A Multicenter, Open-label, Single-arm, Phase 4 Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil Mesylate Tablets in Chinese Adolescents (Aged From 12 to Less Than 18 Years) With Chronic Graft-versus-host Disease (cGVHD) Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies

This is a single group, Phase 4, single-arm post-marketing study for treatment.
The purpose of this study is to verify the pharmacokinetics, efficacy, and safety of belumosudil mesylate tablets in Chinese adolescent participants (aged from 12 to less than 18) with cGVHD who have had an inadequate response to glucocorticoids or other systemic therapies.
Participants will receive treatment with belumosudil tablets 200 mg once daily in 28-day cycles during the study.

开始日期2024-11-07

申办/合作机构

Sanofi

NCT05567406 / Recruiting临床2期

A Phase 2, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Participants With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

The purpose of this study is to measure safety and efficacy of oral belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander male and female participants with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy aged 12 years and above.
The duration of participants participation will be up to 4 weeks for screening, treatment until clinically significant progression of disease, and 4 weeks of safety follow-up, and then long-term follow-up every 12 weeks.1 Cycle = 28 days.

开始日期2024-11-04

申办/合作机构

Kadmon Holdings, Inc.

NCT06476132 / Not yet recruiting临床2期IIT

Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients: A Randomized, Multicenter, Double Blind, Placebo-Controlled Trial (CTOT-47)

The purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks in addition to your usual care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). For this study, biopsies that show evidence of Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP) or Acute Lung Injury (ALI) are referred to as "Qualifying Biopsies"; patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study. Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring and may play a role in the development and progression of CLAD. Belumosudil is a drug approved by the FDA to treat adults and children 12 years and older with chronic graft-versus-host disease (cGVHD), a condition with some similarities to CLAD.
The primary objective it to determine the efficacy of treatment with Belumosudil + maintenance immunosuppression (IS) versus placebo + maintenance IS on preventing the subsequent development of probable or definite CLAD, lung retransplant, or death.

开始日期2024-10-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与贝舒地尔相关的临床结果

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100 项与贝舒地尔相关的转化医学

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100 项与贝舒地尔相关的专利（医药）

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项与贝舒地尔相关的文献（医药）

2024-10-01·BIOORGANIC CHEMISTRY

Discovery of novel pyrazolo[1,5-a]pyrimidine derivatives as selective ROCK2 inhibitors with anti-breast cancer migration and invasion activities

Article

作者: Yue, Lingfeng ; Jiang, Nan ; Zhai, Xin ; Zhang, Jiahe ; Cao, Zhi ; Wei, Xiujian ; Zhang, Jiahao ; Wang, Shuqi ; Xing, Shuming

Rho-associated coiled-coil kinase (ROCK) is involved in multiple cellular activities regulating the actin cytoskeleton, such as cell morphology, adhesion, and migration. The inhibition of ROCK is a feasible strategy to suppress breast cancer metastasis. Herein, based on Belumosudil, a series of pyrazolo[1,5-a]pyrimidine derivatives as selective ROCK2 inhibitors were designed and synthesized. Through systematic investigation of SARs, the piperazine analog 7u was identified with optimum ROCK2 inhibitory activity (IC₅₀ = 36.8 nM) and excellent selectivity over the isoform protein ROCK1 (>250-fold). Intriguingly, upon treatment with 7u, the arrangement of the MDA-MB-231 cytoskeleton was affected accompanied by the alteration of morphology. Furthermore, cell scratch and transwell assays indicated that 7u inhibited MDA-MB-231 cell migration and invasion in a dose-dependent manner. Ultimately, the binding model of 7u with ROCK2 well accounted for the superior activities of 7u as a promising ROCK2 inhibitor with the potential application in breast cancer metastasis treatment.

2024-10-01·AMERICAN JOURNAL OF HEMATOLOGY

An open‐label study of belumosudil, a selective ROCK2 inhibitor, as second or subsequent line of therapy for steroid‐dependent/steroid‐resistant chronic GVHD

Article

作者: Ikegame, Kazuhiro ; Murayama, Shun ; Onishi, Yasushi ; Inamoto, Yoshihiro ; Matsuoka, Ken‐ichi ; Teshima, Takanori ; Katayama, Yuta ; Toyosaki, Masako ; Hiramoto, Nobuhiro ; Kato, Koji ; Maeda, Yoshinobu ; Kawakita, Toshiro ; Sasagawa, Yuji ; Hatake, Kiyohiko ; Shiratori, Soichi

