hyoscine Butylbromide Tablets, and to revoke its drug registration certificate. According to the announcement issued by the National Medical Products Administration on January 3, titled “Announcement on the Revocation of the Drug Registration Certificate for Hyoscine Butylbromide Tablets (2025 No. 2)”, Hyoscine Butylbromide Tablets, an antibacterial drug also known as Loperamide, will no longer circulate in the market of our country. This decision is effective immediately, and the products already on the market will be recalled by the marketing authorization holder and supervised by provincial drug regulatory authorities for destruction or other harmless disposal measures. A total of 80 batches of Hyoscine Butylbromide Tablets are involved. In addition, in another announcement issued by the National Medical Products Administration on December 2, 2024, it was also announced that 58 drug registration certificates, including 11 batches of Hyoscine Butylbromide Tablets, have been revoked. Based on Article 83 of the Drug Administration Law of the People's Republic of China and other relevant regulations, these drugs have been required to stop production and sale due to unclear efficacy, serious adverse reactions, or other hazards to human health. Hyoscine Butylbromide Tablets are a compound preparation, with the main active ingredients including Hyoscine Tincture, Sulfamethoxazole, and Trimethoprim, primarily used to treat dysentery caused by Shigella and other sensitive pathogenic bacteria causing enteritis. However, with the withdrawal of this drug from the market, other drugs such as Montmorillonite Powder will take on the responsibility for treating diarrhea. According to data from Miiine, the incidence of gastrointestinal diseases is on the rise and is becoming more prevalent among younger populations. In the first three quarters of 2022, the sales of anti-diarrheal drugs and intestinal anti-inflammatory/infection drugs in public hospitals in key provinces and cities in China exceeded 1.2 billion yuan, a year-on-year increase of 6.30%. The sales scale of Montmorillonite Powder in the three major terminal markets in China has exceeded 1 billion yuan, with the outpatient market being the main sales channel, rising by 60%, making it the Top 2 product in anti-diarrheal and intestinal anti-inflammatory/infection drugs. Statistics from Cyborg Blue show that 145 drug registration certificates were revoked in 2024. In the announcement on December 2, 2024, in addition to Hyoscine Butylbromide Tablets, it also included 3 batches of Losartan Potassium Tablets, 2 batches of Phenazone Tablets, 2 batches of Amlodipine Besylate Tablets, 2 batches of Entecavir Tablets, 2 batches of Compound Snake Gall and Chuan Bei Powder, and 2 batches of Rifampicin Capsules. Phenazone, as a pyrazolone analgesic and antipyretic, was launched early in our country, but its injection and nasal drops have severe adverse reactions, with risks outweighing benefits, and alternative medications are available, leading to its registration certificate being revoked in 2020. Although oral preparations like Phenazone Tablets still have certain clinical value, the National Medical Products Administration has implemented risk control measures by revising the instructions to add safety warnings, restricting applicable populations and indications. In the domestic market for antipyretic and analgesic drugs, Phenazone has a low market share and is declining. Data from Cyborg Blue shows that there are 861 approvals for "Phenazone Tablets," involving many companies and intense market competition. As related drug approvals are revoked, this market will face further fragmentation. Finally, according to the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, the National Medical Products Administration decided on April 11, 2024, to revoke the registration certificates for 87 drugs, including Pancreatin Injection. Cyborg Blue’s analysis found that drugs such as 7 batches of Iohexol Injection, 6 batches of Insulin Glargine Injection, 4 batches of Detemir Insulin Injection, 4 batches of Vardenafil Hydrochloride Tablets, and 3 batches of Brain Protein Hydrolysate Injection were also revoked. Please note that the number of drugs counted in the text has not been deduplicated. No. Marketing Authorization Holder Approval Number 1 Shijiazhuang Lesheng Pharmaceutical Co., Ltd. SFDA H13023949 2 Jiangzhong Pharmaceutical Co., Ltd. SFDA H36022316 3 Shijiazhuang Fourth Pharmaceutical Co., Ltd. SFDA H13023932 4 Shijiazhuang Grey Pharmaceutical Co., Ltd. SFDA H13023934 5 Handan Bailin Pharmaceutical Co., Ltd. SFDA H13023945 6 Hebei Yongfeng Pharmaceutical