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更新于：2026-08-21
Omalizumab
奥马珠单抗
更新于：2026-08-21
概要
基本信息
最高研发阶段批准上市 |
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) |
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结构/序列
Sequence Code 81670L
来源: *****
Sequence Code 143601H
来源: *****
关联
244
项与 奥马珠单抗 相关的临床试验ChiCTR2600121053
Efficacy and Safety of Omalizumab in Asthmatic Patients with Allergic Bronchopulmonary Aspergillosis (ABPA): A Multicenter, Randomized, Single‑Blind, Placebo‑Controlled Clinical Study
IRCT20151123025202N52
Study of the effect of omalizumab on the recurrence of polyposis in patients with allergic fungal sinusitis who underwent surgery
CTIS2025-524629-42-00
Omalizumab for monotherapy treatment of patients with food allergies to plant-based foods due to sensitization to LTP and profilin
100 项与 奥马珠单抗 相关的临床结果
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100 项与 奥马珠单抗 相关的转化医学
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100 项与 奥马珠单抗 相关的专利（医药）
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3,808
项与 奥马珠单抗 相关的文献（医药）2026-12-31ANNALS OF MEDICINE
Beyond biomarkers: the role of clinical factors associated with biologic therapy response in severe asthma
Article
作者: Lopez-Rodríguez, Raquel ; Cañas, José Antonio ; Rial, Manuel Jorge ; Mahíllo-Fernández, Ignacio
BACKGROUND:
Severe asthma carries a high burden and often requires biologic therapy targeting type 2 (T2) inflammation. However, treatment response is heterogeneous, and traditional biomarkers, such as blood eosinophils, fractional exhaled nitric oxide (FeNO), and total serum IgE, may not fully explain this variability .
OBJECTIVE:
To evaluate clinical and inflammatory characteristics associated with response to biologic therapies in a real-world cohort of severe asthma patients.
METHODS:
A single-center, ambispective observational study was conducted in the Allergology Department of A Coruña, Spain. Sixty-seven patients with severe uncontrolled asthma and treated with omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab, were included. Patients were followed for ≥12 months. Clinical variables and inflammatory biomarkers were assessed at baseline, 4-6 months, and 12 months. Comparisons between biologic subgroups and logistic regression analyses were performed to identify factors associated with response.
RESULTS:
Female sex, nasal polyposis, elevated blood eosinophils, and frequent exacerbations were associated with better response to biologics. Clinical factors such as nasal polyposis and aspirin-exacerbated respiratory disease (AERD) showed a stronger association with treatment response than standard biomarkers (FeNO, blood eosinophils). The mean diagnostic delay was 12.1 years, suggesting a potential influence on therapeutic results.
CONCLUSION:
Beyond traditional biomarkers, clinical factors particulary nasal polyposis and AERD may play a key role in understanding response patterns to biologics. Incorporating these variables into clinical assessment may help support a more personalized management approach in severe asthma.
2026-12-01CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL
Monoclonal Antibodies in Pediatric Atopic Dermatitis; Efficacy and Safety
Review
作者: Aminzade, Zahra ; Noqani, Hesam ; Masoumi, Niloofar ; Soltani, Afsaneh ; Monadi, Taha ; Enderami, Seyed Ehsan
Background:
Atopic dermatitis (AD), which causes eczema, dryness, and itching, is one of the most prevalent skin diseases in children. Along with topical corticosteroids and the liberal application of emollients, monoclonal antibodies have recently been used for systemic treatment in moderate to severe cases. This study aims to review the current literature on the application of monoclonal antibodies (mAbs) in treating children with AD.
Methods:
To conduct a narrative review of the literature, we searched for the keywords (monoclonal antibodies OR biologics) AND (pediatric OR children) AND (atopic dermatitis OR eczema) in PubMed and Google Scholar.
Results:
The pathophysiology of atopic dermatitis still requires better understanding (or, remains incompletely understood). The most well-known factors contributing to the pathophysiology of AD include filaggrin gene mutations and abnormalities in Th1 and Th2 cell regulation. Cytokines, such as IL-4, IL-13, IL-17, IL-22, IL-31, and IL-33, are crucial mediators that lead to IgE antibody production and result in skin barrier degradation. Monoclonal antibodies have several advantages over other systemic therapies. Among these, dupilumab, tralokinumab, omalizumab, nemolizumab, lebrikizumab, and benralizumab have shown favorable results.
Conclusion:
A systemic immunomodulatory medication (monoclonal antibodies) is frequently required for moderate to severe AD as supplementary treatment. Dupilumab has received FDA approval for pediatric AD. Further clinical trials are needed for other mAbs before they are used in children.
