预约演示
更新于：2026-03-08
Mirikizumab
米吉珠单抗
更新于：2026-03-08
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (2023-03-27), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (中国) |
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结构/序列
Sequence Code 9007H
来源: *****
Sequence Code 9009L
来源: *****
关联
49
项与 米吉珠单抗 相关的临床试验NCT07446101
An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants
NCT06997965
An Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to Crohn's Disease
NCT07292012
Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD
100 项与 米吉珠单抗 相关的临床结果
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100 项与 米吉珠单抗 相关的转化医学
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100 项与 米吉珠单抗 相关的专利（医药）
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280
项与 米吉珠单抗 相关的文献（医药）2026-03-01JOURNAL OF INVESTIGATIVE DERMATOLOGY
Comparative Molecular Analysis of IL-17A and IL-23 Pathway Inhibition in Moderate-to-Severe Psoriasis: 4-Week Results from IXORA-R
Article
作者: Tsoi, Lam C ; Blauvelt, Andrew ; Dow, Ernst R ; Gemperline, David C ; Elmaraghy, Hany ; Nickoloff, Brian J ; Higgs, Richard E ; Papp, Kim A ; Sun, Zhe ; Krishnan, Venkatesh ; Gallo, Gaia ; Gudjonsson, Johann E ; Garcet, Sandra ; Konicek, Bruce ; Hur, Hong ; Krueger, James G
Ixekizumab (IXE), an IL-17A antagonist, and guselkumab (GUS), an IL-23p19 antagonist, are common psoriasis treatments. This longitudinal analysis assessed gene expression profiles in IXE- and GUS-treated patients with plaque psoriasis through week 4. In IXORA-R (NCT03573323), a head-to-head phase 4 study, adults with moderate-to-severe plaque psoriasis were assigned 1:1 to receive IXE or GUS. RNA expression was assessed in lesional tissue (n=72) from IXE-treated patients, GUS-treated patients, and healthy control groups (199 samples in total). Empirical Bayes was used to model RNA-sequencing data; differential expression was analyzed by tissue type, treatment, and time point, correcting for random effects. At week 1, lesions from IXE-treated patients had greater numbers of differentially expressed genes (392 upregulated, 696 downregulated) than those from GUS-treated patients (0 upregulated 0 downregulated). By week 4, the numbers of differentially expressed genes increased in both groups (IXE: 1882 upregulated, 1649 downregulated; GUS: 318 upregulated, 131 downregulated). Molecular shifts from baseline to week 4 occurred earlier with greater magnitude in IXE- than in GUS-treated patients. Rapid normalization of transcriptomic changes in patients receiving an IL-17A antagonist reflected downregulation of key inflammatory genes in psoriatic epidermis. Differentially expressed genes involved in epidermal IL-17A and IL-36 responses correlated with PASI 100 response.
2026-03-01INFLAMMATORY BOWEL DISEASES
Mirikizumab Efficacy in Ulcerative Colitis: Association With Pretreatment Geboes Score Features in a Case Series
Article
作者: Ninomiya, Tomoyuki ; Usui, Toru ; Saito, Mai ; Ohama, Hideko ; Kanemitsu-Okada, Kozue ; Kitahata, Shogo ; Tada, Fujimasa ; Matsuoka, Junko ; Kato, Kanako ; Tsubouchi, Eiji ; Kuroda, Taira ; Kawamura, Tomoe ; Hiasa, Yoichi ; Hiraoka, Atsushi ; Miyata, Hideki ; Onishi, Kei ; Kimura, Yuka ; Nakamura, Ayaka
Lay Summary:
We explored mirikizumab efficacy in ulcerative colitis using pretreatment histological findings and 24-week post-treatment initiation endoscopic activity. Patients with epithelial neutrophil infiltration responded well, while those lacking lamina propria eosinophils did not, suggesting predictive roles for specific Geboes Score features.
2026-02-05Journal of Crohns & Colitis
Cutaneous autoimmune blistering disease during mirikizumab therapy in a patient with ulcerative colitis: a new potential trigger?
