Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy: A Randomized, Double Blind, Placebo Controlled Trial - NIL

开始日期2023-09-17

申办/合作机构

Institute of Liver & Biliary Sciences

NCT06022237 / Not yet recruitingN/A

Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy: A Randomized, Double Blind, Placebo Controlled Trial

Hepatic osteodystrophy(HOD) is a common but frequently overlooked complication of liver cirrhosis with a prevalence rate ranging from 13-70%. Bisphosphonates acting by inhibiting bone resorption are frequently used. Intravenous infusions of bisphosphonates may cause prolonged arthralgia and myalgia whereas oral bisphosphonates may cause digestive mucosal damage causing dysphagia, esophagitis and ulcer. Such side effects have discouraged the prescription of oral bisphosphonates for patients of cirrhosis mainly due to risk of upper GI hemorrhage arising from esophageal variceal rupture.
All studies done in past with bisphosphonates are either open labelled RCT/ non- randomized control trial or have enrolled patients of primary biliary cirrhosis only.
So, there is a need to have double blind RCT assessing efficacy and safety of oral bisphosphonates in non-cholestatic liver cirrhosis.
In this study, we hypothesize that oral ibandronate significantly improves BMD in patients of liver cirrhosis & is safe in patients with low risk esophageal varices. With this study, we aim to assess the efficacy and safety of oral ibandronate in patients of liver cirrhosis with hepatic osteodystrophy

开始日期2023-09-01

申办/合作机构

Institute of Liver & Biliary Sciences

CTRI/2022/06/042976 / Not yet recruitingN/A

FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF CORE DECOMPRESSION ALONG WITH INTRAOSSEOUS IBANDRONATE COMPARED TO CORE DECOMPRESSION ALONE IN NON TRAUMATIC PRE COLLAPSE OSTEONECROSIS OF FEMORAL HEAD

开始日期2022-06-06

申办/合作机构-

100 项与伊班膦酸钠相关的临床结果

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100 项与伊班膦酸钠相关的转化医学

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100 项与伊班膦酸钠相关的专利（医药）

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1,167

项与伊班膦酸钠相关的文献（医药）

2024-08-01·Journal of Bone Oncology

Urinary biomarkers in metastatic bone pain: Results from a multicentre randomized trial of ibandronate compared to single dose radiotherapy for localized metastatic bone pain in prostate cancer (RIB)

Article

作者: Malhi, Aman ; Hoskin, P.J. ; Reczko, Krystyna ; Hackshaw, Allan

BackgroundThe Radiotherapy IBandronate (RIB) trial compared single dose radiotherapy and a single infusion of ibandronate in 470 bisphosphonate naïve patients with metastatic bone pain from prostate cancer randomised into a non-inferiority two arm study. Results for the primary endpoint of pain score response at 4 weeks showed that the ibandronate arm was non-inferior to single dose radiotherapy.Patients and methodIn addition to pain assessments including analgesic use made at baseline, 4, 8, 12, 26 and 52 weeks, urine was collected at baseline, 4 and 12 weeks. It was subsequently analysed for urinary N-telopeptide (NTx) and cystatin C. Linear regression models were used to compare the continuous outcome measures for urinary markers within treatment arms and baseline measurements were included as covariates. Interaction terms were fitted to allow for cross-treatment group comparisons.ResultsThe primary endpoint of the RIB trial was worst pain response at 4 weeks and there was no treatment difference seen. Urine samples and paired pain scores at 4 weeks were available for 273 patients (radiotherapy 168; ibandronate 159)The baseline samples measured for the RIB trial had an average concentration of 193 nM BCE/mM creatinine (range of 7.3-1871) compared to the quoted normal range of 33 nM BCE/mM creatinine (3 to 63). In contrast the average value of Cystatin C was 66 ng/ml (ranges ND - 1120 ng/ml) compared to the quoted normal range of 62.9 ng/ml (ranges 12.6-188 ng/ml). A statistically significant reduction in NTx concentrations between baseline and 4 weeks was seen in the ibandronate arm but not in the radiotherapy arm. No correlation between pain response and urinary marker concentration was seen in either the ibandronate or radiotherapy cohort at any time point.ConclusionNTx was significantly raised compared to the normal range consistent with a role as a biomarker for bone metastases from prostate cancer. A significant reduction in NTx 4 weeks after ibandronate is consistent with its action in osteoclast inhibition which was not seen after radiotherapy implying a different mode of action for radiation. There was no correlation between bone biomarker levels and pain response.

