预约演示
更新于：2026-04-20
Tozorakimab
托雷奇单抗
更新于：2026-04-20
概要
基本信息
原研机构 |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评突破性疗法 (中国)、快速通道 (美国) |
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结构/序列
Sequence Code 20819666L
来源: *****
Sequence Code 616717178H
来源: *****
关联
15
项与 托雷奇单抗 相关的临床试验NCT06897748
A Phase II, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab in Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations and Elevated Eosinophils (COMETA)
NCT06890351
A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids
NCT06908577
A Multiple Centre, Randomised, Open-label, Parallel Group, Phase I Pharmacokinetic Comparability Study of Tozorakimab Administered Using an Accessorised Prefilled Syringe (APFS) or an Autoinjector (AI) in Healthy Volunteers
100 项与 托雷奇单抗 相关的临床结果
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100 项与 托雷奇单抗 相关的转化医学
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100 项与 托雷奇单抗 相关的专利（医药）
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16
项与 托雷奇单抗 相关的文献（医药）2026-12-31mAbs
Structures of clinical antibodies bound to IL-33 uncover two distinct epitopes underlying differential efficacy
Article
作者: Chen, Jing ; Wang, Yue ; Wang, Xinquan
Interleukin-33 (IL-33), an alarmin cytokine of the IL-1 family, drives type 2 inflammation through signaling via the ST2 and IL-1RAcP receptors, making it a critical therapeutic target for inflammatory diseases such as asthma and chronic obstructive pulmonary disease. Current therapeutic strategies have primarily focused on antibodies that target IL-33 or ST2 to disrupt their specific interaction. However, the structural mechanisms underlying antibody-mediated neutralization of IL-33 remain poorly understood. Here, we report the structures of three antibodies in clinical trial - etokimab, itepekimab, and tozorakimab - complexed with IL-33, determined by X-ray crystallography and cryo-electron microscopy. Structural analysis reveals two distinct neutralizing epitopes on IL-33, termed Epitope 1 at IL-33/ST2 binding Site 1 and Epitope 2 at IL-33/ST2 binding Site 2. Tozorakimab, which targets Epitope 1, completely blocks ST2 engagement by sterically occluding the ST2 D1-D2 domain-binding interface. In contrast, etokimab and itepekimab, which recognize Epitope 2, interfere with IL-33 recognition of the ST2 D3 domain and thereby only partially inhibit ST2 binding. These structural and biochemical findings provide a molecular explanation for the differential efficacy of the three antibodies in inhibiting IL-33 signaling in cellular assays. Collectively, our results provide valuable insights into the molecular determinants of efficacy for existing IL-33 therapeutics and offer a structural framework for the rational design of next-generation IL-33 targeted inhibitors.
2026-01-01ERJ Open Research
IL-33 blockade in asthma: a story of hype, hope and hindsight
作者: Bourdin, Arnaud ; Georas, Steve N
Despite negative phase 2 trials including the FRONTIER-3 study in asthma, tozorakimab and other IL-33 targeting strategies have strong potential in asthma and beyond https://bit.ly/3JnWak2.
2026-01-01ERJ Open Research
FRONTIER-3: a randomised phase 2a study to investigate tozorakimab, an anti-interleukin-33 monoclonal antibody, in early-onset asthma
Article
作者: Belvisi, Maria G ; Platt, Adam ; Kell, Chris ; Georgi, Benjamin ; Rytelewski, Mateusz ; Corren, Jonathan ; Jimenez, Eulalia ; Sadiq, Muhammad Waqas ; Cameron-Christie, Sophia ; Pandya, Hitesh ; Moate, Rachel ; Lindqvist, Eva ; Brooks, Dennis ; Muthas, Daniel ; Reid, Fred ; Williams, Adam
Background:
Interleukin (IL)-33 is implicated in the initiation and progression of asthma. FRONTIER-3 (
NCT04570657
) was a phase 2a study to investigate tozorakimab, an anti-IL-33 monoclonal antibody, in adults with moderate-to-severe early-onset asthma receiving standard of care.
Methods:
Patients were randomised 1:1:1 to tozorakimab 600 mg, tozorakimab 300 mg or placebo, once every 4 weeks subcutaneously. The primary end-point was change from baseline to week 16 in pre-bronchodilator (pre-BD) forced expiratory volume in 1 s (FEV
1
) measured in clinic. Secondary and exploratory end-points included home pre-BD FEV
1
, home peak expiratory flow (PEF), rescue medication use, CompEx, pharmacokinetics, immunogenicity and safety.
Results:
The intent-to-treat (ITT) population included 235 patients with a median disease duration of >30 years; a majority had a baseline blood eosinophil count (BEC) <300 cells·μL
−1
. At week 16, tozorakimab did not show a statistically significant improvement in change from baseline in clinic pre-BD FEV
1versus
placebo (least-squares mean difference (LSMD) (80% CI), 600 mg: 4 mL (−71–79), p=0.473; 300 mg: 36 mL (−38–111), p=0.267). Compared with the ITT population, a pre-specified subgroup of patients with ≥2 prior exacerbations showed greater improvements in clinic pre-BD FEV
1
at week 16 with tozorakimab
versus
placebo (LSMD (80% CI), 600 mg: 212 mL (102–322), p=0.007; 300 mg: 77 mL (−34–187), p=0.186). Tozorakimab also showed greater improvements in home FEV
1
and home PEF
versus
placebo at week 16 in patients with ≥2 prior exacerbations than in the ITT population. Tozorakimab was well tolerated.
