预约演示

更新于：2026-10-28

Motixafortide

莫替沙福肽

更新于：2026-10-28

概要

基本信息

药物类型

合成多肽、环肽药物

别名

Motixafortide Acetate、莫替福肽、4F-BENZOYL-TN14003

+ [7]

靶点

CXCR4

作用方式

拮抗剂

作用机制

CXCR4拮抗剂(C-X-C基序趋化因子受体4拮抗剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [4]

在研适应症

多发性骨髓瘤胰腺导管癌胰腺癌+ [1]

非在研适应症

急性淋巴细胞白血病急性髓性白血病淋巴母细胞淋巴瘤+ [11]

原研机构

Biokine Therapeutics Ltd.

在研机构

BioLineRx Ltd.

广州吉时生物科技有限公司Ayrmid Pharma Limited

+ [2]

非在研机构

Washington University School of Medicine

The University of Texas MD Anderson Cancer Center

Biokine Therapeutics Ltd.

权益机构

广州吉时生物科技有限公司

劲方医药科技（上海）股份有限公司

Gamida Cell Ltd.

+ [4]

最高研发阶段批准上市

首次获批日期

美国 (2023-09-08),

多发性骨髓瘤

最高研发阶段(中国)临床3期

特殊审评孤儿药 (美国)、孤儿药 (欧盟)

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结构/序列

分子式C97H144FN33O19S2

InChIKeyJJVZSYKFCOBILL-KZGZZEQFSA-N

CAS号664334-36-5

Sequence Code 528941150

来源: *****

关联

项与莫替沙福肽相关的临床试验

NCT07392970

/ Recruiting临床2期IIT

A Pilot Clinical Trial of Motixafortide for Measurable Residual Disease (MRD) Sensitization in Acute Myeloid Leukemia (AML)

This is a pilot phase I study evaluating the effect of motixafortide on determination of measurable residual disease (MRD) level in patients with acute myeloid leukemia (AML) who have completed induction treatment. Consenting and eligible patients will undergo standard of care (SOC) bone marrow and peripheral blood assessments with SOC MRD assays, followed by a single injection of motixafortide. Ten to 14 hours after injection, the patient will undergo peripheral blood collection for the same applicable MRD tests

开始日期2026-07-23

申办/合作机构

Washington University School of Medicine

[+1]

NCT06514508

/ Recruiting临床3期

A Phase Ⅲ, Randomized, Double-Blinded Study Evaluating the Safety and Efficacy of Combination Treatment of Motixafortide and G-CSF as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma

This is a randomized, double-blinded, placebo-controlled, multi-center phase Ⅲ bridging clinical study designed to evaluate the efficacy, safety, and pharmacokinetic and pharmacodynamic profiles of Motixafortide (BL-8040) + G-CSF vs placebo + G-CSF mobilized hematopoietic stem cells for autologous transplantation in Chinese patients with multiple myeloma.

开始日期2025-12-01

申办/合作机构

广州吉时生物科技有限公司

NCT07101445

/ Recruiting临床4期IIT

Prevent Allergic Reactions to Aphexda With Dexamethasone (PARADE)

This phase IV trial compares the effect of premedication regimens with methylprednisolone versus dexamethasone for the prevention of allergic reaction to motixafortide in patients with multiple myeloma (MM) undergoing stem cell mobilization. MM patients that receive an autologous stem cell transplantation (ASCT) have better outcomes. However, not all MM patients are able to have a successful stem cell mobilization and collection which is needed to proceed to ASCT. The addition of motixafortide prior to stem cell mobilization has allowed more MM patients to collect the needed number of stem cells to proceed to ASCT. However, motixafortide does produce systemic and injection site reactions in many patients. The optimal medication regimen to prevent reactions remains unknown. A premedication regimen with dexamethasone prior to motixafortide decreases the incidence of reactions in many patients and is considered the standard of care regimen for the prevention of systemic and injection site reactions to motixafortide in patients with MM undergoing stem cell mobilization. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen side effects/allergic reactions. However, dexamethasone is associated with other side effects like headache, difficulty sleeping, high blood glucose, high blood pressure, mood changes, fluid retention, and infection, among others. A premedication regimen with methylprednisolone prior to motixafortide may work better to decrease the incidence of reactions to motixafortide in patients with MM undergoing stem cell mobilization. Methylprednisolone is in a class of medications called corticosteroids. It works to decrease side effects/allergic reactions by changing the way the immune system works. Giving methylprednisolone may be safe, tolerable and/or more effective than dexamethasone as part of a premedication regimen for the prevention of allergic reaction to motixafortide in patients with MM undergoing stem cell mobilization.

