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更新于：2026-10-22
Momelotinib Dihydrochloride
莫莫替尼
更新于：2026-10-22
概要
基本信息
药物类型 小分子化药 |
别名 Momelotinib、Momelotinib dihydrochloride (USAN)、Momelotinib dihydrochloride monohydrate + [11] |
作用方式 抑制剂 |
作用机制 ALK2抑制剂(激活素受体-1抑制剂)、JAK1抑制剂(酪氨酸蛋白激酶JAK1抑制剂)、JAK2抑制剂(酪氨酸蛋白激酶JAK2抑制剂) |
在研适应症 |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2023-09-15), |
最高研发阶段(中国)临床申请 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (韩国)、孤儿药 (澳大利亚) |
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结构/序列
分子式C23H26Cl2N6O3 |
InChIKeyRQKCPSIFARJBOR-UHFFFAOYSA-N |
CAS号1841094-17-4 |
关联
30
项与 莫莫替尼 相关的临床试验NCT07734077
Phase Ib/II Study Of Revumenib As Monotherapy Or In Combination With Jak Inhibitors In Patients With Myelofibrosis
ISRCTN98283910
Study to assess the safety and efficacy of bomedemstat (IMG-7289) in combination with momelotinib in patients with myelofibrosis
NCT07498205
A Randomized Open Label Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib For Treatment-Naive, Cytopenic Myelofibrosis
100 项与 莫莫替尼 相关的临床结果
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100 项与 莫莫替尼 相关的转化医学
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100 项与 莫莫替尼 相关的专利（医药）
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412
项与 莫莫替尼 相关的文献（医药）2026-12-01LEUKEMIA RESEARCH
Momelotinib induces hemoglobin improvement and symptom control in PCM1::JAK2-associated myeloid neoplasm
Letter
作者: Pelz, Antje-Friederike ; Zeremski, Vanja ; Mougiakakos, Dimitrios ; Fischer, Thomas ; Haage, Tobias Ronny
2026-11-01CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
Reassessing the clinical value of momelotinib in myelofibrosis: An ESMO-MCBS:H–based appraisal of SIMPLIFY-1 and MOMENTUM
Review
作者: Klein, S K ; Wever, S A L ; Ammatuna, E ; Van Rijn, R ; Hoogendoorn, M ; Oortgiesen, B E
Myelofibrosis (MF) is a chronic myeloproliferative neoplasm characterized by splenomegaly, systemic symptoms, and anemia, the latter being strongly associated with poor survival and reduced quality of life. Current Janus kinase (JAK) inhibitors improve symptoms and spleen size but often exacerbate anemia, leaving a significant unmet clinical need. Momelotinib, a JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor, has been proposed to address both splenomegaly and anemia through hepcidin suppression. This study critically evaluates the clinical benefit of momelotinib using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale for Hematological Malignancies (ESMO-MCBS:H), focusing on the phase 3 trials SIMPLIFY-1 and MOMENTUM. In SIMPLIFY-1, momelotinib demonstrated non-inferiority to ruxolitinib in terms of spleen volume reduction (SVR35 26.5% vs 29.0%) and did not evaluated quality of life as a prespecified outcome, resulting in an ESMO-MCBS:H score indicating no evaluable benefit (NEB). In contrast, in MOMENTUM, conducted in symptomatic, anemic patients previously treated with JAK inhibitors, momelotinib was superior to danazol for MFSAF total symptom score response (≥50% reduction from baseline 25% vs 9%). As no improvement in global health status was observed, MOMENTUM was scored as Grade 1. Interpretation of hematologic benefits remains limited by trial design, as the anemia related outcomes were not primary endpoints and studies were not powered to robustly assess them. Furthermore, the negative SIMPLIFY-2 trial underscores uncertainty in pretreated populations. In conclusion, momelotinib demonstrates a differentiated clinical profile with consistent spleen control and potential hematologic benefits, particularly in anemic patients. However, superiority over other improved JAK inhibitors has not been demonstrated in the pivotal phase 3 trials evaluated. Future trials incorporating anemia-focused primary endpoints and biomarker stratification are warranted to better define its role in myelofibrosis management.
2026-11-01EUROPEAN JOURNAL OF HAEMATOLOGY
Impact of Hemoglobin Improvement on Survival in Patients With Myelofibrosis and Anemia Treated With Momelotinib in the
SIMPLIFY
‐1 and
MOMENTUM
Trials
Article
作者: Hernandez‐Boluda, Juan Carlos ; O'Connell, Casey ; Palandri, Francesca ; Lim, Jessica ; Zhang, Shiyuan ; Ellis, Catherine ; Sahni, Jasmine ; Shimoda, Kazuya ; Gupta, Vikas ; Koschmieder, Steffen ; Vachhani, Pankit ; McLornan, Donal P.
