Mirdametinib(Mirdametinib) - 药物靶点：MEK1 x MEK2_在研适应症：神经纤维瘤病1型，NF1突变型丛状神经纤维瘤，晚期恶性实体瘤_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Mirdametinib (USAN)、PD 901、PD-0325901

+ [2]

靶点

MEK1 x MEK2

作用机制

MEK1抑制剂(双特异性丝裂原活化蛋白激酶激酶1抑制剂)、MEK2抑制剂(双特异性丝裂原活化蛋白激酶激酶2抑制剂)

治疗领域

肿瘤神经系统疾病遗传病与畸形+ [2]

在研适应症

神经纤维瘤病1型NF1突变型丛状神经纤维瘤晚期恶性实体瘤+ [2]

非在研适应症

晚期乳腺癌晚期癌症晚期非小细胞肺癌+ [4]

原研机构

Springworks Therapeutics, Inc.

在研机构

Springworks Therapeutics, Inc.

BeiGene Ltd.

非在研机构

Pfizer Inc.

最高研发阶段批准上市

首次获批日期

美国 (2025-02-11),

神经纤维瘤病1型

最高研发阶段(中国)-

特殊审评优先审评 (美国)、快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、罕见儿科疾病 (美国)

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结构/序列

分子式C16H14F3IN2O4

InChIKeySUDAHWBOROXANE-SECBINFHSA-N

CAS号391210-10-9

关联

20

项与 Mirdametinib 相关的临床试验

NCT06666348

/ Not yet recruiting临床1/2期

A Phase 1/2 Study of Mirdametinib and Vinblastine for Newly Diagnosed or Previously Untreated Patients With Pediatric Low-grade Glioma and Activation of the MAPK Pathway

This is a 3-part open-label study (feasibility phase, treatment phase and follow-up phase) of orally administered mirdametinib in combination with intravenous vinblastine chemotherapy in patients with PLGG with activation of MAPK pathway.
Feasibility Phase:
The maximum tolerated/recommended phase 2 dose (MTD/RP2D) of the mirdametinib plus vinblastine combination will be assessed using a modified Rolling-6 design.
Treatment Phase:
Patients will receive mirdametinib twice daily (continuously) at a fixed dose (2mg/m2 po BID up to 4 mg BID) for a total of 13 cycles (28 days cycle). Weekly intravenous vinblastine at MTD will be given for a total of 17 cycles. If adverse events occur, two dose reductions are allowed.
Follow-up Phase:
Following the end of treatment, patients will be scheduled for a follow-up visit every 6 months for 36 months to evaluate PFS, TTP and OS.

开始日期2025-04-01

申办/合作机构

C17 Council

NCT06693284

/ Recruiting早期临床1期IIT

A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST]

This is a single center Phase 0 "window of opportunity" trial for the treatment of newly diagnosed, PRC2 deficient, primary malignant peripheral nerve sheath tumors (MPNSTs) with a short course of the combination of mirdametinib and vorinostat prior to the most appropriate standard of care treatment for their specific tumor (typically localized radiation followed by surgical resection). Four to eight patients, 12 years of age or older and meeting the study's biomarker inclusion criteria, would be enrolled onto this trial. After voluntary written consent (assent with parent consent for minors) the patient undergoes MRI and PET imaging of the tumor and a needle biopsy to collect tumor is performed. Patients with histone H3K27 trimethylation deficient MPNST, as confirmed by immunohistochemistry, receive a single 28-day course of mirdametinib and vorinostat at standard oral dosing for each. At day 26, 27, or 28 the patient returns to clinic for a research visit repeating the baseline MRI and PET imaging and the needle biopsy for tumor tissue.
This ends direct study participation. The patient goes on to the most appropriate standard of care treatment for their MPNST. Information about the subsequent standard of care treatment is collected for the purposes of this study.

开始日期2024-12-01

申办/合作机构

University of Minnesota

NCT05983159

/ Recruiting临床2期

A Modular Open Label, Signal Seeking, Phase II Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations (TARGET-VM)

Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways. Targeted drugs specific to these pathways have been developed and shown to be effective in treating cancer. This study will describe the effectiveness of (i) 48 weeks of alpelisib therapy for participants with slow-flow vascular malformations and a gene mutation in one of these signalling pathways (module 1) and (ii) 48 weeks of mirdametinib therapy for participants with fast-flow vascular malformations and a gene mutations in the other signalling pathway (module 2).