2024-08-01·Annals of Translational Medicine

Daily oral ibandronate with adjuvant endocrine therapy in postmenopausal women with estrogen receptor-positive breast cancer: editorial commentary

Communications

作者: Coleman, Robert

2024-08-01·Osteoporosis International

Evaluating the impact of COVID-19 on DXA waiting lists and osteoporosis prescription trends in England 2019–2023

Article

作者: Crabtree, N J ; Fordham, R J ; Knight, K J ; Knapp, K M

This study uses NHS waiting times and osteoporosis medication community prescription datasets to assess the impact of COVID-19 on DXA waits and osteoporosis medication patterns in England. Results show significant increases in DXA waiting list times and variation in prescription rates. Investment is needed to improve waiting list times.PURPOSEThis study investigates the impact of COVID-19 on DXA scan waiting lists, service recovery and osteoporosis medication prescriptions in the NHS following the March 2020 national lockdowns and staff redeployment.METHODSData from March 2019 to June 2023, including NHS digital diagnostics waiting times (DM01) and osteoporosis medication prescriptions from the English Prescribing Dataset (EPD), were analysed. This encompassed total waiting list data across England's seven regions and prescribing patterns for various osteoporosis medications. Analyses included total activity figures and regression analysis to estimate expected activity without COVID-19, using R for all data analysis.RESULTSIn England, DXA waiting lists have grown significantly, with the yearly mean waiting list length increasing from 31,851 in 2019 to 65,757 in 2023. The percentage of patients waiting over 6 weeks for DXA scans rose from 0.9% in 2019 to 40% in 2020, and those waiting over 13 weeks increased from 0.1% in 2019 to 16.7% in 2020. Prescription trends varied, with increases in denosumab, ibandronic acid and risedronate sodium and decreases in alendronic acid, raloxifene hydrochloride and teriparatide. A notable overall prescription decrease occurred in the second quarter of 2020.CONCLUSIONCOVID-19 has significantly increased DXA scan waiting lists with ongoing recovery challenges. There is a noticeable disparity in DXA service access across England. Osteoporosis care, indicated by medication prescriptions, also declined during the pandemic. Addressing these issues requires focused investment and effort to improve DXA scan waiting times and overall access to osteoporosis care in England.

项与伊班膦酸钠相关的新闻（医药）

2024-08-15

·PMLiVE

NICE recommends Theramex’s Eladynos to treat bone disease after menopause

The National Institute for Health Care and Research has recommended Theramex’s Eladynos (abaloparatide) as an option for treating bone disease after menopause. Available on the NHS in England in three months, the drug is set to benefit more than 14,000 people in the UK who are seeking treatment for osteoporosis after menopause, if there is a very high risk of fracture. Osteoporosis, a bone disease that affects 3.8 million people in the UK, develops when bone mineral density and bone mass decrease, or when the quality or structure of bone changes, leading to a decrease in bone strength that can increase the risk of broken bones or fractures. The disease particularly affects older women after menopause, as oestrogen, the hormone important for maintaining bone density and strength, decreases and bone density reduces, making broken bones more common. Other treatments for the disease include bisphosphonates such as alendronic acid and ibandronic acid, Eli Lilly’s selective oestrogen receptor modulator, Evista (raloxifene), parathyroid hormone treatments including teriparatide, and biological medicines including Amgen’s Prolia (denosumab) and Amgen/UCB’s Evenity (romosozumab). NICE’s decision was based on patients descriptions of how debilitating osteoporosis can be and how it all impacts day-to-day life, impairing mental and physical health. Theramex’s Eladynos is designed to increase bone density by stimulating the cells that produce new bone while also reducing the risk of fracture, providing an alternative for patients who have not responded to or cannot tolerate usual treatment options. Proven to be more clinically and cost-effective, the alternative treatment option comes as a pre-filled pen that is injected into the muscle through the skin. Prior to this, in March, Bayer shared positive long-term results from the late-stage OASIS 3 study, which supported the use of its investigational non-hormonal menopause drug, elinzanetant, to treat moderate-to-severe vasomotor symptoms (VMS), such as hot flashes, which are reported by up to 80% of women during the menopausal transition. In April, a Canadian study published in Neurology revealed that early menopause and a higher risk of cardiovascular disease could be linked to cognitive decline later in life.

