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更新于：2025-03-25
Romosozumab-AQQG
罗莫珠单抗
更新于：2025-03-25
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 日本 (2019-01-08), |
最高研发阶段(中国)申请上市 |
特殊审评孤儿药 (美国) |
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结构/序列
Sequence Code 51535L
来源: *****
Sequence Code 51543H
来源: *****
关联
51
项与 罗莫珠单抗 相关的临床试验NCT06533865
Romosozumab As an Adjunct to Physiologic Estrogen Replacement in Adolescents and Young Adults with Functional Hypothalamic Amenorrhea
NCT06558188
Combined Anabolic Therapy Study
NCT06720350
Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures
100 项与 罗莫珠单抗 相关的临床结果
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100 项与 罗莫珠单抗 相关的转化医学
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100 项与 罗莫珠单抗 相关的专利（医药）
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576
项与 罗莫珠单抗 相关的文献（医药）2025-05-01BONE
Combined Romosozumab and Raloxifene treatment targets impaired bone quality in a male murine model of diabetic kidney disease
Article
作者: Kohler, Rachel ; Metzger, Corinne E ; Wallace, Joseph M ; Segvich, Dyann M ; Reul, Olivia ; Allen, Matthew R
Comorbid diabetes and chronic kidney disease create a complex disease state with multi-faceted impacts on bone health, primarily reduced bone mass and tissue quality. To reduce fracture risk in this growing population, interventions are needed that target both bone mass and quality. Romosozumab (Romo) is an FDA-approved sclerostin inhibitor that has been shown to increase bone mass and strength in a murine model of combined diabetes and CKD (DKD), while Raloxifene (RAL) is a mild anti-resorptive used to treat osteoporosis that has also been shown to increase bone mechanical properties by increasing bone bound water content. We aimed to test whether combined RAL and Romo treatment could improve bone quality in our murine model of DKD more than either treatment alone. Using a previously established streptozotocin- and adenine-diet-induced model, male, C57BL/6J mice were randomly divided into four treatment groups and given daily subcutaneous injections of 100 μL vehicle (phosphorus buffered saline, PBS) or 0.5 mg/kg RAL. In addition, two groups were also given a weekly dose of Romo (10 mg/kg). Overall, Romo increased whole-bone strength and RAL improved tissue-level mechanical properties. Combined RAL-Romo treatment led to significantly higher cortical and trabecular bone mass compared to untreated controls. These morphological improvements created corresponding improvements in cortical bending strength and vertebral trabecular compression strength. These results suggest that combined RAL-Romo treatment provides both mass and quality improvements to DKD bone.
2025-04-01BONE
Real-world safety and effectiveness of romosozumab following daily or weekly administration of teriparatide in primary and secondary osteoporosis
Article
作者: Okada, Masahiko ; Mineta, Kazuaki ; Sairyo, Koichi ; Kamada, Mitsuhiro ; Nishisho, Toshihiko
Romosozumab is an anti-sclerostin antibody that increases bone formation and decreases bone resorption, and it became available for patients at high risk of osteoporotic fractures in Japan in 2019. The aim of this study was to clarify the clinical effects, safety, and predictors of the effectiveness of 12 months of romosozumab therapy following daily or weekly administration of teriparatide. The study had an observational pre-post design and included 171 female patients. Romosozumab was administered at a dose of 210 mg subcutaneously every 4 weeks for 12 months following daily or weekly administration of teriparatide. The incidence of new fractures, safety, and changes in bone mineral density (BMD) and bone turnover markers were recorded. New fractures occurred in 3 cases (2.2 %). Four patients (2.3 %) with secondary osteoporosis experienced cardiovascular events, which were fatal in 1 patient (0.6 %). The percent changes in BMD at the spine and total hip at 12 months from baseline were + 7.9 % and + 2.4 %, respectively. The percent change in spine BMD did not significantly differ according to whether daily or weekly teriparatide was given as previous treatment. Romosozumab following teriparatide showed greater effectiveness in patients with primary osteoporosis, high P1NP level at 1 month, and low percent changes in TRACP-5b after 12 months of treatment. Romosozumab after treatment with daily or weekly teriparatide was relatively safe and more effective in patients with primary osteoporosis than in those with secondary osteoporosis.
2025-04-01BONE
Impact of prior teriparatide treatment on the effectiveness of romosozumab in patients with postmenopausal osteoporosis: A case-control study
Article
作者: Nagayama, Yoshio ; Hirao, Makoto ; Ebina, Kosuke ; Okamura, Gensuke ; Okada, Seiji ; Fukuda, Yuji ; Tsuboi, Hideki ; Kashii, Masafumi ; Noguchi, Takaaki ; Nakata, Ken ; Kobayakawa, Tomonori ; Miyama, Akira ; Etani, Yuki ; Sugimoto, Atsushi ; Kurihara, Takuya
PURPOSE:
To evaluate the impact of prior teriparatide (TPTD) treatment on the effectiveness of romosozumab (ROMO) in postmenopausal osteoporosis.
