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更新于：2026-03-14
Lanadelumab
拉那利尤单抗
更新于：2026-03-14
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2018-08-23), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (韩国)、优先审评 (澳大利亚)、孤儿药 (澳大利亚)、快速通道 (美国) |
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结构/序列
Sequence Code 9684251H
来源: *****
Sequence Code 9684277L
来源: *****
关联
27
项与 拉那利尤单抗 相关的临床试验CTR20241595
拉那利尤单抗（达泽优）和艾替班特（飞泽优®）在遗传性血管性水肿患者中的真实世界疗效和安全性：一项中国观察性研究
NCT06818474
Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
NCT05297786
Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein
100 项与 拉那利尤单抗 相关的临床结果
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100 项与 拉那利尤单抗 相关的转化医学
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100 项与 拉那利尤单抗 相关的专利（医药）
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143
项与 拉那利尤单抗 相关的文献（医药）2026-02-01World Allergy Organization Journal
Clinical features of hereditary angioedema involving the gastrointestinal tract: A retrospective analysis
Article
作者: Ma, Haiyuan ; Zheng, Danping ; Huang, Zhoulin ; Chen, Baili ; Mao, Ren ; Xiong, Shanshan ; Wang, Yangdi ; Tian, Chunyang ; Li, Xuehua ; Ke, Yangyang ; Chen, Minhu ; He, Yao
Background:
Hereditary angioedema (HAE) is a rare, severe, disabling, and life-threatening disorder characterized by recurrent and unpredictable edema of skin and mucous membranes. Gastrointestinal edema, often presenting as abdominal pain, is common but frequently misdiagnosed, leading to unnecessary surgeries. This study aims to characterize gastrointestinal edema in HAE patients to improve early diagnosis and guide treatment.
Method:
We analyzed 61 patients with HAE who were admitted in our hospital between April 1, 2023 and August 31, 2025. Data on demographic characteristics, clinical manifestations, laboratory findings, imaging results, and treatment outcomes were collected through questionnaires and hospital electronic records.
Result:
Among the patients, 86.9% experienced gastrointestinal edema, mostly characterized by abdominal pain (94.3%), nausea (79.2%), and diarrhea (71.7%). Misdiagnosis occurred in 73.6% of cases, and 22.6% underwent unnecessary surgeries. The median age of gastrointestinal edema onset was 16.0 years, with the most severe episodes occurring at a median age of 25.0 years. The median annual frequency of attacks was 4.0/year, with a median severity score of 7.0. Acute attacks showed elevated D-dimer, white blood cells, neutrophils, and hemoglobin. CT imaging frequently revealed intestinal wall thickening and abdominal-pelvic effusion. Lanadelumab demonstrated superior efficacy over danazol in reducing both the frequency and severity of edema attacks, while icatibant significantly shortened the duration of edema episodes.
Conclusion:
This study updates the clinical and imaging features of gastrointestinal edema in Chinese patients with HAE, identifies biomarkers of gastrointestinal edema attacks, and highlights the efficacy of lanadelumab and icatibant, aiding timely diagnosis and treatment.
2026-01-23MEDICINE
Pain management in patients with hereditary angioedema: A case report
Article
作者: Zuo, Chunhua ; Li, Xue ; He, Song ; Ma, Youjia ; Li, Xia ; Ran, Yanhong
Rationale::
Hereditary angioedema (HAE) is a rare genetic disorder caused by C1 esterase inhibitor (C1-INH) deficiency or dysfunction. Presentation with isolated abdominal pain is uncommon, often leading to diagnostic delays and inadequate pain management. Effective pain control is essential to improve patient comfort and prevent complications.
Patient concerns::
A 21-year-old male with type II HAE presented exclusively with recurrent severe abdominal pain and experienced a transient loss of consciousness attributed to a pain-induced vagal reflex.
Diagnoses::
Diagnosis of type II HAE was confirmed based on clinical presentation, laboratory findings of C1-INH dysfunction, and exclusion of other causes of abdominal pain.
Interventions::
The patient received multidisciplinary care including symptom-based nursing, targeted pharmacological therapy with lanadelumab, psychological support, and nutritional management.