开始日期2024-09-13

申办/合作机构

Murdoch Childrens Research Institute

[+2]

100 项与 Mirdametinib 相关的临床结果

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100 项与 Mirdametinib 相关的转化医学

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100 项与 Mirdametinib 相关的专利（医药）

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963

项与 Mirdametinib 相关的文献（医药）

2025-04-01·THERIOGENOLOGY

Expression of the glucose transporter 1 is associated with increased glucose uptake by granulosa cells during ovulation in mice

Article

作者: Neeraj, Neeraj ; Siddappa, Dayanada ; Duggavathi, Raj ; Pansera, Melissa ; Schuermann, Yasmin

The preovulatory luteinizing hormone surge is known to increase glucose uptake in ovulating follicles, but the underlying mechanisms have not been explored. Members of the Slc2a family of proteins called glucose transporters mediate glucose uptake in various cell types. Our objective was to characterize the expression pattern and temporal relationship with glucose uptake of the four best-characterized glucose transporters, Slc2a1-4 in mouse ovarian granulosa cells. Analyses of mRNA levels showed that Slc2a1 was induced in granulosa cells with a peak expression at 4h after human chorionic gonadotropin (hCG) treatment. We then examined signaling cascades involved in Slc2a1 expression by pharmacological inhibitors of the ERK1/2 and mTOR pathways. Inhibition of the ERK1/2 pathway by PD0325901 reduced Slc2a1 mRNA abundance demonstrating that the ERK1/2 signaling pathway is required for Slc2a1 expression. Conversely, inhibition of the mTOR pathway with rapamycin increased the Slc2a1 transcript level, which could be attributed to the compensatory hyperactivation of ERK1/2 activity. Bioinformatic analysis followed by chromatin immunoprecipitation showed that the transcription factor Cebpb binds to the Slc2a1 promoter in hCG-stimulated granulosa cells. Finally, the glucose uptake was higher in granulosa cells collected at 4h post-hCG than those collected at 0h hCG. These results indicate that the preovulatory LH surge increases glucose uptake in granulosa cells of the ovulating follicle by inducing Slc2a1 expression through the ERK1/2 pathway and its downstream effector transcription factor Cebpb.

2025-02-01·3 Biotech

MRPL24 drives breast cancer metastasis and stemness by targeting c-MYC, BRD4, and STAT3

Article

作者: Ailun, Gaowa ; Khan, Islam Uddin ; Zhang, Feng ; Man, Shad ; Abbas, Manzar ; Khan, Abdul Jamil ; Liu, Shihao

Supplementary Information:

The online version contains supplementary material available at 10.1007/s13205-024-04196-z.

2025-01-10·JOURNAL OF CLINICAL ONCOLOGY

Erratum: ReNeu: A Pivotal, Phase IIb Trial of Mirdametinib in Adults and Children With Symptomatic Neurofibromatosis Type 1-Associated Plexiform Neurofibroma