开始日期2025-09-24

申办/合作机构

Emory University

[+2]

100 项与莫替沙福肽相关的临床结果

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100 项与莫替沙福肽相关的转化医学

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100 项与莫替沙福肽相关的专利（医药）

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项与莫替沙福肽相关的文献（医药）

2026-07-30·BLOOD

Inhibition of high CXCR4 with motixafortide and absence of single-cell MRD predict outcome after AML consolidation

Article

作者: Hänel, Mathias ; Götze, Katharina S. ; Wickenhauser, Claudia ; Brandts, Christian ; Glicko-Kabir, Irit ; Rieger, Kathrin ; Röllig, Christoph ; Jaramillo Segura, Sonia ; Krug, Utz ; Edemir, Bayram ; Hemmati, Philipp ; Platzbecker, Uwe ; Rohde, Christian ; Edemir, Sabine ; Kadosh, Shaul ; Ludwig-Kraus, Beatrice ; Baldus, Claudia D. ; Arribas-Layton, Marc ; Subklewe, Marion ; Stölzel, Friedrich ; Lotze, Michelle ; Frickhofen, Norbert ; Tavor, Sigal ; Wienke, Andreas ; Nogai, Axel ; Rank, Andreas ; Bauer, Marcus ; Junghanß, Christian ; Jost, Edgar ; Buske, Sebastian ; Wass, Maxi ; Müller, Lutz P. ; Cerwenka, Adelheid ; Schmidt-Hieber, Martin ; Schlenk, Richard F. ; Florschütz, Axel ; Eßeling, Eva ; von Witzendorff, Stephan ; Schubert, Jörg ; Sciambi, Adam ; Kunzmann, Volker ; Scheller, Marina ; Müller-Tidow, Carsten ; Sayer, Herbert ; Bornhäuser, Martin ; Ceran, Enise ; Opitz, Bernhard ; Sorani, Ella ; Durruthy-Durruthy, Robert ; Schüler, Frank ; Kaufmann, Martin ; Noppeney, Richard ; Serve, Hubert ; Vainstein-Haras, Abi ; Merbach, Anne Kathrin ; Gromann, Cora ; Steighardt, Jörg ; Schaffrath, Judith ; Kowoll, Simone ; Schäfer-Eckart, Kerstin ; Scholz, Christian W. ; Herbst, Regina

Abstract:

Relapse after remission remains the primary cause of treatment failure in acute myeloid leukemia (AML), underscoring the need for strategies to eliminate residual leukemic cells. The bone marrow (BM) microenvironment, largely orchestrated by the CXC chemokine receptor 4 (CXCR4)–CXC motif chemokine 12 axis (CXCL12), enables leukemia cell survival and chemoresistance by anchoring blasts in their protective BM niche. Motixafortide, a selective CXCR4 antagonist, mobilizes leukemic cells and disrupts tumor microenvironment interactions in preclinical models. In this randomized, double-blind, placebo-controlled phase 2 trial, 128 patients in first remission received high-dose cytarabine plus motixafortide or placebo. Median relapse-free survival did not substantially differ between groups: 10.3 months (95% confidence interval [CI], 8.0-12.0) for motixafortide and 11.5 months (95% CI, 8.6-24.1) for placebo (log-rank P = .98). But single-cell measurable residual disease (scMRD) analysis, performed before consolidation, demonstrated heterogeneity of CXCR4 inhibition benefit; in the placebo group, higher CXCR4 expression was associated with increased relapse risk (P = .02), whereas in the motixafortide group, higher CXCR4 expression was linked to a reduced relapse rate (P = .047). Exploratory analyses identified scMRD levels at which higher MRD burden was associated with inferior overall survival. Taken together, combining functional MRD profiling with biomarker-driven patient selection, such as CXCR4 expression, may enable more precise and effective postremission interventions in AML. This trial was registered at www.clinicaltrials.gov as NCT02502968 and at EudraCT as 2014-002702-21.

