预约演示
更新于：2026-01-30
Evocalcet
依伏卡塞
更新于：2026-01-30
概要
基本信息
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
28
项与 依伏卡塞 相关的临床试验CTR20254471
依伏卡塞片在健康受试者中空腹和餐后状态下随机、开放、两序列、两周期、交叉生物等效性试验
CTR20253549
依伏卡塞片人体生物等效性试验
CTR20253103
依伏卡塞片在健康受试者中空腹和餐后状态下随机、开放、两序列、两周期、交叉生物等效性预试验
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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59
项与 依伏卡塞 相关的文献（医药）2026-02-01JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
Quantitative LC-MS/MS Assay for Evocalcet in Human Plasma: Comparative Pharmacokinetic Evaluation in Fasted and Fed Healthy Chinese Volunteers
Article
作者: Dhawelbate, Mohammed ; Abdelrahman, Mohammed ; Siddig, Orwa ; Hang, Tai-Jun ; Wu, Xinrui ; Shogar, Alrazi Eisa ; Chen, Keran ; Yang, Jucui
A validated LC-MS/MS analytical method was established for quantifying evocalcet in human plasma, using evocalcet-d4 as the internal standard. Chromatographic separation was performed on a Thermo ODS C8 column (150 × 4.6 mm, 5 μm) with gradient elution of water and methanol, both containing 0. formic acid, as the mobile phases. Detection was carried out in positive ion mode using an electrospray ionization source. The plasma sample was spiked with an internal standard solution, followed by protein precipitation, and the resulting supernatant was injected into the LC-MS/MS system. The method, validated under ICH guidelines for quantitative biological analysis, demonstrated linearity from 1 to 1000 ng/mL (R2 > 0.99) with an LLOQ of 1 ng/mL. Accuracy and precision were confirmed by recovery studies, and all other validation parameters were within acceptable limits. This validated method was successfully applied to characterize the pharmacokinetic profile of evocalcet in fasting and postprandial healthy Chinese volunteers after oral administration. Results showed significantly higher Cmax and AUC values in the fasting group compared to the postprandial group, as well as delayed Tmax (p < 0.01). The pharmacokinetic parameters, including Cmax, Tmax, t1/2, and AUC0-∞, were consistent with those reported in earlier studies. Moreover, hyperthyroid patients exhibited longer Tmax and t1/2, along with increased AUC0-t and AUC0-∞ values, compared to healthy individuals. These findings offer valuable methodological insights and pharmacokinetic data to advance clinical research on evocalcet, thereby contributing to a deeper understanding of its safety and efficacy profile.
2026-01-01INTERNAL MEDICINE
Medically Managed Dropped Head Syndrome: Outcomes in Isolated Neck Extensor Myopathy and Primary Hyperparathyroidism-related Myopathy
Article
作者: Hatayama, Naoki ; Nishimori, Yukako ; Sugie, Kazuma ; Tomoda, Takahiro ; Yamada, Takeshi ; Sato, Takuma ; Sumikura, Hiroyuki ; Eura, Nobuyuki ; Shimada, Yuki ; Sakaguchi, Manabu
Objective We herein report our experience with medically treated patients presenting with dropped head syndrome (DHS) due to isolated neck extensor myopathy (INEM) or primary hyperparathyroidism (PHPT)-related myopathy, focusing on the treatment response and the correlation between muscle pathology and INEM outcomes. Methods This single-center retrospective observational study reviewed 20 consecutive patients who presented with DHS as their primary complaint between March 2021 and June 2025. Sixteen patients were included in this study: 13 with INEM who received immunotherapy as the primary medical treatment and 3 with PHPT-related myopathy who received oral evocalcet. The severity of DHS and treatment response were graded semi-quantitatively. Muscle biopsy findings were analyzed in one patient with INEM. We conducted a literature review of biopsy-proven INEM cases. Results INEM was the most common cause of DHS (13/20). Patients with INEM with a shorter disease duration experienced dramatic improvement, whereas those with a longer disease duration showed only partial improvement. Relapse occurred in six patients with INEM. All three patients with PHPT-related myopathy achieved complete remission of DHS with oral evocalcet. Although our single biopsy case showed no pathological inflammation and responded well to immunotherapy, a literature review revealed that inflammatory infiltrates were present in 38% of the 56 INEM cases and correlated with a significantly better immunotherapy response. Conclusion INEM is the predominant etiology of DHS at initial presentation, and immunotherapy is an effective management strategy, especially with early intervention. PHPT-related myopathy represents another important etiology of DHS, with a favorable response to medical therapy with evocalcet.