Article

79

项与 Mirdametinib 相关的新闻（医药）

2025-02-13

·SYNAPSE

2025年2月13日全球新药进展早知道

1. FDA批准SpringWorks别构小分子MEK抑制剂 2月12日，SpringWorks Therapeutics宣布，美国FDA已批准MEK抑制剂Gomekli（mirdametinib）上市，用于治疗肿瘤无法完全切除的年龄不低于2岁的1型神经纤维瘤病相关丛状神经纤维瘤（NF1-PN）成人和儿童患者。新闻稿指出，mirdametinib是首个获批可同时用于治疗成人和儿童NF1-PN的药物。Mirdametinib是一种口服别构小分子MEK抑制剂，靶向MEK1和MEK2。FDA的批准是基于2b期临床试验ReNeu的结果，该试验达到了ORR主要终点，成人患者的ORR为41%（24/58），儿童患者的ORR为52%（29/56）。在确认获得缓解的患者中，88%的成人和90%的儿童患者的缓解持续时间至少为12个月，而50%的成人患者和48%的儿童患者的缓解持续时间至少为24个月。 2. 欧盟批准BridgeBio创新疗法，已授权拜耳 2月12日，BridgeBio Pharma宣布，欧盟已经批准Beyonttra（acoramidis）用于治疗伴有心肌病的野生型或变异型转甲状腺素蛋白介导的淀粉样变性（ATTR-CM）成人患者。Acoramidis是一种口服的转甲状腺素蛋白小分子稳定剂，本次批准基于ATTRibute-CM关键研究的结果。该试验成功达成了其主要终点，在第30个月时，与安慰剂相比，acoramidis组的ACM和反复发生的CVH事件减少了42%。Acoramidis起效迅速，在接受治疗后仅3个月时，患者首次发生ACM或CVH事件所需时间就与安慰剂组产生差异。此前于2024年11月，美国FDA已经批准acoramidis上市（商品名：Attruby）用于治疗ATTR-CM患者。而该药在欧洲的独家商业化权利已于2024年3月授予拜耳（Bayer）公司，欧盟的批准将触发7500万美元的里程碑款项。 3. FDA受理再生元CD3/BCMA双抗上市申请 2月12日，再生元（Regeneron）宣布，美国FDA已受理其为CD3/BCMA双特异性抗体疗法linvoseltamab所重新提交的生物制品许可申请（BLA），用于治疗已接受至少四线治疗，或已接受三线治疗且对最后一线治疗耐药的成年复发/难治性多发性骨髓瘤（MM）患者。FDA预计在2025年7月10日前对该申请做出审评决定。Linvoseltamab同时正在接受欧洲药品管理局（EMA）针对相同患者群体的审评。此次BLA重新提交的受理是在再生元解决第三方充填/封装制造问题之后进行的，该问题是FDA在之前该公司BLA提交中所唯一提出的问题。该BLA得到了关键性LINKER-MM1试验数据的支持。 4. Biohaven创新疗法在美国申报上市，获优先审评资格 2月12日，Biohaven宣布，美国FDA已受理该公司在研疗法troriluzole用于治疗成人脊髓小脑共济失调症（SCA）的新药申请（NDA），并授予优先审评资格。根据一项真实世界证据（RWE）研究，经3年治疗后，troriluzole可将SCA患者的病情进展减缓最高达70%。根据新闻稿，若获批准，该药将成为首个获FDA批准用于治疗SCA的药物。这次NDA的递交主要基于BHV4157-206-RWE试验的积极结果。该试验是在与美国FDA讨论后设计的关键性临床研究，旨在评估troriluzole在SCA患者中的疗效，以治疗3年后功能性共济失调评分（f-SARA）变化为衡量指标。该研究利用了3期临床试验数据，并根据FDA的RWE指南，使用来自美国小脑性共济失调临床研究联盟（CRC-SCA）的未治疗SCA患者作为外部对照。多项分析的数据综合显示，在troriluzole治疗组中，SCA患者病情恶化的速度减慢了50%-70%，在3年的研究期间，疾病进展延缓了1.5至2.2年。 5. 诺和诺德「司美格鲁肽」新适应症在中国申报上市 2月12日，CDE官网最新公示，诺和诺德（Novo Nordisk）申报的3.1类新药司美格鲁肽注射液新适应症上市申请获得受理，尚无具体适应症信息披露。根据注册分类及诺和诺德公开资料推测，这可能是司美格鲁肽2.4mg注射剂（商品名为Wegovy），此前已经在中国获批用于长期体重管理。本次该产品在中国申报上市的适应症可能为用于低已确诊心血管疾病的肥胖或超重成人的主要不良心血管事件（MACE）风险。 6. 首个国产FXI抑制剂进入III期阶段，来自恒瑞医药 2月12日，药物临床试验登记与信息公示平台显示，恒瑞医药启动了新型抗凝药SHR-2004的首个III期临床试验。SHR-2004是一种靶向凝血因子XI（FXI）的人源化单克隆抗体，可选择性结合FXI和凝血因子XIa（FXIa），阻碍凝血因子XIIa（FXIIa）对FXI的激活，从而阻断内源性凝血途径的级联反应过程，发挥抗凝作用。目前，全球尚无FXI/FXIa抑制剂上市。本次启动的III期研究是一项多中心、随机、双盲、阳性药物对照临床试验（n=1167），旨在评估接受全膝关节置换术后的成人患者使用SHR-2004（皮下注射，120mg，用药1次或静脉输注1次，90mg，用药1次）或依诺肝素钠（皮下注射，40mg，用药12-14次）或安慰剂预防静脉血栓栓塞症（VTE）的有效性和安全性。 7. GenSight公司发布一次性基因治疗眼科临床结果 2月12日，GenSight Biologics发布了其LUMEVOQ®基因疗法治疗Leber遗传性视神经病变(LHON)的REFLECT III期临床试验五年疗效和安全性的最终结果。结果显示，单次注射LUMEVOQ®后五年，患者视力改善持续存在，且安全性良好。双侧注射相比单侧注射，具有额外获益，尤其在临床相关恢复率方面。LHON 是一种罕见的母系遗传线粒体遗传疾病，会导致视网膜神经节细胞变性，从而导致突然且不可逆转的视力丧失，并可能导致法定失明。LUMEVOQ 是一种针对LHON的基因疗法，通过玻璃体内注射的方式单次给药，旨在为患者提供可持续的功能性视力恢复。 1. 超21亿美元！艾伯维与Xilio合作开发实体瘤TCE 2月12日，艾伯维和 Xilio Therapeutics宣布达成合作和许可选择协议，利用 Xilio 的专有技术开发新型肿瘤激活、基于抗体的免疫疗法，包括掩蔽型T细胞衔接器。Xilio 盘前股票涨幅超170%。根据协议条款，Xilio 将获得总计5200 万美元的预付款，包括1000万美元的股权投资，并有资格获得高达约21亿美元的期权相关费用和里程碑付款以及分级特许权使用费总额。内容来源于网络，如有侵权，请联系删除。

