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更新于：2026-04-19
Blosozumab
更新于：2026-04-19
概要
基本信息
原研机构 |
在研机构 |
最高研发阶段临床1期 |
首次获批日期- |
最高研发阶段(中国)临床1期 |
特殊审评- |
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结构/序列
Sequence Code 99833H
来源: *****
Sequence Code 99851L
来源: *****
关联
7
项与 Blosozumab 相关的临床试验NCT05391776
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TST002 Intervenous Injection in Postmenopausal Women and Men With Reduced Bone Mineral Density
NCT02337387
A Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 2 Formulations of Blosozumab in Postmenopausal Women
NCT02109042
A Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Blosozumab Proposed Phase 3 Formulation in Postmenopausal Women
100 项与 Blosozumab 相关的临床结果
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100 项与 Blosozumab 相关的转化医学
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100 项与 Blosozumab 相关的专利（医药）
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23
项与 Blosozumab 相关的文献（医药）2025-08-01The Journal of the Association of Physicians of India
Newer Therapies for Osteoporosis: A Systematic Review
Review
作者: Das, Parthajit ; Goyal, Mohit ; Ravindran, Vinod ; Roy, Debaditya
OBJECTIVE:
The current management of osteoporosis has several unmet needs. Consequently, the newer and upcoming agents and targets are being expectantly looked at. We aim to appraise the evidence examining the efficacy of the newer therapies for the management of osteoporosis.
METHODS:
Scopus, Embase, and MEDLINE databases were screened from January 2013 to December 2023 to identify clinical trials that evaluated the efficacy of newer agents for the treatment of osteoporosis in men and postmenopausal women (PMO). Changes in bone mineral density (BMD) and incidences of vertebral fractures (VFs) and nonvertebral fractures (NVFs) or relative risk reduction (RRR) for VF and NVF were retrieved. The Oxford quality scoring system was applied to evaluate the methodological quality of the included clinical trials.
RESULTS:
Eighteen randomized controlled trials (RCTs) that had enrolled 22,868 PMO and 473 male participants were included. Anabolic agents abaloparatide and romosozumab exhibited significant BMD gain and relative RRR for fractures and greater efficacy than teriparatide. Blosozumab was reported to exhibit substantial BMD gains. The efficacy of a sequential therapeutic strategy with anabolic agent followed by antiresorptive agents was superior to the reverse sequence.
CONCLUSION:
Newer therapies for osteoporosis exhibited significant BMD gain and fracture risk reduction in men and PMO. The newer anabolic agents demonstrated greater efficacy than any of the previously available therapeutic options.
2023-12-31mAbs
Rapid
in vitro
assessment of the immunogenicity potential of engineered antibody therapeutics through detection of CD4
+
T cell interleukin-2 secretion
Article
作者: Mishima, Masayuki ; Ikuno, Tatsuya ; Mizuno, Hideaki ; Takeiri, Akira ; Yano, Mariko ; Arata, Yoshiyuki ; Motoyama, Shigeki ; Nishito, Yukari ; Tabo, Mitsuyasu ; Yabuki, Nami ; Matsushita, Tomochika ; Kiyokawa, Jumpei ; Suzuki, Hiromi ; Ito, Shunsuke ; Chiba, Shuichi ; Kubo, Chiyomi ; Honda, Masaki ; Sampei, Zenjiro
Therapeutic antibodies sometimes elicit anti-drug antibodies (ADAs) that can affect efficacy and safety. Engineered antibodies that contain artificial amino acid sequences are potentially highly immunogenic, but this is currently difficult to predict. Therefore, it is important to efficiently assess immunogenicity during the development of complex antibody-based formats. Here, we present an in vitro peripheral blood mononuclear cell-based assay that can be used to assess immunogenicity potential within 3 days. This method involves examining the frequency and function of interleukin (IL)-2-secreting CD4+ T cells induced by therapeutic antibodies. IL-2-secreting CD4+ T cells seem to be functionally relevant to the immunogenic potential due to their proliferative activity and the expression of several cytokines. The rates of the donors responding to low and high immunogenic proteins, mAb1, and keyhole limpet hemocyanin were 1.3% and 93.5%, respectively. Seven antibodies with known rates of immunogenicity (etanercept, emicizumab, abciximab, romosozumab, blosozumab, humanized anti-human A33 antibody, and bococizumab) induced responses in 1.9%, 3.8%, 6.4%, 10.0%, 29.2%, 43.8%, and 89.5% of donors, respectively. These data are comparable with ADA incidences in clinical settings. Our results show that this assay can contribute to the swift assessment and mechanistic understanding of the immunogenicity of therapeutic antibodies.