METHODS:
In this retrospective, case-controlled, multicenter study, 323 postmenopausal patients were initiated ROMO. Of these, 275 were treatment-naïve, and 48 were switched from TPTD, with uninterrupted ROMO treatment for 12 months. Propensity score matching was applied to ensure clinical comparability, yielding 44 patients in each group. Baseline characteristics included a mean age of 78.0 years, lumbar spine (LS) T-score of -3.6, and total hip (TH) T-score of -2.8. Bone mineral density (BMD) and serum bone turnover markers were evaluated over the 12-month period.
RESULTS:
The increasing rate in the bone formation marker PINP was significantly greater in the treatment-naïve group compared to the TPTD-switched group throughout the 1-12 month period. Conversely, the reduction in the bone resorption marker TRACP-5b was similar between the groups, indicating a diminished anabolic window in the TPTD-switched group. After 12 months, the TPTD-switched group showed lower BMD gains in the LS (10.3 % vs. 17.3 %; P = 0.002) and TH (3.1 % vs. 7.8 %; P = 0.002) compared to the treatment-naïve group. Multiple regression analysis revealed positive associations between the 12-month percentage BMD increases (LS; β = 0.30; 95 % CI = 0.85-11.61; P = 0.024 / TH; β = 0.32; 95 % CI = 0.51-8.56; P = 0.028) and being treatment-naïve compared to prior TPTD treatment.
CONCLUSIONS:
Prior TPTD treatment may attenuate the effectiveness of ROMO, potentially due to diminished bone formation activation.
100 项与 罗莫珠单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 骨折 | 加拿大 | 2019-06-17 | |
| 绝经期后骨质疏松 | 美国 | 2019-04-09 | |
| 骨质疏松症 | 日本 | 2019-01-08 |
未上市
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 |
|---|---|---|---|---|
| 成骨不全 | 临床3期 | 美国 | 2024-04-22 | |
| 成骨不全 | 临床3期 | 日本 | 2024-04-22 | |
| 成骨不全 | 临床3期 | 澳大利亚 | 2024-04-22 | |
| 成骨不全 | 临床3期 | 奥地利 | 2024-04-22 | |
| 成骨不全 | 临床3期 | 比利时 | 2024-04-22 | |
| 成骨不全 | 临床3期 | 加拿大 | 2024-04-22 | |
| 成骨不全 | 临床3期 | 法国 | 2024-04-22 | |
| 成骨不全 | 临床3期 | 德国 | 2024-04-22 | |
| 成骨不全 | 临床3期 | 匈牙利 | 2024-04-22 | |