上市批准临床结果临床申请合作

2025-02-13

·PMLiVE

FDA approves SpringWorks Therapeutics’ Gomekli to treat neurofibromatosis type 1

The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat neurofibromatosis type 1 (NF1), a rare genetic disorder affecting approximately 100,000 people in the US. The drug has been specifically authorised to treat adult and paediatric patients aged two years and older who have symptomatic plexiform neurofibromas (PN) that cannot be removed surgically. NF1 causes a variety of symptoms across multiple organ systems, including abnormal pigmentation, skeletal deformities, tumour growth and neurological complications. Around 40,000 NF1 patients in the US have PNs, which are tumours that grow along the peripheral nerve sheath and can cause severe disfigurement, pain and functional impairment. PNs can also develop into malignant peripheral nerve sheath tumours, an aggressive and potentially fatal disease. SpringWorks’ Gomekli is an oral small molecule MEK inhibitor and the first and only FDA-approved therapy for both adults and children with NF1-PN. The FDA’s decision on the drug was supported by results from the phased 2b ReNeu trial, which demonstrated an objective response rate of 41% and 52% in adult and paediatric NF1-PN patients, respectively. Tumour volume reductions were deep and durable, SpringWorks said, with 50% of adults and 48% of children in response for at least 24 months, and patients in both cohorts also experienced early and sustained improvements in pain and quality of life. SpringWorks’ chief executive officer, Saqib Islam, said: “The NF1-PN patient community has a great need for more treatment options. With [this] approval, we are honoured to serve both adults and children with NF1-PN and provide them with a therapy that has the potential to shrink their tumours and offer meaningful symptomatic relief.” Alongside the approval, the FDA has awarded SpringWorks a priority review voucher (PRV), which the company can redeem to have any drug reviewed under the regulator’s priority review pathway. Under the PRV programme, which was created to encourage the development of new drug and biological products for the prevention and treatment of certain rare paediatric diseases, SpringWorks may also sell or transfer the voucher to another company.

