Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK 3β) Inhibitor, Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma

9-ING-41 is a small molecule potent selective GSK-3β inhibitor with antitumor activity. This study investigates 9-ING-41 in combination with carboplatin chemotherapy in patients with incurable, recurrent or metastatic salivary gland carcinomas (SGC). Patients with advanced SGC (including all histologic subtypes and adenoid cystic carcinoma [ACC]) will receive 9-ING-41 intravenously (IV) along with carboplatin IV at standard dosing together on Day 1, and 9-ING-41 alone on Day 4 of a 21-day cycle. Participants will be enrolled to two histologic cohorts: Cohort 1 will be comprised of those with ACC, and Cohort 2 will include patients with non-ACC SGC (or all other salivary gland cancer histologies). Treatment will continue until progression of disease, death, or discontinuation of therapy for any reason.

开始日期2030-12-18

申办/合作机构

Actuate Therapeutics, Inc.

NCT06896188

/ Recruiting临床1期IIT

A Phase Ib Study of 9-ING-41 (Elraglusib), a Glycogen Synthase Kinase 3-beta (GSK-3β) Inhibitor, Combined With Retifanlimab, a PD-1 Inhibitor, Plus Modified FOLFIRINOX as Frontline Therapy for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)

This is a study of the combination of 9 ING-41 (elraglusib) and retifanlimab plus mFOLFIRINOX in patients with pancreatic cancer without prior systemic therapy for advanced disease. The safety lead-in cohort will consist of 6 patients, followed by dose de-escalation if necessary, based on safety assessments. After evaluating the safety and tolerability at the initial dose level, the study will proceed to an expansion cohort at the determined safe dose level, with the total maximum enrollment not exceeding 12 patients for the entire study.

开始日期2025-09-22

申办/合作机构

University of Pittsburgh

[+2]

NCT05077800

/ Active, not recruiting临床2期IIT

A Phase II Study of FOLFIRINOX Combined With the Glycogen Synthase Kinase-3 Beta (GSK-3 β) Inhibitor Elraglusib and the Transforming Growth Factor-β (TGF-β) Inhibitor Losartan in Patients With Untreated Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to find out if an experimental drug will prevent metastatic pancreatic adenocarcinoma from becoming resistant to standard treatment for the disease.
The names of the study drugs involved in this study are:
* 9-ING-41
* Losartan
* Ferumoxytol
* FOLFIRINOX (made up of 4 different drugs):
* 5-Fluorouracil (5-FU)
* Oxaliplatin
* Irinotecan
* Leucovorin

开始日期2022-03-21

申办/合作机构

The Massachusetts General Hospital

[+2]

100 项与 Elraglusib 相关的临床结果

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100 项与 Elraglusib 相关的转化医学

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100 项与 Elraglusib 相关的专利（医药）

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项与 Elraglusib 相关的文献（医药）

2026-01-06·CLINICAL CANCER RESEARCH

Elraglusib, a Glycogen Synthase Kinase 3β Inhibitor, plus Chemotherapy with or without Immunotherapy in Patients with Recurrent, Metastatic Salivary Gland Carcinoma

Article

作者: Hanna, Glenn J. ; Jo, Vickie Y. ; Haddad, Robert I. ; Ugolkov, Andrey ; Wong, Kristine ; Scarfo, Nicole ; Sehgal, Kartik ; Mazar, Andrew ; Dennis, Michael J. ; O’Neill, Anne ; Shin, Kee-Young ; Bedard, Veronica

Abstract:

Purpose::

Glycogen synthase kinase 3β (GSK-3β) is a known therapeutic target in cancer. Aberrant nuclear GSK-3β (nGSK-3β) expression has been shown in some salivary gland cancers. Elraglusib is a small-molecule GSK-3β inhibitor with immunomodulatory potential. We hypothesized that elraglusib plus platinum-based chemotherapy and immunotherapy priming would be a novel treatment approach for salivary gland cancer.

Patients and Methods::

This phase II, open-label trial enrolled patients with recurrent or metastatic salivary gland cancer [adenoid cystic carcinoma (ACC) vs. other subtypes] with disease progression in the preceding year. Cohort 1 received elraglusib (15 mg/kg i.v. on days 1 and 4) plus carboplatin (AUC = 5) or cisplatin (75 mg/m2) every 21 days. Cohort 2 received two cycles of pembrolizumab (200 mg i.v.) every 21 days prior to the same regimen. The primary endpoint included best overall response rate (ORR) by RECIST v1.1 (>5/32 in response to detect 25% ORR).

Results::

Thirty-two patients were enrolled, including 15 (47%) with ACC and 17 (53%) with non-ACC. The best ORR was 9.4% [3/32; 95% confidence interval (CI), 2–25; three partial responses, all non-ACC]. Nineteen (59%) patients achieved stable disease. The median duration of response was 6.9 months. Common treatment-related adverse events were anemia (22, 69%), nausea (16, 50%), and neutropenia (14, 44%). At the median follow-up of 18.3 months, the median progression-free survival was 6.4 months (95% CI, 2.3–8.8), and the median overall survival was 18.6 months (95% CI, 9.7–29.4) overall. The median nGSK-3β expression was 50% versus 2% for responders versus nonresponders.

Conclusions::

The trial did not meet its primary endpoint, although 18% of patients with non-ACC treated with immune priming followed by cisplatin plus elraglusib achieved a response. Higher nGSK-3β expression was observed in tumor samples obtained from responders.