Co., Ltd. SFDA H13023943 7 China National Pharmaceutical Group Wuhan Zhonglian Fourth Pharmaceutical Co., Ltd. SFDA H42022497 8 Jiangsu Enhua Pharmaceutical Co., Ltd. SFDA H32025932 9 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022013 10 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022244 11 Jiangsu Chenpai Pharmaceutical Group Co., Ltd. SFDA H32025935 12 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024102 13 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024073 14 Hebei Hengli Group Pharmaceutical Co., Ltd. SFDA H13024253 15 Hebei Tianzhi Pharmaceutical Co., Ltd. SFDA H13024245 16 Hebei Dongfeng Pharmaceutical Co., Ltd. SFDA H13024170 17 Hebei Jinzhuan Pharmaceutical Co., Ltd. SFDA H13024269 18 Tianjin Baihai Pharmaceutical Co., Ltd. SFDA H12021099 19 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41024876 20 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41025013 21 Shanxi Xinxing Pharmaceutical Co., Ltd. SFDA H14023068 22 Jiangxi Jiminke Pharmaceutical Co., Ltd. SFDA H36022305 23 Suzhou Hongsun Pharmaceutical Co., Ltd. SFDA H32025897 24 Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd. SFDA H32026256 25 Guangxi Tiantianle Pharmaceutical Co., Ltd. SFDA H45021319 26 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021120 27 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021117 28 Shanghai Modern Harsen (Shangqiu) Pharmaceutical Co., Ltd. SFDA H41024989 29 Tianjin Pacific Pharmaceutical Co., Ltd. SFDA H12021100 30 Hebei Guojin Pharmaceutical Co., Ltd. SFDA H13023940 31 Hebei Kaiwei Pharmaceutical Co., Ltd. SFDA H13023920 32 Hebei Sanshi Pharmaceutical Co., Ltd. SFDA H13023928 33 Yuanda Pharmaceutical (China) Co., Ltd. SFDA H42022649 34 Shanxi Tongda Pharmaceutical Co., Ltd. SFDA H14023309 35 Shanxi Guorun Pharmaceutical Co., Ltd. SFDA H14023402 36 Shanxi Fenhe Pharmaceutical Co., Ltd. SFDA H14023200 37 Shanxi Wanhui Pharmaceutical Co., Ltd. SFDA H14023333 38 Jilin Wantong Pharmaceutical Co., Ltd. SFDA H22025288 39 Changchun Overseas Pharmaceutical Group Co., Ltd. SFDA H22026726 40 Shijiazhuang Xiehe Pharmaceutical Co., Ltd. SFDA H13024084 41 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023541 42 Kuihua Pharmaceutical Group (Hengshui) Defier Co., Ltd. SFDA H13023979 43 Shijiazhuang Kanghewai Pharmaceutical Co., Ltd. SFDA H13024261 44 Shandong Xinhua Pharmaceutical Co., Ltd. SFDA H37023523 45 Hebei Yuzhilin Pharmaceutical Co., Ltd. SFDA H13024426 46 Xinhai Yansheng Pharmaceutical Co., Ltd. SFDA H41024907 47 Fu'an Pharmaceutical Group Yantai Zhichu Pharmaceutical Co., Ltd. SFDA H37023543 48 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025139 49 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025174 50 Changchun Changqing Pharmaceutical Group Co., Ltd. SFDA H22025234 51 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41024840 52 Changzhou Kangpu Pharmaceutical Co., Ltd. SFDA H32025910 53 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41025575 54 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41024862 55 Hebei Ruicen Pharmaceutical Co., Ltd. SFDA H13023953 56 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020588 57 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020604 58 Yaodu Pharmaceutical Group Co., Ltd. SFDA H13023951 59 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023939 60 Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. SFDA H13023952 61 Tianfang Pharmaceutical Co., Ltd. SFDA H41024887 62 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41025576 63 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022412 64 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022411 65 Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. SFDA H41024834 66 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41024896 67 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41025009 68 Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. SFDA H13023994 69 Handan Furong Pharmaceutical Co., Ltd. SFDA H13024077 70 Hebei Tiancheng Pharmaceutical Co., Ltd. SFDA H13024056 71 Hebei Kangtai Pharmaceutical Co., Ltd. SFDA H13024041 72 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44025328 73 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44024963 74 Zhengzhou Furuitang Pharmaceutical Co., Ltd. SFDA H41025579 75 Chongqing Kerui Pharmaceutical (Group) Co., Ltd. SFDA H50021730 76 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41024872 77 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41024895 78 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41025012 79 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41025008 80 Tianfang Pharmaceutical Co., Ltd. SFDA H41025010

