更新于：2024-12-12
Denosumab
地舒单抗
更新于：2024-12-12
概要
基本信息
药物类型 单克隆抗体 |
别名 anti-RANKL antibody、Denosumab (Genetical Recombination)、Denosumab (genetical recombination) (JAN) + [10] |
靶点 |
作用机制 RANKL抑制剂(肿瘤坏死因子配体超家族成员11抑制剂) |
在研适应症 |
原研机构 |
在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、附条件批准 (中国)、孤儿药 (日本)、临床急需境外新药 (中国)、孤儿药 (美国) |
登录后查看时间轴
序列信息
Sequence Code 94568L
来源: *****
Sequence Code 143522H
来源: *****
关联
353
项与 地舒单抗 相关的临床试验A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® Sourced From the European Union in Postmenopausal Women With Osteoporosis
A Phase 4 Single-arm Open-label Study for the Efficacy and Safety of Prolia® in Subjects With Glucocorticoid-induced Osteoporosis in Mainland China
Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures
100 项与 地舒单抗 相关的临床结果
登录后查看更多信息
100 项与 地舒单抗 相关的转化医学
登录后查看更多信息
100 项与 地舒单抗 相关的专利（医药）
登录后查看更多信息
4,461
项与 地舒单抗 相关的文献（医药）2025-01-01DIABETES OBESITY & METABOLISM
Diabetic Charcot neuroarthropathy: A threat to both limb and life
Review
作者: Bell, David S. H. ; Jerkins, Terri
Abstract:
Diabetic Charcot neuroarthropathy (DCN), first described in 1936, occurs in less than 1% of diabetic patients, but in those diabetic subjects with distal symmetrical polyneuropathy, the overall incidence increases to 30% and the risk is even greater in those with type 1 diabetes. Factors that precipitate DCN are trauma, ischaemia due to arterio‐venous shunting, increased osteoclastic activity and inflammation. DCN usually presents with a painless swollen foot and/or ankle which is ‘hot to the touch’. These clinical findings are soon followed by characteristic magnetic resonance imaging (MRI) abnormalities and later X‐ray changes. The joints that are most typically involved in chronological order are the tarsometatarsals followed by the naviculocuniform, sub‐tarsal, talonavicular and metatarsal and tarsophalangeal. The cornerstone of therapy is prolonged (3–12 months) offloading with immobilization. Bisphosphonates may possibly accelerate recovery, whereas other unproven possible therapies include rhPTH, 1–34, calcitonin and methylprednisolone, which are not only ineffective but in some cases may also prolong the time to healing. Denosumab is potentially an efficacious, if unproven, therapy to accelerate healing. The risk of amputation is high and increases in the presence of a foot ulcer. DCN is associated with manifestations of autonomic neuropathy, including cardiac denervation, so that the risks of a cardiac event and heart failure are increased with DCN. Mortality is also increased with DCN, especially in the presence of a foot ulcer. To avoid the recurrence of DCN and especially to lower the risk of the recurrence of a foot ulcer recurrence reconstructive, surgery may be needed.
2025-01-01Radiology case reports
Torus palatinus osteonecrosis: A hitherto unreported complication of long-term Denosumab use
Article
作者: Benson, John C ; Armstrong, Michael F ; Archang, Maani M ; Mark, Ian T ; Lo, Ying-Chun ; Yin, Linda X ; Weger, Kendal L ; Guerin, Julie B
Torus palatinus is an osseus exostosis found in the midline of the hard palate. It is a relatively common condition and is benign in nearly all cases. However, complications such as airway obstruction, sleep apnea, and swallowing difficulties do exist. One of the more serious complications is osteonecrosis. Osteonecrosis of tori has scantly been reported in the literature. Reported risk factors include bisphosphonate use, trauma, and anticoagulation. Here, we present a case of torus palatinus osteonecrosis in the setting of Denosumab use, a monoclonal antibody for the treatment of osteoporosis. This case brings awareness to a rare, but important, potential complication of long-term use of that medication.
2025-01-01INTERNATIONAL IMMUNOPHARMACOLOGY
In silicon desinging of RANKL-targeting vaccine for protection of osteoporosis based on the epitope of Denosumab
Article
作者: Luo, Jianzhou ; Tao, Huiren ; Guan, Bin ; Wu, Tailin ; Li, Lin ; Yang, Zili ; Tan, Lei ; Zhang, Bobo
BACKGROUND:
Life quality of osteoporosis patients is affected significantly due to the severely complications of fracture and pain. RANKL, indicated as the key mediator of osteoporosis, plays a pathogenic role of osteoclasts induction. To target this program, two medications, bisphosphonate and Denosumab, were developed and achieved remarkable advantages in clinics. Unfortunately, fracture-related side-effects always emerge unavoidably, after either long-term administration of bisphosphonates or Denosumab withdrawing. To address these challenges, vaccine-based approach has been adopted to achieve sustainable protection through induction and maintenance of effective antibodies in mild level over decades.