2022-10-01Annals of palliative medicine
Blosozumab in the treatment of postmenopausal women with osteoporosis: a systematic review and meta-analysis
Review
作者: Li, Hao ; Su, Yanlin ; Cai, Yuli ; Li, Nianhu ; Ma, Liang ; Liu, Fei ; Li, Gang ; Wang, Wenzhao
BACKGROUND:
Postmenopausal women are one of the most vulnerable groups to osteoporosis. Romosozumab is a newly monoclonal drug that inhibits the activity of sclerostin. Since it has been on the market for only 3 years, there is a lack of systematic analysis on postmenopausal women and the efficacy is not clear. In this study, we compared randomized controlled trials to assess the effects of blosozumab versus placebo in perimenopausal and postmenopausal women.
METHODS:
This meta-analysis has been registered in the PROSPERO registry (number CRD42020145839). The PubMed, Cochrane Library, ClinicalKey, and Embase databases were searched from inception date to July 01, 2021. We used the keywords "osteoporosis", "decreased bone mass", and "blosozumab" to retrieve studies on the relationship between blosozumab and osteoporosis in each database. The inclusion criteria were: (I) randomized controlled trials (RCTs) comparing the treatment of osteoporosis with blosozumab and a placebo or without treatment, (II) studies on postmenopausal women aged over 50 years, and (III) studies providing bone mineral density data. The quality of all randomized controlled trials included in this study was independently assessed by two researchers according to the Cochrane risk manual and was divided into high, medium and low quality. The main results analyzed were bone mineral density (BMD) and T-score. Our results mainly include BMD and procollagen type I N-terminal propeptide (P1NP), C-terminal telopeptide of type I collagen (CTX), bone-specific alkaline phosphatase (BSAP), and osteocalcin (OC).
RESULTS:
Three RCTs with 105 patients were selected from 157 retrieved articles. Due to high heterogeneity [BMD: Tau2=2.79; Chi2=11.70, degrees of freedom (df) =1 (P=0.0006); I2=91%], we could not perform statistical analysis of BMD. The results of BMD were then evaluated systematically. Three RCT studies were included in the evaluation. Compared with that of the placebo, blosozumab increased levels of the BMD biomarker osteocalcin [mean deviation (MD) 12.55; 95% confidence interval (CI), 8.18, 16.91; P<0.00001]. None of the 3 RCTs presented a risk of bias during the meta-analysis.
CONCLUSIONS:
The results suggested that blosozumab could be used as a target drug to improve BMD in postmenopausal women. This will provide a reference for the clinical treatment of postmenopausal women with osteoporosis.