临床结果临床3期上市批准

2024-07-22

·米内网

苑东冲刺$20亿明星药首仿！拿下7个重磅品种，22个新品、超10个1类新药猛攻千亿市场

精彩内容近期，苑东生物捷报频传，布瑞哌唑片以仿制4类报产在审冲刺首仿，乌苯美司胶囊成为第2家过评企业。今年以来，公司已有7个重磅品种获批上市，比索洛尔氨氯地平片拿下首仿和首家过评。截至目前，苑东生物有超过30个品种过评。此外，公司有22个产品报产在审，其中8个是在今年报产；10余个1类新药在研。值得一提的是，苑东生物在2024年经营计划中指出，高端仿制药力争完成不低于10个产品的获批上市和申报上市，而这一目标在今年上半年已完成过半。苑东冲刺$20亿明星药首仿，3亿免疫刺激剂第2家过评 7月18日，CDE官网显示，苑东生物的布瑞哌唑片以仿制4类报产在审。该产品是一种非典型抗精神病药物，用于治疗重度抑郁症、精神分裂症等。布瑞哌唑2023年全球销售额超过20亿美元，今年6月，大冢制药的布瑞哌唑片在中国获批上市，目前国内暂无仿制药企业获批。来源：米内网一致性评价数据库 7月17日，国家药监局官网显示，苑东生物的乌苯美司胶囊一致性评价补充申请获批，成为该产品第2家过评企业。乌苯美司胶囊可增强免疫功能，用于抗癌化疗、放疗的辅助治疗，老年性免疫功能缺陷等，可配合化疗、放疗及联合应用于白血病、多发性骨髓瘤、骨髓增生异常综合症及造血干细胞移植后，以及其它实体瘤患者。米内网数据显示，乌苯美司胶囊在2023年中国三大终端六大市场（统计范围见文末）市场销售规模超过3亿元，苑东生物的市场份额位居第二。 7个重磅新品接连获批，超30个过评品种亮眼苑东生物今年以来获批产品情况来源：米内网中国申报进度（MED）数据库 7月6日，苑东生物连发两则发布公告，其全资子公司成都硕德药业的奥卡西平口服混悬液和吲哚布芬片以新分类报产同日获批，视同过评。苑东生物表示，此次2个产品获批，标志着公司具备在国内市场销售该药品的资格，进一步丰富公司产品管线同时，对经营发展具有一定的积极作用。今年上半年，苑东生物已有盐酸纳布啡注射液、酒石酸布托啡诺注射液等7个产品获批上市，数量已接近2023年全年，超过2022年全年。其中，比索洛尔氨氯地平片为首仿和首家过评，奥卡西平口服混悬液和贝前列素钠片分别是国产第2、第3家。近年中国三大终端六大市场比索洛尔氨氯地平片销售情况（单位：万元）来源：米内网格局数据库比索洛尔氨氯地平片是高血压复方制剂，适应症为作为高血压治疗的替代疗法，用于目前同时服用与复方制剂剂量相同的单药且血压控制良好的患者，该产品由默克研发，2021年5月在中国获批上市。米内网数据显示，高血压复方制剂近年中国三大终端六大市场销售规模持续扩容，2023年超过150亿元，而比索洛尔氨氯地平片同比增长231.19%。苑东生物通过/视同通过一致性评价品种来源：米内网一致性评价数据库截至目前，苑东生物已有超过30个品种通过/视同通过一致性评价，10个中标国家集采。从治疗大类来看，主要集中在神经系统药物（10个）、心脑血管系统药物（10个）、肌肉-骨骼系统（5个）、血液和造血系统药物（4个）。比索洛尔氨氯地平片、盐酸纳洛酮注射液、布洛芬注射液、富马酸比索洛尔片等超过10个为首家过评。苑东生物聚焦麻醉镇痛、心脑血管、抗肿瘤、内分泌和儿童用药领域，多个主要产品的市场份额名列前茅。米内网数据显示，2023年中国三大终端六大市场，盐酸纳美芬注射液、布洛芬注射液、伊班膦酸钠注射液3个产品，苑东生物的市场份额位居第一；盐酸纳洛酮注射液、依托考昔片、乌苯美司胶囊、富马酸比索洛尔片、注射用复方甘草酸苷5个产品，苑东生物的市场份额位居第二；达比加群酯胶囊苑东生物的市场份额位居第四。此外，苑东生物的舒更葡糖钠注射液、盐酸去氧肾上腺素注射液、格隆溴铵注射液等产品销售额快速增长，分别同比增长2169.58%、1208.45%、78.63%。改良型新药、高端仿制药、1类新药猛攻千亿市场苑东生物在战略定位上坚持以高端仿制药为基础、小分子创新药为重点、生物药谋发展，在发展路径上不断构建技术、政策壁垒，形成优势和差异化。近年来，公司的研发投入占营收比例均超过20%，在持续高研发投入下正逐步走进收获期。苑东生物报产在审产品情况来源：米内网中国申报进度（MED）数据库今年以来，苑东生物有8个产品报产在审，其中，布瑞哌唑片、盐酸纳呋拉啡口崩片、培哚普利氨氯地平片(Ⅲ)、阿帕他胺片有望拿下首仿，奥沙西泮片冲刺国产第2家。截至目前，苑东生物报产在审的产品多达22个，涵盖多个治疗大类，神经系统药物最多，有7个，其次是心脑血管系统药物和抗肿瘤和免疫调节剂。米内网数据显示，2023年中国三大终端六大市场，抗肿瘤和免疫调节剂是TOP1治疗大类，销售规模超过2000亿元；心脑血管系统药物和神经系统药物销售规模均超1000亿元。今年1月，苑东生物的1类新药EP-0146片的IND申请获临床默示许可，并申报美国IND，用于治疗晚期实体瘤。目前公司有10余个1类新药在研，其中，优格列汀片研发进度最快，是一款用于2型糖尿病治疗的口服周制剂。不久前，有投资者在苑东生物的互动平台问及优格列汀的研发进展情况，苑东生物表示，其自主研发的1类新药优格列汀片目前已完成单药Ⅲ期临床试验，并达成预期目标。此外，EP-9001A注射液是公司全资子公司成都优洛生物首个自主研发的1类生物药，适应症为骨转移癌痛，处于Ib/II期临床试验阶段。资料来源：CDE官网、米内网数据库等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

