Icatibant
證據等級: L1 | 預測適應症: 7 個
## 藥師評估報告
Icatibant：從遺傳性血管性水腫到 C1 Inhibitor Deficiency
一句話總結
Icatibant 原本用於遺傳性血管性水腫(HAE)急性發作的症狀治療。 TxGNN 模型預測它可能對 **C1 Inhibitor Deficiency** 有效， 目前有 **22 項臨床試驗** 和 **13 篇文獻** 支持這個方向，證據充足。
快速總覽
| 項目 | 內容 |
|---|---|
| 原適應症 | 遺傳性血管性水腫(HAE)急性發作症狀治療 |
| 預測新適應症 | C1 inhibitor deficiency、hereditary angioedema with C1Inh deficiency、serpinopathy with toxic serpin polymerization、hereditary angioedema、pseudo-von Willebrand disease、primary release disorder of platelets、immune-mediated necrotizing myopathy |
| TxGNN 預測分數 | 99.99% |
| 證據等級 | L1 |
| 台灣上市 | 已上市 |
| 許可證數 | 3 張 |
| 建議決策 | Proceed |
預測適應症詳細分析
1. C1 inhibitor deficiency L1 99.99% 主要分析
為什麼這個預測合理？
Icatibant 是一種緩激肽 B2 受體拮抗劑(Bradykinin B2 Receptor Antagonist)，透過阻斷緩激肽的作用來減少血管通透性增加所導致的水腫。在 C1 酯酶抑制劑缺乏的情況下，血漿緩激肽系統會異常活化，產生過量的緩激肽，進而導致血管性水腫。
這個預測在機轉上高度合理，因為：
- C1 Inhibitor Deficiency 是導致遺傳性血管性水腫的根本病因
- Icatibant 直接阻斷緩激肽介導的血管通透性增加
- 此適應症與原核准適應症(HAE急性發作)在病理生理學上完全一致
臨床試驗
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT01457430 | PHASE4 | COMPLETED | 19 | Open Label, Multicenter Study to Evaluate Efficacy, Safety and Tolerability of a... |
| NCT00997204 | PHASE3 | COMPLETED | 151 | Open Label, Multicenter Study to Evaluate Safety, Local Tolerability, Convenienc... |
| NCT00912093 | PHASE3 | COMPLETED | 98 | A Phase III Randomized, Double-Blind,Placebo-Controlled, Multicenter Study of Ic... |
| NCT03888755 | PHASE3 | COMPLETED | 8 | An Open-Label Study of Icatibant in Japanese Subjects With Acute Attacks of Here... |
| NCT00500656 | PHASE3 | COMPLETED | 85 | Randomised Double Blind, Controlled, Parallel Group, Multicentre Study of a Subc... |
| NCT02584959 | PHASE3 | COMPLETED | 75 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Two-period, Three-seque... |
| NCT04208412 | PHASE2 | COMPLETED | 84 | A Randomized, Double-blind, Placebo-controlled, Phase II, Cross-over Clinical Tr... |
| NCT01034969 | N/A | COMPLETED | 1761 | Icatibant Outcome Survey (IOS) Registry |
| NCT05509569 | N/A | COMPLETED | 32 | Specified Drug Use Surveillance of FIRAZYR Subcutaneous Injection 30mg Syringe f... |
| NCT05489640 | N/A | COMPLETED | 85 | A Real-World Study to Determine Patient Characteristics, Treatment Patterns, Cli... |
| NCT07290855 | PHASE4 | COMPLETED | 5 | A Phase IV Clinical Study of Evaluating the Safety and Efficacy of Icatibant Inj... |
| NCT03240133 | PHASE2 | COMPLETED | 58 | A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study to Evaluate ... |
| NCT04057131 | N/A | COMPLETED | 179 | FIRAZYR General Drug Use-Results Survey (Japan) |
| NCT04654351 | PHASE3 | COMPLETED | 2 | A Multicenter, Open-Label, Non-randomized Phase 3 Study to Assess the Safety, Ef... |
| NCT01386658 | PHASE3 | COMPLETED | 32 | A Multicenter, Open-Label, Non-Randomized Study to Assess the Pharmacokinetics, ... |
| NCT04898309 | PHASE2, PHASE3 | WITHDRAWN | 0 | A Placebo-controlled Randomized Trial to Evaluate the Efficacy and Safety of GNR... |
| NCT02870972 | PHASE2 | COMPLETED | 75 | A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-group Stu... |
| NCT06587464 | N/A | COMPLETED | 19 | Exploring Symptom Profile and Treatment Patterns in Korean HAE Patients Using Di... |
| NCT05460325 | PHASE3 | COMPLETED | 20 | A Multi-center, Open-label Study to Evaluate the Safety, Pharmacokinetics, and E... |
| NCT06346899 | N/A | COMPLETED | 115 | The Real-World Effectiveness and Safety of Lanadelumab (Takhzyro) and Icatibant ... |
| NCT00097695 | PHASE3 | COMPLETED | 84 | Randomized, Double Blind, Placebo-Controlled, Multicenter Study of a Subcutaneou... |
| NCT02045264 | PHASE1 | COMPLETED | 12 | An Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tole... |
| NCT07009262 | N/A | COMPLETED | 88 | A Prospective, Non-interventional Study in Patients With Type I or II Hereditary... |
相關文獻
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 29757016 | 2018 | Article | Expert review of clinical immu | Icatibant for the treatment of hereditary angioedema with C1-inhibitor deficienc... |
| 28687105 | 2017 | Article | Immunology and allergy clinics | Acquired C1 Inhibitor Deficiency. |