Abstract:

Belumosudil mesylate is a selective Rho‐associated coiled‐coil kinase 2 inhibitor with immunomodulatory and antifibrosis effects. This multicenter, open‐label, single‐arm study evaluated belumosudil 200 mg once daily as second or subsequent line of therapy (LOT) in 21 Japanese patients ≥12 years of age with steroid‐dependent/steroid‐resistant chronic graft‐versus‐host disease (cGVHD). The primary endpoint of best overall response rate (ORR) at 24 weeks after enrollment of the last patient was 85.7% (95% confidence interval [CI]: 63.7–97.0), and the lower limit of the 95% CI exceeded the pre‐defined threshold of 25%. The Kaplan–Meier estimate of duration of response rate at 24 weeks was 75% (95% CI: 46–90); 13/18 responders (72.2%) had a sustained response for ≥20 weeks. The median time to response was 4.1 weeks (range 3.90–8.10); ORR was 47.6% at 4 weeks and 75.0% at 24 weeks; best ORR was 80% for joints/fascia, 66.7% for the mouth, and 54.5% for skin. Overall, 57.1% of patients had clinically meaningful symptom improvement at least once; the median duration of symptom improvement was 22.2 weeks (range 4.0–51.3). Corticosteroid dose reductions were recorded for 57.1% of patients. Median failure‐free and overall survival were not reached. Treatment‐emergent adverse events occurred in 85.7% of patients (most commonly diarrhea, 19.0%), of which 38.1% were drug‐related. There were no drug‐related discontinuations or deaths. In summary, belumosudil 200 mg once daily as second or subsequent LOT in Japanese patients with steroid‐dependent/steroid‐resistant cGVHD was effective, with no new safety concerns.

2024-10-01·Heliyon

Comprehensive chromatographic analysis of Belumosudil and its degradation products: Development, validation, and In silico toxicity assessment

Article

作者: Alanazi, Mohammed M. ; Darwish, Hany W. ; Attwa, Mohamed W ; Attwa, Mohamed W. ; Darwish, Ibrahim A ; Alanazi, Mohammed M ; Darwish, Hany W ; Ali, Awadh M. ; Ali, Awadh M ; Darwish, Ibrahim A.

Following ICH guidelines, the stability of Belumosudil, a novel protein kinase inhibitor, was tested under different stress conditions (hydrolytic, oxidative, photolytic, and thermal). A selective and efficient separation of Belumosudil and its degradation products was achieved using a Quality by Design approach. In-silico predictions using Zeneth Nexus® software were employed to assess the compound's degradation under various stress scenarios. The methodology developed through experimental design analyzed crucial process parameters connected with chromatographic systems. Reversed-phase high-performance liquid chromatography with a C18 column and a gradient mobile phase of acetonitrile and 25 mM ammonium hydrogen carbonate buffer (pH 5.6) were utilized. For structural characterization and identification of degradation products, UPLC-quadrupole tandem mass spectrometry was employed. Four distinct degradation products were identified under different stress settings. The method was thoroughly validated, assessing accuracy, selectivity, repeatability, system suitability, and linearity range (5.0-120.0 μg/mL). To predict mutagenicity and toxicity, DEREK Nexus® software was used. Two degradation products were predicted to induce skin sensitization, irritation, and hepatotoxicity in humans.