2026-03-20·JOURNAL OF CLINICAL ONCOLOGY

WBC Growth Factors: ASCO Guideline Update

Review

作者: Schott, Sally ; Knopf, Kevin B. ; Shilpakar, Ramila ; Woodard, Amy B. ; Trapani, Dario ; Roof, Logan ; Dickter, Jana K. ; Rapoport, Bernardo L. ; Kelkar, Amar H. ; Seshadri, Madhav R. ; Cigler, Tessa ; Smith, Thomas J. ; Bohlke, Kari ; Gyawali, Bishal

PURPOSE:

To update the ASCO guideline on use of hematopoietic colony-stimulating factors (CSFs) in patients with cancer.

METHODS:

A systematic review identified randomized controlled trials (RCTs), meta-analyses, and systematic reviews that addressed use of CSFs for the prevention or treatment of neutropenic events, or for mobilization of stem cells, in adults with cancer. PubMed and the Cochrane Library were searched for articles published from September 1, 2014, to August 22, 2025. ASCO convened an Expert Panel to review the evidence and formulate recommendations.

RESULTS:

The updated systematic review included 33 RCTs and 16 systematic reviews. Additions to the body of evidence include approval of new CSFs and additional biosimilars, and approval of an additional CXCR4 inhibitor that may be used with CSFs for the mobilization of hematopoietic stem cells.

RECOMMENDATIONS:

Prophylactic use of CSFs to reduce the risk of febrile neutropenia is warranted when the risk of febrile neutropenia from chemotherapy is approximately 20% or higher and no other equally effective and safe regimen that does not require CSFs is available. For patients receiving chemotherapy with a <20% risk of febrile neutropenia, primary prophylaxis with a CSF may be warranted if patients are at a high risk of febrile neutropenia based on age, medical history, or disease characteristics. For stem-cell mobilization, CSFs may be used either alone, after chemotherapy, or in combination with plerixafor or motixafortide. The guideline also provides information about the dosing and selection of CSFs. Additional information is available at www.asco.org/supportive-care-guidelines .

2026-03-09·ONCOLOGIST

Atezolizumab and motixafortide, cobimetinib or simlukafusp alfa in pretreated advanced pancreatic cancer: phase I/IIb MORPHEUS-PDAC umbrella study

Article

作者: Siveke, Jens T ; Ponz-Sarvisé, Mariano ; Cha, Edward ; Lopez, Charles D ; Manji, Gulam A ; O’Reilly, Eileen M ; Macarulla, Teresa ; Kim, Kyu-Pyo ; George, Ben ; Chung, Vincent ; Lacy, Jill ; Xu, Yun ; Lau, Janet ; Thomas, Roby ; Alistar, Angela ; Oh, Do-Youn

Abstract:

Background:

The MORPHEUS platform comprised multiple open-label, randomized, phase Ib/II trials to identify early signals with different treatment combinations across multiple cancers. MORPHEUS-PDAC (NCT03193190) evaluated atezolizumab combinations in pancreatic ductal adenocarcinoma (PDAC). We describe outcomes with atezolizumab plus either motixafortide, cobimetinib, or two simlukafusp alfa regimens.

Methods:

Eligible patients with advanced, pretreated PDAC were randomized to receive second-line (2 L) atezolizumab plus either motixafortide (BL8040; n = 15), cobimetinib (n = 14), simlukafusp alfa every 2 weeks (q2w; n = 15), or simlukafusp alfa every 3 weeks (q3w; n = 16); or control (mFOLFOX6 [n = 25] or gemcitabine plus nab-paclitaxel [n = 25]). Patients experiencing disease progression or toxicity who met eligibility criteria were enrolled to receive third-line (3 L) atezolizumab plus cobimetinib (n = 14), or atezolizumab plus simlukafusp alfa q2w (n = 1) or q3w (n = 6). Primary endpoints were objective response rates (ORRs) per RECIST 1.1 and safety.