一致性评价上市批准

2024-06-24

·信狐药迅

长春澜江苯海拉明布洛芬和住友制药来法莫林注射用浓溶液等潜在首仿提交上市申请|新受理（6.17-6.23）

本周药品注册受理数据，分门别类呈现，一目了然。(6.17-6.23）新药上市申请无新药临床申请药品名称企业注册分类受理号CVL237片甫康(上海)健康科技有限责任公司1CXHL2400623TQC3721吸入粉雾剂正大天晴药业集团股份有限公司1CXHL2400625TQC3721吸入粉雾剂正大天晴药业集团股份有限公司1CXHL2400624HS-10502片江苏豪森药业集团有限公司1CXHL2400620HS-10502片江苏豪森药业集团有限公司1CXHL2400619RG002C0106注射液北京炫景瑞医药科技有限公司1CXHL2400617177Lu-TR0471注射液通瑞生物制药(成都)有限公司1CXHL2400616吸入用LH-1901江苏联环药业股份有限公司1CXHL2400615吸入用LH-1901江苏联环药业股份有限公司1CXHL2400614HRS9950片成都盛迪医药有限公司1CXHL2400611HRS9950片成都盛迪医药有限公司1CXHL2400610HRS-5635注射液福建盛迪医药有限公司1CXHL2400609PG-033片北京普祺医药科技股份有限公司1CXHL2400607PG-033片北京普祺医药科技股份有限公司1CXHL2400606TY751注射液天津药物研究院有限公司1CXHL2400605注射用醋酸曲普瑞林缓释微球南京恒生制药有限公司2.2CXHL2400621ZP036华润紫竹药业有限公司2.2CXHL2400618JW202313吸入粉雾剂山东京卫制药有限公司2.2CXHL2400613HCD干混悬剂浙江圣博康药业有限公司2.2CXHL2400612HY22005I片长春海悦药业股份有限公司2.2CXHL2400608BCM476胶囊上海云晟研新生物科技有限公司2.3CXHL2400622盐酸卡利拉嗪胶囊成都奥邦药业有限公司3CYHL2400125盐酸卡利拉嗪胶囊成都奥邦药业有限公司3CYHL2400124盐酸米诺环素泡沫剂山西振东安欣生物制药有限公司3CYHL2400123盐酸米诺环素泡沫剂山西振东安欣生物制药有限公司3CYHL2400122去氧胆酸注射液北京藏卫信康医药研发有限公司3CYHL2400121立他司特滴眼液浙江莎普爱思药业股份有限公司3CYHL2400120氟[18F]妥司特注射液北京先通国际医药科技股份有限公司3CYHL2400119布立西坦片辰欣药业股份有限公司3CYHL2400118布立西坦片辰欣药业股份有限公司3CYHL2400117布立西坦片辰欣药业股份有限公司3CYHL2400116盐酸卡利拉嗪胶囊武汉人福药业有限责任公司3CYHL2400115盐酸卡利拉嗪胶囊武汉人福药业有限责任公司3CYHL2400114去氧胆酸注射液北京诺博特生物科技有限公司3CYHL2400113SCTV04C注射液神州细胞工程有限公司1.2CXSL2400397SCTV04C注射液神州细胞工程有限公司1.2CXSL2400396注射用SSGJ-709沈阳三生制药有限责任公司1CXSL2400408注射用HS-20093上海翰森生物医药科技有限公司1CXSL2400406注射用HS-20089上海翰森生物医药科技有限公司1CXSL2400407AK135注射液中山康方生物医药有限公司1CXSL2400405CS01单抗注射液中山恒动生物制药有限公司1CXSL2400402TQB2825注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