项与贝舒地尔相关的新闻（医药）

2024-10-28

·GBIHealth

赛诺菲Y24Q3财报速读：制药业务收入121.67亿欧元，中国市场增长3.6%

2024年10月25日，赛诺菲发布了2024年第三季度财务业绩。2024年第三季度（报告期），公司收入134.38亿欧元（约145.47亿美元），同比增长15.7%（按固定汇率计算，下同）。制药业务收入121.67亿欧元，中国市场增长3.6% 制药业务收入121.67亿欧元，同比增长16.6%；消费者保健业务Opella收入12.71亿欧元，同比增长7.9%。 2024年前三季度，公司收入达346.47亿欧元（约375.11亿美元），同比增长11.1%。制药业务增长强劲，主要由达必妥（度普利尤单抗）和疫苗驱动。报告期内（2024年第三季度），达必妥销售额34.76亿欧元，同比增长23.8%；达必妥前三季度销售额达96.14亿欧元，同比增长25.9%。公司预测，2024年全年，达必妥销售收入可达130亿欧元。报告期内，疫苗销售额38.02亿欧元，同比增长25.5%。其中，RSV疫苗Beyfortus（尼塞韦单抗）销售额增长381.8%达6.45亿欧元。报告期内，新上市药品收入7.27亿欧元，同比增长67.1%，主要由血友病疗法ALTUVIIIO（+278.3%）、庞贝病酶替代疗法Nexviazyme/Nexviadyme（+53.6%）等驱动。报告期内，其他药品销售收入41.62亿欧元，同比增长0.4%。按市场分美国市场收入68.86亿欧元，同比增长23.6%；欧洲市场收入28.86亿欧元，同比增长6.6%；其他市场收入36.66亿欧元，同比增长10.3%。中国市场收入增长3.6% 2024年第三季度，中国市场收入7.57亿欧元（约8.19亿美元），同比增长3.6%，主要由达必妥的强劲销售驱动，但又被依诺肝素（受VBP影响）和其他药品的销售低迷抵消。中国市场也驱动贝舒地尔、胰岛素来优时（甘精胰岛素）全球销售额分别增长57.8%和18.1%。波立维尽管在中国市场已进入带量采购，但由于应用范围持续扩大，推动全球销售增长8.3%。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