2025-12-31·CANCER BIOLOGY & THERAPY

Potential therapeutic GSK-3β inhibitor 9-ING-41 is active in combination with venetoclax in double-hit lymphoma (DHL)

Article

作者: Guo, Xutao ; Zhang, Yunxia ; Wei, Xiaolei ; Shi, Pengcheng ; Zheng, Haiqing ; Lei, Haohao

BACKGROUND:

Double-hit lymphoma (DHL) exhibits aggressive behavior due to dysregulated proliferation and resistance to apoptosis. Current therapies, including R-CHOP, show limited efficacy, necessitating novel strategies. 9-ING-41, a novel ATP-competitive small-molecule inhibitor that targets glycogen synthase kinase-3β (GSK-3β), has emerged as a promising therapeutic agent because of its ability to disrupt oncogenic signaling pathways associated with tumor progression and treatment resistance. However, the antitumor effects of 9-ING-41 in DHL remain unclear.

MATERIALS AND METHODS:

DHL cell lines (Karpas-422 and SuDHL2) were treated with venetoclax and 9-ING-41, either alone or in combination. Cell viability in cytotoxicity assays was assessed using the CCK-8 assay, while apoptosis and cell cycle changes were analyzed via flow cytometry. Western blotting was employed to evaluate alterations in the levels of GSK-3β and WNT/β-catenin pathway proteins following treatment.

RESULTS:

In preclinical studies utilizing DHL cell models, the single agent 9-ING-41 demonstrated robust biological activity through inducing significant G1/S phase cell cycle arrest and triggering apoptosis. When coadministered with venetoclax, a clinically approved BCL-2 inhibitor, the combination exhibited marked synergistic cytotoxicity in DHL cells, achieving superior inhibitory effects compared to either agent alone. The combined treatment enhanced cell cycle arrest, significantly reducing the number of S-phase cells and reinforcing G0/G1 arrest. Further mechanistic studies revealed that the combination modulated key proteins in the GSK-3 pathway and downstream WNT/β-catenin pathway, revealing a potential synergistic mechanism.

CONCLUSION:

The demonstrated single-agent efficacy and combination synergy with venetoclax support the potential of 9-ING-41 as a novel therapeutic strategy for DHL. These findings provide a proof-of-concept that may serve as a basis for future preclinical investigations in DHL.

2025-09-01·AMERICAN JOURNAL OF RESPIRATORY CELL AND MOLECULAR BIOLOGY

The Role of Tuftelin-1 in Mesomesenchymal Transition of Pleural Mesothelial Cells and the Progression of Pleural Fibrosis

Article

作者: Durojaye, Olamipejo ; Keshava, Shiva ; Florence, Matt ; Idell, Steven ; Ikebe, Mitsuo ; Okeke, Peace ; Qin, Wenyi ; Tucker, Torry A. ; Jeffers, Ann ; Owens, Shuzi ; Destarac, Luis

Abstract:

Pleural conditions causing exudative effusions (empyema or complicated parapneumonia) can result in pathological pleural organization leading to pleural fibrosis (PF). Pleural mesothelial cells (PMCs) undergo mesenchymal transition (MesoMT) and acquire a profibrotic phenotype characterized by increased expression of ACTA2; collagen type I (Col-1); and phenotypic changes, including elongation, stress fiber formation, and contraction. Using RNA-sequencing analysis, we identified Tuftelin-1 (Tuft1) as a novel potential target. Although prior studies have shown that Tuft1 expression is associated with aggressive cellular phenotypes, its role in PF is unknown. Our prior studies show that inhibition of PI3K/Akt, mTORC2, or GSK-3β blocks MesoMT. In this study, we build on previous findings and suggest that Tuft1 plays a key role in promoting MesoMT. In human PMCs, various mediators that induce MesoMT result in upregulation of Tuft1 expression. Furthermore, we also found that Tuft1 was increased in human pleuritis tissues and in murine models of PF compared with normal lung. In our studies, TGF-β–mediated increase in Tuft1 was blocked by the GSK-3β inhibitor 9-ING-41. Knockdown of Tuft1 in vitro blocked TGF-β–mediated MesoMT. Conversely, Tuft1 overexpression induced mTORC2 signaling and promoted MesoMT in the absence of TGF-β. In vivo analyses showed that mesothelial cell–specific Tuft1 knockout mice (Tuft1PMC−/−) were protected from Streptococcus pneumoniae–mediated pleural injury. Histological analysis showed that pleural thickening and profibrotic markers were significantly reduced in Tuft1PMC−/− mice compared with wild-type control animals. These studies strongly support therapeutic targeting of Tuft1 as a novel means to mitigate PF.

