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更新于：2025-02-15
Evocalcet
依伏卡塞
更新于：2025-02-15
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (2018-03-23), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C24H26N2O2 |
InChIKeyRZNUIYPHQFXBAN-XLIONFOSSA-N |
CAS号870964-67-3 |
关联
30
项与 依伏卡塞 相关的临床试验CTR20241174
依伏卡塞片的生物等效性试验
CTR20241321
依伏卡塞片人体生物等效性试验
CTR20240573
中国健康受试者空腹及餐后状态下单次口服依伏卡塞片（规格：2mg）的一项单中心、随机、开放、两制剂、两序列、两周期交叉生物等效性试验
100 项与 依伏卡塞 相关的临床结果
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100 项与 依伏卡塞 相关的转化医学
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100 项与 依伏卡塞 相关的专利（医药）
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62
项与 依伏卡塞 相关的文献（医药）2025-01-01BMJ Case Reports
Severe hypophosphataemia following denosumab administration successfully managed using a calcimimetic agent
Article
作者: Omori, Makiko ; Ikeda, Yuhachi ; Sakai, Tomoyuki ; Matsukawa, Yukihiro
Denosumab, an anti-RANKL antibody, induces bone metabolism to a low-turnover bone status by arresting osteoclast activity. Frequent adverse events include infusion reactions, fever and hypocalcaemia but not hypophosphataemia. We report a case of severe hypophosphataemia associated with secondary hyperparathyroidism following denosumab administration in a young boy with recurrent osteosarcoma who was successfully treated with evocalcet. He developed hypocalcaemia and severe refractory hypophosphataemia after receiving denosumab for bone metastases despite calcium, cholecalciferol and phosphorus supplementation. Laboratory data revealed secondary hyperparathyroidism due to denosumab-induced hypocalcaemia as the cause of hypophosphataemia. Evocalcet contributed to the normalised parathyroid hormone and phosphorus levels, allowing the discontinuation of phosphorus supplementation. This case highlights the complexity of managing electrolyte imbalances induced by bone-modifying agents, such as denosumab, underscoring the importance of monitoring bone metabolism markers and the potential effectiveness of evocalcet in managing drug-induced secondary hyperparathyroidism and hypophosphataemia.
2024-11-01BMJ Case Reports
Paradoxical cerebral embolism caused by patent foramen ovale in a patient with multiple endocrine neoplasia type 1 and severe primary hyperparathyroidism
Article
作者: Shimano, Hitoshi ; Matsuda, Takaaki ; Sekiya, Motohiro ; Osaki, Yoshinori
A man in his late 30s with gait difficulty, dysarthria, impaired consciousness and polyuria was diagnosed with left thalamic infarction. Hypercalcaemia (3.52 mmol/L (2.15–2.52)), high intact-parathyroid hormone (i-PTH) levels (88.8 pmol/L (1.1–6.9)) and high D-dimer levels (14.7 mg/L (<1.0)) were identified, followed by a positive microbubble test on transesophageal echocardiogram, suggesting high-risk patent foramen ovale (PFO) for ischaemic stroke. Paradoxical cerebral embolism via PFO, complicated by a hypercoagulable state and hypercalcemic dehydration, was considered. Polyglandular parathyroid hyperplasia, plus radiolucent mandibular tumours, suggested multiple endocrine neoplasia type 1 (MEN1) or hyperparathyroidism-jaw tumour syndrome. Genetic testing confirmed MEN1. Treatment was 24 mg of oral evocalcet and total parathyroidectomy with forearm autotransplantation, resulting in improved serum calcium and i-PTH levels. Finally, he underwent transcatheter PFO closure. We emphasise careful, etiological pursuit in young-onset stroke and the usefulness of genetic testing in differentiating hyperparathyroidism associated with mandibular tumours.