财报疫苗带量采购

2024-10-28

·药时代

保二冲一，ROCK2抑制剂为何能连续冲击cGVHD治疗前线？

近期，中国临床肿瘤学会（CSCO）和中华医学会血液学分会相继发布和更新了慢性移植物抗宿主病（cGVHD）治疗的权威指南文件，其中Rho相关卷曲螺旋蛋白激酶2（ROCK2）甲磺酸贝舒地尔是唯一新纳入二线治疗的推荐用药，进一步应对cGVHD治疗中的纤维化难题。与此同时，近期国家药品监督管理局（NMPA）也批准了甲磺酸贝舒地尔联合糖皮质激素治疗12岁及以上新诊断为中重度慢性移植物抗宿主病（cGVHD）的III期临床试验，也就是说ROCK2抑制剂或将有望实现“保二冲一”，即在二线治疗的基础上进一步探索一线治疗的疗效。不难看出ROCK2靶点的科学优势正在不断显现，有望重构cGVHD未来治疗格局。尤其是在造血干细胞移植（HSCT）井喷式发展的当下，cGVHD等移植后并发症管理创新更为关键。HSCT目前已经成为根治恶性血液肿瘤、骨髓衰竭性疾病及其他难治性疾病的有效方法。2023年，我国216家医疗单位共完成异基因造血干细胞移植（allo-HSCT）14,952例1，为全球第一。随着造血干细胞移植适应症从恶性血液病拓展到非恶性血液病，以及相关疾病发病率持续走高，预计未来国内造血干细胞移植数量仍将持续增长。临床中接受allo-HSCT的患者中有最高达70%者会出现cGVHD2，若未进行规范防治，将严重影响患者的生活质量和远期生存。 cGVHD长期以来难解的纤维化困境 cGVHD的发生可分为3个阶段：（1）组织损伤引起的早期炎症；（2）慢性炎症引起的胸腺损伤及免疫系统失调；（3）组织纤维化。这3个阶段通常顺序发展，但第一阶段的患者也可以同时进入第二和第三阶段，各阶段可共同致病3。作为一种免疫介导的炎症和纤维化疾病4，cGVHD可累及全身各个器官系统，包括皮肤、毛发、指甲、口腔、眼部、胃肠道、肝脏、肺部、生殖器和关节筋膜等。目前在cGVHD的临床治疗中，纤维化是典型的病理生理特征，也是临床治疗的长期难点。例如，当纤维化累及关节或广泛的皮肤区域时，会引起关节活动进行性受限，导致慢性残疾5。同时，累及眼部、肺部、胃肠道等其他器官的cGVHD同样非常棘手，严重影响着患者的生活质量。根据中华医学会血液学分会今年8月发布的《慢性移植物抗宿主病诊断与治疗中国专家共识（2024年版）》（专家共识），糖皮质激素联合或不联合钙调磷酸酶抑制剂（CNI）仍是cGVHD一线治疗的标准方案。虽在临床上使用多年，但其有效率仅在50%左右3。约70%的cGVHD患者因一线治疗失败或无法耐受治疗的副作用而需要接受二线治疗6。近年来，虽然有一些创新疗法获批用于cGVHD的二线治疗，但主要作用于cGVHD的炎症阶段，同样难以从根源解决组织纤维化问题7,8。逆转纤维化+恢复免疫稳态，ROCK2靶点直击痛点并爆发更大潜力 2021年7月，美国食品药品监督管理局（FDA）批准甲磺酸贝舒地尔用于既往至少接受过2线系统性治疗失败后的cGVHD成年患者和≥12岁的儿童患者。2023年8月，甲磺酸贝舒地尔在我国获批用于治疗对糖皮质激素或其他系统治疗应答不充分的≥12岁cGVHD患者。 ROCK又称Rho相关卷曲螺旋蛋白激酶，是驱动cGVHD相关炎症和多种促纤维化过程的的关键靶点之一，是cGVHD纤维化的重要治疗靶点9,10。因此抑制该靶点成为预防和治疗纤维化的重要策略，尤其通过早期介入，兼顾“免疫稳态”和“逆转纤维化”，以甲磺酸贝舒地尔为代表的ROCK2抑制剂为cGVHD逆转纤维化带来了曙光。基于甲磺酸贝舒地尔的临床研究证据，除了本次的《慢性移植物抗宿主病（cGVHD）诊断与治疗中国专家共识（2024年版）》更新，国内外cGVHD相关权威指南陆续将其列入推荐疗法。表1 cGVHD相关指南中甲磺酸贝舒地尔的临床治疗推荐（图自：医脉通血液科）多项国内外多中心II期研究显示，在既往多线治疗失败的中重度cGVHD患者中，甲磺酸贝舒地尔的最佳总缓解率（ORR）分别为73.3%-76%，且耐受性良好。在cGVHD诊断后更早启用甲磺酸贝舒地尔治疗的患者中，ORR高达83%11，说明更早介入能够为患者带来更多获益。凭借“恢复免疫稳态”和“逆转纤维化”的核心，ROCK2靶点也正拓展更多科学潜力。今年5月，甲磺酸贝舒地尔的一线III期临床试验获得NMPA批准，成为cGVHD首个纳入中国人群的全球多中心III期临床研究。据悉，目前该项研究已经完成首例患者入组，ROCK2抑制剂正向着一线疗法发起最后的冲刺。此外，NMPA还获批了一项甲磺酸贝舒地尔用于治疗成人双肺移植后慢性移植肺功能丧失（CLAD）III期临床研究，使得ROCK2抑制剂从血液移植向实体器官移植进一步探索。针对儿童和青少年cGVHD患者的临床研究也在计划中，有望进一步拓宽年龄范围。结语此次专家共识更新中二线疗法，纳入ROCK2抑制剂，其恢复免疫稳态和逆转纤维化方面独特作用机制，进一步解决治疗痛点。随着更多临床试验的探索，以及临床经验和数据的积累，这一机制也支撑其继续高歌猛进，继续向一线疗法发起冲击，并向实体器官移植、青少年及儿童拓展，或将有望改写cGVHD及更广阔移植后并发症治疗格局。参考文献： 1.中华医学会血液学分会造血干细胞应用学组.造血干细胞移植登记2023.1.1-2023.12.31[R].中华医学会血液学分会,2023:2. 2.王筱淇，张曦.《慢性移植物抗宿主病（cGVHD）诊断与治疗中国专家共识（2024年版）》解读[J].临床血液学杂志，2024，37（9）：597-601.DOI：10.13201/j.issn.1004-2806.2024.09.001. 3.中华医学会血液学分会干细胞应用学组，慢性移植物抗宿主病诊断与治疗中国专家共识（2024年版）[J].中华血液学杂志, 20240814 ，DOI：10.3760/cma.j.cn121090-20240611-00217 4.MacDonald KP,et al.Blood.2017 Jan 5;129(1):13-21.pii:S0006-4971(20)33821-0. 5.Socié, G. Blood. 2018;131(13):1396-1397. 6.Cutler, C., et al., Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study. Blood, 2021. 138(22): 2278-2289. 7. Zeiser R, et al. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2021 Jul 15;385(3):228-238. 8.Miklos D, et al. Ibrutinib for chronic graft-versus-host disease after failure of prior therapy. Blood. 2017 Nov 23;130(21):2243-2250. 9.Knipe, R.S., et al. The Rho kinases: critical mediators of multiple profibrotic processes and rational targets for new therapies for pulmonary fibrosis. Pharmacol Rev, 2015. 67(1): 103-17. 10.Offer, EP, et al. Selective ROCK2 inhibitors for the treatment of fibrosis. Paris NASH Meeting 2019. 11.Cutler C, Lee SJ, Arai S, et al. Belumosudil for chronic graft ‐ versus ‐host disease after 2 or more prior lines of therapy: the ROCKstar Study[J]. Blood, 2021, 138(22): 2278 ‐ 2289. 点击了解更多！