项与 Elraglusib 相关的新闻（医药）

2026-03-26

·药时空

胰腺癌治疗全景：前沿靶点、临床格局与千亿市场预测

胰腺癌因其高侵袭性、低生存率、治疗选择有限，成为全球恶性肿瘤中最棘手的癌种之一。本文系统梳理胰腺导管腺癌（PDAC）与胰腺神经内分泌肿瘤（pNETs）的标准治疗、靶向及免疫最新进展、后期临床在研药物，并给出2025—2034年市场规模预测，为临床与产业决策提供参考。一、疾病概况：两类胰腺癌，预后天差地别胰腺癌的癌症相关死亡人数与发病率极不匹配，凸显其恶性程度极高。外分泌肿瘤（90%–95%）以胰腺导管腺癌（PDAC）为主，起源于胰腺导管上皮，5年生存率仅约13%。胰腺神经内分泌肿瘤（pNETs，<5%）起源于激素分泌型胰岛细胞，恶性程度相对较低，5年生存率约50%。二、当前标准治疗1. 胰腺导管腺癌（PDAC）（1）可切除术后：辅助化疗体能状态好（ECOG 0–1）改良FOLFIRINOX（mFOLFIRINOX）：5‑氟尿嘧啶+亚叶酸钙+伊立替康+奥沙利铂，剂量调整后疗效与毒性更平衡。体能状态差/合并症多（ECOG 2）吉西他滨±卡培他滨。（2）不可切除局部晚期/转移：一线化疗标准方案： mFOLFIRINOX 吉西他滨 + 白蛋白结合型紫杉醇 2024年FDA新获批方案：NALIRIFOX 含脂质体伊立替康，相比FOLFIRINOX：更低血液学毒性、更少神经病变腹泻发生率更高（3）二线化疗一线用FOLFIRINOX → 二线以吉西他滨为基础方案一线用吉西他滨 → 二线脂质体伊立替康 + 5‑FU + 亚叶酸钙（4）分子靶向治疗（仅适用于特定亚型） BRCA胚系突变（4%–7%）奥拉帕利（PARP抑制剂）：一线铂类化疗≥16周未进展后的维持治疗。 MSI‑H/dMMR（1%–2%）帕博利珠单抗（PD‑1抑制剂）：后线治疗。 NRG1融合（1%–3%）泽诺妥珠单抗（HER2×HER3双抗）：FDA加速批准，用于既往治疗进展后。2. 胰腺神经内分泌肿瘤（pNETs）（1）早期手术切除为根治手段。（2）晚期/不可切除/转移控制激素症状：生长抑素类似物：奥曲肽、兰瑞肽（一线标准）。全身治疗：依维莫司（mTOR抑制剂）舒尼替尼、卡博替尼（TKI） 177Lu‑Dotatate（肽受体放射性核素治疗PRRT）适用于SSTR阳性（90%–95%）、生长抑素类似物进展后的GEP‑NETs。三、新兴疗法：后期管线重点靶点1. PDAC核心在研药物（1）RAS(ON)抑制剂：daraxonrasib 覆盖90%–95% RAS突变晚期PDAC 多项III期研究进行中，覆盖：既往治疗的转移患者术后辅助治疗一线联合化疗 2025年获： FDA突破性疗法认定（BTD）孤儿药资格（ODD）专员国家优先券（CNPV）（2）其他后期在研靶点 CD73抑制剂：quemliclustat 联合化疗（III期） PRMT5抑制剂：navlimetostat（针对MTAP缺失，约21%患者）多胺类似物：ivospemin GSK‑3β抑制剂：elraglusib（II期达到主要终点） MEK抑制剂：atebimetinib（2026年将启动全球III期）2. pNETs新兴疗法新型放射性药物 177Lu‑edotreotide：FDA审评中，PDUFA 2026-08-28 225Ac‑Dotatate：用于既往PRRT进展后新一代TKI：zanzalintinib表 1 | 胰腺癌在研药物精选靶点类似卡博替尼，但半衰期更短，用于晚期pNETs。四、市场预测：2034年逼近百亿美元据科睿唯安（Clarivate）预测：整体市场 2025年：32亿美元 2034年：97亿美元 PDAC（占绝对主体） 2025年：25亿美元 2034年：88亿美元 2025年主力：白蛋白结合型紫杉醇（12亿美元） 2034年主力： RAS抑制剂（daraxonrasib）：38亿美元 MEK抑制剂（atebimetinib）：15亿美元吉西他滨+白蛋白紫杉醇：近20亿美元 pNETs市场 2034年：接近10亿美元放射性药物 + TKI 合计约4.6亿美元按药物类别划分的主要市场胰腺癌核心疗法销售额预估要点总结 1.PDAC仍是预后最差的常见实体瘤，化疗仍为基石，RAS、MEK、CD73、PRMT5是未来突破方向。 2.分子分型（BRCA、MSI‑H、NRG1）已真正改变胰腺癌治疗模式。 3.pNETs走向长效生长抑素类似物 + 靶向 + PRRT的精准阶梯治疗。 4.2030年后，RAS抑制剂将重塑胰腺癌市场与临床格局。原文DOI：https://doi.org/10.1038/d41573-026-00027-3 识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

临床3期孤儿药突破性疗法临床结果加速审批

2026-03-24

·BioSpace

Actuate Therapeutics: Poised for Potential $200M+ Pediatric Priority Review Vouchers and Transformative Combinations in RAS-Driven Cancers

