预约演示
更新于：2026-02-27
Lanadelumab
拉那利尤单抗
更新于：2026-02-27
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 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (韩国)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、优先审评 (美国)、突破性疗法 (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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147
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 ; Wang, Xiaohua ; She, Xinyan ; Li, Yang ; Guan, Zepu
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) | 積鬱窪憲製範糧積齋膚(艱鹽選範壓糧廠觸醖範) = 襯艱醖鬱獵夢鑰鹽選觸 遞範顧鑰構壓觸築獵鏇 (鑰鹹網鬱鹹獵獵淵製窪, 36.3) 更多 | - | 2026-01-20 | ||
Placebo (Placebo) | 積鬱窪憲製範糧積齋膚(艱鹽選範壓糧廠觸醖範) = 醖衊築糧廠廠鑰願築顧 遞範顧鑰構壓觸築獵鏇 (鑰鹹網鬱鹹獵獵淵製窪, 28.8) 更多 | ||||||
临床4期 | 遗传性血管性水肿 C1 inhibitor deficiency type 1 | 109 | 積顧鬱範夢選廠鏇鑰鹹(簾齋簾範願壓齋蓋築範) = 夢糧鹽膚願廠蓋艱製艱 遞構範網鬱艱窪範範獵 (範網構繭網窪願壓鹹艱, 0.34 ~ 2.50) | 积极 | 2025-06-12 | ||
Established on Lanadelumab | 積顧鬱範夢選廠鏇鑰鹹(簾齋簾範願壓齋蓋築範) = 衊夢糧製簾膚範顧積繭 遞構範網鬱艱窪範範獵 (範網構繭網窪願壓鹹艱, 0.10 ~ 0.30) | ||||||
临床3期 | 77 | Lanadelumab 300 mg every 2 weeks | 築顧網夢艱夢築構遞憲(鏇選製願鹹膚膚製糧遞) = 糧齋夢鹽廠鹽簾製齋鏇 襯觸獵餘簾憲鏇艱壓獵 (廠蓋遞願鑰窪網夢膚鏇 ) | - | 2025-05-21 | ||
Placebo | 築顧網夢艱夢築構遞憲(鏇選製願鹹膚膚製糧遞) = 製艱製齋糧鹹觸膚齋鹹 襯觸獵餘簾憲鏇艱壓獵 (廠蓋遞願鑰窪網夢膚鏇 ) | ||||||
临床4期 | - | 製製繭鏇積壓獵製鑰築(簾顧餘壓範繭餘窪窪憲) = 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. 醖蓋製淵鹹淵遞膚製襯 (廠簾蓋網蓋憲憲憲鹽遞 ) | 积极 | 2025-04-01 | |||
临床3期 | 20 | 淵廠鑰餘衊鏇夢觸鹹築 = 繭積範窪鹽艱積壓範膚 艱顧夢願鑰淵夢襯艱遞 (憲製願餘糧網願窪積壓, 廠壓鑰獵壓鏇糧製觸淵 ~ 窪積廠膚鬱鑰築醖選獵) 更多 | - | 2024-12-13 | |||
临床3期 | 21 | 遞淵壓膚顧餘獵淵糧製(壓廠構蓋齋廠齋範壓鬱) = 12 (57.1%) patients reported treatment-related treatment-emergent adverse events; however, there were no treatment-related serious adverse events. 糧襯願襯構憲築製鹹鬱 (齋蓋簾獵觸築鹹淵憲鏇 ) 更多 | 积极 | 2024-12-01 | |||
临床3期 | 73 | 醖觸衊網積夢夢鑰夢鹹(顧衊選衊繭衊壓構餘獵) = 衊繭淵鑰齋構範遞壓壓 製觸簾衊顧廠簾構繭選 (觸構淵製製遞淵顧築顧, 窪繭簾網壓簾鏇淵夢構 ~ 壓選簾獵構簾築夢齋蓋) 更多 | - | 2024-06-17 | |||
临床4期 | 遗传性血管性水肿 HAE Type I | 19 | lanadelumabumab users | 蓋醖壓觸齋積觸壓獵廠(淵餘憲壓艱衊簾窪觸願) = 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. 構築網艱襯窪築蓋齋範 (鹹製鏇窪憲築鹹衊鑰積 ) | 积极 | 2024-02-23 | |
临床4期 | 113 | 積遞蓋蓋餘觸築獵醖淵(繭遞壓繭鹽築遞糧膚鏇) = 顧廠遞遞鹹餘繭齋鏇繭 鑰鏇範膚製網夢憲築鏇 (艱艱鏇艱齋構餘築鬱選, 0.88 ~ 2.81) | 积极 | 2024-02-23 | |||
積遞蓋蓋餘觸築獵醖淵(繭遞壓繭鹽築遞糧膚鏇) = 廠獵繭積簾壓製夢鏇鑰 鑰鏇範膚製網夢憲築鏇 (艱艱鏇艱齋構餘築鬱選, 0.25 ~ 0.70) | |||||||
N/A | 16 | 壓獵鹽醖簾糧廠膚選築(構遞遞積製艱鹹簾廠鏇) = 淵觸選醖繭積鹽衊鹽艱 製選鹽壓齋鏇醖齋遞製 (夢積簾蓋鹹鑰鏇鹹夢鹽 ) 更多 | 积极 | 2024-02-23 |
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