预约演示
更新于：2026-01-28
Mirikizumab
米吉珠单抗
更新于：2026-01-28
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)申请上市 |
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
47
项与 米吉珠单抗 相关的临床试验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
NCT07235904
Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis: A 52-week, Multicenter, Open-label, Randomized Controlled Trial
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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288
项与 米吉珠单抗 相关的文献（医药）2026-02-01Lancet Gastroenterology & Hepatology
Efficacy and safety of mirikizumab in paediatric participants with moderately-to-severely active ulcerative colitis (SHINE-1): a multicentre, open-label, non-randomised phase 2 trial
Article
作者: Turner, Dan ; Kaplan, Jess L ; Bousvaros, Athos ; Dubinsky, Marla ; Komocsar, Wendy J ; Otani, Yuki ; Johns, Jordan ; Hyams, Jeffrey S ; Larkin, Amy ; Crandall, Wallace
BACKGROUND:
Mirikizumab, a humanised immunoglobulin G4 monoclonal antibody, targets the p19 subunit of IL-23, with demonstrated efficacy and safety in adults with ulcerative colitis and Crohn's disease. This study evaluated the pharmacokinetics, efficacy, and safety of mirikizumab in paediatric participants with moderately-to-severely active ulcerative colitis.
METHODS:
This 52-week, multicentre, open-label, non-randomised, phase 2 study enrolled paediatric participants (2 to <18 years) with moderately-to-severely active ulcerative colitis with inadequate or loss of response or intolerance to corticosteroids, immunomodulators, biologics, or JAK inhibitors from 19 centres in Canada, Israel, Japan, South Korea, and the USA. Participants received induction doses of intravenous mirikizumab 5 mg/kg or 10 mg/kg (for bodyweight ≤40 kg) or 300 mg (bodyweight >40 kg) at weeks 0, 4, and 8. Clinical response was determined by the modified Mayo score (mMS). Responders at week 12 entered the maintenance period and received subcutaneous doses of mirikizumab 50 mg (bodyweight ≤20 kg), 100 mg (bodyweight >20 to ≤40 kg), or 200 mg (bodyweight >40 kg) every 4 weeks through week 48. Non-responders at week 12 received three additional intravenous induction doses (10 mg/kg [bodyweight ≤40 kg] or 300 mg [bodyweight >40 kg] every 4 weeks), before continuing to subcutaneous maintenance dosing. Here we present the secondary outcomes of safety and efficacy; pharmacokinetics (primary endpoint) data have been reported previously. The modified intention-to-treat and safety populations included participants who received at least one dose of treatment, regardless of adherence to the protocol or treatment. This study is registered with ClinicalTrials.gov, NCT04004611.
FINDINGS:
26 participants were enrolled between May 18, 2020, and March 15, 2023; mean age was 11·8 years (SD 3·4) and mean weight was 40·5 kg (SD 16·0). 15 (58%) participants were female and 11 (42%) were male. At week 12, 18 (69·2%, 95% CI 50·0-83·5) participants had a clinical response by mMS, ten (38·5%, 95% CI 22·4-57·5) achieved clinical remission by mMS, 14 (53·8%, 95% CI 35·5-71·2) achieved endoscopic remission, four (15·4%, 6·2-33·5) had histologic-endoscopic mucosal improvement (HEMI), one (3·8%, 0·7-18·9) had histologic-endoscopic mucosal remission (HEMR), and 12 (46·2%, 28·8-64·5) achieved symptomatic remission. When assessed by Pediatric Ulcerative Colitis Activity Index (PUCAI), 20 (76·9%, 57·9-89·0) of the 26 participants had a clinical response, and ten (38·5%, 22·4-57·5) achieved clinical remission at week 12. At week 52, 14 (53·8%, 35·5-71·2) of 26 participants achieved mMS-based clinical response, ten (38·5%, 22·4-57·5) were in mMS-based clinical remission, 14 (53·8%, 35·5-71·2) had a PUCAI-based clinical response and 13 (50·0%, 32·1-67·9) were in PUCAI-based clinical remission. At week 52, ten (38·5%, 95% CI 22·4-57·5) of 26 patients were in endoscopic remission, nine (34·6%, 19·4-53·8) had HEMI, nine (34·6%, 19·4-53·8) had HEMR, and 12 (46·2%, 28·8-64·5) were in symptomatic remission. At week 52, ten (38·5%, 95% CI 22·4-57·5) of the 26 participants had achieved clinical remission without corticosteroid use or ulcerative colitis-related surgery for at least 12 weeks leading up to week 52. Three (12%) participants experienced serious adverse events across induction and maintenance periods (non-infective appendicitis, worsening of ulcerative colitis, and pseudarthrosis), of which one (4%; worsening of ulcerative colitis) led to study discontinuation. The most common adverse events were COVID-19 (in six [23%] of 26 participants); injection site pain (six [23%]); headache (five [19%]); pyrexia (four [15%]); and viral upper respiratory tract infection (four [15%]).