CSCO会议临床3期

2024-10-28

·echemi

Merck's RSV Antibody Faces Major Challenges vs. Sanofi's Beyfortus Exhibiting 83% Efficacy in Reducing Hospitalization

While Merck & Co. 's infant respiratory syncytial virus (RSV) antibody clesrovimab is nearing approval, sanofi also won approval last year for its RSV prevention drug beyforts in partnership with astrazeneca. This news undoubtedly brings new hope to the global healthcare industry, especially in the field of RSV vaccines. "We would very much welcome having more participants on board because it increases the scale of the competition," Thomas Triomphe, Sanofi's executive vice president for vaccines, said of the upcoming RSV competition during an analyst call on Friday. He stressed that more players mean more innovation and better healthcare solutions, which is good for the industry as a whole and for patients. Triomphe noted that Merck still has more data on clesrovimab after announcing phase 2b/3 clinical results last week. In the meantime, Sanofi remains "very confident" in the Beyfortus numbers it has released so far, he said. He mentioned that the protection data provided by Beyfortus in six months is very encouraging, as the effect has not diminished. "After six months, we were still seeing 83 percent hospitalization efficacy," he said, adding that he believed "the duration of protection from Beyfortus was significantly more favorable compared to clesrovimab." This data suggests that Beyfortus has a significant advantage in preventing RSV infection. In Merck's infant RSV study, clesrovimab successfully reduced RSV-related hospitalizations and RSV-related lower respiratory tract infection hospitalizations by 84 percent and 91 percent, respectively, over five months compared to placebo. This result is impressive and shows the great potential of clesrovimab in preventing RSV infection. At the trial's primary endpoint, clesrovimab reduced the incidence of RSV-related medical lower respiratory tract infections by 60 percent compared to placebo. This data provides further evidence of the effectiveness of clesrovimab in preventing RSV infection. Sanofi Chief Financial Officer franois-xavier Roger noted in a conference call on Friday that the inherent uncertainty of cross-trial comparisons suggested that existing Beyfortus data showed a reduction of about 75 percent in the incidence of lower respiratory tract infections with clesrovimab compared to 60 percent with Clesrovimab. This data further reinforces Beyfortus' advantage in preventing RSV infection. And, whether or not Merck brings clesrovimab into the 2025-2026 RSV season as planned, "2025 will be a year of growth for Beyfortus," the CFO stressed. He is confident that Beyfortus' sales will grow significantly as it gradually gains market share. Since it was approved last July, Beyfortus has gradually built up its sales profile. In the third quarter of 2024, sales of this preventive antibody reached 645 million euros ($699), an increase of 382% compared to the same period in 2023. Overall, sales of the drug have reached 845 million euros since the beginning of the year, which is close to the best-selling threshold. Sanofi said at the time that Beyfortus quickly fell into a supply crunch shortly after going public last year due to "higher than expected demand." To counter this, Sanofi and its partner Astrazeneca have moved quickly to ensure there is no repeat of the supply crunch in 2024. Recently they added a new filling line and shipped antibody doses ahead of the 2024 RSV season. "There are 20 markets and we don't see any capacity constraints," Triumph said on Sanofi's conference call. "We will increase supply next year and the year after to make sure there are no supply constraints." This initiative demonstrates Sanofi's confidence in the future of Beyfortus and its commitment to meeting the needs of the global market. The comments by Sanofi executives came as the French pharmaceutical company reported a 15.7 per cent rise in third-quarter sales. This growth was mainly driven by the excellent performance of its immunology product Dupixent, which brought in sales of nearly 3.5 billion euros (about $3.8 billion), an increase of about 24 percent over the third quarter of 2023. Sanofi confirmed DuPont's full-year sales target of about 13 billion euros. Elsewhere, newly launched drugs rose 67.1 percent to 727 million euros ($787), led by hemophilia drug Altuviiio, Pompeii disease treatment Nexviazyme and Rezurock for graft-versus-host disease. The strong performance of these new drugs further strengthens Sanofi's position in the field of innovative medicines. Meanwhile, Sanofi's consumer health division, Opella, saw revenue rise 7.9 percent. This growth shows that Sanofi is also making significant progress in consumer health. Earlier this week, Sanofi confirmed it had entered exclusive talks with U.S. private equity firm Clayton, Dubilier & Rice to sell a controlling 50 percent stake in its consumer healthcare business, which is valued at around 16 billion euros. This move will further strengthen Sanofi's financial strength and provide additional financial support for its future expansion.