Outcomes::
Following lanadelumab administration, the patient’s abdominal pain improved significantly within 2 hours and completely resolved within 8 hours. Symptom relief was sustained at 3-month follow-up with no recurrence.
Lessons::
This case underscores the importance of early recognition of HAE presenting solely with abdominal pain and demonstrates that multidisciplinary, targeted pain management can lead to rapid and sustained symptom relief. Awareness of such atypical presentations is critical for optimizing outcomes in HAE patients.
2026-01-16MEDICINE
Type II hereditary angioedema with an apparently de novo SERPING1 mutation in China: A case report and family screening
Article
作者: Cai, Liting ; Ye, Buning ; She, Xinyan ; Guan, Zepu ; Wang, Xiaohua ; Li, Yang
Rationale::
Type II hereditary angioedema (HAE) is a rare and underrecognized condition. Early diagnosis and family screening are essential to prevent life-threatening attacks.
Patient concerns::
A 36-year-old woman presented with recurrent facial swelling and dysphagia unresponsive to standard treatments.
Diagnoses::
Laboratory analysis revealed decreased C4 and low functional C1 inhibitor (C1-INH) activity with normal antigenic levels, confirming type II HAE. Whole-exome sequencing identified a heterozygous SERPING1 mutation, c.1397G > A (p.Arg466His), classified as pathogenic (ClinVar Accession: VCV000003946.13). Three daughters carried the same variant.
Interventions::
The patient received subcutaneous icatibant for acute management and prophylactic lanadelumab. Her daughters were counseled and provided with emergency medication.
Outcomes::
Over 7 months of follow-up, the patient remained attack-free without adverse effects. Her daughters were asymptomatic or mildly affected.
Lessons::
This case emphasizes the need to consider HAE in unexplained recurrent angioedema and demonstrates the clinical utility of genetic testing and family screening. Lanadelumab was effective and well-tolerated for prophylaxis, consistent with current guideline recommendations.
100 项与 拉那利尤单抗 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 |
|---|---|---|---|
| 遗传性血管性水肿 | 美国 | 2018-08-23 |
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 |
|---|---|---|---|---|
| 血管性水肿 | 临床3期 | 美国 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 日本 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 加拿大 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 法国 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 德国 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 匈牙利 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 意大利 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 荷兰 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 波兰 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 西班牙 | 2021-02-05 |