Meg Flippin, Benzinga Staff Writer CHICAGO, IL AND FORT WORTH, TX / ACCESS Newswire / March 24, 2026 / Actuate Therapeutics, Inc. (NASDAQ:ACTU) is a clinical-stage biopharmaceutical company advancing elraglusib, a first-in-class, highly selective small-molecule inhibitor of glycogen synthase kinase-3 beta (GSK-3β). This multimodal agent targets tumor survival pathways, DNA damage response, NF-κB signaling and the tumor immune microenvironment, offering a new potential treatment across multiple difficult-to-treat cancers including metastatic pancreatic ductal adenocarcinoma (mPDAC), melanoma, colorectal cancer and sarcomas. What sets Actuate apart is its dual formulation strategy and recent momentum in pediatrics. While the company reports that the intravenous (IV) form has generated compelling clinical data, it is also advancing an oral tablet version of elraglusib that could significantly expand the drug's utility and commercial appeal. The Oral Compound: Convenience, Compliance And Broader Reach Actuate has successfully completed a phase 1 study of elraglusib oral formulation in healthy volunteers, demonstrating robust bioavailability-approximately 51% relative to IV when dosed with food-and dose-proportional pharmacokinetics without unexpected safety signals. A Phase 1 dose-escalation trial of the oral tablet in advanced cancer patients (Actuate-2401) is planned, with the oral formulation offering key advantages: daily dosing for steady-state exposure, improved patient compliance (especially in long-duration responses), lower manufacturing costs at commercial scale and potential expansion into pediatric populations or adult indications where oral therapies are preferred. This shift to oral could broaden elraglusib's addressable market while maintaining the same potent GSK-3β inhibition that has already shown disease control and responses when combined with chemotherapy backbones. Pediatric Breakthroughs And The Rare Pediatric Disease Priority Review Voucher (PRV) In January 2026, Actuate reported highly encouraging phase 1 data from the open-label Actuate-1902 trial in 40 children and adolescents (ages 3-21) with relapsed/refractory malignancies. Notable highlights included two complete responses in relapsed/refractory metastatic Ewing sarcoma and one complete response in relapsed/refractory metastatic neuroblastoma when elraglusib was combined with cyclophosphamide/topotecan. No maximum tolerated dose was reached, and responses supported plans to advance into Ewing sarcoma (and potentially neuroblastoma) in 2026. Crucially, the FDA first granted Rare Pediatric Disease Designation to elraglusib for neuroblastoma and subsequently for Ewing sarcoma in November 2024. Upon approval of a New Drug Application for either indication, Actuate would be eligible to receive a Priority Review Voucher (PRV). The PRV program incentivizes development for rare pediatric diseases (affecting fewer than 200,000 U.S. children) by granting the sponsor a voucher redeemable for a six-month priority FDA review of any future marketing application-potentially shaving four months off the standard 10-month timeline. Vouchers are fully transferable and can be sold to other companies, providing a non-dilutive financing mechanism that has historically delivered substantial value. The High Value Of Pediatric Review Vouchers And Recent Sales Actuate reports that PRVs have traded at premium prices in recent years, reflecting their ability to accelerate revenue for blockbuster candidates. Following the program's reauthorization through September 2029 via the Consolidated Appropriations Act of 2026, transaction values have remained strong: Jazz Pharmaceuticals sold a voucher for $200 million (January 2026) Fortress Biotech reportedly sold one for $205 million (February 2026) Abeona Therapeutics: $155 million (June 2025) Zevra Therapeutics: $150 million (April 2025) Ipsen: $158 million (August 2024) Acadia Pharmaceuticals and PTC Therapeutics: $150 million each (late 2024) Average recent sales have clustered around $150-200 million, with some exceeding that level. For a small-cap company like Actuate, monetizing a PRV could represent transformative non-dilutive capital to fund late-stage development, oral formulation advancement or strategic partnerships-without relying solely on equity raises or debt. Why RAS Inhibitor Leaders Like Revolution Medicines (RVMD) And Erasca (ERAS) May Need To Combine With Elraglusib RAS mutations drive ~30% of all human cancers, including the majority of pancreatic, colorectal and certain lung cancers-areas where single-agent RAS(ON) or RAS pathway inhibitors have shown promise but face adaptive resistance. In March 2026, Actuate launched a dedicated research initiative evaluating elraglusib in combination with emerging RAS-targeted therapies. Preclinical combination data are expected in the second half of 2026. The scientific rationale is compelling and multi-pronged, reports Actuate. Elraglusib's GSK-3β inhibition disrupts downstream survival signaling (via NF-κB and MYC suppression), impairs DNA damage repair and enhances anti-tumor immunity by boosting antigen presentation and activating T- and NK-cell responses. When paired with RAS(ON) inhibitors-which potently block proliferative RAS-GTP signaling-the combination can push tumor cells past the apoptotic threshold and overcome resistance mechanisms that limit monotherapy durability. Revolution Medicines (RVMD) is advancing a leading RAS(ON) portfolio, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12C-selective elironrasib and G12D-selective zoldonrasib, with strong focus on KRAS-mutant pancreatic ductal adenocarcinoma (PDAC), NSCLC and colorectal cancer. Erasca (ERAS) is similarly pursuing RAS/MAPK pathway inhibitors. Both companies' assets excel at shutting down oncogenic RAS signaling but may benefit from orthogonal mechanisms like GSK-3β blockade to address tumor intrinsic resistance, immune evasion and microenvironment support. Actuate's initiative positions elraglusib as a natural complementary agent. In RAS-addicted tumors, the combination strategy could deliver deeper, more durable responses - potentially expanding the clinical and commercial opportunity for RVMD, ERAS and other RAS-focused players while creating high-value partnership or licensing opportunities for Actuate. Outlook: Multiple Catalysts And Strategic Optionality With positive pediatric data, an advancing oral formulation, mPDAC phase 2 overall survival signals and a new RAS combination program, Actuate is entering a high-impact period. A potential PRV monetization upon pediatric approvals could provide immediate capital, while the oral program and RAS research initiative open doors to broader adult oncology markets and collaborations. As the only clinical-stage GSK-3β inhibitor with this breadth of mechanistic and clinical support, Actuate believes elraglusib could become a backbone therapy in both rare pediatric cancers and the much larger RAS-mutant solid tumor landscape. For investors and patients alike, Actuate Therapeutics may deserve a closer look as a rather compelling case where scientific innovation, regulatory incentives and strategic positioning converge. Click here for more information on Actuate Therapeutics. Featured image from Shutterstock . This post contains sponsored content and was created in collaboration with a third-party partner. Benzinga is a publisher and does not provide personalized investment advice or act as a broker or dealer. This content is for informational purposes only and is not intended to be investing advice or an offer or solicitation to buy or sell any security. Contact: Investor Relations info@actuatetherapeutics.com SOURCE: Actuate Therapeutics, Inc. View the original press release on ACCESS Newswire