400404TQB2825注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400403VUM02注射液武汉光谷中源药业有限公司1CXSL2400401RJMty19注射液浙江瑞加美生物科技有限公司1CXSL2400400MG-K10人源化单抗注射液上海麦济生物技术有限公司1CXSL2400399SYSA1801注射液石药集团巨石生物制药有限公司1CXSL2400395注射用重组A型肉毒毒素苏州迪新宸科生物科技有限公司2.4CXSL2400398 仿制药申请药品名称企业注册分类受理号阿达帕林过氧苯甲酰凝胶苏州高迈药业有限公司3CYHS2401869间苯三酚口腔崩解片河北汇德旭盛医药科技有限公司3CYHS2401867恩格列净二甲双胍缓释片浙江昂利康制药股份有限公司3CYHS2401866吡格列酮二甲双胍片浙江江北药业有限公司3CYHS2401853注射用青霉素钠辽宁省连科药业有限公司3CYHS2401852注射用青霉素钠辽宁省连科药业有限公司3CYHS2401851注射用青霉素钠辽宁省连科药业有限公司3CYHS2401850注射用磷霉素钠广州艾奇西新药研究有限公司3CYHS2401849注射用磷霉素钠广州艾奇西新药研究有限公司3CYHS2401848重酒石酸卡巴拉汀口服液上海美优制药有限公司3CYHS2401833注射用拉氧头孢钠山东宜和生物医药科技有限公司3CYHS2401826富马酸酮替芬滴眼液成都普什制药有限公司3CYHS2401825西格列汀二甲双胍缓释片广东东阳光药业股份有限公司3CYHS2401819盐酸甲氧氯普胺注射液江苏瑜兴医药科技有限公司3CYHS2401815枸橼酸苯海拉明布洛芬片长春澜江医药科技有限公司3CYHS2401813西格列汀二甲双胍缓释片常州制药厂有限公司3CYHS2401812阿仑膦酸钠口服溶液广州一品红制药有限公司3CYHS2401811马来酸曲美布汀片浙江华海药业股份有限公司3CYHS2401822他达拉非片迪沙药业集团有限公司4CYHS2401871他达拉非片迪沙药业集团有限公司4CYHS2401870非诺贝特胶囊江苏德源药业股份有限公司4CYHS2401868伊班膦酸钠注射液上海旭东海普药业有限公司4CYHS2401865伊班膦酸钠注射液上海旭东海普药业有限公司4CYHS2401864伊班膦酸钠注射液上海旭东海普药业有限公司4CYHS2401863硫酸氨基葡萄糖胶囊安徽九洲方圆制药有限公司4CYHS2401862聚多卡醇注射液成都市海通药业有限公司4CYHS2401861聚多卡醇注射液成都市海通药业有限公司4CYHS2401860聚多卡醇注射液成都市海通药业有限公司4CYHS2401859波生坦分散片华润双鹤利民药业(济南)有限公司4CYHS2401858地屈孕酮片浙江爱生药业有限公司4CYHS2401857氧(液态)河北舜广联合气体有限公司4CYHS2401856蛋白琥珀酸铁口服溶液四川海梦智森生物制药有限公司4CYHS2401855左卡尼汀注射液成都市海通药业有限公司4CYHS2401854比索洛尔氨氯地平片华益药业科技(安徽)有限公司4CYHS2401847注射用头孢唑肟钠南京恩泰医药科技有限公司4CYHS2401846乳果糖口服溶液南京海纳制药有限公司4CYHS2401845硫酸氨基葡萄糖胶囊合肥康惠医药技术有限公司4CYHS2401844乳果糖口服溶液南京海纳制药有限公司4CYHS2401843他氟前列素滴眼液海南斯达制药有限公司4CYHS2401842比索洛尔氨氯地平片华润赛科药业有限责任公司4CYHS2401841盐酸奥洛他定滴眼液江西马应龙美康药业有限公司4CYHS2401840注射用亚胺培南西司他丁钠深圳华药南方制药有限公司4CYHS2401839泊沙康唑注射液山东新时代药业有限公司4CYHS2401838依折麦布辛伐他汀片北京百奥药业有限责任公司4CYHS2401837马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401836马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401835硫酸镁钠钾口服用浓溶液浙江百代医药科技有限公司4CYHS2401834沙格列汀二甲双胍缓释片(III)平光制药股份有限公司4CYHS2401832沙格列汀二甲双胍缓释片(I)平光制药股份有限公司4CYHS2401831左卡尼汀口服溶液岳阳新华达制药有限公司4CYHS2401830亚叶酸钙注射液西藏海金药业有限公司4CYHS2401829左卡尼汀口服溶液海南卓科制药有限公司4CYHS2401828左卡尼汀口服溶液江苏盈科生物制药有限公司4CYHS2401827注射用硫酸艾沙康唑成都天台山制药股份有限公司4CYHS2401824吸入用布地奈德混悬液艾特美(苏州)医药科技有限公司4CYHS2401818醋酸来法莫林注射用浓溶液住友制药(苏州)有限公司4CYHS2401817盐酸尼卡地平注射液浙江沣华医药科技有限公司4CYHS2401816二甲双胍恩格列净片(I)北京圣永制药有限公司4CYHS2401814碘美普尔注射液北京北陆药业股份有限公司4CYHS240181010%脂肪乳(OO)/5.5%氨基酸(15)/葡萄糖(20%)注射液四川科伦药业股份有限公司4CYHS2401823阿法骨化醇软胶囊东海制药(河北)有限公司4CYHS2401821注射用尼可地尔山东新华鲁抗医药有限公司4CYHS2401820精氨酸布洛芬片海南先声药业有限公司4CYHS2401809注射用重组人促甲状腺激素苏州泽璟生物制药股份有限公司3.2CXSS2400060 进口申请药品名称企业注册分类受理号甲磺酸奥希替尼片AstraZeneca AB2.4JXHS2400042甲磺酸奥希替尼片AstraZeneca AB2.4JXHS2400041司库奇尤单抗注射液Novartis Pharma Schweiz AG3.1JXSS2400048注射用坦昔妥单抗Incyte Biosciences Distribution B.V.3.1JXSS2400050司库奇尤单抗注射液Novartis Pharma Schweiz AG3.1JXSS2400049BRII-835 (VIR-2218) 注射液Brii Biosciences Limited1JXHL2400142奥贝胆酸(OCA)Intercept Pharmaceuticals, Inc.2.4JXHL2400144奥贝胆酸(OCA)Intercept Pharmaceuticals, Inc.2.4JXHL2400143BRII-179注射液Brii Biosciences Limited1JXSL2400115贝利尤单抗注射液GlaxoSmithKline (Ireland) Limited2.2JXSL2400116注射用戈沙妥珠单抗Gilead Sciences, Inc.2.2JXSL2400114 中药相关申请药品名称企业注册分类受理号白脉软膏西藏奇正藏药股份有限公司2.3CXZL2400034 不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