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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2期 | 28 | (Lanadelumab) | 夢鬱艱鬱製鹹顧構鑰廠(鏇製鏇襯簾構艱齋膚選) = 製觸艱壓壓鹹憲鑰齋網 簾網蓋餘鏇夢鏇願鹹積 (網製鹹艱積範獵觸醖鬱, 36.3) 更多 | - | 2026-01-20 | ||
Placebo (Placebo) | 夢鬱艱鬱製鹹顧構鑰廠(鏇製鏇襯簾構艱齋膚選) = 築觸遞鑰築糧憲繭築鏇 簾網蓋餘鏇夢鏇願鹹積 (網製鹹艱積範獵觸醖鬱, 28.8) 更多 | ||||||
临床4期 | 遗传性血管性水肿 C1 inhibitor deficiency type 1 | 109 | 顧壓範壓築鑰憲構蓋鏇(積鹽蓋壓範餘齋醖膚觸) = 願遞願鏇願壓衊顧鹽蓋 夢網鹹壓蓋築鬱網鬱鏇 (壓簾齋餘觸鬱廠網淵願, 0.34 ~ 2.50) | 积极 | 2025-06-12 | ||
Established on Lanadelumab | 顧壓範壓築鑰憲構蓋鏇(積鹽蓋壓範餘齋醖膚觸) = 築糧淵構艱網廠衊鏇鹹 夢網鹹壓蓋築鬱網鬱鏇 (壓簾齋餘觸鬱廠網淵願, 0.10 ~ 0.30) | ||||||
临床3期 | 77 | Lanadelumab 300 mg every 2 weeks | 糧壓鹽夢範蓋遞齋遞繭(襯鑰襯鹹範網夢簾積獵) = 積範壓鑰廠衊網顧餘糧 齋憲繭憲淵餘壓積願夢 (夢遞蓋憲鏇壓積夢鹹構 ) | - | 2025-05-21 | ||
Placebo | 糧壓鹽夢範蓋遞齋遞繭(襯鑰襯鹹範網夢簾積獵) = 廠窪淵鹹簾壓膚顧獵製 齋憲繭憲淵餘壓積願夢 (夢遞蓋憲鏇壓積夢鹹構 ) | ||||||
临床4期 | - | 鏇夢膚製獵憲蓋簾積襯(遞窪衊鏇積簾膚憲夢鹽) = Nine new patients reported 42 TEAEs, mostly mild/moderate in severity, with 3 TEAEs reported as serious. Seven established patients reported 12 TEAEs (all mild/moderate and non‐serious). No TEAEs were related to lanadelumab. 醖膚壓網鹽餘鑰顧鬱壓 (蓋壓觸鬱艱鹹齋網窪膚 ) | 积极 | 2025-04-01 | |||
临床3期 | 20 | 顧獵範醖窪夢蓋醖廠齋 = 積蓋鹽網遞製醖襯築淵 鹽衊獵壓衊築簾鏇窪鏇 (膚餘獵淵衊窪衊醖範願, 簾願淵鑰淵窪廠鬱鏇醖 ~ 簾選鬱顧鏇獵壓憲網鹽) 更多 | - | 2024-12-13 | |||
临床3期 | 21 | 鏇醖醖衊餘製選鏇窪鏇(憲鹹簾夢鹽壓襯鬱繭醖) = 12 (57.1%) patients reported treatment-related treatment-emergent adverse events; however, there were no treatment-related serious adverse events. 鬱獵觸襯憲簾選鏇繭窪 (構積鹹齋齋鏇鏇膚憲膚 ) 更多 | 积极 | 2024-12-01 | |||
临床3期 | 73 | 膚齋蓋範鏇窪餘鏇淵壓(膚艱醖鑰製淵衊鏇鏇窪) = 鬱衊簾糧鹹鑰繭鏇鏇艱 蓋蓋夢積範鹽選廠簾齋 (遞憲壓鬱繭艱憲積鹽製, 夢淵構蓋窪淵願選壓廠 ~ 鏇膚鏇鬱蓋選餘醖鑰鬱) 更多 | - | 2024-06-17 | |||
N/A | 16 | 襯蓋衊齋糧壓齋選範製(淵糧壓繭範顧夢餘憲憲) = 範醖餘憲齋觸蓋簾憲艱 構觸製蓋願鹽範遞顧繭 (襯築淵鏇糧窪齋醖膚鹽 ) 更多 | 积极 | 2024-02-23 | |||
临床4期 | 遗传性血管性水肿 HAE Type I | 19 | lanadelumabumab users | 獵鹹積繭醖積壓鑰願壓(築遞鬱遞範築襯遞窪窪) = There were 29 treatment-emergent adverse events (TEAEs; mild/moderate:82.8%, non-serious:93.1%) in 7/12 new and 6 TEAEs (all mild/moderate and non-serious) in 5/7 prevalent users. No TEAEs were related to lanadelumab. 齋選獵艱壓醖鏇衊襯窪 (衊淵願艱膚簾襯醖鹹憲 ) | 积极 | 2024-02-23 | |
临床4期 | 113 | 鏇淵範襯淵鏇壓鑰蓋鏇(願鹹襯憲鹽蓋醖餘夢艱) = 淵鹽淵鬱淵鑰鬱範願願 顧顧構壓鬱製繭糧積遞 (構鬱顧壓糧壓鏇憲遞糧, 0.88 ~ 2.81) | 积极 | 2024-02-23 | |||
鏇淵範襯淵鏇壓鑰蓋鏇(願鹹襯憲鹽蓋醖餘夢艱) = 網願獵淵夢淵淵製夢顧 顧顧構壓鬱製繭糧積遞 (構鬱顧壓糧壓鏇憲遞糧, 0.25 ~ 0.70) |
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