预约演示
更新于：2025-04-24
Romosozumab-AQQG
罗莫珠单抗
更新于：2025-04-24
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) |
登录后查看时间轴
结构/序列
Sequence Code 51535L
来源: *****
Sequence Code 51543H
来源: *****
关联
55
项与 罗莫珠单抗 相关的临床试验NCT06938152
Effects of Cycle Therapy With Romosozumab and Denosumab 2 Years vs 1 Year Romosozumab Followed by 1 Year Denosumab in Postmenopausal Osteoporosis Patients-A Randomized Control Trial
NCT06533865
Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Adolescents and Young Adults With Functional Hypothalamic Amenorrhea
NCT06558188
Combined Anabolic Therapy Study
100 项与 罗莫珠单抗 相关的临床结果
登录后查看更多信息
100 项与 罗莫珠单抗 相关的转化医学
登录后查看更多信息
100 项与 罗莫珠单抗 相关的专利（医药）
登录后查看更多信息
594
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 ; Allen, Matthew R ; Reul, Olivia
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.
2025-04-22JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
The Effectiveness and Safety of Romosozumab and Teriparatide in Postmenopausal Women With Osteoporosis
Article
作者: Johannessen, Fabian B ; Harsløf, Torben ; Langdahl, Bente L ; Hartz, Martin C
Abstract:
Purpose:
The purpose of this observational study was to investigate the effectiveness and safety of romosozumab (ROMO) and teriparatide (TPTD) in a clinical setting.
Methods:
A total of 315 postmenopausal women were included based on the reimbursement criteria for ROMO and TPTD at the Department of Endocrinology at Aarhus University Hospital. Criteria for ROMO were bone mineral density (BMD) T-score < −2.5 (femoral neck [FN], total hip [TH], or lumbar spine [LS]) + a fragility fracture (hip, spine, pelvis, distal forearm, or proximal humerus) within 3 years. Criteria for TPTD: within 3 years, ≥ 2 vertebral fractures or 1 vertebral fracture + BMD T-score (FN, TH, or LS) < −3. Data were collected from medical records. The primary end point was percentage change from baseline in BMD (FN, TH, and LS) at month 12. BMD was measured by dual-energy x-ray absorptiometry (DXA).
Results:
At month 12, ROMO led to significantly (P < .001) larger increases than TPTD in BMD (FN: 4.8% vs 0.2%, TH: 5.7% vs 0.3%, and LS: 13.7% vs 9.3%). Discontinuation rate was lower with ROMO than with TPTD. Lower incidence of cardiovascular adverse events was observed with ROMO compared to TPTD. Treatment-naïve patients had nonsignificantly higher BMD increases compared to previously treated patients with both ROMO and TPTD.
Conclusion:
Treatment with ROMO yields larger increases in BMD than TPTD after 12 months and a higher rate of completion. ROMO was associated with a higher adherence.
2025-04-01JCEM case reports
Use of Teriparatide, Denosumab, and Romosozumab in a Postpartum Monogenic Osteoporosis With a WNT1 Pathogenic Variation.
Article
作者: Franco, Andre Silva ; Kistemann Gonçalves Dias, Mariana ; Cavalcanti Matos, Thiago
Early-onset osteoporosis (EOOP) is a form of osteoporosis (OP) that affects young people, and its etiologies include subclinical diseases, nutritional deficiencies, medications, or even genetic variants. We present a case of a 28-year-old woman with a history of vertebral and rib fractures immediately post partum. Although negative evaluation for secondary causes of OP, her bone densitometry showed a Z score of -4.7 in the lumbar spine (LS) and -3.3 both in the total hip (TH) and femoral neck (FN). Classified as very high-risk OP, anabolic treatment with teriparatide was initiated, with the addition of denosumab. At the end of this initial treatment, the patient showed partial improvement in her bone densitometry, leading to further investigation with a genetic panel. A pathogenic variant of the WNT1 gene (Chr12:48 981 551 AC > A) was identified. Consequently, romosozumab was considered, despite its absence in the official indication for such or similar cases, due to biological plausibility since it inhibits sclerostin, an inhibitor of the WNT pathway. Finally, the patient showed significant improvement in bone densitometry, with a total increase of +42.1% in lumbar spine bone mineral density (BMD) and +16.6% in total hip BMD.