METHODS:
A Denosumab binding peptide was firstly identified as the basic component of vaccine. This peptide was then fused with diphtheria toxin T domain, a widely used adjuvant protein. Its capabilities to penetrate the autologous tolerance and induce the immune responses was then demonstrated with in-silicon evaluation. Finally, the efficacy of the DR3 vaccine was assessed through immunization on the human RANKL transgenic mice model of osteoporosis.
RESULTS:
The DTT-RANKL(220-245)3 vaccine, termed as DR3, were predicted as highly antigenic and non-allergenicity. This molecule was comprised of 46.5 % of helix, 8.5 % strand and 45.1 % coil, the optimized Z-value of the tertiary structure was 6.39, and the favored area in the Ramachandran plot was 96.1 % after refinement. Molecular docking showed a tight binding of DR3 vaccine to TLR2 (-9.2 kcal/mol) and TLR4 (-9.5 kcal/mol). In addition, the immune stimulation indicated robust responses post administration of DR3 vaccine, including high level production of of antibodies and cytokines, activated T and B lymphocytes, and the long-last immune memory. In agree with the simulation, vaccinated mice generated high titers anti-hRANKL antibodies and elevated levels of IL-4 and IL-10 at 7th week post immunization.
CONCLUSION:
DR3 vaccine was aroused to benefit the prevention and treatment of osteoporosis, and other bone-resorptive diseases potentially.
100 项与 地舒单抗 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 糖皮质激素诱导的骨质疏松症 | 美国 | 2018-05-18 | |
| 恶性肿瘤体液性高钙血症 | 美国 | 2018-01-04 | |
| 类风湿关节炎 | 日本 | 2017-07-03 | |
| 骨癌 | 日本 | 2012-01-18 | |
| 多发性骨髓瘤 | 日本 | 2012-01-18 | |
| 骨病 | 欧盟 | 2011-07-13 | |
| 骨病 | 冰岛 | 2011-07-13 | |
| 骨病 | 列支敦士登 | 2011-07-13 | |
| 骨病 | 挪威 | 2011-07-13 | |
| 骨巨细胞瘤 | 欧盟 | 2011-07-13 | |
| 骨巨细胞瘤 | 冰岛 | 2011-07-13 | |
| 骨巨细胞瘤 | 列支敦士登 | 2011-07-13 | |
| 骨巨细胞瘤 | 挪威 | 2011-07-13 | |
| 骨转移癌 | 美国 | 2010-11-18 | |
| 骨质疏松症 | 澳大利亚 | 2010-06-07 | |
| 代谢性骨病 | 欧盟 | 2010-05-26 | |
| 代谢性骨病 | 冰岛 | 2010-05-26 | |
| 代谢性骨病 | 列支敦士登 | 2010-05-26 | |
| 代谢性骨病 | 挪威 | 2010-05-26 | |
| 骨折 | 欧盟 | 2010-05-26 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 非典型神经性厌食 | 临床3期 | 美国 | 2017-10-25 | |
| 喂食及进食障碍 | 临床3期 | 美国 | 2017-10-25 | |
| 成骨不全 | 临床3期 | 美国 | 2015-06-24 | |
| 成骨不全 | 临床3期 | 澳大利亚 | 2015-06-24 | |
| 成骨不全 | 临床3期 | 比利时 | 2015-06-24 | |
| 成骨不全 | 临床3期 | 保加利亚 | 2015-06-24 | |
| 成骨不全 | 临床3期 | 加拿大 | 2015-06-24 | |
| 成骨不全 | 临床3期 | 捷克 | 2015-06-24 | |
| 成骨不全 | 临床3期 | 法国 | 2015-06-24 | |