临床1期优先审批临床2期临床结果

2026-03-20

·研报客-行业研究报告

药渡全球药物研发进展报告_创新药篇_61页_2mb.pdf

📝 研报客AI助手-AI报告总结 2026年1月3日—1月9日药渡全球药物研发进展报告（创新药篇）核心内容概述本周药渡数据汇总了全球及国内药物研发与批准的最新进展，重点覆盖了新药上市、申报进展、临床试验更新以及医药交易动态。报告内容涉及多个治疗领域，包括肿瘤、神经疾病、感染、皮肤和结缔组织疾病、心血管疾病、消化系统疾病等，同时包含了重要的医药合作与许可事件。一、全球药物批准/研发动态1.1 全球新药批准情况 NDA批准： Aprocitentan：Idorsia Pharmaceuticals，用于治疗成人难治性高血压，2026年1月5日获得加拿大HC批准。 Plozasiran sodium：Arrowhead，用于降低家族性乳糜微粒血症(FCS)患者的甘油三酯水平，2026年1月5日获得加拿大HC批准。 BLA批准： Depemokimab：GSK，用于治疗重度或难治性支气管哮喘及伴有鼻息肉的慢性鼻窦炎，2026年1月6日获得日本PMDA批准。新制剂批准：重组带状疱疹疫苗：GSK，2026年1月7日获得EMA批准新制剂。 1.1.2 其他批准情况疫苗批准：本周暂无相关药物获批。新复方批准：本周暂无相关药物获批。新适应症批准：本周暂无相关药物获批。拒绝批准/主动撤回/撤市：本周暂无相关药物。二、全球新药申报进展1.2.1 NDA/BLA申报 Lorecivivint：Biosplice Therapeutics，用于治疗膝关节炎(OA)，2026年1月6日向FDA递交NDA。 Teplizumab：Sanofi，用于治疗1岁及以上2期I型糖尿病，2026年1月5日FDA受理sBLA。 1.2.2 特殊资格认定 Teplizumab：Sanofi，获得FDA优先审评资格认定。 Atacicept：Vera Therapeutics，获得FDA优先审评资格认定。三、全球新药研发进展1.3.1 肿瘤领域 Elraglusib：Actuate Therapeutics，针对难治性恶性肿瘤，公布I/II期临床积极数据。 BBO-8520：BridgeBio Oncology，用于KRAS G12C突变非小细胞肺癌，公布Ia/Ib期临床积极数据。 BBO-11818：BridgeBio Oncology，用于局部晚期不可切除或转移性KRAS突变实体瘤，公布Ia/Ib期临床积极数据。 BBO-10203：BridgeBio Oncology，用于HER2+乳腺癌、HR+/HER2-乳腺癌、KRAS突变结直肠癌等，公布Ia/Ib期临床积极数据。 APG-3288：Ascentage Pharma，用于治疗复发/难治性B细胞恶性肿瘤，FDA批准IND。 Atebimetini b：Immuneer ing Corporation，用于胰腺癌，公布IIa期临床积极数据。 ODM-212：Orion Pharma，用于恶性胸膜间皮瘤和上皮样血管内皮瘤，启动II期临床。 Calderasib：Merck，用于KRAS G12C突变非小细胞肺癌，公布III期临床积极数据。 Spevatamig：Phanes Therapeutics，用于CLDN18.2阳性转移性胰导管腺癌，公布II期临床积极数据。 1.3.2 神经疾病领域 BMB-101：Bright Minds Biosciences，用于治疗失神发作与发育性及脑病性癫痫，公布II期临床积极数据。 Zervimesine fumarate：Cognition Therapeutics，用于治疗路易体痴呆症(DLB)，公布II期临床积极数据。 ARO-HTT：Sarepta Therapeutics，用于亨廷顿舞蹈症，向Medsafe递交IND。 Bezisterim：BioVie，用于未经卡比多巴/左旋多巴治疗的早期帕金森病(PD)，公布III期临床积极数据。 1.3.3 感染领域 Bepirovirsen：GSK，用于治疗慢性乙型肝炎，公布II期临床积极数据。 Opelconazole：Pulmocide，用于治疗难治性侵袭性肺曲霉病(IPA)，终止III期临床试验。 1.3.4 皮肤和结缔组织疾病领域 IDOR-1117-2520：Idorsia Pharmaceuticals，用于中重度银屑病，启动II期临床。 Envudeuciti nib：Alumis，用于中重度斑块型银屑病，公布III期临床积极数据。 Cantharidin：Verrica Pharmaceuticals，用于寻常疣，启动III期临床。 1.3.5 病理状态、体征和症状领域 Daridorexant hydrochloride：Idorsia Pharmaceuticals，用于治疗更年期过渡期女性失眠，公布III期临床积极数据。 1.3.6 内分泌系统疾病领域 ASC-30：歌礼制药，用于糖尿病，FDA批准II期临床。 Eflapegrastim：Assertio Holdings，用于乳腺癌，公布I期临床积极数据。 Eloralintide：Eli Lilly，用于肥胖，启动III期临床。 Ixekizumab：礼来，用于治疗活动性银屑病关节炎与肥胖或超重，公布IIIb期临床积极数据。 1.3.7 精神疾病领域 Evenamide Hydrochloride：Newron Pharmaceuticals，用于精神分裂症，启动III期临床。 M4-PAM：Addex Therapeutics，用于精神分裂症，启动I期临床。 Brilaroxazine：Reviva Pharmaceuticals，用于精神分裂症，公布III期临床积极数据。 1.3.8 泌尿和生殖系统疾病领域 Vonafexor：ENYO Pharma，用于Alport综合征，公布II期临床积极数据。 1.3.9 免疫系统疾病领域 Obexelimab：Zenas Biopharma，用于治疗IgG4相关疾病，公布III期临床积极数据。 Nipicalimab：Johnson & Johnson，用于治疗系统性红斑狼疮(SLE)，公布II期临床积极数据。 HMBD-501：Humming bird Bioscience，用于治疗晚期HER3表达的实体恶性肿瘤，公布II期临床积极数据。 1.3.10 呼吸系统疾病领域 IBI-324：信达生物与Ollin Biosciences，用于治疗糖尿病性黄斑水肿(DME)或湿性年龄相关性黄斑变性(wAMD)，公布Ib期临床积极数据。 CMTX-101：EnteroBiotix，用于肠易激综合征(IBS)，公布II期临床积极数据。 1.3.11 血液和淋巴疾病领域 Teclistamab：Johnson & Johnson，用于治疗复发/难治性多发性骨髓瘤(RRMM)，公布III期临床积极数据。 AB-8939：AB Science，用于治疗急性髓系白血病，公布I期临床积极数据。 1.3.12 心血管疾病领域 SRD-002：Medera，用于治疗射血分数保留心力衰竭(HFpEF)，完成I/IIa期临床B队列患者给药。 