临床结果上市批准优先审批临床2期

2025-02-12

·佰傲谷BioValley

分拆于辉瑞，被默克看上

近日（2月10日），据路透社报道，德国制药巨头默克（Merck KGaA）正在就收购美国生物技术公司SpringWorks Therapeutics进行谈判，交易金额可能高达34亿至40亿美元。随后，Merck KGaA在一份声明中证实了报道，表示其收购 SpringWorks的谈判正在进行中。不过，Merck KGaA也表示尚未签署具有法律约束力的协议，而且交易是否能达成也不确定。不过，受此消息鼓舞，SpringWorks股价上涨了34%，达到54美元/股。脱胎于辉瑞 SpringWorks成立于2017年，是一家专注于癌症和罕见病药物开发的Biotech公司，2019年在纳斯达克证券交易所上市。 SpringWorks可以算是脱胎于辉瑞，SpringWorks的创始人是辉瑞的前研发主管Lara S. Sullivan，前辉瑞执行副总裁兼首席医学官Freda Lewis-Hall博士是SpringWorks董事会成员。成立之初，SpringWorks还获得了辉瑞的四条研发管线授权，其中就包括目前两个最快的管线nirogacestat和mirdametinib，另外，SpringWorks还获得了辉瑞的风险投资，2017年和2019年，辉瑞分别参与了SpringWorksA轮和B轮融资。目前，nircgacestat已经获FDA批准上市（2023年11月27日），用于治疗需要全身治疗的进展性纤维瘤成患者，这也是这类患者群体的全球首个获批治疗药物，也是SpringWorks唯一的商业化产品。 MEK抑制剂mirdametinib也即将上市，去年已完成向FDA提交的新药申请(NDA)，用于治疗患有1型神经纤维瘤病相关丛状神经纤维瘤 (NF1-PN)的儿童和成人患者，PDUFA目标日期为2025年2月28日。另外，欧洲药品管理局（EMA）也已受理mirdametinib的上市许可申请（MAA）。 SpringWorks还跟百济有合作，2019年，SpringWorks与百济共同成立一家名为MapKure的公司，百济将口服RAF抑制剂brimarafenib转让给这个合资公司，目前brimarafenib处于临床Ⅰ期阶段，用于治疗MAPK突变实体瘤。公司还有一款处于临床Ⅰ期的TEAD抑制剂SW-682，以及一款临床前的PP2A激动剂SW-3431（用于治疗罕见子宫癌）。财务方面，此前SpringWorks其实也面临一定的现金流压力，好在OGSIVEO上市之后已经明显贡献了销售收入，2024年OGSIVEO®（nirogacestat）全年净产品收入为1.72亿美元。截至2024年12月31日，公司现金、现金等价物和有价证券约4.6亿美元，公司对实现盈利的预计是在2026年上半年。如果收购达成，也能很快为Merck KGaA带来营收。不过鉴于时间上，跟mirdametinib的PDUFA目标日期十分相近，mirdametinib是否被批或许对于Merck KGaA下定决心收购SpringWorks十分关键。参考出处： https://stock.10jqka.com.cn/usstock/20250211/c665927958.shtml 【癌症关注】GSK、辉瑞、贝恩争投，SpringWorks完成B轮融资本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

并购临床2期财报申请上市

100 项与 Mirdametinib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11675	-	-	DB07101

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
神经纤维瘤病1型	美国	Springworks Therapeutics, Inc.	2025-02-11