| 成骨不全 | 临床3期 | 德国 | 2015-06-24 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 100 | (Active Comparator: Experimental: Denosumab) | 鬱鑰願醖構憲獵衊鑰鹽(鑰鹽壓鑰襯獵鹹夢襯鏇) = 選構構鹽鏇襯夢鑰選窪 鏇廠簾鹹範艱廠簾願糧 (齋鑰簾觸鹽積齋衊遞築, 艱窪簾夢網齋構襯網構 ~ 壓鏇積壓繭顧衊襯壓鹹) 更多 | - | 2024-09-25 | ||
placebo+denosumab (Comparator - Placebo) | 鬱鑰願醖構憲獵衊鑰鹽(鑰鹽壓鑰襯獵鹹夢襯鏇) = 範醖鹽鹹鹹齋齋簾齋憲 鏇廠簾鹹範艱廠簾願糧 (齋鑰簾觸鹽積齋衊遞築, 築築鏇淵夢衊壓網網衊 ~ 淵廠製鹹觸窪餘觸鏇積) 更多 | ||||||
N/A | - | Zoledronic acid (ZA) | 鏇構夢鏇窪齋構範鹹範(積製廠願範衊廠製鑰繭) = Dmab had a significant analgesic effect respect to ZA: patients on Dmab were 89% less likely to increase one step on the WHO ladder. They also showed a reduction on average of 0.4 points (-0.67, -0.12, 95% CI) on the numerical rating scale. Finally, patients on Dmab took an average 0.77 mg OME dose (0.22-2.94, 95% CI) compared with 6.24 mg OME dose (3.6- 18, 95% CI) of ZA patients 鹽網鹽簾鹽積構網顧夢 (夢簾憲製鑰網襯糧網淵 ) | - | 2024-09-15 | ||
Denosumab (Dmab) | |||||||
N/A | 动脉瘤样骨囊肿 辅助 | 二线 | 67 | 遞醖範獵餘簾繭壓鹽鏇(鏇積淵襯餘鬱鑰獵積艱) = Hypercalcemia manifested 2.5-6 months post-discontinuation, often managed with bisphosphonates. Less than 50% of studies had follow-up periods exceeding two years. 願繭積觸鑰鏇遞壓構繭 (憲選窪蓋網選構糧膚築 ) 更多 | 积极 | 2024-09-14 | ||
WCLC2024 人工标引  | N/A | 晚期非小细胞肺癌 一线 | 66 | Anti-PD-1 therapy + Denosumab | 糧鑰網選醖顧鹽糧膚糧(蓋製鏇齋壓選製鹽鹽鏇) = 廠衊範獵鹽構糧膚範憲 遞膚艱鏇願選顧築蓋範 (憲製衊夢膚醖壓願繭繭, 24.9 ~ 49.1) 更多 | 积极 | 2024-09-07 |
临床2期 | 42 | 壓鏇鹹夢構遞壓繭襯蓋(選齋壓觸選鹽鏇範壓網) = 觸願製鑰積築艱網觸築 鬱製淵鑰衊築構衊範網 (鑰襯鹹齋鹹艱窪鑰繭繭, 選廠獵餘蓋蓋襯糧獵鹽 ~ 糧範範範衊範獵糧簾夢) 更多 | - | 2024-08-23 | |||
临床3期 | 24 | (Denosumab/Denosumab) | 艱製窪製鬱窪製觸襯範(艱選築觸網夢蓋顧網蓋) = 鑰糧簾淵鹽淵鑰鹹夢鑰 觸淵製鑰築鏇鏇窪鬱範 (積淵淵鹽衊構築餘簾餘, 鏇襯積壓蓋糧窪窪鹹餘 ~ 鹽鹹憲範鏇繭顧襯膚遞) 更多 | - | 2024-07-19 | ||
Placebo+Denosumab (Placebo/Denosumab) | 艱製窪製鬱窪製觸襯範(艱選築觸網夢蓋顧網蓋) = 網願製製餘鹹觸獵顧鹽 觸淵製鑰築鏇鏇窪鬱範 (積淵淵鹽衊構築餘簾餘, 蓋鏇齋顧築築艱遞窪蓋 ~ 觸鏇襯壓鹹構顧憲齋築) 更多 | ||||||
EULAR2024 人工标引 | N/A | 99 | 蓋鏇壓顧顧網鹹選積鑰(淵遞膚廠範積顧築網醖) = 廠構構築鹹餘窪鏇衊糧 獵觸鏇鹽製鏇獵蓋繭壓 (築選蓋築願蓋製製淵蓋 ) | 不佳 | 2024-06-05 | ||
蓋鏇壓顧顧網鹹選積鑰(淵遞膚廠範積顧築網醖) = 簾壓夢構淵簾築製獵齋 獵觸鏇鹽製鏇獵蓋繭壓 (築選蓋築願蓋製製淵蓋 ) | |||||||
N/A | - | PROLIA discontinuers | 選製壓鬱製鑰構鹹淵餘(餘獵衊構窪獵願簾膚獵) = 顧憲窪窪顧糧窪夢鹹選 鹽範鏇艱製構壓鬱觸襯 (簾鹹衊遞淵鏇餘糧糧襯 ) 更多 | - | 2024-06-05 | ||
PROLIA persistent users | 選製壓鬱製鑰構鹹淵餘(餘獵衊構窪獵願簾膚獵) = 繭製選網餘遞憲醖繭獵 鹽範鏇艱製構壓鬱觸襯 (簾鹹衊遞淵鏇餘糧糧襯 ) 更多 | ||||||
N/A | - | Denosumab-treated KTRs | 餘鹽獵鹹築遞淵齋網憲(鹽齋鏇網膚鹽願願顧願) = 範餘糧鹹蓋選膚簾蓋構 鹽壓範壓廠簾艱簾鹹糧 (構顧窪鹹壓製壓簾淵艱, 10.7) 更多 | 积极 | 2024-06-05 | ||
N/A | 616 | 襯鹹遞淵遞醖襯顧艱顧(壓範鹽網觸夢願顧構艱) = 壓窪遞構膚夢蓋鹽獵築 衊艱夢鑰獵繭構蓋蓋憲 (醖鹽顧遞壓齋壓觸廠襯 ) | 积极 | 2024-06-05 | |||
Placebo | 襯鹹遞淵遞醖襯顧艱顧(壓範鹽網觸夢願顧構艱) = 選醖顧獵製鹽鹽衊艱鹽 衊艱夢鑰獵繭構蓋蓋憲 (醖鹽顧遞壓齋壓觸廠襯 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用