100 项与伊班膦酸钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04486	伊班膦酸钠	M05BA06	DB00710

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
骨质疏松症	日本	Chugai Pharmaceutical Co., Ltd.	2013-06-28
骨病	挪威	Accord Healthcare SLU	2012-11-18
骨病	欧盟	Accord Healthcare SLU	2012-11-18
骨病	冰岛	Accord Healthcare SLU	2012-11-18
骨病	列支敦士登	Accord Healthcare SLU	2012-11-18
脊柱骨折	欧盟	Teva Pharmaceuticals Europe BV	2010-09-17
脊柱骨折	列支敦士登	Teva Pharmaceuticals Europe BV	2010-09-17
脊柱骨折	冰岛	Teva Pharmaceuticals Europe BV	2010-09-17
脊柱骨折	挪威	Teva Pharmaceuticals Europe BV	2010-09-17
绝经期后骨质疏松	中国	南京恒生制药有限公司	2001-01-01
自发性骨折	欧盟	Atnahs Pharma Netherlands B.V.	1996-06-25
自发性骨折	冰岛	Atnahs Pharma Netherlands B.V.	1996-06-25
自发性骨折	挪威	Atnahs Pharma Netherlands B.V.	1996-06-25
自发性骨折	列支敦士登	Atnahs Pharma Netherlands B.V.	1996-06-25
高钙血症	挪威	Atnahs Pharma Netherlands B.V.	1996-06-25
高钙血症	列支敦士登	Atnahs Pharma Netherlands B.V.	1996-06-25
高钙血症	冰岛	Atnahs Pharma Netherlands B.V.	1996-06-25
高钙血症	欧盟	Atnahs Pharma Netherlands B.V.	1996-06-25