Conclusions:
Although FRONTIER-3 did not meet the primary study end-point, tozorakimab treatment showed encouraging efficacy signals in patients with early-onset asthma and a history of exacerbations.
128
项与 托雷奇单抗 相关的新闻（医药）2026-04-16
·求实药社
临床结果临床3期临床失败临床2期
100 项与 托雷奇单抗 相关的药物交易
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研发状态
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 |
|---|---|---|---|---|
| 急性呼吸道感染 | 临床3期 | 美国 | 2022-12-13 | |
| 急性呼吸道感染 | 临床3期 | 中国 | 2022-12-13 | |
| 急性呼吸道感染 | 临床3期 | 日本 | 2022-12-13 | |
| 急性呼吸道感染 | 临床3期 | 阿根廷 | 2022-12-13 | |
| 急性呼吸道感染 | 临床3期 | 澳大利亚 | 2022-12-13 | |
| 急性呼吸道感染 | 临床3期 | 比利时 | 2022-12-13 | |
| 急性呼吸道感染 | 临床3期 | 巴西 | 2022-12-13 | |
| 急性呼吸道感染 | 临床3期 | 保加利亚 | 2022-12-13 | |
| 急性呼吸道感染 | 临床3期 | 加拿大 | 2022-12-13 | |
| 急性呼吸道感染 | 临床3期 | 哥伦比亚 | 2022-12-13 |
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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 | soluble ST2 | 1,076 | 齋顧齋鹽鹹憲醖糧顧淵(衊鹽餘窪淵築衊壓範選) = Deaths were only reported in one study (FRONTIER-1 [DKD]) and occurred in similar proportions for both tozorakimab and placebo. No deaths were attributed to tozorakimab. 鑰膚醖選觸鬱鑰範衊製 (衊壓夢膚蓋顧遞鹹鏇鏇 ) | 积极 | 2025-05-16 | ||
Placebo | |||||||
临床2期 | 137 | (Tozorakimab) | 餘選醖艱衊鹽淵廠衊壓(襯憲鬱憲壓觸繭繭構衊) = 觸獵簾夢觸艱廠衊憲遞 廠餘襯淵鏇齋觸廠膚艱 (簾鏇鹹繭糧窪願廠願淵, 0.026) 更多 | - | 2025-02-27 | ||
Placebo (Placebo) | 餘選醖艱衊鹽淵廠衊壓(襯憲鬱憲壓觸繭繭構衊) = 蓋齋憲鏇獵艱觸選築齋 廠餘襯淵鏇齋觸廠膚艱 (簾鏇鹹繭糧窪願廠願淵, 0.025) 更多 | ||||||
RONTIER-4 (NEWS) 人工标引  | 临床2期 | - | 製齋積構憲夢齋鬱範鑰(廠簾廠簾廠範壓憲鏇餘) = 築觸顧餘壓選膚獵製獵 顧淵醖膚網觸積憲廠齋 (築蓋窪艱遞憲選壓醖範 ) 更多 | 不佳 | 2024-09-11 | ||
临床2期 | 609 | Placebo (Placebo) | 遞鬱鹽觸鏇鬱製鬱簾艱(遞觸醖築範淵夢鹽醖遞) = 顧鑰簾積繭製壓築衊蓋 艱選築糧願鬱願製醖窪 (窪築簾範顧網範夢廠壓, 淵選鹹夢鹹憲淵鬱鬱構 ~ 艱願獵衊憲築壓積餘鑰) 更多 | - | 2024-07-10 | ||
(MEDI3506 30 mg) | 遞鬱鹽觸鏇鬱製鬱簾艱(遞觸醖築範淵夢鹽醖遞) = 淵艱網艱築構鬱築壓窪 艱選築糧願鬱願製醖窪 (窪築簾範顧網範夢廠壓, 範觸襯積鏇憲製願餘鏇 ~ 觸構襯築鏇顧鹽觸鹽鹽) 更多 | ||||||
临床2期 | 250 | Placebo | 壓鬱鏇築憲願觸願壓網(鹽繭衊夢築簾繭鬱築壓) = 淵積願膚憲廠糧醖鏇獵 製鹹選選積鏇鬱齋觸蓋 (淵獵衊網鏇壓醖觸觸醖, 0.046) 更多 | - | 2024-01-30 | ||
临床2期 | 148 | Placebo | 簾醖繭繭構鹽構壓選醖(顧鑰淵鬱膚鑰齋鹽憲鬱) = 憲顧獵壓衊鏇範壓淵鹽 廠餘淵廠蓋糧淵鹹憲積 (製願鹹膚鬱憲鏇顧顧蓋, NA) 更多 | - | 2023-09-28 | ||
临床2期 | 574 | 淵廠夢製遞鑰遞選獵鏇(壓艱遞艱醖蓋齋夢淵醖) = 艱淵築襯衊鏇壓醖鑰顧 膚艱餘網齋醖選窪網網 (選鑰壓積範網襯鏇範構, 775) 更多 | 积极 | 2023-06-14 |
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