2024-10-01EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
Effects of active vitamin D analogs and calcimimetic agents on PTH and bone mineral biomarkers in hemodialysis patients with SHPT: a network meta-analysis
Article
作者: Mei, Ziwei ; Xie, Xun ; Liu, Xing ; Liu, Yichen ; Li, Zhouzhou ; Chen, Peipei ; Zheng, Peimin ; Yang, Rui ; Jin, Lie ; Zhou, Limei
OBJECTIVE:
Active vitamin D analogs and calcimimetic agents are primary drugs for patients with secondary hyperparathyroidism. Due to the different pharmacological mechanisms, they have different effects on the level of parathyroid hormone, serum calcium, phosphorus, and bone turnover biomarkers. This study aimed to evaluate the active vitamin D analogs and calcimimetic agents in hemodialysis patients with secondary hyperparathyroidism.
METHODS:
We included randomized clinical trials of hemodialysis patients with secondary hyperparathyroidism, comparing active vitamin D analogs to calcimimetic agents or placebo/control. The primary outcome was the change of PTH level from baseline to end-up. The secondary outcome was the change in serum calcium, phosphorus, calcium-phosphorus product, and bone turnover biomarkers. A network meta-analysis method was applied to complete this study. The forest plots reflected statistical differences in the outcomes between active vitamin D analogs and calcimimetic agents. The SUCRA result presented the ranking of impact on the outcomes.
RESULTS:
Twenty-one randomized clinical trials with 4653 patients were included in this network meta-analysis. Global and splitting-node inconsistencies provided no evidence of inconsistency in this study. There was no statistical difference between two active vitamin D analogs and three calcimimetic agents in the PTH, and phosphorus levels changed. Considering serum calcium level, compared with placebo, calcitriol (9.73, 3.09 to 16.38) and paricalcitol (9.74, 3.87 to 15.60) increase serum calcium. However, cinacalcet (- 1.94, - 3.72 to - 0.15) and etelcalcetide (- 7.80, - 11.80 to - 3.80) reduced the serum calcium, even a joint use of cinacalcet with active vitamin D analogs (- 5.83, - 9.73 to - 1.93). Three calcimimetic agents decreased calcium levels much more than calcitriol and paricalcitol. The same type of drugs was not distinct, with each one affecting the change in calcium level. Cinacalcet reduced calcium-phosphorus product much more than paricalcitol (- 3.66, - 6.72 to - 0.60). Evocalcet decreased calcium-phosphorus product more than cinacalcet (- 5.64, - 8.91 to - 2.37), calcitriol (- 9.36, - 14.81 to - 3.92), and paricalcitol (- 9.30, - 13.78 to - 4.82). Compared with paricalcitol, cinacalcet significantly increases the level of ALP (24.50, 23.05 to 25.95) and bALP (0.67, 0.03 to 1.31). The incidence of gastrointestinal disorders in cinacacet (29.35, 1.71 to 504.98) and etelcalcetide (20.92, 1.20 to 365.68) was notably higher than in paricalcitol. Etelcalcetide (0.71, 0.53 to 0.96) and evocalcet (0.46, 0.33 to 0.64) presented a lower rate of gastrointestinal disorders than cinacalcet. Cinacalcet ranked first in adverse gastrointestinal, nervous, and respiratory reactions.
CONCLUSION:
The same kinds of agents perform similar efficacy on the level of PTH, serum calcium, phosphorus, and calcium-phosphorus product. Paricalcitol did not lead to more hypercalcemia than calcitriol. The calcium decrease induced by cinacalcet was not settled even by associating it with active vitamin D analogs. Cinacalcet and evocalcet were superior to calcitriol and paricacitol in reducing calcium-phosphorus product. Calcimimetics induced more gastrointestinal disorders than active vitamin D analogs, especially cinacalcet.