| 23420425 | 2013 | Article | Pneumonologia i alergologia po | [Administration of conestat alfa, human C1 esterase inhibitor and icatibant in t... |
| 24925394 | 2014 | Article | Chemical immunology and allerg | Bradykinin-mediated diseases. |
| 35662289 | 2022 | Article | Clinical and experimental alle | Registry-based analysis of Icatibant and C1-inhibitor use in treatment of laryng... |
| 32753245 | 2020 | Article | La Revue de medecine interne | [Acquired angioedema due to C1-inhibitor deficiency: CREAK recommendations for d... |
| 26842379 | 2016 | Article | Polskie Archiwum Medycyny Wewn | Bradykinin-mediated angioedema. |
| 37146882 | 2023 | Article | The journal of allergy and cli | A National Survey of Hereditary Angioedema and Acquired C1 Inhibitor Deficiency ... |
| 37716525 | 2023 | Article | The journal of allergy and cli | Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)-A Bicenter Retro... |
| 33602658 | 2021 | Article | Journal of investigational all | Treatment of Hereditary Angioedema. |
| 20667117 | 2010 | Article | Allergy, asthma, and clinical | Acquired angioedema. |
| 28284781 | 2017 | Article | The journal of allergy and cli | Diagnosis, Course, and Management of Angioedema in Patients With Acquired C1-Inh... |
| 31690390 | 2019 | Article | Allergy and asthma proceedings | Hereditary and acquired angioedema. |
| 33472202 | 2021 | Article | International archives of alle | Acquired Angioedema with C1 Inhibitor Deficiency: Occurrence, Clinical Features,... |
| 26972189 | 2016 | Article | Journal der Deutschen Dermatol | Prophylaxis in hereditary angioedema (HAE) with C1 inhibitor deficiency. |
| 26106828 | 2015 | Article | Current opinion in allergy and | Diagnostic and therapeutic management of hereditary angioedema due to C1-inhibit... |
| 37898409 | 2024 | Article | The Journal of allergy and cli | Uncovering the true burden of hereditary angioedema due to C1-inhibitor deficien... |
| 22686628 | 2012 | Article | Allergy | Icatibant treatment for acquired C1-inhibitor deficiency: a real-world observati... |
| 30280305 | 2018 | Article | Journal of clinical immunology | Treatment of Hereditary Angioedema Attacks with Icatibant and Recombinant C1 Inh... |
| 35871284 | 2023 | Article | Journal of clinical pharmacolo | Large Predominance of Off-Label Prescriptions of C1-Inhibitor Concentrates and I... |
2. serpinopathy with toxic serpin polymerization L5 99.99%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
3. pseudo-von Willebrand disease L5 99.21%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
4. primary release disorder of platelets L5 99.14%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
5. immune-mediated necrotizing myopathy L5 99.06%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
6. antisynthetase syndrome L5 99.02%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
7. Glanzmann thrombasthenia L5 99.00%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
台灣上市資訊
| 許可證號 | 品名 | 劑型 | 核准適應症 |
|---|---|---|---|
| 衛部罕藥製字第000021號 | 益康倍注射劑 | 注射液劑 | C1酯酶抑制劑不足的成人、青少年及2歲以上兒童 HAE 急性發作症狀治療 |
| 衛部罕藥輸字第000066號 | 凡得適注射劑30毫克 | 注射液劑 | C1酯酶抑制劑不足的成人、青少年及2歲以上兒童 HAE 急性發作症狀治療 |
安全性考量
- 藥物交互作用：
- 主要交互作用：ACE 抑制劑類藥物(Benazepril、Captopril、Enalapril、Lisinopril、Perindopril、Trandolapril、Moexipril)（中度）
- 機轉說明：Icatibant 可能降低 ACE 抑制劑的降壓效果
- 常見副作用：注射部位反應（紅斑、腫脹）
結論與下一步
決策：Proceed
理由： 此預測與原核准適應症高度一致。Icatibant 已獲核准用於 C1 酯酶抑制劑缺乏導致的 HAE 急性發作，而 C1 Inhibitor Deficiency 正是此疾病的根本病因。大量臨床試驗和文獻均支持其療效與安全性。
目前狀態：
- 已有充分的臨床證據支持
- 台灣已有核准適應症涵蓋此用途
- 可直接應用於臨床實踐
相關藥物報告
- Anastrozole - 證據等級 L1
- Temozolomide - 證據等級 L1
- Ipratropium - 證據等級 L1
- Docetaxel - 證據等級 L1
- Naftifine - 證據等級 L1
用 AI 幫我深入分析
想進一步了解這個藥物的老藥新用潛力嗎？點擊下方按鈕，直接開啟 AI 助手進行分析。
Claude：點擊後會複製提問並開啟新視窗，請按 Ctrl+V（Mac: Cmd+V）貼上
ChatGPT：點擊後直接開啟並自動帶入提問
引用本報告
如需引用本報告，請使用以下格式：
APA 格式：
TwTxGNN. (2026). Icatibant老藥新用驗證報告. https://twtxgnn.yao.care/drugs/icatibant/
BibTeX 格式：
@misc{twtxgnn_icatibant,
title = {Icatibant老藥新用驗證報告},
author = {TwTxGNN Team},
year = {2026},
url = {https://twtxgnn.yao.care/drugs/icatibant/}
}
免責聲明
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
歡迎分享您對本報告的看法、補充資訊或提出問題。討論內容會同步到 GitHub Discussions。 需要 GitHub 帳號才能留言。