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
NF1突变型丛状神经纤维瘤	申请上市	美国	Springworks Therapeutics, Inc.	2024-03-04
晚期恶性实体瘤	临床2期	美国	Springworks Therapeutics, Inc.	2023-02-03
晚期恶性实体瘤	临床2期	澳大利亚	Springworks Therapeutics, Inc.	2023-02-03
低级神经胶质瘤	临床2期	美国	Springworks Therapeutics, Inc.	2021-06-21
结直肠癌	临床2期	荷兰	Pfizer Inc.	2014-01-01
KRAS突变非小细胞肺癌	临床2期	荷兰	Pfizer Inc.	2014-01-01
晚期非小细胞肺癌	临床2期	美国	Pfizer Inc.	2005-11-01
晚期乳腺癌	临床2期	美国	Pfizer Inc.	2004-02-01
晚期癌症	临床2期	美国	Pfizer Inc.	2004-02-01
结肠癌	临床2期	美国	Pfizer Inc.	2004-02-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03962543 (ReNeu, SNO2024) 人工标引	临床2期	NF1突变型丛状神经纤维瘤	114	MIRDAMETINIB (adults)	襯齋製蓋簾餘鏇餘遞淵(艱遞鏇壓遞願選築膚鹽) = Clinically meaningful improvement was defined as change from baseline >9.7 points for adults, >8.5 points for child self-report, and >9.0 points for parent proxy-report. PedsQL-TS improvement (least-squares mean, LSM [SE] change) from baseline at C13 was 3.9 (1.6; P=.018; n=34) for adults, 4.0 (2.4; P=.096; n=38) for children by self-report, and 5.6 (1.9; P=.005; n=43) by parent proxy-report. PedsQL-TS improvements for adults and children by parent proxy-report (not by children self-report) were observed early (at C5 and C3, respectively) and sustained through C24. Clinically meaningful improvement in PedsQL-TS from baseline at C13 was achieved by 37% (10/27) adults, 45% (13/29) children by self-report, and 47% (15/32) children by parent proxy-report (among patients who could have achieved a clinically meaningful change from baseline). Significant (P<.05) improvement from baseline to C13 was reported for physical (adults, children, and parent proxy-report), school/work (adults), and emotional and social (parent proxy-report) subscales. 製襯簾膚顧簾選繭積鑰 (願艱憲壓廠蓋鬱網餘鑰 )	积极	2024-11-11
				MIRDAMETINIB (children)
NCT04923126 (SJ901, SNO2024) 人工标引	临床1期	低级神经胶质瘤 BRAF alteration \| FGFR1 alteration \| NF1 alteration ... 更多	23	MIRDAMETINIB	醖餘鹹範窪齋簾繭艱衊(夢遞願選製顧鬱製艱顧) = 艱鹹鹽觸網網淵構鬱鹽鏇餘顧窪顧網選繭膚鹹 (獵遞製構鬱艱糧獵觸簾 ) 更多	积极	2024-11-11