Results:

ORRs were 7.1% with atezolizumab-simlukafusp alfa q2w, 8.7% with mFOLFOX6 (both 2 L; 0% in other arms), 14.3% with atezolizumab-cobimetinib, and 16.7% with atezolizumab-simlukafusp alfa q3w (both 3 L). Grade 3-5 adverse event rates were 53.3% (2 L atezolizumab-motixafortide), 64.3% (2 L atezolizumab-cobimetinib), 57.1% (2 L atezolizumab-simlukafusp alfa q2w), 53.3% (2 L atezolizumab-simlukafusp alfa q3w), 63.0% (2 L mFOLFOX6 or gemcitabine-nab-paclitaxel), 50.0% (3 L atezolizumab-cobimetinib), and 100% (3 L atezolizumab-simlukafusp alfa q3w).

Conclusions:

The overall safety of atezolizumab combinations was manageable and consistent with each agent’s known safety profile. This novel trial design enabled rapid evaluations of 3 atezolizumab combinations; all had limited efficacy as 2 L or 3 L treatment for metastatic PDAC. New treatments are needed to improve outcomes in previously treated PDAC.

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项与莫替沙福肽相关的新闻（医药）

2026-10-23

·癌度

胰腺癌PD-1无效？11人64%肿瘤缩小

为什么PD-1在胰腺癌里几乎无效？不是T细胞不想打，是它根本进不去。胰腺癌微环境像一道厚墙，把杀伤性T细胞挡在外面。PD-1的作用是“松刹车”，可T细胞连门都进不去，松刹车也没用。破局思路：先开门，再进攻哥伦比亚大学团队设计四药方案MCGN： motixafortide：阻断CXCR4/CXCL12通路，把T细胞放进来 cemiplimab：PD-1抑制剂，激活已进入的T细胞吉西他滨+白蛋白紫杉醇：杀伤肿瘤，调节Treg 关键在顺序：必须先用motixafortide重塑微环境，把门打开，后续药物才有效。 11例患者的结果 64%（7/11）肿瘤明显缩小 91%（10/11）疾病控制中位PFS 9.7个月（历史化疗数据5.5个月）配对活检：11例CD8+T细胞密度全部上升一例特殊患者 59岁男性，肝转移后手术中止。MCGN治疗后肿瘤缩小53%，第457天接受手术，病理显示原发灶和肝转移灶均无存活癌细胞——病理完全缓解。截至发表，无病生存约2.8年。必须谨慎看待单臂、11例、无对照中位OS 10.1个月，历史数据8.5个月，提升幅度远小于PFS PFS改善明显而OS有限，说明数据尚不成熟耐药后T细胞耗竭、TIGIT/LAG-3/VISTA上调，肿瘤会重建防线下一步随机对照II期已启动，计划108例，2:1对比MCGN vs 化疗，主要终点PFS。一句话总结：这项研究的价值不只在64%，更在验证了一个思路——与其加大免疫治疗力度，不如先想办法把T细胞放进去。 📞 关注癌度公众号，菜单栏“联系我们”，评估临床试验机会。