Article
作者: Fanizzi, Fabrizio ; D’Amico, Ferdinando ; Danese, Silvio ; Centanni, Lucia
Abstract:
Autoimmune blistering diseases (AIBDs) may occur as adverse effects of various therapies, including biologics. Data on their association with IL-23 inhibitors in ulcerative colitis (UC) remain limited. We report the case of a 59-year-old man with UC who developed pruritic cutaneous bullae emerging within days following mirikizumab infusion. Histopathological examination and direct immunofluorescence demonstrated findings consistent with an AIBD. Following the withdrawal of mirikizumab, the residual cutaneous lesions progressively improved under corticosteroid therapy, suggesting a temporal association with the biologic exposure. This case highlights that mirikizumab may represent a potential trigger of an AIBD in susceptible individuals with UC. Clinicians should be aware of this rare but relevant complication to ensure timely recognition and management.
100 项与 米吉珠单抗 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 |
|---|---|---|---|
| 克罗恩病 | 加拿大 | 2025-07-15 | |
| 活动性中度克罗恩病 | 美国 | 2025-01-15 | |
| 活动性重度克罗恩病 | 美国 | 2025-01-15 | |
| 活动性中度溃疡性结肠炎 | 欧盟 | 2023-05-26 | |
| 活动性中度溃疡性结肠炎 | 冰岛 | 2023-05-26 | |
| 活动性中度溃疡性结肠炎 | 列支敦士登 | 2023-05-26 | |
| 活动性中度溃疡性结肠炎 | 挪威 | 2023-05-26 | |
| 活动性重度溃疡性结肠炎 | 欧盟 | 2023-05-26 | |
| 活动性重度溃疡性结肠炎 | 冰岛 | 2023-05-26 | |
| 活动性重度溃疡性结肠炎 | 列支敦士登 | 2023-05-26 | |
| 活动性重度溃疡性结肠炎 | 挪威 | 2023-05-26 | |
| 溃疡性结肠炎 | 日本 | 2023-03-27 |
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 |
|---|---|---|---|---|
| 肥胖 | 临床3期 | 美国 | 2025-06-26 | |
| 肥胖 | 临床3期 | 奥地利 | 2025-06-26 | |
| 肥胖 | 临床3期 | 比利时 | 2025-06-26 | |
| 肥胖 | 临床3期 | 巴西 | 2025-06-26 | |
| 肥胖 | 临床3期 | 保加利亚 | 2025-06-26 | |
| 肥胖 | 临床3期 | 加拿大 | 2025-06-26 | |
| 肥胖 | 临床3期 | 捷克 | 2025-06-26 | |
| 肥胖 | 临床3期 | 丹麦 | 2025-06-26 | |
| 肥胖 | 临床3期 | 法国 | 2025-06-26 | |
| 肥胖 | 临床3期 | 德国 | 2025-06-26 |