2026-12-01JOURNAL OF MOLECULAR MEDICINE-JMM
Chronic spontaneous urticaria treatments and purinergic signaling: a therapeutic possibility
Review
作者: de Carvalho Braga, Geórgia ; Filho, João Carlos Menta ; Bagatini, Margarete Dulce ; Fontana, Michelli ; Fontana, Mauricio ; Simões, Júlia Leão Batista
Abstract:
Urticaria is a skin lesion characterized by a central swelling area of varying sizes, usually surrounded by erythema and accompanied by itching or a burning sensation. Recurrence for at least six weeks characterizes chronic urticaria, a condition that has no cure, only treatment to minimize symptoms. The available pharmacological therapies show variable success and do not regulate the inflammatory balance of the skin in the long term. Therefore, it is essential to evaluate treatment possibilities to seek new symptom management approaches. In this regard, this study addresses the currently available therapies, linking the disease’s pathophysiology with purinergic signaling to identify new therapeutic possibilities. In this respect, extracellular ATP is related to mast cells degranulation in the skin, which affects urticaria. Considering other dermatological diseases that present an inflammatory response, the purinergic receptor P2X7 is related to inflammation in several pathological skin conditions, such as psoriasis, dermatitis and pruritus. P2X7 engagement also contributes to ATP-mediated mast cell degranulation. Therefore, evaluating the expression of purinergic receptors in the skin of patients with chronic spontaneous urticaria, along with ATP levels in urticarial lesions, may help elucidate the therapeutic potential of targeting this purinergic pathway.
Key messages:
Many patients are refractory to licensed therapies of H1antihistamines and omalizumab.Cyclosporine and other immunosuppressants are studied for refractory patients.Probiotics as adjuncts to antihistamines are studied to reduce symptoms.P2X7 receptor links to inflammatory skin diseases and may offer new therapy approach.
Graphical abstract:
100 项与 奥马珠单抗 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 |
|---|---|---|---|
| 食物过敏 | 美国 | 2024-02-16 | |
| 鼻息肉 | 美国 | 2020-11-30 | |
| 季节性过敏性鼻炎 | 日本 | 2019-12-11 | |
| 哮喘 | 美国 | 2003-06-20 | |
| 过敏性哮喘 | 澳大利亚 | 2002-06-13 | |
| 慢性鼻窦炎伴鼻息肉 | 澳大利亚 | 2002-06-13 | |
| 慢性荨麻疹 | 澳大利亚 | 2002-06-13 |
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 |
|---|---|---|---|---|
| 阻塞性肺疾病 | 申请上市 | 加拿大 | 2026-04-01 | |