临床2期临床结果免疫疗法

2026-10-23

·癌度

为什么PD-1在胰腺癌里几乎无效?这项研究给出了破局思路，11个人的试验,64%肿瘤缩小,一例患者肿瘤细胞全部消失！

点击蓝字关注我们在我们癌度社群，还是经常碰到胰腺癌患者用PD-1治疗的情况，PD-1药物从很多意义上被当做万能药来用了，但在胰腺癌PD-1抑制剂不一定管用，因为目前没有任何PD-1抑制剂批准用于胰腺癌。不是T细胞不想打,是它根本进不去。搞清楚这一点之后,研究者决定先派人去把门撞开。一、为什么免疫治疗在胰腺癌里几乎失灵 PD-1抑制剂这些年在肺癌、黑色素瘤里的表现有目共睹,但到了胰腺癌这里,几乎全军覆没。转移性胰腺癌患者的五年生存率只有大约3%,而免疫治疗基本没能改变这个数字。问题出在胰腺癌的肿瘤微环境。这是一个由免疫细胞、结缔组织、血管组成的复杂生态,在胰腺癌里表现得极度免疫抑制,像一道厚墙,把杀伤性T细胞挡在肿瘤外面。这也解释了为什么PD-1抑制剂单用没效果——这类药的作用是给T细胞"松刹车",可T细胞连门都进不去,松刹车又有什么用。具体的机制之一,是CXCR4/CXCL12这条信号通路。肿瘤周围的癌症相关成纤维细胞会分泌大量CXCL12,通过结合T细胞表面的CXCR4受体,把T细胞物理性地推开、挡在外围。二、先开门,再进攻哥伦比亚大学的团队十多年前就开始琢磨怎么拆掉这道防线。他们除了盯上CXCR4通路,还发现胰腺癌里另有一套依赖调节性T细胞(Treg)的免疫抑制机制,而化疗药吉西他滨恰好能减少这类细胞。顺着这两条线索,团队设计了一个四药方案,简称MCGN:motixafortide负责阻断CXCR4信号,把被挡在外面的T细胞放进来;cemiplimab作为PD-1抑制剂,负责激活已经进入肿瘤的T细胞;吉西他滨和白蛋白紫杉醇这两个标准化疗药,一边直接杀伤肿瘤,一边调节Treg。最关键的一点是顺序。团队在小鼠模型里反复测试后发现,必须先用motixafortide重塑微环境,把门打开,后面的药物才有发挥的余地。顺序反了,效果就大打折扣。三、11个人的结果这项单臂二期试验入组了11例未经治疗的转移性胰腺导管腺癌患者。7例(64%)出现肿瘤明显缩小,其中6例经过确认;10例(91%)疾病得到控制;中位无进展生存期9.7个月。作为对照,单用吉西他滨联合白蛋白紫杉醇的历史数据是缓解率23%、疾病控制率48%、中位无进展生存期5.5个月。不过有一点要如实说明:虽然无进展生存期几乎翻倍,但公布的中位总生存期是10.1个月,和历史数据的8.5个月相比提升幅度小得多。PFS改善明显而OS改善有限,通常意味着数据还不够成熟,或者早期的肿瘤控制没能完全转化为生存期的延长。这个落差在解读时不能忽略。另外,配对活检显示,11例患者的肿瘤组织里CD8+T细胞密度全部上升(p=0.007)——这说明"开门"这一步确实做到了,机制层面的假设站得住。四、那一例特殊的患者 11个人里有一位59岁男性的经历值得单独说。他原本计划手术,腹腔镜探查时在肝脏表面发现了转移灶,手术被迫中止。当时原发肿瘤直径3.2厘米。接受MCGN方案后,肿瘤持续缩小,到第12个治疗周期(第332天)时缩小了53%,只剩1.5厘米。第457天,他接受了胰十二指肠切除术和肝转移灶切除。术后病理检查的结果是:原发灶和肝转移灶里都找不到存活的癌细胞——达到了病理完全缓解。他随后拒绝了辅助化疗。截至论文发表时,他从开始治疗算起已经无病生存1023天(约2.8年),从手术算起无病生存567天(约1.6年)。在转移性胰腺癌里,这种情况极为罕见。研究负责人Gulam Manji医生的说法是,看到这个病例和整体结果,"我们有理由相信自己可能触到了一些重要的东西"。五、耐药是怎么发生的团队对患者做了治疗前、治疗中和进展后的连续活检,用单细胞核测序追踪微环境的变化,这部分可能是这项研究最有价值的地方。有效的患者呈现出几个共同特征:肿瘤异质性降低,上皮-间质转化状态减少,CXCL12阳性的成纤维细胞富集,CD8+T细胞浸润增加而且更贴近肿瘤细胞。而疾病进展的时候,情况又变了:T细胞进入"耗竭"状态,TIGIT、LAG-3、VISTA这几个免疫检查点上调,被压制住的CXCL12-CXCR4信号轴重新被激活。也就是说,这套方案确实撕开了胰腺癌的一道防线,但肿瘤会重新筑起新的防线。这个发现的现实意义在于,它直接指出了下一步该往哪里走——后续联合抗TIGIT或抗LAG-3药物,可能是应对耐药的方向。六、接下来会怎样基于这些初步数据,团队已经把研究升级为随机对照的二期试验,计划入组108例,按2比1随机分配接受MCGN方案或单纯化疗,主要终点是无进展生存期,预计2027年完成入组,在观察到40%的进展事件时会做一次期中分析。同时实验室也在分析患者样本,试图找到能预测疗效的标志物,尤其是CXCL12阳性成纤维细胞的丰度能不能用来筛选受益人群。胰腺癌这个"免疫荒漠",这些年一直是免疫治疗攻不下的堡垒。这项研究的价值,不只在于64%这个数字,更在于它验证了一个思路:与其一味加大免疫治疗的力度,不如先想办法把T细胞放进去。 11个人,单臂,没有对照组,历史数据比较只能提供线索。总生存期的改善幅度也远不如缓解率那么亮眼。这些都要等108例的随机对照研究来回答。如果你或家人正面临转移性胰腺癌的治疗困境,尚未接受过一线系统治疗,可以关注这项研究的后续进展,并与主治医生讨论是否有合适的临床试验机会。解读基因检测报告,评估临床试验入组机会,欢迎扫码咨询癌度。 👉 •点击文末【阅读原文】； •或扫码关注公众号后点菜单栏“联系我们”；免责声明:本文仅为科普参考,不构成任何医疗建议。MCGN方案为临床研究阶段方案,尚未获批上市。往期推荐肺癌术后病理报告上写着"EGFR罕见突变"的患者:全球首个专属辅助靶向研究,正在全国招募！ CT说进展就是真的进展？肿瘤复发判断里，有几个容易踩的坑——假性进展、寡进展、标志物升高！从8.3个月到17.4个月:一项Ⅱ期研究背后,值得关注也值得谨慎的信号，全国40家中心可入组！化疗该用还得用，但临床试验该了解要趁早——疫苗、蛋白降解剂、细胞治疗、双抗，四类新药正在改写规则！点赞收藏分享点亮小手爱心，送来温暖鼓励