INTERPRETATION:
Mirikizumab exhibited safety and efficacy in paediatric participants with moderately-to-severely active ulcerative colitis. These results support further evaluation of mirikizumab in the paediatric population.
FUNDING:
Eli Lilly and Company.
2026-02-01Clinical Gastroenterology and Hepatology
Bowel Urgency in Crohn’s Disease: Effects of Mirikizumab in a Randomized Controlled Phase 3 Study
Article
作者: Travis, Simon ; Protic, Marijana ; Jairath, Vipul ; Sands, Bruce E ; D'Haens, Geert ; Dubinsky, Marla ; Appelmans, Saskia ; Chen, Min-Hu ; Lin, Zhantao ; Schreiber, Stefan ; Ferrante, Marc ; Vadhariya, Aisha ; McGinnis, Kim ; Ghosh, Subrata ; Chaparro, María ; Peyrin-Biroulet, Laurent ; Yu, Guanglei ; Moses, Richard
BACKGROUND & AIMS:
Bowel urgency (BU) is an underrecognized and debilitating symptom of Crohn's disease. Mirikizumab, an interleukin-23p19 inhibitor, is efficacious for BU resolution in ulcerative colitis. We evaluated the efficacy of mirikizumab in achieving early BU response and remission among participants with Crohn's disease enrolled in the phase 3 VIVID-1 study. The associations of disease characteristics with baseline BU and BU resolution were explored.
METHODS:
Adult participants were randomized to receive mirikizumab or placebo. BU was assessed using the Urgency Numeric Rating Scale (NRS) (range 0-10) at baseline, and every 4 weeks. The proportion of participants with baseline Urgency NRS ≥3 and ≥6 who achieved BU clinically meaningful improvement (CMI) (≥3 change in Urgency NRS) and BU remission (Urgency NRS ≤2) was calculated, and associations of BU CMI and BU remission with clinical outcomes were assessed.
RESULTS:
At baseline, 94.2% of participants had an Urgency NRS score ≥3. BU positively correlated with the Crohn's Disease Activity Index and abdominal pain. Improvement in BU from baseline was significantly greater in mirikizumab-treated participants as early as week 6 and sustained to week 52 vs patients receiving placebo. Participants treated with mirikizumab achieved significantly higher rates of BU CMI and BU remission at weeks 12 and 52 vs placebo. Mirikizumab-treated participants who achieved BU CMI at week 12 had better clinical and endoscopic outcomes at weeks 12 and 52.
CONCLUSIONS:
Mirikizumab-treated participants achieved significantly higher rates of BU CMI and remission at weeks 12 and 52, which was associated with better short- and longer-term clinical outcomes.
CLINICALTRIALS:
gov, Number: NCT03926130.
2026-02-01CURRENT OPINION IN PHARMACOLOGY
Beyond tumor necrosis factor and interleukin-12/23: The rise of interleukin-23 inhibitors in inflammatory bowel disease management
Review
作者: Estevinho, Maria Manuela ; Costa, Catarina ; Noor, Nurulamin M
Interleukin-23 (IL-23) has been identified as a key driver of chronic intestinal inflammation and treatment resistance, particularly in patients who have failed anti-tumor necrosis factor (TNF) therapy. Genetic studies and preclinical models have confirmed IL-23's pivotal role in promoting both innate and adaptive immune responses in the gut. This review examines the biology of IL-23 and the evidence supporting its targeting in inflammatory bowel disease (IBD). Clinical trials of IL-23p19 inhibitors-such as risankizumab, mirikizumab, and guselkumab-have shown promising results in patients with moderate-to-severe Crohn's disease and ulcerative colitis, with improvements in clinical and endoscopic outcomes and favorable safety profiles. Recent real-world data further support their effectiveness, including in treatment-experienced populations. With regulatory approvals expanding in both the United States and Europe, IL-23 inhibitors are now firmly established as a part of the IBD treatment landscape. Looking ahead, efforts are underway to identify biomarkers of response and to explore oral IL-23 inhibitors, with the goal of advancing more personalized and accessible care.