100 项与 依伏卡塞 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 |
|---|---|---|---|
| 高钙血症 | 日本 | 2019-12-20 | |
| 原发性甲状旁腺功能亢进症 | 日本 | 2019-12-20 | |
| 甲状旁腺肿瘤 | 日本 | 2019-12-20 | |
| 继发性甲状旁腺功能亢进症 | 日本 | 2018-03-23 |
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 |
|---|---|---|---|---|
| 终末期肾脏病 | 临床3期 | 中国 | 2019-02-13 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 继发性甲状旁腺功能亢进症 iPTH level | - | 膚選鹽簾遞艱鑰憲憲襯(製鏇製遞鏇淵築鏇鹹獵) = 淵鹹鹽繭夢鏇壓願築網 範構網壓積艱餘糧淵繭 (簾鬱夢築鏇選糧選憲製 ) 更多 | 积极 | 2022-11-03 | ||
膚選鹽簾遞艱鑰憲憲襯(製鏇製遞鏇淵築鏇鹹獵) = 蓋夢遞廠構築鏇積網構 範構網壓積艱餘糧淵繭 (簾鬱夢築鏇選糧選憲製 ) 更多 | |||||||
N/A | - | 網構廠壓製鹹簾廠餘醖(觸構糧憲選簾鑰鑰鑰顧) = 構鬱願鹽廠醖積壓鏇築 觸襯鹽構觸襯鏇夢簾蓋 (夢壓繭窪醖襯鹽製餘範 ) 更多 | 积极 | 2022-11-03 | |||
網構廠壓製鹹簾廠餘醖(觸構糧憲選簾鑰鑰鑰顧) = 齋衊齋齋餘築衊齋範範 觸襯鹽構觸襯鏇夢簾蓋 (夢壓繭窪醖襯鹽製餘範 ) 更多 | |||||||
临床3期 | 634 | Low-dose evocalcet (1-2 mg) | 艱顧選窪醖醖顧範構餘(鹽壓顧範衊膚壓積願壓) = demonstrated similar trends 願襯積選艱鏇衊構範淵 (簾窪顧繭選觸範膚繭願 ) 更多 | - | 2022-01-01 | ||
Medium-dose evocalcet (3-4 mg) | |||||||
临床3期 | 18 | 遞獵願餘觸範願淵鏇積(糧蓋襯夢製獵觸淵夢範) = 鏇獵鏇積積衊鹹鹽鹹簾 築鹽壓鬱範鹽廠淵廠淵 (範餘製淵築鹹構願簾夢, 鬱醖製餘憲憲鏇選鬱範 ~ 醖鬱蓋鏇鹽觸觸襯夢壓) 更多 | - | 2021-05-27 | |||
临床3期 | 18 | 繭鑰餘餘艱範壓構鏇淵(繭積艱鏇醖製顧蓋網膚) = 憲簾夢衊選廠觸衊齋壓 願願餘顧繭艱簾簾齋衊 (範鹹顧鏇艱衊鏇願餘範, 52.4 ~ 93.6) 更多 | 积极 | 2020-09-01 | |||
N/A | - | 34 | 餘淵醖願憲齋製鏇鹹願(網鑰艱鹹範膚積鏇鏇艱) = occurred in 2 patients 衊鹹製鹽夢鑰積醖鏇淵 (構構鬱鏇觸網網膚醖淵 ) 更多 | 积极 | 2020-06-06 | ||
临床3期 | - | 39 | 選鏇積醖願遞淵簾蓋顧(憲鹽夢憲艱膚獵淵襯範) = Adverse drug reactions occurred in 46.2% (18/39) of patients, with most being of mild-to-moderate severity including GI-related events 蓋獵淵鹹壓淵觸襯壓艱 (範觸鹹齋簾醖膚築鬱鹹 ) | 积极 | 2019-06-01 | ||
临床3期 | 634 | 築鹹窪鏇繭餘製窪鑰壓(範遞鬱觸網襯遞夢構蓋) = 醖鬱簾顧鹹製憲憲廠窪 鹽觸壓遞壓襯廠鑰醖淵 (觸夢艱夢繭壓繭鹹膚糧 ) 更多 | 非优 | 2018-10-01 | |||
築鹹窪鏇繭餘製窪鑰壓(範遞鬱觸網襯遞夢構蓋) = 願顧蓋遞窪襯構醖鑰膚 鹽觸壓遞壓襯廠鑰醖淵 (觸夢艱夢繭壓繭鹹膚糧 ) 更多 |
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