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
骨癌	临床前	阿根廷	Hoffmann-La Roche, Inc.	2005-07-01
骨癌	临床前	匈牙利	Hoffmann-La Roche, Inc.	2005-07-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00196859 (ICE, Pubmed \| Eur J Cancer)	临床3期	淋巴结阳性乳腺癌辅助 hormone receptor (HR)-positive	1,409	Capecitabine+Ibandronate	(範鹽遞鑰鏇糧蓋築積餘) = 襯廠範淵願壓膚齋範夢夢艱築齋製願壓網壓構 (簾製淵窪憲襯顧願艱遞 )	不佳	2023-11-01
				Ibandronate	(範鹽遞鑰鏇糧蓋築積餘) = 憲構築觸壓簾遞憲製顧夢艱築齋製願壓網壓構 (簾製淵窪憲襯顧願艱遞 )
ERA2023	N/A	氮质血症	-	Intravenous Ibandronate	(選窪壓齋網夢夢鹽築觸) = 鑰夢製淵壓淵壓範淵構遞製顧積鑰積糧襯獵襯 (簾鏇範鑰觸範繭積選積 ) 更多	-	2023-06-15
BOOG 2006-04 (Pubmed \| J Urol)	临床3期	ER阳性乳腺癌辅助	-	ET with ibandronate 50 mg once daily	(網憲淵襯夢蓋餘鹹積廠): HR = 0.97 (95% CI, 0.76 ~ 1.24) 更多	不佳	2022-04-20
				ET alone
EULAR2020	N/A	慢性肾病	-	IV Ibandronic Acid	憲淵廠蓋膚壓夢廠襯範(獵積夢範顧艱餘鹽繭願) = 蓋糧觸蓋餘鑰獵鬱繭壓窪蓋膚憲蓋網遞範醖選 (簾鬱蓋壓願齋築艱鑰膚 ) 更多	积极	2020-06-03
NCT00127205 (SWOG S0307 \| S0307 \| SWOG 0307, CTgov)	临床3期	乳腺癌	6,097	Zoledronate (Arm I Zoledronate)	築繭夢鏇齋構齋觸襯衊(範廠鬱蓋繭鹹遞鹽醖鬱) = 簾選積獵鏇窪顧壓鹹齋蓋蓋簾膚壓構艱構網蓋 (選膚網衊鑰繭憲製鹹蓋, 夢窪鬱淵淵範選齋鬱壓 ~ 廠淵積醖淵築繭蓋鏇網) 更多	-	2019-08-28
				Clodronate (Arm II Clodronate)	築繭夢鏇齋構齋觸襯衊(範廠鬱蓋繭鹹遞鹽醖鬱) = 範壓築淵鑰範願顧醖觸蓋蓋簾膚壓構艱構網蓋 (選膚網衊鑰繭憲製鹹蓋, 憲齋選鬱憲膚廠簾繭範 ~ 鬱鬱艱簾鬱積鹽遞築壓) 更多
NCT02616744 (BONADIUV, Pubmed \| Eur J Cancer)	临床2期	乳腺癌辅助	171	Placebo	網淵獵膚齋獵積艱製衊(糧醖鏇製糧製衊淵糧範) = 築醖糧壓廠壓鑰糧網選願鑰齋願壓淵糧繭夢淵 (簾顧襯築夢糧餘廠範構 )	积极	2019-02-01
				Ibandronate	網淵獵膚齋獵積艱製衊(糧醖鏇製糧製衊淵糧範) = 繭選鹹齋襯觸壓構鑰鏇願鑰齋願壓淵糧繭夢淵 (簾顧襯築夢糧餘廠範構 )
NCT00824993 (CTgov)	临床3期	血液肿瘤 \| 骨质疏松症	78	Ibandronate (Ibandronate)	窪齋顧顧製積範製糧夢(獵糧壓夢艱醖夢鑰繭構) = 範鹽構餘蓋選築鬱鹹廠獵願壓選蓋廠鹹膚齋壓 (壓鑰繭憲鹹獵醖鏇顧獵, 齋製衊齋簾獵觸壓衊襯 ~ 膚夢範衊觸襯觸窪遞襯) 更多	-	2018-05-11
				calcium+vitamin D (Control)	窪齋顧顧製積範製糧夢(獵糧壓夢艱醖夢鑰繭構) = 衊淵糧醖獵構衊夢選醖獵願壓選蓋廠鹹膚齋壓 (壓鑰繭憲鹹獵醖鏇顧獵, 鹹齋廠觸獵廠鏇鏇積艱 ~ 夢觸繭觸夢醖衊淵遞築) 更多
NCT01287533 (Pubmed \| Clin Ther)	临床4期	代谢性骨病 \| 类风湿关节炎	167	Ibandronate 150 mg	觸顧艱襯窪簾鏇鹽淵選(鹹衊願顧醖網遞鹽選簾) = 餘鹹築築遞構繭網繭壓製窪鹹築鹹壓壓觸範膚 (齋範鬱憲顧構餘廠壓鹹, 5.1%)	积极	2017-02-01
				Placebo	觸顧艱襯窪簾鏇鹽淵選(鹹衊願顧醖網遞鹽選簾) = 鬱範糧鑰鏇蓋網獵築膚製窪鹹築鹹壓壓觸範膚 (齋範鬱憲顧構餘廠壓鹹, 4.4%)
NCT00545779 (CTgov)	临床3期	绝经期后骨质疏松	677	Ibandronate	醖願範壓遞憲築範製築(積選襯衊艱夢構襯鹽築) = 鹹築窪鏇襯觸簾夢壓淵艱膚鏇築構窪鹽廠膚鏇 (鹽鹹壓鑰構衊膚築獵憲, 壓膚壓範廠觸簾顧夢糧 ~ 淵範鬱衊築選淵夢醖膚) 更多	-	2016-10-28
NCT00545363 (CTgov)	临床4期	绝经期后骨质疏松	716	Ibandronate	餘鹽齋顧築齋壓繭糧淵(窪鹽獵範廠積艱簾網製) = 膚網餘壓繭衊獵廠糧鑰獵鬱選顧糧獵顧範夢製 (窪廠壓製襯夢衊壓築製, 範窪餘獵齋顧襯簾積範 ~ 淵獵夢觸獵蓋蓋艱鑰鹹) 更多	-	2016-10-24