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
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临床1期 | - | 498 | (200 mg Mirikizumab (Reference)) | 襯糧壓範繭襯鏇淵窪鏇(糧構膚鹽廠齋窪衊製鹽) = 顧壓鑰醖製餘鑰壓獵壓 簾餘鬱積衊壓鑰艱鹽艱 (獵衊齋廠構製鏇糧糧鬱, 40) 更多 | - | 2025-12-30 | |
(200 mg Mirikizumab (Test)) | 襯糧壓範繭襯鏇淵窪鏇(糧構膚鹽廠齋窪衊製鹽) = 製糧繭齋構範選構鏇顧 簾餘鬱積衊壓鑰艱鹽艱 (獵衊齋廠構製鏇糧糧鬱, 39) 更多 | ||||||
临床3期 | 996 | (AMAM Miri: Miri 900 mg IV Then 300 mg SC) | 築繭窪製衊選範顧糧壓 = 簾積範鬱築獵積壓憲範 夢選膚糧壓範廠遞夢夢 (網願築簾鹽獵艱窪淵獵, 範齋餘廠範餘獵選築願 ~ 繭繭積鑰壓簾範選膚網) 更多 | - | 2025-12-15 | ||
(AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC) | 築繭窪製衊選範顧糧壓 = 獵壓顧鑰夢積築壓遞製 夢選膚糧壓範廠遞夢夢 (網願築簾鹽獵艱窪淵獵, 壓窪遞鏇積構鹹醖願簾 ~ 艱鹽選夢構蓋顧獵顧襯) 更多 | ||||||
临床1期 | - | 484 | (one 2-ml SC injection) | 鬱壓觸襯製觸簾繭膚衊(網衊淵蓋餘壓餘淵蓋繭) = 繭積淵夢繭簾願顧顧齋 獵鏇蓋選觸廠製衊簾壓 (觸餘艱簾壓齋構鬱獵顧 ) | 积极 | 2025-11-28 | |
(two 1-ml SC injections) | 鬱壓觸襯製觸簾繭膚衊(餘艱窪鹽餘選願壓壓廠) = 鏇糧積襯齋壓觸範築築 鏇壓憲醖膚窪壓夢淵糧 (艱淵鹽鹹積觸鹽壓鹽廠 ) 更多 | ||||||
临床2期 | 26 | (Moderately-to-severely active ulcerative colitis) | 繭積範憲觸憲網願壓鬱(襯餘鹹鹹醖積醖淵積淵) = 蓋壓夢鏇遞獵遞壓製觸 襯觸鹹襯繭構餘遞鬱遞 (製鹹壓衊鑰蓋選壓遞鹹 ) | 积极 | 2025-11-01 | ||
临床3期 | - | 獵糧製獵鹹憲繭鏇夢夢(鹽醖鏇遞壓鬱淵製蓋範) = 壓糧繭鑰壓廠蓋淵網窪 齋膚夢膚壓鹽獵鹽鬱製 (衊積簾築鹹壓構襯製餘 ) 更多 | 积极 | 2025-10-07 | |||
临床3期 | 172 | 糧廠醖襯遞膚獵糧餘膚(獵憲憲醖遞廠淵獵餘鹽) = 夢憲築蓋積鏇鏇鹽鏇製 願獵鑰襯積鹽網簾遞選 (獵淵顧網遞壓淵顧構糧, 獵夢餘鏇衊構淵衊膚衊 ~ 顧醖簾積鏇鏇鏇願簾淵) 更多 | - | 2025-09-30 | |||
临床1期 | - | 150 | Mirikizumab administered by Prefilled Syringe | 襯艱窪積壓選艱艱鹹選(廠範蓋衊獵鹹憲積齋獵) = 窪衊齋網憲選製顧淵鬱 壓遞製艱製膚顧鑰鏇淵 (獵構淵淵鏇壓繭顧範憲, bioequivalence) 更多 | 积极 | 2025-09-03 | |
襯艱窪積壓選艱艱鹹選(廠範蓋衊獵鹹憲積齋獵) = 製蓋顧憲糧製壓繭醖製 壓遞製艱製膚顧鑰鏇淵 (獵構淵淵鏇壓繭顧範憲, bioequivalence) 更多 | |||||||
临床1期 | - | 450 | (Mirikizumab) | 網衊壓壓憲簾範範鬱襯(範製鏇積願顧構蓋鹽獵) = 齋選餘簾構襯鑰鬱齋衊 繭艱醖鹹範遞鹽構艱齋 (夢壓築糧簾衊廠範顧遞, 43) 更多 | - | 2025-03-28 | |
(Citrate-Free Mirikizumab) | 網衊壓壓憲簾範範鬱襯(範製鏇積願顧構蓋鹽獵) = 簾衊鏇願遞蓋餘齋膚鬱 繭艱醖鹹範遞鹽構艱齋 (夢壓築糧簾衊廠範顧遞, 39) 更多 | ||||||
临床3期 | - | 網衊餘艱積憲製簾範觸(艱網獵餘鹹鏇遞顧顧淵) = 衊夢繭憲遞齋廠膚願鏇 壓夢鹹窪齋膚醖網願醖 (齋網積簾製繭鹹鹹蓋築 ) 更多 | 积极 | 2025-03-12 | |||
临床1期 | - | 237 | (Mirikizumab PFS) | 構淵鏇觸醖網窪鬱壓簾(鬱鏇齋衊夢獵簾膚觸鹽) = 構廠夢網襯糧淵鹽願築 夢醖廠壓構願築簾鹹衊 (鏇醖廠獵鹽餘艱壓選選, 44) 更多 | - | 2025-03-04 | |
(Mirikizumab AI) | 構淵鏇觸醖網窪鬱壓簾(鬱鏇齋衊夢獵簾膚觸鹽) = 鹽願鹹壓繭壓鬱鏇簾選 夢醖廠壓構願築簾鹹衊 (鏇醖廠獵鹽餘艱壓選選, 40) 更多 |
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