2025-12-15INTERNAL MEDICINE
Primary Hyperparathyroidism with Severe Vitamin D Deficiency in Chronic Kidney Disease
Article
作者: Takami, Reiji ; Barroga, Edward ; Oshiro, Tsuyoshi ; Koiwa, Fumihiko ; Nishiwaki, Hiroki ; Omiya, Shinya
A 71-year-old woman with altered consciousness was diagnosed with primary hyperparathyroidism (PHPT) after presenting with severe hypercalcemia (serum Ca 15.3 mg/dL) and parathyroid adenoma. Unusually, her 1,25 (OH) 2D3 level was undetectable, despite PHPT. Hemodialysis and evocalcet failed to control the calcium levels, but denosumab effectively reduced hypercalcemia. However, both 25 (OH) D3 and 1,25 (OH) 2D3 remained low. This case highlights the importance of vitamin D assessment in PHPT, as its metabolism can vary. Denosumab may be a viable treatment option for calcimimetic hypercalcemia.
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
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临床3期 | 继发性甲状旁腺功能亢进症 iPTH level | - | 窪遞鑰廠獵齋鑰蓋範餘(齋獵積夢齋窪積獵獵觸) = 餘繭蓋繭鹹網齋壓築繭 淵齋鹹選構蓋廠顧艱餘 (遞淵鏇積鬱衊醖簾鹽繭 ) 更多 | 积极 | 2022-11-03 | ||
窪遞鑰廠獵齋鑰蓋範餘(齋獵積夢齋窪積獵獵觸) = 構憲網艱鏇醖齋廠醖夢 淵齋鹹選構蓋廠顧艱餘 (遞淵鏇積鬱衊醖簾鹽繭 ) 更多 | |||||||
临床3期 | 634 | Low-dose evocalcet (1-2 mg) | 襯網鹽鬱遞夢蓋窪繭願(艱窪齋憲製範鑰鹹觸鏇) = demonstrated similar trends 願鹹遞襯憲鏇顧網簾窪 (願蓋蓋網膚範齋觸憲顧 ) 更多 | - | 2022-01-01 | ||
Medium-dose evocalcet (3-4 mg) | |||||||
临床3期 | 18 | 膚網鏇鹽憲鹽糧網觸築 = 鏇壓鹹艱夢襯憲遞壓夢 積獵鹹醖餘蓋衊廠遞簾 (獵醖糧選艱遞鏇襯鹽憲, 夢遞鏇選積廠糧鬱網膚 ~ 壓網衊鑰鹽鹹網遞淵膚) 更多 | - | 2021-05-27 | |||
临床3期 | 18 | 憲餘鹽餘願膚鏇鏇淵壓(觸觸鏇廠廠壓簾願齋壓) = 製願簾夢夢廠壓範鑰網 蓋餘願廠夢願鏇壓襯獵 (選艱鬱觸遞選糧鏇鏇築, 52.4 ~ 93.6) 更多 | 积极 | 2020-09-01 | |||
临床3期 | - | 39 | 鹽簾願願鬱醖艱顧廠憲(築願構鹽獵製構蓋齋簾) = Adverse drug reactions occurred in 46.2% (18/39) of patients, with most being of mild-to-moderate severity including GI-related events 齋膚憲壓鹽繭積築觸窪 (齋選壓築糧觸繭窪齋築 ) | 积极 | 2019-06-01 | ||
临床3期 | 634 | 鹽餘蓋壓廠願窪憲壓構(鏇鹽顧襯糧繭顧獵網構) = 糧鹹糧鹹顧構願築簾夢 獵積鬱壓鬱衊艱鬱遞憲 (窪憲鏇簾糧範鬱蓋網醖 ) 更多 | 非优 | 2018-10-01 | |||
鹽餘蓋壓廠願窪憲壓構(鏇鹽顧襯糧繭顧獵網構) = 衊憲鹽鏇鏇鏇觸艱鏇蓋 獵積鬱壓鬱衊艱鬱遞憲 (窪憲鏇簾糧範鬱蓋網醖 ) 更多 |
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