免疫疗法临床2期

2026-10-08

·PRNewswire

BioLineRx and Hemispherian Announce Two GLIX1 Presentations at the 31st Society for Neuro-Oncology (SNO) Annual Meeting & Education Day

TEL AVIV, Israel and OSLO, Norway, Oct. 8, 2026 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, today announced that two abstracts featuring GLIX1 will be presented at the 31st Society for Neuro-Oncology (SNO) Annual Meeting & Education Day, taking place November 12-15 in Philadelphia, Pennsylvania. Continue Reading Hemispherian Logo The presentations will highlight preclinical research evaluating GLIX1 across multiple glioblastoma models, as well as the design of the ongoing Phase 1/2a clinical trial evaluating GLIX1 in patients with recurrent or progressive high-grade glioma and other solid tumors. Presentation Details: Title: GLIX1, a TET2 activator targeting DNA damage response: potent anti-tumor activity across multiple glioblastoma models; orthotopic CDX models and a subcutaneous TMZ-resistant PDX model Presenter: Dr. Adam Robertson, Ph.D., Chief Scientific Officer, Hemispherian AS Abstract code: EXTH-31 Format: Poster presentation Date/time: Friday, November 13, 2026, 7:30-9:30 p.m. EST Location: Pennsylvania Convention Center, Exhibit Halls D and E Title: Phase 1/2a study of GLIX1, a novel first-in-class oral TET2 activator, for the treatment of recurrent or progressive high-grade glioma Presenter: Ditte Primdahl, MD, Northwestern University Feinberg School of Medicine Abstract code: CTNI-25 Format: Poster presentation Date/time: Friday, November 13, 2026, 7:30-9:30 p.m. EST Location: Pennsylvania Convention Center, Exhibit Halls D and E About the Society for Neuro-Oncology (SNO)The Society for Neuro-Oncology (SNO) Annual Meeting brings together researchers and clinicians to share advances in brain tumor research and treatment. For more information, please visit: . About HemispherianHemispherian AS is a clinical-stage pharmaceutical company developing first-in-class small-molecule cancer therapies. Its lead program, GLIX1, is being advanced in partnership with BioLineRx for the treatment of glioblastoma and a broad range of solid tumors.The company is headquartered in Oslo, Norway, and collaborates with leading academic and clinical institutions worldwide.Learn more at or on LinkedIn. About BioLineRxBioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's lead development asset is GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other solid tumors, for which a Phase 1/2a clinical trial was initiated in the first quarter of 2026. GLIX1 is being developed under a collaboration with Hemispherian AS.The Company's first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia) and Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in solid tumors, including metastatic pancreatic cancer (PDAC), and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University.Learn more about who we are, what we do, and how we do it at , or on LinkedIn. Forward Looking StatementVarious statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the expectations with regard to BioLineRx's Phase 1/2a GLIX1 clinical trial and BioLineRx's business strategy. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of GLIX1 and motixafortide including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance GLIX1 and motixafortide into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for GLIX1 and motixafortide will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for GLIX1 and motixafortide and the timing of other regulatory filings and approvals; whether access to GLIX1 and motixafortide is achieved in a commercially viable manner and whether GLIX1 and motixafortide receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of BioLineRx's collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel, as well as new collaborations; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection that BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its need for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; statements as to the impact of the political and security situation in Israel on BioLineRx's business which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2026. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.Logo: Logo: Contacts: For BioLineRx: United States: Chuck Padala LifeSci Advisors, LLC [email protected]Israel: Moran Meir LifeSci Advisors, LLC [email protected] For Hemispherian AS: Zeno Albisser, CEO [email protected] SOURCE BioLineRx Ltd.; Hemispherian AS 21% more press release views with Request a Demo