Drug ApprovalNDA

100 Deals associated with Entecavir

External Link

KEGG	Wiki	ATC	Drug Bank
D04008	Entecavir	J05AF10	DB00442

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B, Chronic	United States	Bristol Myers Squibb Co.	29 Mar 2005

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic Disease	Phase 3	United States	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	Canada	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	Hong Kong	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	Indonesia	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	Philippines	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	Singapore	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	Taiwan Province	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	Thailand	Bristol Myers Squibb Co.	01 Dec 2004
Hepatitis B	Phase 3	United States	Bristol Myers Squibb Co.	01 Sep 2002
Viremia	Phase 3	United States	Bristol Myers Squibb Co.	01 Sep 2002

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04536337 (ALG-000184-201, EASL2024) Manual	Phase 1	Hepatitis B, Chronic	22	ALG-000184 + ETV	ygrioivxrm(qmkwkrhfat) = In a multiple regression model, baseline HBsAg (< or ≥4 log10 IU/ ml) and steady state plasma ALG-001075 exposure (AUC or Ctrough) statistically significantly predicted change from baseline in HBsAg at week 24 (p < 0.00018, R2 = 0.65). obgxxiivjw (zfmmzggzed ) View more	Positive	01 Jun 2024
				ALG-000184
NCT04536337 (ALG-000184-201, EASL2024) Manual	Phase 1	Hepatitis B, Chronic	22	ALG-000184 + Entecavir	oyghtqgpqx(tjvlqmysoo) = tnusekkezi hqhudvatgf (iydutnxpza, 0.4) View more	Positive	01 Jun 2024
				ALG-000184	-
NCT03887702 (CTgov)	Phase 3	Hepatitis B \| Malignant Solid Neoplasm	4	Tenofovir Alafenamide+Tenofovir Disoproxil Fumarate+Entecavir (Arm 1 (TAF, TDF, Entecavir: Prophylactic))	tgyobmyszj(otgtmafyst) = ijmtnnvcwf ahgsocapfn (sdkgtscafo, lpgxvnwoxi - tbytkkmncd) View more	-	20 May 2024
				Tenofovir Alafenamide+Tenofovir Disoproxil Fumarate+Entecavir (Arm 2 (TAF, TDF, Entecavir: Upon Indication))	tgyobmyszj(otgtmafyst) = ynvoykpnnr ahgsocapfn (sdkgtscafo, wypemaactb - nussprwkqc) View more
DDW2024	Not Applicable	Hepatitis B, Chronic	-	Tenofovir therapy (TAF)	fqxrysgoaq(pejmdhbsfw): RR = 4.76 (95% CI, 2.13 - 10.64), P-Value = 0.0001 View more	-	18 May 2024
				Entecavir therapy (ETV)
DDW2024	Not Applicable	Hepatitis B, Chronic	-	Tenofovir therapy (TAF)	cmnftfhqfd(bfokdhzmmv): RR = 4.76 (95% CI, 2.13 - 10.64), P-Value = 0.0001 View more	-	18 May 2024
				Entecavir therapy (ETV)
DDW2024	Not Applicable	Hepatitis B, Chronic	-	Tenofovir therapy (TAF)	xbcuuylktm(zozwwpstxs): RR = 4.76 (95% CI, 2.13 - 10.64), P-Value = 0.0001 View more	-	18 May 2024
				Entecavir therapy (ETV)
DDW2024	Not Applicable	Hepatitis B, Chronic	-	Tenofovir therapy (TAF)	lokjepqnhy(jejgzitpcw): RR = 4.76 (95% CI, 2.13 - 10.64), P-Value = 0.0001 View more	-	18 May 2024
				Entecavir therapy (ETV)
NCT03083821 (CTgov)	Phase 1	Hepatitis B	6	Baraclude	jkrwolouyb(dznwvhfdtm) = ypbqsnohiu mepjbxcsar (xtxfmxesrv, 2.517) View more	-	18 Nov 2023
AASLD2023	Not Applicable	Hepatitis B	194	Entecavir	xtfjbtrdou(bixsregxhq) = vvqxnzyxvj xptgpznkks (lynomxiemn, 18.0 - 31.0) View more	-	10 Nov 2023
AASLD2023	Not Applicable	Decompensated cirrhosis of liver	283	Entecavir	igymatcbau(tgjbqcfymy) = jckxecnnwe kiosjuncyb (auqbbdrcxt ) View more	-	10 Nov 2023
				Entecavir	igymatcbau(tgjbqcfymy) = dqgiblwnia kiosjuncyb (auqbbdrcxt ) View more

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