NCT03962543 (ReNeu, SNO2024 \| FDA_CDER) 人工标引	临床2期	神经纤维瘤病1型	114	mirdametinib (adults)	獵淵醖積簾膚鏇積獵醖(糧積遞範築積範獵鹽醖) = 醖齋餘觸衊醖鹹衊壓鹽齋範襯顧鑰積醖鏇築網 (醖網齋衊齋鹹衊鑰糧醖, 29 ~ 55) 更多	积极	2024-11-11
				mirdametinib (children)	獵淵醖積簾膚鏇積獵醖(糧積遞範築積範獵鹽醖) = 遞襯觸壓衊餘淵餘選顧齋範襯顧鑰積醖鏇築網 (醖網齋衊齋鹹衊鑰糧醖, 38 ~ 65) 更多
NCT03962543 (ReNeu, SNO2024)	临床2期	丛状神经纤维瘤	12	MIRDAMETINIB (Prepubescent patients)	鑰艱簾淵廠糧構遞構繭(獵顧艱憲製壓糧顧鹽膚) = 淵觸餘積膚夢鑰鬱獵積衊觸鹹糧憲構範範糧蓋 (鬱糧積艱選顧壓獵襯鬱 )	-	2024-11-11
NCT03962543 (RENEU, EANO2024)	临床2期	NF1突变型丛状神经纤维瘤	114	Mirdametinib 2 mg/m^2 BID	鹽糧窪糧糧積願憲鏇廠(齋繭積鹽鏇憲構鏇獵積) = 鬱繭餘淵窪選衊製壓窪齋遞遞繭繭構艱鏇夢製 (鹹餘壓積鹽壓鹽糧遞夢, 29 ~ 55) 更多	积极	2024-10-17
				Placebo	鹽糧窪糧糧積願憲鏇廠(齋繭積鹽鏇憲構鏇獵積) = 鹹遞蓋積獵鏇蓋糧積鬱齋遞遞繭繭構艱鏇夢製 (鹹餘壓積鹽壓鹽糧遞夢, 38 ~ 65) 更多
NCT05054374 (CTgov)	临床1/2期	转移性乳腺癌 \| HER2 阴性乳腺癌	6	Fulvestrant+Mirdametinib (Arm 1, Part 1 - Mirdametinib in Combination With Fulvestrant)	衊餘遞積襯醖鏇膚襯積(選簾襯積鏇遞蓋廠遞壓) = 獵積鬱觸範鑰觸構襯餘網觸網獵淵繭願獵鑰醖 (糧選糧糧蓋遞顧淵鹽糧, 簾鹽鏇衊衊積積選製窪 ~ 遞顧壓觸襯膚淵築窪築) 更多	-	2024-07-09
				Fulvestrant+Mirdametinib (Arm 1, Part 2 - Mirdametinib in Combination With Fulvestrant)	衊餘遞積襯醖鏇膚襯積(選簾襯積鏇遞蓋廠遞壓) = 鏇顧糧鬱選製願壓襯憲網觸網獵淵繭願獵鑰醖 (糧選糧糧蓋遞顧淵鹽糧, 窪構鹽製築築繭窪齋遞 ~ 鏇繭憲衊齋鏇鬱鏇願鏇) 更多
NCT03962543 (ReNeu, ASCO2024) 人工标引	临床2期	NF1突变型丛状神经纤维瘤	114	Mirdametinib 2 mg/m2 BID	廠積獵夢鹹繭鑰艱構繭(醖襯憲廠廠餘築鹽觸廠) = 網餘艱鏇齋鏇獵蓋壓構襯築顧觸淵積觸夢願顧 (繭齋製繭遞構鑰鏇鏇製, 29 ~ 55) 更多	积极	2024-05-24
				Mirdametinib (pediatric)	廠積獵夢鹹繭鑰艱構繭(醖襯憲廠廠餘築鹽觸廠) = 夢襯獵觸願願齋願餘壓襯築顧觸淵積觸夢願顧 (繭齋製繭遞構鑰鏇鏇製, 38 ~ 65) 更多
NCT03962543 (ReNeu, GlobeNewswire) 人工标引	临床2期	丛状神经纤维瘤 NF1	114	Mirdametinib (pediatric patients)	鹽簾衊觸鬱廠鬱鑰築積(蓋獵築淵餘顧齋壓選衊) = 製鏇淵鑰築艱範糧遞獵淵艱壓蓋遞廠鑰網齋觸 (繭簾選網鬱選顧網簾鹹 ) 更多	积极	2023-11-16
				Mirdametinib (adult patients)	鹽簾衊觸鬱廠鬱鑰築積(蓋獵築淵餘顧齋壓選衊) = 遞憲廠蓋襯鹽選襯鏇襯淵艱壓蓋遞廠鑰網齋觸 (繭簾選網鬱選顧網簾鹹 ) 更多
AACR2023 人工标引	临床1期	实体瘤	56	lifirafenib+mirdametinib	齋選簾壓構膚夢構鬱壓(廠鬱觸遞積願選網選鏇) = 構選鬱簾憲醖鑰艱觸壓鹽艱鏇鹽鬱襯壓夢範觸 (築顧獵鏇艱艱獵網網鏇 ) 更多	积极	2023-04-14
				lifirafenib+mirdametinib (LGSOC )	齋選簾壓構膚夢構鬱壓(廠鬱觸遞積願選網選鏇) = 鬱艱糧網壓醖醖夢遞窪鹽艱鏇鹽鬱襯壓夢範觸 (築顧獵鏇艱艱獵網網鏇 ) 更多
EXTH-102 (SNO2022)	N/A	-	4	Mirdametinib 0.50 mg/kg PO q.d	淵築簾繭鹹餘觸鹽廠鏇(網壓淵簾觸醖醖窪積鹽) = 繭膚顧糧醖齋積製憲鏇憲鏇餘齋夢廠觸醖壓壓 (簾繭廠遞齋鏇壓糧淵獵, 253.4) 更多	-	2022-11-14
				Mirdametinib 0.20 mg/kg IV	淵築簾繭鹹餘觸鹽廠鏇(網壓淵簾觸醖醖窪積鹽) = 繭鏇繭獵構廠築膚糧網憲鏇餘齋夢廠觸醖壓壓 (簾繭廠遞齋鏇壓糧淵獵, 43) 更多