100 项与 Blosozumab 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10094 | Blosozumab | - |
研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 骨质疏松症 | 临床2期 | 美国 | 2010-08-01 | |
| 骨质疏松症 | 临床2期 | 日本 | 2010-08-01 | |
| 骨质疏松症 | 临床2期 | 丹麦 | 2010-08-01 | |
| 骨质疏松症 | 临床2期 | 爱沙尼亚 | 2010-08-01 | |
| 骨质疏松症 | 临床2期 | 立陶宛 | 2010-08-01 | |
| 绝经期后骨质疏松 | 临床1期 | 美国 | 2014-04-01 |
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临床结果
临床结果
适应症
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临床1期 | - | 60 | (7.5 mg LY2541546 - IV) | 簾鏇觸蓋膚餘鬱壓淵鑰 = 製願鬱網艱範製顧齋鬱 窪衊鑰鬱獵蓋範製蓋選 (餘醖蓋簾襯壓夢築壓齋, 鹹積選觸鑰襯廠艱遞艱 ~ 齋鑰憲齋糧廠鹹餘壓願) 更多 | - | 2019-01-23 | |
(25 mg LY2541546 - IV) | 簾鏇觸蓋膚餘鬱壓淵鑰 = 願簾蓋鹹夢顧壓鑰鹹鹽 窪衊鑰鬱獵蓋範製蓋選 (餘醖蓋簾襯壓夢築壓齋, 壓衊鹹壓窪襯衊憲顧鹽 ~ 選廠膚窪窪襯衊鬱繭餘) 更多 | ||||||
临床1期 | 28 | (Blosozumab Formulation A) | 壓餘鬱鑰遞願廠夢構衊 = 糧簾鹽網顧餘鬱廠構鹽 鏇蓋糧壓積範鏇窪構構 (醖壓壓觸簾壓衊積構製, 廠繭製膚餘餘願選選衊 ~ 艱糧糧選夢餘鹽積壓壓) 更多 | - | 2019-01-22 | ||
(Blosozumab Formulation B) | 壓餘鬱鑰遞願廠夢構衊 = 獵鏇齋積鹽餘顧範膚憲 鏇蓋糧壓積範鏇窪構構 (醖壓壓觸簾壓衊積構製, 衊範壓觸憲憲衊範夢淵 ~ 醖鑰糧衊膚衊觸觸鬱憲) 更多 | ||||||
临床1期 | - | 59 | Placebo - SC+LY2541546 - SC (180 mg LY2541546 SC Q4W) | 願顧餘壓襯壓鹹繭觸築 = 構鹹膚糧鏇鏇憲艱構簾 醖範觸醖鹹構鑰襯鹹築 (鹹範餘醖鏇壓衊憲蓋膚, 鬱網蓋襯廠願餘鬱醖築 ~ 鹽壓願膚築夢醖網鏇鏇) 更多 | - | 2018-07-18 | |
(270 mg LY2541546 SC Q2W) | 願顧餘壓襯壓鹹繭觸築 = 鏇願簾築窪願選鏇鑰餘 醖範觸醖鹹構鑰襯鹹築 (鹹範餘醖鏇壓衊憲蓋膚, 壓糧艱鑰構糧壓夢觸醖 ~ 鏇憲選積窪遞廠選鹽糧) 更多 | ||||||
临床1期 | 15 | (Weekly SC Blosozumab Injections) | 簾製齋夢構艱積憲鹽夢(壓餘壓壓蓋餘壓淵顧衊) = 襯築鹽憲積鬱繭窪膚積 蓋築獵網艱簾衊淵鏇窪 (蓋糧膚糧構構壓鏇夢繭, 54) 更多 | - | 2018-07-16 | ||
(180 mg SC Blosozumab Injection) | 選鏇窪鹹蓋鹹鏇繭繭齋(鑰窪構淵築壓網衊膚鬱) = 遞鹽網積醖廠獵衊網壓 網襯蓋觸顧範淵蓋構顧 (鹽獵鹽鏇積艱艱鹹醖糧, 憲築淵襯膚鑰獵簾積觸 ~ 鹹齋鹹餘願鹽繭壓鑰積) 更多 | ||||||
临床2期 | 154 | Placebo+LY2541546 (180 mg LY2541546 Q4W + Placebo) | 夢窪夢鏇襯鬱淵網壓蓋(醖製網鬱網憲鏇築糧糧) = 願膚築顧鹽蓋衊廠觸構 觸構衊簾鹽顧製積網襯 (憲簾齋繭範膚憲願壓網, 夢範簾願壓網範鑰選衊 ~ 觸廠齋範廠顧顧鏇鏇餘) 更多 | - | 2017-12-04 | ||
(180 mg LY2541546 Q2W) | 夢窪夢鏇襯鬱淵網壓蓋(醖製網鬱網憲鏇築糧糧) = 製願膚糧淵遞鏇願糧鹽 觸構衊簾鹽顧製積網襯 (憲簾齋繭範膚憲願壓網, 壓鬱淵構衊選簾鏇襯製 ~ 顧築廠夢衊憲觸遞衊窪) 更多 |
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