1.3.13 肌肉和骨骼系统疾病领域 Navepegriti de：Ascendis Pharma，用于治疗软骨发育不全(ACH)，公布II期临床积极数据。 Lonapegso matropin：Ascendis Pharma，用于治疗儿童软骨发育不全(ACH)，已上市。 1.3.14 先天性遗传性疾病和畸形领域 Diazoxide choline controlled release：Soleno Therapeutics，用于治疗Prader-Willi综合征患者的食欲亢进，公布III期临床积极数据。 Lonimecogene renparvovec：Taysha Gene Therapies，用于治疗雷特综合征，FDA积极意见反馈。 1.3.15 营养代谢病领域 ARO-INHBE：Arrowhead，用于治疗肥胖，公布I/IIa期临床积极数据。 ARO-ALK7：Arrowhead，用于治疗肥胖，公布I/IIa期临床积极数据。 Eloralintide：Eli Lilly，用于治疗肥胖，启动III期临床。 Ixekizumab：礼来，用于治疗活动性银屑病关节炎与肥胖或超重，公布IIIb期临床积极数据。 1.3.16 眼部疾病领域 IBI-324：信达生物与Ollin Biosciences，用于治疗糖尿病性黄斑水肿(DME)或湿性年龄相关性黄斑变性(wAMD)，公布Ib期临床积极数据。 GEB-101：引正基因，用于治疗TGFBI相关角膜营养不良，FDA批准I/II期临床。 1.3.17 消化系统疾病领域 Nitazoxanide (Genfit)：GENFIT，用于治疗急性慢性肝衰竭(ACLF)，公布I期临床积极数据。 EP-104GI：Eupraxia Pharmaceuticals，用于治疗嗜酸性食管炎(EoE)，公布Ib/IIa期临床积极数据。 EBX-102-02：EnteroBiotix，用于治疗肠易激综合征(IBS)，公布II期临床积极数据。四、全球医药交易事件汇总 | 事件名称 | 交易主体方 | 交易合作方 | 交易项目 | 治疗领域 | 交易类型 | 交易金额（百万） | 交易时间 ||----------|------------|------------|----------|----------|----------|------------------|-----------|| 罗氏获得YL201的独家许可 | 苏州宜联生物医药有限公司 | 罗氏 | YL-201 [临床三期] | 多种实体瘤 | 许可 | N/A | 2026.01.09 || 育世博获得双特异性抗体及双载荷ADC项目的独家许可 | 百奥赛图(北京)医药科技股份有限公司 | 育世博生物科技股份有限公司 | 双特异性抗体及双载荷ADC项目 | 肿瘤 | 许可；期权 | N/A | 2026.01.09 || Madrigal获得辉瑞关于MASH pipeline assets的独家许可 | 辉瑞 | Madrigal Pharmaceuticals Inc | two additional early-stage MASH pipeline assets | 代谢功能障碍相关脂肪肝炎(MASH) | 许可 | 50.00 USD | 2026.01.09 || Zealand Pharma与The Danish Centre for AI Innovation合作 | Zealand Pharma A/S | The Danish Centre for AI Innovation A/S | drug discovery | 癌症 | 合作 | N/A | 2026.01.09 || 诺纳生物与Link Cell Therapies合作 | 诺纳生物 | Link Cell Therapies Inc | 新型CAR-T细胞疗法候选药物 | 实体瘤；血液肿瘤 | 合作 | N/A | 2026.01.09 || Chai Discovery与礼来制药合作 | Chai Discovery | 礼来制药 | AI/ML-enabled membrane interactomics (MInt) platform | 肿瘤 | 合作；许可；投资 | 950.00 USD | 2026.01.07 || Ventex Biosciences被礼来制药收购 | Ventex Biosciences Inc | 礼来制药 | Ventex Biosciences Inc | 炎症介导疾病 | 收购 | 1200.00 USD | 2026.01.07 || 苏州新芽基因与DystrophyAnnihilation合作 | 苏州新芽基因生物技术有限公司 | DystrophyAnnihilationResearchTrust | 创新型DMD疗法 | 杜氏肌营养不良症 | 合作 | N/A | 2026.01.07 || Prokaryotics与Basilea合作 | Prokaryotics Inc | Basilea Pharmaceuticals Ltd | first-in-class broad-spectrum antifungal | 严重侵袭性感染 | 合作 | 48.50 USD | 2026.01.07 || 苏州新芽基因与DystrophyAnnihilation合作 | 苏州新芽基因生物技术有限公司 | DystrophyAnnihilationResearchTrust | 创新型DMD疗法 | 杜氏肌营养不良症 | 合作 | N/A | 2026.01.07 |关键信息总结全球新药批准：本周全球共有4条新药批准更新，主要集中在高血压、哮喘及FCS领域。全球新药申报：全球有2条新药申报进展，其中一项为FDA受理sBLA。全球新药研发：涉及17个治疗领域，其中肿瘤、神经疾病、内分泌系统疾病及免疫系统疾病进展显著。医药交易：本周有多项合作及收购事件，涉及CAR-T细胞疗法、基因疗法、AI平台开发等，显示全球医药行业在创新与合作方面的活跃趋势。报告正文免费获取报告源文件，请点下方图片研报客 - 全球行业报告图表数据聚合AI平台 5000多家机构，五百万+报告覆盖全行业深度研究一站式行业研究报告平台，汇聚全球百强智库，百万中英文报告 ✨ 核心功能 📊 海量报告：覆盖全行业，AI搜索+全文检索 🤖 AI翻译：多语言互译，保留原排版 💬 AI对话：智能研报助手，深度解读文档 🔔 实时推送：订阅关键词，更新主动通知 📱 全平台：网页、APP、小程序数据同步 🤖 AI能力 🔍 智能检索：快速理解问题意图，提供精准信息 🌐 多源整合：综合多个可靠来源，给出全面答案 💡 语境理解：不只是字面翻译，更能理解上下文和文化差异 🎯 专业领域：适应技术、文学、商务等不同领域的翻译需求 🧠 自然交流：理解复杂对话上下文，保持连贯性 📚 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临床2期上市批准优先审批临床申请