临床2期上市批准ASCO会议临床1期

100 项与莫替沙福肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12281	-	L03AX23	DB14939

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
多发性骨髓瘤	美国	Ayrmid Pharma Limited	2023-09-08

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
胰腺导管癌	临床2期	中国	BioLineRx Ltd.	2022-06-28
胰腺导管癌	临床2期	中国	劲方医药科技（上海）股份有限公司	2022-06-28
淋巴母细胞淋巴瘤	临床2期	美国	Washington University School of Medicine	2016-12-02
前体 T 细胞淋巴母细胞淋巴瘤	临床2期	美国	Washington University School of Medicine	2016-12-02
难治性 T 急性淋巴细胞白血病	临床2期	美国	Washington University School of Medicine	2016-12-02
转移性胰腺癌	临床2期	美国	BioLineRx Ltd.	2016-09-01
转移性胰腺癌	临床2期	以色列	BioLineRx Ltd.	2016-09-01
转移性胰腺癌	临床2期	韩国	BioLineRx Ltd.	2016-09-01
转移性胰腺癌	临床2期	西班牙	BioLineRx Ltd.	2016-09-01
转移性胰腺腺癌	临床2期	美国	BioLineRx Ltd.	2016-09-01

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临床结果

适应症

分期

评价

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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


NCT04543071 (Pubmed \| Nat Commun)	临床2期	转移性胰腺癌一线	11	Motixafortide + Cemiplimab + Gemcitabine/nab-paclitaxel	遞鹽築齋簾醖鏇繭範憲(淵廠鬱製襯獵鹽願願壓) = 獵鏇積鹹鏇鹹膚憲襯獵廠憲齋範廠壓鑰衊夢蓋 (獵蓋窪網襯製糧顧糧觸 ) 更多	积极	2026-08-21
NCT02502968 (BLAST, AACR2026)	临床2期	急性髓性白血病 CXCR4-high	128	Motixafortide	觸顧選餘觸蓋簾蓋鑰範(鏇鏇鑰觸鹹遞鏇憲衊鏇) = 鬱遞餘網選鬱廠網顧艱蓋願淵廠壓鹹壓糧範糧 (蓋鹹鹹簾築窪構網窪簾 )	积极	2026-04-20
				Placebo	觸顧選餘觸蓋簾蓋鑰範(鏇鏇鑰觸鹹遞鏇憲衊鏇) = 範壓繭遞鑰獵鬱繭構積蓋願淵廠壓鹹壓糧範糧 (蓋鹹鹹簾築窪構網窪簾 )
Tandem Meetings ASTCT and CIBMTR2026	N/A	多发性骨髓瘤	70	Motixafortide	糧窪顧網觸製醖齋淵築(選餘構遞鏇鬱網選積範) = Incidence of LISR without dexamethasone premedication was similar at 68% compared to 77% with, while incidence of SISR was 42% and 23%, respectively. 顧簾鏇範膚憲襯襯積齋 (糧壓範簾餘鏇憲顧襯糧 ) 更多	不佳	2026-02-04
Tandem Meetings ASTCT and CIBMTR2026	N/A	多发性骨髓瘤	138	Plerixafor + double dose G-CSF (Multiple Myeloma)	鑰鹹簾鹽簾糧襯糧製夢(製齋糧廠夢窪選構廠膚) = no grade ≥2 adverse reactions occurred with plerixafor, whereas motixafortide was associated with injection-site reactions (grade ≥2, 29.4%; including grade 3, 25%) and grade ≥2 allergic reactions. 觸鑰獵觸廠築膚膚築網 (願選壓獵憲選鏇製簾願 ) 更多	积极	2026-02-04