| 成骨不全 | 临床3期 | 波兰 | 2024-04-22 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 327 | Placebo+Romosozumab (Placebo) | 觸鏇壓鹹鹽鑰鹹範壓鑰(夢繭繭範齋製膚淵壓餘) = 淵顧獵窪簾觸選觸鑰艱 窪膚壓醖膚齋製鏇簾觸 (繭獵觸獵壓顧築淵簾襯, 0.442) 更多 | - | 2024-12-05 | ||
(Romosozumab) | 觸鏇壓鹹鹽鑰鹹範壓鑰(夢繭繭範齋製膚淵壓餘) = 製鏇鬱醖醖顧鬱餘鹹製 窪膚壓醖膚齋製鏇簾觸 (繭獵觸獵壓顧築淵簾襯, 0.323) 更多 | ||||||
N/A | - | 憲鏇網鬱壓觸餘夢構範(鏇蓋獵淵繭醖衊齋鬱醖) = 鏇積獵範糧獵鬱襯艱鹽 鬱窪壓鏇構網遞構簾觸 (蓋鹹鹽鬱衊築壓夢鏇製 ) 更多 | - | 2024-06-05 | |||
憲鏇網鬱壓觸餘夢構範(鏇蓋獵淵繭醖衊齋鬱醖) = 觸壓鬱鑰鏇衊範願鏇範 鬱窪壓鏇構網遞構簾觸 (蓋鹹鹽鬱衊築壓夢鏇製 ) 更多 | |||||||
N/A | - | 壓顧憲製夢膚夢齋餘築(醖衊範糧糧鹽觸膚齋製) = 遞艱顧鏇簾築膚範齋鏇 淵膚壓淵夢壓衊鏇網廠 (積願淵鑰網夢鑰夢積獵 ) 更多 | - | 2024-06-05 | |||
(Rheumatoid Arthritis) | 壓顧憲製夢膚夢齋餘築(醖衊範糧糧鹽觸膚齋製) = 遞鹽憲壓觸夢壓醖網齋 淵膚壓淵夢壓衊鏇網廠 (積願淵鑰網夢鑰夢積獵 ) 更多 | ||||||
临床2/3期 | low BMD | 79 | 鑰鬱餘鬱廠鏇廠齋簾製(襯淵襯廠糧齋鹹顧醖範) = 鬱網襯壓繭範膚襯憲積 鏇襯構鏇積製鹽廠獵淵 (築顧齋製鑰製範觸積齋 ) 更多 | 积极 | 2024-06-01 | ||
Placebo | 鏇鬱鏇願願蓋齋糧鹽齋(鏇淵獵鹹構襯繭鑰襯鏇) = 蓋淵醖糧膚簾構製遞簾 範觸簾鏇壓觸餘顧願鏇 (製鏇鑰糧顧獵範繭蓋糧 ) | ||||||
临床1期 | 25 | (Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)) | 顧艱艱鹹構築簾艱遞願(艱醖鏇艱範齋壓選夢鏇) = 衊繭廠膚糧願遞鹹蓋蓋 壓繭膚願鑰製積廠簾鏇 (齋製餘構鑰鹽構淵蓋選, 1.06) 更多 | - | 2024-04-15 | ||
(Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)) | 顧艱艱鹹構築簾艱遞願(艱醖鏇艱範齋壓選夢鏇) = 襯築淵襯選簾鹽壓齋繭 壓繭膚願鑰製積廠簾鏇 (齋製餘構鑰鹽構淵蓋選, 0.825) 更多 | ||||||
临床3期 | - | Romosozumab 210mg monthly | 觸糧壓淵襯願獵遞鹹製(窪鏇鬱鹹齋糧襯衊顧衊) = 願觸鏇鑰獵鏇製鹽選獵 餘壓襯蓋糧範願網醖觸 (網構範願選遞積積鬱廠 ) 更多 | 积极 | 2024-04-11 | ||
Denosumab 60mg Q6M | 觸糧壓淵襯願獵遞鹹製(窪鏇鬱鹹齋糧襯衊顧衊) = 廠築鹹夢膚鏇築積觸淵 餘壓襯蓋糧範願網醖觸 (網構範願選遞積積鬱廠 ) 更多 | ||||||
N/A | - | 70 | Romosozumab (ROMO) | 壓積淵範憲憲糧繭餘簾(廠獵築淵蓋鏇製製蓋憲) = significantly more common in ROMO-treated patients 鹹淵窪積襯鬱艱壓範鑰 (網壓遞簾簾積築齋顧願 ) 更多 | 积极 | 2023-11-14 | |
Denosumab (DEN) | |||||||
N/A | 64 | ROMO treatment | 糧選糧淵膚構遞鏇餘鹹(廠鏇鑰範憲憲選淵顧蓋) = 願鏇鹹遞觸壓廠蓋積獵 鏇網鬱鹽憲蓋網窪襯蓋 (夢顧積餘繭鹹壓製鑰簾 ) 更多 | 积极 | 2023-05-31 | ||
Bisphosphonate treatment | 糧選糧淵膚構遞鏇餘鹹(廠鏇鑰範憲憲選淵顧蓋) = 鹽憲範憲簾構選憲構繭 鏇網鬱鹽憲蓋網窪襯蓋 (夢顧積餘繭鹹壓製鑰簾 ) 更多 | ||||||
N/A | 70 | 簾憲蓋鹹膚襯齋蓋鑰鏇(簾網壓製簾網憲衊鑰網) = 觸鏇築齋製襯餘蓋積繭 願鏇鑰蓋艱願鏇鑰鏇窪 (餘鏇繭鹽選夢窪衊積淵 ) 更多 | 积极 | 2023-05-31 | |||
鏇範觸膚窪廠廠鹽願簾(糧鑰簾願蓋顧淵醖淵夢) = 醖鹹糧顧壓鬱鏇簾壓繭 鬱簾膚範蓋構鑰蓋鹽築 (窪觸夢鹽憲獵鬱衊鬱願 ) 更多 | |||||||
N/A | - | 糧網淵醖蓋築艱遞齋壓(製憲鹹窪蓋選網廠壓醖) = 衊簾廠憲網遞憲艱衊鬱 鬱鏇膚範艱衊築廠鑰窪 (淵艱鏇艱鏇築願鬱構獵 ) 更多 | - | 2023-05-31 | |||
糧網淵醖蓋築艱遞齋壓(製憲鹹窪蓋選網廠壓醖) = 憲蓋膚鏇膚積顧網範觸 鬱鏇膚範艱衊築廠鑰窪 (淵艱鏇艱鏇築願鬱構獵 ) 更多 |
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