100 项与 Elraglusib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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
转移性胰腺导管腺癌	临床2期	美国	Mayo Clinic	2025-05-30
转移性黑色素瘤	临床2期	美国	Actuate Therapeutics, Inc.	2023-05-31
转移性黑色素瘤	临床2期	美国	Lantern Pharma, Inc.	2023-05-31
转移性胰腺腺癌	临床2期	美国	Actuate Therapeutics, Inc.	2022-03-21
转移性骨肉瘤	临床2期	美国	Actuate Therapeutics, Inc.	2022-03-01
小细胞肉瘤	临床2期	美国	Actuate Therapeutics, Inc.	2022-03-01
晚期胰腺腺癌	临床2期	美国	Incyte Corp.	2022-01-26
晚期胰腺腺癌	临床2期	美国	Actuate Therapeutics, Inc.	2022-01-26
胰腺导管腺癌	临床2期	美国	Actuate Therapeutics, Inc.	2022-01-26
胰腺导管腺癌	临床2期	美国	Incyte Corp.	2022-01-26

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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


NCT03678883 (1801 Part 3B, ASCO_GI2026)	临床2期	转移性胰腺癌一线 KRAS \| TP53 \| CDKN2A	170	Elraglusib/Gemcitabine/nab-paclitaxel	鬱餘築選壓壓顧網廠獵(艱憲淵鏇艱淵構齋積獵) = KRAS and TP53 gene mutations were associated with worse overall survival (OS) in patients treated with elraglusib/GnP (p<0.05) but not in GnP-treated patients. 築襯簾窪築廠窪糧簾鏇 (襯窪廠積築醖鹹觸壓艱 )	积极	2026-01-08
NCT03678883 (1801 Part 3B, ASCO_GI2026)	临床2期	转移性胰腺癌一线 KRAS \| TP53 \| CDKN2A	170	Gemcitabine/nab-paclitaxel		积极	2026-01-08
NCT04239092 (Actuate-1902, GlobeNewswire) 人工标引	临床1期	肉瘤 \| 尤文肉瘤	10	elraglusib	鹽範顧襯築壓顧夢淵製(獵糧壓夢鏇製壓膚觸繭) = 遞鏇憲繭糧壓夢壓觸鬱淵齋憲蓋鑰廠夢淵淵淵 (膚鏇範願鹽襯願膚遞繭 ) 更多	积极	2025-07-17
NCT05239182 (RiLEY, CTgov)	临床2期	胰腺腺癌 \| 胰腺导管腺癌 \| 晚期胰腺腺癌	7	9-ING-41+Abraxane+Gemcitabine+Retifanlimab	範糧繭廠廠築鑰廠獵簾 = 蓋繭鹹範築膚顧鏇選構鬱顧壓繭廠鬱觸鑰夢壓 (獵網遞築艱艱顧獵鏇鹹, 夢艱廠窪夢醖鏇遞衊顧 ~ 網鹹鏇壓鹽觸簾鹽獵顧) 更多	-	2025-07-17
NCT03678883 (1801 part 3B, ASCO2025)	临床2期	转移性胰腺导管腺癌 CA 19-9 levels \| IFNβ \| PD-L1	-	Elraglusib 9.3 mg/kg IV once weekly + Gemcitabine/nab-paclitaxel	製積衊膚觸製鬱夢襯積(廠獵願積網壓願獵選醖) = 築窪壓廠顧範築膚選淵憲觸積夢選獵製蓋壓淵 (積窪製觸鑰鏇網鑰構鬱 ) 更多	积极	2025-05-30