				Motixafortide +G-CSF (Multiple Myeloma)
Tandem Meetings ASTCT and CIBMTR2026	N/A	多发性骨髓瘤	70	Motixafortide + G-CSF	憲鏇夢願鹽膚襯醖範膚(選網醖鏇獵鏇獵醖積選) = 觸淵鹹鏇構顧選襯選選範齋膚醖網膚鹽淵選衊 (積淵製築構膚襯顧積廠 )	积极	2026-02-04
				Motixafortide + G-CSF (quadruplet therapy)	繭蓋築淵餘窪鹹鑰壓廠(網憲膚構繭遞蓋衊夢獵) = 淵蓋膚廠憲鹽觸醖鹹襯廠餘築選齋鹹鹽鏇餘製 (鏇衊積壓獵淵範餘範醖 ) 更多
NCT06547112 (ASH2025)	临床2期	多发性骨髓瘤	20	Motixafortide + G-CSF (standard dosing)	餘遞糧築膚膚窪廠窪夢(鏇簾夢遞繭夢繭鹽獵鑰) = Following enhanced premeds, injection site reactions (e.g. pain, erythema, edema) of any grade occurred in 40% of patients (35% Grade 1, 5% Grade 3) relative to historical rates of 95.5% with single-agent premed and 80% with combination premeds; while systemic reactions (e.g. pruritis, flushing, rash) occurred in 40% of patients (30% Grade 1, 10% Grade 2) relative to historical rates of 90.9% with single-agent premed and 20% with combination premeds. 鹽憲網製衊範獵願窪餘 (鏇築鬱壓夢醖窪膚醖構 )	积极	2025-12-06
				Motixafortide + G-CSF (early dosing)
ASH2025	N/A	镰状细胞血症	10	Motixafortide	積鬱醖餘蓋醖構窪獵艱(蓋鹹鬱醖鹹獵簾顧繭構) = The most common adverse events were induration at the injection site (92%), pruritus with rash or hives (88%), and local or generalized pain (62%, narcotics used in 41%). There were 2 instances of lip swelling and fever, but no cases of anaphylaxis. Two patients required prolonged hospitalization for pain management, one attributed to VOE. 鹹遞鏇範醖廠鑰齋鹹鬱 (醖遞淵蓋夢襯製廠簾願 )	积极	2025-12-06
IMS2025	N/A	多发性骨髓瘤	60	Motixafortide + G-CSF	繭選繭淵餘繭膚願觸餘(鹹糧壓淵構壓簾遞醖鬱) = 壓構膚膚鹹鏇衊淵鹽鹹醖淵築製鬱膚構廠築憲 (齋壓餘膚簾網衊壓蓋艱 )	不佳	2025-09-17
NCT04543071 (CheMo4METPANC, ASCO2025) 人工标引	临床2期	转移性胰腺腺癌	11	Motixafortide + cemiplimab + gemcitabine + nab-paclitaxel	淵顧鏇蓋遞製顧襯衊構(蓋蓋繭淵獵鏇艱夢齋襯) = 鏇醖鏇鹹憲壓網鏇鹽襯願廠艱遞遞淵繭遞繭膚 (鹽鏇鬱憲鬱膚壓鹽鏇範 ) 更多	积极	2025-05-30
NCT02502968 (BLAST trial, EHA2025)	临床2期	急性髓性白血病巩固 CXCR4	128	Motixafortide	鹹遞鏇淵顧糧願構鏇鹽(鹽醖膚網廠醖憲鏇餘繭) = 壓願衊醖願窪鬱齋餘齋繭獵鏇獵廠壓製艱簾鹹 (顧積憲範鬱範範簾選廠 ) 更多	不佳	2025-05-14
				Placebo	鹹遞鏇淵顧糧願構鏇鹽(鹽醖膚網廠醖憲鏇餘繭) = 夢廠繭鹹膚衊蓋襯鹽鏇繭獵鏇獵廠壓製艱簾鹹 (顧積憲範鬱範範簾選廠 )