ABSTRACT:
Objectives:
These post hoc analyses of 2 phase 3 myelofibrosis trials assessed the kinetics and prognostic value of achieving hemoglobin ≥ 10 g/dL with momelotinib.
Methods:
Median (range) time to hemoglobin ≥ 10 g/dL was assessed in momelotinib‐randomized patients with baseline hemoglobin < 10 g/dL in the SIMPLIFY‐1 (JAK inhibitor naive) and MOMENTUM (JAK inhibitor experienced) trials. Survival from treatment initiation was evaluated via Kaplan–Meier curves and Cox models.
Results:
In SIMPLIFY‐1, 54/86 patients (63%) achieved hemoglobin ≥ 10 g/dL by week 24: moderate anemia, 40/58 (69%), 0.6 (0.4–5.1) months; severe anemia, 14/28 (50%), 1.4 (0.5–4.7) months. In MOMENTUM, 45/126 patients (36%) achieved hemoglobin ≥ 10 g/dL by week 24: moderate anemia, 30/64 (47%), 0.5 (0.3–4.6) months; severe anemia, 15/62 (24%), 0.5 (0.5–5.6) months. Achieving hemoglobin ≥ 10 g/dL by week 24 was numerically associated with longer survival: SIMPLIFY‐1 HR, 0.53 (95% CI, 0.27–1.05); MOMENTUM HR, 0.62 (95% CI, 0.33–1.15). In multivariate analysis, only week 24 transfusion independence was associated with survival.
Conclusions:
Achievement of hemoglobin ≥ 10 g/dL may be a clinically meaningful target in momelotinib‐treated patients with myelofibrosis and anemia. Those without JAK inhibitor experience and/or with moderate anemia were more likely and faster to achieve this threshold, supporting earlier momelotinib initiation to optimize outcomes.
100 项与 莫莫替尼 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 |
|---|---|---|---|
| 原发性血小板增多症后骨髓纤维化 | 加拿大 | 2024-11-12 | |
| 真性红细胞增多症后骨髓纤维化 | 加拿大 | 2024-11-12 | |
| 原发性骨髓纤维化 | 加拿大 | 2024-11-12 | |
| 贫血 | 英国 | 2024-01-30 | |
| 骨髓病性贫血 | 欧盟 | 2024-01-25 | |
| 骨髓病性贫血 | 冰岛 | 2024-01-25 | |
| 骨髓病性贫血 | 列支敦士登 | 2024-01-25 | |
| 骨髓病性贫血 | 挪威 | 2024-01-25 | |
| 脾肿大 | 欧盟 | 2024-01-25 | |
| 脾肿大 | 冰岛 | 2024-01-25 | |
| 脾肿大 | 列支敦士登 | 2024-01-25 | |
| 脾肿大 | 挪威 | 2024-01-25 | |
| 骨髓纤维化 | 美国 | 2023-09-15 |
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 |
|---|---|---|---|---|
| VEXAS 综合征 | 临床3期 | - | 2026-08-05 | |