NCT03678883 (1801 part 3B, ASCO2025)	临床2期	转移性胰腺导管腺癌 CA 19-9 levels \| IFNβ \| PD-L1	-	Gemcitabine/nab-paclitaxel	製積衊膚觸製鬱夢襯積(廠獵願積網壓願獵選醖) = 築範壓壓淵壓構淵鏇夢憲觸積夢選獵製蓋壓淵 (積窪製觸鑰鏇網鑰構鬱 ) 更多	积极	2025-05-30
NCT03678883 (Actuate-1801 Part 3B, GlobeNewswire) 人工标引	临床2期	转移性胰腺癌一线	-	elraglusib + gemcitabine/nab-paclitaxel (GnP)	膚襯襯鬱齋鏇憲夢艱膚(構齋廠憲獵遞簾壓齋廠) = elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met the primary endpoints and achieved statistical significance in topline results. 膚鹹積簾鬱窪窪顧齋壓 (憲遞鑰鏇製淵憲艱觸繭 ) 达到	积极	2025-05-09
NCT03678883 (Actuate-1801 Part 3B, GlobeNewswire) 人工标引	临床2期	转移性胰腺癌一线	-	gemcitabine/nab-paclitaxel (GnP)		积极	2025-05-09
NCT05010629 (AACR2025)	临床2期	唾液腺肿瘤 tumor PD-L1 \| GSK-3β expression	32	Elraglusib	構顧積夢醖築遞糧簾衊(衊獵構選鹹簾膚觸觸窪) = 鹹壓積製蓋願壓鑰鑰範築鏇選壓壓衊餘顧淵憲 (膚餘醖淵顧築窪網顧廠, 2 ~ 25) 更多	积极	2025-04-29
NCT04239092 (Actuate-1801, GlobeNewswire) 人工标引	临床2期	胰腺癌一线	286	Elraglusib + gemcitabine/nab-paclitaxel	齋壓蓋齋顧醖網遞窪鏇(憲膚齋範壓鬱製壓鏇窪) = 範觸襯選憲範製繭餘鹹顧選艱鏇顧窪壓夢製齋 (製遞襯蓋構製齋獵繭醖 ) 达到更多	积极	2024-12-17
NCT04239092 (Actuate-1801, GlobeNewswire) 人工标引	临床2期	胰腺癌一线	286	gemcitabine/nab-paclitaxel	齋壓蓋齋顧醖網遞窪鏇(憲膚齋範壓鬱製壓鏇窪) = 願糧範鏇觸廠築夢製製顧選艱鏇顧窪壓夢製齋 (製遞襯蓋構製齋獵繭醖 ) 达到更多	积极	2024-12-17
NCT05077800 (AACR2024 \| NEWS)	临床2期	转移性胰腺癌一线	6	Elraglusib+FOLFIRINOX+氯沙坦	製齋襯選窪餘選顧鬱鏇(鹹廠壓醖繭鑰糧窪憲構) = 膚獵網衊鹽簾獵襯鹹膚餘夢簾顧鬱衊獵鹹醖簾 (構製構觸醖襯鹽顧廠餘 ) 更多	积极	2024-09-16
NCT04239092 (GlobeNewswire) 人工标引	临床1/2期	尤文肉瘤 \| 促纤维增生性小圆细胞瘤	8	elraglusib	積願積範鏇醖鬱醖願衊(壓淵夢繭鑰鬱網糧選鬱) = 鹽襯繭觸醖範餘鬱遞顧遞積範醖鏇餘襯夢艱製 (窪壓窪蓋構糧壓鬱選襯 ) 更多	积极	2024-09-09
NCT03678883 (ASCO 12023 \| ASCO 22023) 人工标引	临床2期	晚期胰腺导管腺癌	42	gemcitabine+Albumin-Bound Paclitaxel+Elraglusib	構廠築襯齋觸選廠餘構(醖製選觸願範鹽積繭醖) = 鏇餘衊選鹹衊醖構蓋顧獵壓衊簾鹹觸網襯顧夢 (鬱鏇糧醖簾餘膚憲築繭, 32.5 ~ 70.6) 更多	积极	2023-05-26