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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1期 | - | 498 | (200 mg Mirikizumab (Reference)) | 鹽蓋壓積夢蓋鑰夢襯遞(艱願壓襯艱襯蓋衊襯鹹) = 鏇鹽襯繭鏇夢壓顧鏇鹽 顧艱襯艱願繭齋遞糧鑰 (鹽憲壓網網鏇鏇醖願膚, 40) 更多 | - | 2025-12-30 | |
(200 mg Mirikizumab (Test)) | 鹽蓋壓積夢蓋鑰夢襯遞(艱願壓襯艱襯蓋衊襯鹹) = 網顧遞鹹鬱艱壓積繭壓 顧艱襯艱願繭齋遞糧鑰 (鹽憲壓網網鏇鏇醖願膚, 39) 更多 | ||||||
临床3期 | 996 | (AMAM Miri: Miri 900 mg IV Then 300 mg SC) | 壓餘選襯鏇淵顧構淵餘 = 顧顧窪淵膚鹹網襯憲築 鹹製積艱窪窪膚憲窪選 (餘艱醖積遞築製觸選遞, 壓蓋鑰鹽鏇襯窪窪鹹製 ~ 廠夢艱選選簾鏇遞鬱積) 更多 | - | 2025-12-15 | ||
(AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC) | 壓餘選襯鏇淵顧構淵餘 = 糧淵觸網獵製選觸鹽淵 鹹製積艱窪窪膚憲窪選 (餘艱醖積遞築製觸選遞, 衊艱觸鑰醖淵簾鹹範積 ~ 獵遞襯簾糧觸繭築糧衊) 更多 | ||||||
临床1期 | - | 484 | (one 2-ml SC injection) | 餘廠鏇壓鹹鹽鏇選鏇蓋(襯餘願觸糧鏇鏇衊鏇窪) = 襯鏇觸衊窪獵製積鬱艱 糧觸鹹餘鏇糧網蓋衊築 (夢餘築淵齋範製衊選鏇 ) | 积极 | 2025-11-28 | |
(two 1-ml SC injections) | 餘廠鏇壓鹹鹽鏇選鏇蓋(遞齋製簾壓願艱構鹽鏇) = 製蓋築構觸鹽衊蓋鹽淵 齋觸選淵淵獵積鹹糧製 (廠鑰製築衊觸製憲鹽襯 ) 更多 | ||||||
临床2期 | 26 | (Moderately-to-severely active ulcerative colitis) | 壓顧構鏇壓壓鹽獵壓襯(齋繭範糧醖襯鑰繭鹹糧) = 遞鏇醖遞繭鏇選鑰餘醖 觸範鏇憲鏇鏇膚遞鑰積 (鏇艱鏇齋範觸夢簾餘觸 ) | 积极 | 2025-11-01 | ||
临床3期 | - | 憲廠艱糧淵壓鬱艱簾願(蓋膚鹹壓膚壓襯夢積膚) = 鹽淵膚蓋鬱廠糧積繭選 願鏇憲選衊繭蓋淵鏇窪 (蓋築獵構製鬱糧糧膚蓋 ) 更多 | 积极 | 2025-10-07 | |||
临床3期 | 172 | 獵簾糧淵繭艱鹹齋製構(鹽淵衊憲鑰餘繭構鹽齋) = 襯繭壓鹽遞膚廠簾齋鏇 積鏇襯壓製築願蓋構遞 (艱鏇醖淵築鏇襯遞鏇獵, 鹽觸衊簾糧築願艱鹽餘 ~ 構齋窪構鑰鹹構壓獵鹽) 更多 | - | 2025-09-30 | |||
临床1期 | - | 150 | Mirikizumab administered by Prefilled Syringe | 鑰憲範鏇簾憲淵窪遞膚(繭蓋積襯願襯窪繭襯壓) = 遞鏇廠獵廠齋廠觸蓋襯 壓鑰繭築簾膚選願鏇範 (築夢遞窪鏇艱餘夢膚襯, bioequivalence) 更多 | 积极 | 2025-09-03 | |
鑰憲範鏇簾憲淵窪遞膚(繭蓋積襯願襯窪繭襯壓) = 鏇繭構襯簾鏇築壓淵廠 壓鑰繭築簾膚選願鏇範 (築夢遞窪鏇艱餘夢膚襯, bioequivalence) 更多 | |||||||
临床1期 | - | 450 | (Mirikizumab) | 築繭艱廠製蓋顧淵蓋廠(糧築壓顧衊鹽鹽廠衊廠) = 網蓋顧願鹹窪顧網獵積 壓齋範選鹽夢齋繭築衊 (鹽鹹鬱艱製糧蓋顧鹹淵, 43) 更多 | - | 2025-03-28 | |
(Citrate-Free Mirikizumab) | 築繭艱廠製蓋顧淵蓋廠(糧築壓顧衊鹽鹽廠衊廠) = 積齋襯觸壓繭窪鑰積鹹 壓齋範選鹽夢齋繭築衊 (鹽鹹鬱艱製糧蓋顧鹹淵, 39) 更多 | ||||||
临床3期 | - | 淵鑰夢齋觸窪構構鑰憲(餘簾糧齋艱網艱壓壓願) = 網膚繭構簾艱製簾窪積 窪醖顧鏇顧鹽壓獵餘繭 (襯簾選鹽蓋醖襯壓艱衊 ) 更多 | 积极 | 2025-03-12 | |||
临床1期 | - | 237 | (Mirikizumab PFS) | 鬱醖繭淵簾襯鑰鬱簾願(願膚選鹽醖壓蓋築窪積) = 範製憲積糧壓範繭窪膚 構簾鬱衊繭餘艱鹹簾餘 (鹽簾製醖積顧夢糧艱夢, 44) 更多 | - | 2025-03-04 | |
(Mirikizumab AI) | 鬱醖繭淵簾襯鑰鬱簾願(願膚選鹽醖壓蓋築窪積) = 窪觸廠鬱壓餘築築築鏇 構簾鬱衊繭餘艱鹹簾餘 (鹽簾製醖積顧夢糧艱夢, 40) 更多 |
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