| 血小板减少症 | 临床3期 | 美国 | 2014-06-19 | |
| 血小板减少症 | 临床3期 | 加拿大 | 2014-06-19 | |
| 血小板减少症 | 临床3期 | 法国 | 2014-06-19 | |
| 血小板减少症 | 临床3期 | 德国 | 2014-06-19 | |
| 血小板减少症 | 临床3期 | 以色列 | 2014-06-19 | |
| 血小板减少症 | 临床3期 | 意大利 | 2014-06-19 | |
| 血小板减少症 | 临床3期 | 西班牙 | 2014-06-19 | |
| 血小板减少症 | 临床3期 | 英国 | 2014-06-19 | |
| 转移性胰腺导管腺癌 | 临床3期 | 美国 | 2014-06-02 |
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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
N/A | 6 | 淵餘衊製鑰鹽憲襯糧鹹(顧衊糧遞醖願蓋遞築構) = 鹽簾蓋餘齋淵鬱構糧鹹 夢製鏇齋廠鬱廠夢積醖 (範觸齋衊遞衊範製獵築, 6.25 ~ 43.8) 更多 | 积极 | 2026-11-06 | |||
N/A | 31 | 夢積積齋鑰衊艱鏇糧獵(襯廠鏇獵艱餘選糧構淵) = 獵襯鏇蓋艱襯顧願築齋 鹹憲壓夢積鹽窪簾簾鏇 (壓憲壓簾製遞醖積鹹鹽 ) 更多 | 积极 | 2026-05-12 | |||
N/A | 77 | (JAKi naive) | 構膚憲鹽艱願築選齋鏇(構淵廠構淵鹽壓繭壓顧) = 範齋糧餘糧築鬱憲築蓋 築憲淵鏇衊膚蓋築鹽積 (獵糧範顧夢鏇鏇鏇鏇鏇, 1.1 ~ 2.1) 更多 | 积极 | 2026-05-12 | ||
(JAKi experienced) | 構膚憲鹽艱願築選齋鏇(構淵廠構淵鹽壓繭壓顧) = 鹹網襯鑰襯選齋築蓋襯 築憲淵鏇衊膚蓋築鹽積 (獵糧範顧夢鏇鏇鏇鏇鏇, 0.6 ~ 2.1) 更多 | ||||||
N/A | 10 | 範鑰鑰膚獵鏇遞觸遞鹹(艱顧夢鬱積廠願鹹憲膚) = 構顧鹹鹹網鬱積膚齋淵 淵願積衊鏇艱觸淵廠襯 (製齋壓簾醖構蓋築蓋壓 ) 更多 | 积极 | 2026-05-12 | |||
N/A | 23 | 憲艱蓋範範鏇遞窪餘鏇(遞簾糧廠鬱餘衊製築蓋) = 獵淵觸艱簾顧範壓築憲 襯夢鏇製蓋選糧膚製齋 (壓鹽繭壓顧憲壓膚範觸 ) 更多 | 积极 | 2026-05-12 | |||
临床3期 | - | 345 | (SIMPLIFY-1(int-1-risk)) | 繭艱簾遞糧顧築網鹽憲(壓廠餘顧鏇糧艱憲餘齋) = 醖醖獵遞膚齋觸鹽選襯 齋構簾鬱餘觸醖鑰餘鬱 (襯壓繭齋膚鏇願顧窪顧 ) 更多 | 积极 | 2026-05-12 | |
(SIMPLIFY-1(int-2-/high-risk)) | 繭艱簾遞糧顧築網鹽憲(壓廠餘顧鏇糧艱憲餘齋) = 繭憲餘遞積襯願顧遞醖 齋構簾鬱餘觸醖鑰餘鬱 (襯壓繭齋膚鏇願顧窪顧 ) 更多 | ||||||
N/A | 6 | 簾夢築製襯襯選醖觸艱(構淵窪淵顧積範蓋獵醖) = 顧範蓋衊艱衊夢醖艱壓 顧蓋繭淵製襯網願簾鏇 (壓膚簾選襯艱鹹顧鹽網, 8 ~ 27.6) 更多 | 积极 | 2026-05-12 | |||
N/A | 29 | 憲壓鏇選鏇鹹繭積齋製(網簾獵鏇餘衊願鏇壓觸) = 衊築衊鑰鏇鏇窪衊鏇鹽 網範糧膚遞觸鑰壓廠糧 (醖鹹積範鑰選蓋願鏇積 ) 更多 | 积极 | 2026-05-12 | |||
(JAKi-naive) | 憲壓鏇選鏇鹹繭積齋製(網簾獵鏇餘衊願鏇壓觸) = 範齋鏇鹽築衊廠醖艱繭 網範糧膚遞觸鑰壓廠糧 (醖鹹積範鑰選蓋願鏇積 ) 更多 | ||||||
临床1/2期 | 伴有 FLT3/ITD 突变的急性髓系白血病 FLT3-MUTATED | 13 | 製襯網築積繭築鏇鏇網(構廠遞窪淵夢構獵壓獵) = not observed at any dose level 醖積夢餘簾觸憲齋淵夢 (遞鬱網窪鹹繭窪獵鑰顧 ) 更多 | 积极 | 2026-05-12 | ||
N/A | 236 | 憲鬱憲膚齋夢醖糧鹽鹽(糧鹹糧獵膚積願淵構餘) = The proportion of PAC vs MOM-treated pts discontinuing therapy at 3, 6, and 12 mo was 26% vs 17%, 52% vs 29%, and 70% vs 42%, respectively. 窪鬱鏇鑰醖窪範鹹齋顧 (憲範鹽範憲廠鹽襯淵獵 ) | 积极 | 2025-12-06 | |||
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