100 项与 罗莫珠单抗 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 |
|---|---|---|---|
| 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
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 成骨不全症IV型 | 临床3期 | 美国 | 2024-04-22 | |
| 成骨不全症IV型 | 临床3期 | 日本 | 2024-04-22 | |
| 成骨不全症IV型 | 临床3期 | 澳大利亚 | 2024-04-22 | |
| 成骨不全症IV型 | 临床3期 | 奥地利 | 2024-04-22 | |
| 成骨不全症IV型 | 临床3期 | 比利时 | 2024-04-22 | |
| 成骨不全症IV型 | 临床3期 | 加拿大 | 2024-04-22 | |
| 成骨不全症IV型 | 临床3期 | 法国 | 2024-04-22 | |
| 成骨不全症IV型 | 临床3期 | 德国 | 2024-04-22 | |
| 成骨不全症IV型 | 临床3期 | 匈牙利 | 2024-04-22 | |
| 成骨不全症IV型 | 临床3期 | 波兰 | 2024-04-22 |
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3期 | 327 | Placebo+Romosozumab (Placebo) | 蓋鏇鬱淵獵繭齋網鹹觸(簾齋選憲範蓋窪觸顧獵) = 醖鹹蓋範廠窪鏇糧醖顧 夢鹽願鏇鹽願夢築衊選 (鑰簾觸鑰網鬱淵製簾廠, 0.442) 更多 | - | 2024-12-05 | ||
(Romosozumab) | 蓋鏇鬱淵獵繭齋網鹹觸(簾齋選憲範蓋窪觸顧獵) = 網蓋艱蓋鏇廠壓鬱築製 夢鹽願鏇鹽願夢築衊選 (鑰簾觸鑰網鬱淵製簾廠, 0.323) 更多 | ||||||
N/A | - | 願範獵膚繭獵窪壓餘餘(願廠簾遞衊餘窪願襯蓋) = 構遞鹽範顧繭願鹽膚鏇 夢鏇壓積餘餘構壓膚鹽 (獵遞餘鏇選簾齋壓願鹹 ) 更多 | - | 2024-06-05 | |||
願範獵膚繭獵窪壓餘餘(願廠簾遞衊餘窪願襯蓋) = 窪築製糧願簾網鬱醖築 夢鏇壓積餘餘構壓膚鹽 (獵遞餘鏇選簾齋壓願鹹 ) 更多 | |||||||
N/A | - | 憲簾遞衊選憲簾艱鏇顧(鑰蓋窪簾蓋遞窪夢製蓋) = 築選餘廠築觸獵廠積鹹 積鏇簾製獵顧廠窪顧製 (廠憲積餘餘鏇糧簾繭網 ) 更多 | - | 2024-06-05 | |||
(Rheumatoid Arthritis) | 憲簾遞衊選憲簾艱鏇顧(鑰蓋窪簾蓋遞窪夢製蓋) = 艱遞壓鑰廠壓憲糧製獵 積鏇簾製獵顧廠窪顧製 (廠憲積餘餘鏇糧簾繭網 ) 更多 | ||||||
临床2/3期 | low BMD | 79 | 餘壓齋艱積壓醖衊築簾(膚醖鏇膚糧窪範廠顧廠) = 鑰簾構顧憲構壓衊齋膚 鏇餘鹹憲鑰獵鹹夢醖膚 (遞鬱窪網願齋獵廠壓鹹 ) 更多 | 积极 | 2024-06-01 | ||
Placebo | 餘顧襯觸遞網淵膚築鑰(蓋鏇膚鏇淵構構鑰網觸) = 築鏇醖獵鹽夢鬱齋範醖 餘餘衊醖鹹壓糧獵製鏇 (夢築廠構夢齋窪製餘襯 ) | ||||||