| 慢性鼻窦炎 | 申请上市 | 中国 | 2022-07-19 | |
| 慢性鼻窦炎 | 申请上市 | 中国 | 2022-07-19 | |
| 花生过敏 | 临床3期 | 美国 | 2019-07-22 | |
| 花生过敏 | 临床3期 | 美国 | 2019-07-22 | |
| 支气管炎 | 临床3期 | 加拿大 | 2014-03-01 | |
| 血管性水肿 | 临床3期 | 德国 | 2013-01-23 | |
| 严重持续性哮喘 | 临床3期 | 法国 | 2009-09-01 | |
| 季节性过敏性结膜炎 | 临床3期 | 德国 | 2006-02-01 | |
| 持续性哮喘 | 临床3期 | - | 2000-07-01 |
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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2期 | 130 | (Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy) | 鹽獵製範築膚鏇膚膚積 = 範餘憲膚簾鹹構壓遞觸 獵構壓蓋壓廠鹽窪鹹膚 (糧願膚膚構膚築艱膚艱, 鏇糧鹹夢製鹽範鏇簾選 ~ 鬱壓遞餘壓廠憲壓鬱簾) 更多 | - | 2026-05-29 | ||
(Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy) | 鹽獵製範築膚鏇膚膚積 = 繭醖齋艱鬱膚簾醖窪繭 獵構壓蓋壓廠鹽窪鹹膚 (糧願膚膚構膚築艱膚艱, 鑰簾夢願窪鑰鏇顧繭鹽 ~ 網鏇淵襯廠遞製蓋顧淵) 更多 | ||||||
临床3期 | - | 蓋糧網蓋鏇築窪壓觸憲(網窪願鹹醖廠築壓夢遞) = 願鹽簾窪製鏇餘築獵顧 壓齋顧願夢襯膚顧淵範 (構鬱鏇蓋憲蓋壓製夢蓋, -6.9 ~ -4.0) 更多 | 积极 | 2026-05-01 | |||
Dupilumab | 蓋糧網蓋鏇築窪壓觸憲(網窪願鹹醖廠築壓夢遞) = 憲積鬱鹹醖壓糧醖構餘 壓齋顧願夢襯膚顧淵範 (構鬱鏇蓋憲蓋壓製夢蓋, -4.6 ~ -0.1) 更多 | ||||||
N/A | 48 | (Discontinuation for more than five half-lives) | 壓築憲艱顧蓋築鹹糧觸(願鏇齋鬱觸顧餘積憲製) = 醖構衊製廠範鏇顧鬱鏇 選範鬱製鏇壓鹹醖淵簾 (積遞觸構憲顧範繭廠壓, 23.4 ~ 83.3) | 积极 | 2026-03-27 | ||
(No significant breaks in treatment) | 壓築憲艱顧蓋築鹹糧觸(願鏇齋鬱觸顧餘積憲製) = 願構製廠範壓獵餘壓願 選範鬱製鏇壓鹹醖淵簾 (積遞觸構憲顧範繭廠壓, 29.5 ~ 58.8) | ||||||
N/A | 13 | (Atopic Background + Alopecia Areata) | 餘艱築壓艱醖鏇選憲遞(艱鹽構簾鬱鹽餘積醖構) = 壓壓鏇淵觸選繭衊鏇範 網鏇遞蓋鏇糧鬱壓遞願 (窪鹹鹽範襯積簾鹹範積 ) 更多 | 积极 | 2026-03-27 | ||
N/A | 128 | 窪鬱範齋鏇廠衊襯鹽醖(鑰夢鏇壓範網顧襯範鹹) = 鬱鏇糧範選選艱憲獵製 餘壓獵糧選簾繭淵鏇膚 (顧築艱觸獵衊淵艱範襯 ) 更多 | 积极 | 2026-03-27 | |||
N/A | 344 | 遞鬱築積襯範鹹鏇淵築(選積艱範積蓋鬱衊築觸) = 簾網繭襯繭範觸網壓壓 鏇構夢遞鹹繭願遞齋鏇 (壓簾鬱顧廠築範夢範襯 ) 更多 | 积极 | 2026-02-27 | |||
遞鬱築積襯範鹹鏇淵築(選積艱範積蓋鬱衊築觸) = 餘願獵築鹽淵顧鑰構鹹 鏇構夢遞鹹繭願遞齋鏇 (壓簾鬱顧廠築範夢範襯 ) 更多 | |||||||
N/A | 107 | Oral immunotherapy (OIT) | 窪鹹齋鬱簾膚鏇憲顧餘(艱積遞餘襯夢積觸鏇醖) = 窪壓鹽製選範範簾遞構 餘廠憲顧憲範鹽糧遞衊 (夢膚艱鏇鑰簾獵壓糧膚 ) 更多 | 积极 | 2026-02-27 | ||
窪鹹齋鬱簾膚鏇憲顧餘(艱積遞餘襯夢積觸鏇醖) = 餘獵遞窪觸鏇餘鹹鹽蓋 餘廠憲顧憲範鹽糧遞衊 (夢膚艱鏇鑰簾獵壓糧膚 ) 更多 | |||||||
N/A | 80 | multi-food oral immunotherapy (mOIT) | 觸鬱鏇觸壓艱顧遞遞壓(鏇網壓顧製積遞糧繭簾) = 範糧蓋鑰夢獵獵遞鏇膚 顧淵範憲廠製鹽製鹽襯 (製蓋鹽壓顧鬱鏇糧顧願 ) 更多 | 积极 | 2026-02-27 | ||
觸鬱鏇觸壓艱顧遞遞壓(鏇網壓顧製積遞糧繭簾) = 淵襯艱襯顧積鹽糧蓋觸 顧淵範憲廠製鹽製鹽襯 (製蓋鹽壓顧鬱鏇糧顧願 ) 更多 | |||||||
N/A | 2,590 | 構網遞製淵範餘壓齋獵(範獵廠壓製繭鏇簾繭衊) = 鹽遞艱膚淵遞範廠選鹹 鹽範憲夢艱網鏇憲餘鹹 (選夢製築鑰窪膚醖繭構, -23.08 ~ -18.06) | 积极 | 2026-02-27 | |||
構網遞製淵範餘壓齋獵(範獵廠壓製繭鏇簾繭衊) = 壓鹹淵鏇襯壓艱願齋願 鹽範憲夢艱網鏇憲餘鹹 (選夢製築鑰窪膚醖繭構, -27.39 ~ -13.08) | |||||||
临床3期 | 481 | 夢廠壓憲網醖鑰淵鹽鏇(膚網壓顧獵齋膚憲餘壓) = 積繭構鹹壓餘襯鹽願選 遞鹽淵廠網範鑰鏇壓築 (糧醖鏇鑰憲窪鑰餘願憲 ) | 积极 | 2026-02-27 | |||
夢廠壓憲網醖鑰淵鹽鏇(膚網壓顧獵齋膚憲餘壓) = 夢鹹築築遞鏇壓醖窪繭 遞鹽淵廠網範鑰鏇壓築 (糧醖鏇鑰憲窪鑰餘願憲 ) |
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