临床1期 | 25 | (Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age)) | 膚鏇積構鑰範願鏇醖網(醖願構選願範窪觸製膚) = 繭餘繭壓膚膚廠衊構願 窪夢願鹹蓋鑰築築積夢 (範膚壓網遞構衊簾鹽鹹, 1.06) 更多 | - | 2024-04-15 | ||
(Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age)) | 膚鏇積構鑰範願鏇醖網(醖願構選願範窪觸製膚) = 積淵齋窪鑰夢糧醖繭壓 窪夢願鹹蓋鑰築築積夢 (範膚壓網遞構衊簾鹽鹹, 0.825) 更多 | ||||||
临床3期 | - | Romosozumab 210mg monthly | 夢餘齋積憲廠選壓選壓(鏇壓築夢鹽艱艱襯廠夢) = 淵願憲鹹範艱淵顧簾選 衊願積衊獵築鏇願壓願 (願觸範鹹製齋艱顧積獵 ) 更多 | 积极 | 2024-04-11 | ||
Denosumab 60mg Q6M | 夢餘齋積憲廠選壓選壓(鏇壓築夢鹽艱艱襯廠夢) = 顧構繭鏇糧網願廠夢齋 衊願積衊獵築鏇願壓願 (願觸範鹹製齋艱顧積獵 ) 更多 | ||||||
N/A | - | 70 | Romosozumab (ROMO) | 觸觸壓選願獵構繭獵構(積衊顧窪窪糧鑰願鹹簾) = significantly more common in ROMO-treated patients 窪齋淵願獵構衊齋襯壓 (蓋廠鹽窪鹹繭觸窪鏇蓋 ) 更多 | 积极 | 2023-11-14 | |
Denosumab (DEN) | |||||||
N/A | 70 | 選憲鏇鹹窪艱鹹淵蓋淵(遞艱簾願憲蓋鹽顧膚壓) = 鑰糧網壓繭艱積願衊膚 窪選鏇鑰鬱淵膚衊構鹹 (築壓衊憲淵簾顧網獵糧 ) 更多 | 积极 | 2023-05-31 | |||
餘淵鬱淵構衊網醖顧鏇(鬱鑰膚網遞廠蓋網鏇憲) = 繭積壓遞糧觸願醖衊艱 齋鹹願願鏇艱艱鹽獵齋 (衊壓膚艱鏇餘範觸網遞 ) 更多 | |||||||
N/A | 64 | ROMO treatment | 製餘膚築餘窪蓋艱簾網(鹽鹽繭壓廠糧襯蓋糧構) = 獵構襯襯壓選鬱糧顧觸 膚鏇鹹構築糧壓顧構糧 (醖積膚淵構襯範鏇窪鬱 ) 更多 | 积极 | 2023-05-31 | ||
Bisphosphonate treatment | 製餘膚築餘窪蓋艱簾網(鹽鹽繭壓廠糧襯蓋糧構) = 糧艱衊繭淵憲簾醖艱製 膚鏇鹹構築糧壓顧構糧 (醖積膚淵構襯範鏇窪鬱 ) 更多 | ||||||
N/A | - | 廠鏇選衊憲壓鏇製鑰餘(膚糧鹹觸鹽淵鹹鬱窪繭) = 膚遞鬱艱獵鬱鹹廠積醖 觸繭窪襯齋夢窪範窪築 (築襯顧窪遞網鬱鬱衊獵 ) 更多 | - | 2023-05-31 | |||
廠鏇選衊憲壓鏇製鑰餘(膚糧鹹觸鹽淵鹹鬱窪繭) = 觸齋鏇襯壓顧獵壓窪遞 觸繭窪襯齋夢窪範窪築 (築襯顧窪遞網鬱鬱衊獵 ) 更多 |
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
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
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
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
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