上市批准临床结果疫苗

100 项与贝舒地尔相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11815 D11816	-	-	-

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
慢性移植物抗宿主病	美国	Kadmon Pharmaceuticals LLC	2021-07-16

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
同种异体移植排斥反应	临床3期	美国	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	中国	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	澳大利亚	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	奥地利	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	比利时	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	加拿大	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	捷克	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	丹麦	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	芬兰	Sanofi	2023-10-10
同种异体移植排斥反应	临床3期	法国	Sanofi	2023-10-10

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临床结果

适应症

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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


EHA2024 人工标引	临床3期	慢性移植物抗宿主病	21	Belumosudil 200 mg	艱窪鹹獵襯製襯壓願窪(製膚鏇餘積願憲鬱壓網) = 鹽壓鑰壓願鹹餘壓鹽襯糧觸齋艱廠積繭淵窪醖 (簾鏇廠願糧鑰簾衊遞蓋, 63.66 ~ 96.95) 更多	积极	2024-05-14
KD-025-2134 (EHA2024) 人工标引	N/A	类固醇难治性移植物抗宿主病	45	Belumosudil	糧鹹膚構範鑰遞夢簾衊(觸襯醖淵範淵遞糧範簾) = 築艱遞膚鬱鑰窪獵餘遞觸選鏇壓觸廠製壓選蓋 (鹽願選廠襯壓鏇襯淵顧 ) 更多	积极	2024-05-14
EHA2024	N/A	移植物抗宿主病	35	Belumosudil	廠選顧獵鏇壓鹹網衊鹽(鹹獵顧繭構範鑰膚艱鬱) = 2 patients where additional treatment for cGvHD had to be initiated 廠範糧廠夢鹽製餘願遞 (網廠構醖餘憲願鏇積網 ) 更多	积极	2024-05-14
NCT04930562 (Pubmed) 人工标引	临床2期	慢性移植物抗宿主病二线	30	Belumosudil 200 mg	觸積網蓋壓膚壓艱糧積(鏇範壓膚壓繭鬱襯窪築) = 鬱襯範顧廠選願繭憲製範網願壓網鑰鏇選簾夢 (積壓範壓構簾窪願蓋艱, 54.1 ~ 87.7) 更多	积极	2024-03-26
Tandem Meetings ASTCT and CIBMTR2024 人工标引	N/A	类固醇难治性移植物抗宿主病	14	Belumosudil+Ruxolitinib	遞衊積糧鏇襯積夢蓋製(鹽鹽製衊觸膚築鹽窪鹹) = 鹽顧夢餘鏇鹽鹹鹽齋艱糧壓窪鬱鑰獵醖顧願窪 (壓遞壓獵繭獵糧範鏇簾 ) 更多	积极	2024-02-01
NCT03640481 (ROCKstar, Tandem Meetings ASTCT and CIBMTR2024) 人工标引	临床2期	移植物抗宿主病末线 \| 三线	152	Belumosudil 200 mg QD	積鑰齋廠網鑰艱選艱鹹(廠觸製築夢製簾餘積膚) = 艱積齋鏇夢獵廠淵構餘廠製願選淵壓醖製憲淵 (齋鏇繭獵顧窪糧艱鏇糧 ) 更多	积极	2024-02-01
	临床2期	移植物抗宿主病末线 \| 三线	152	Belumosudil 200 mg BID	積鑰齋廠網鑰艱選艱鹹(廠觸製築夢製簾餘積膚) = 壓範衊憲餘積獵製鏇築廠製願選淵壓醖製憲淵 (齋鏇繭獵顧窪糧艱鏇糧 ) 更多	积极	2024-02-01
Tandem Meetings ASTCT and CIBMTR2024 人工标引	N/A	类固醇难治性移植物抗宿主病	66	Belumosudil	醖繭餘觸醖蓋網蓋齋願(壓淵積壓窪艱醖鑰膚鏇) = 構繭醖糧鏇獵糧築選遞艱壓壓鏇蓋醖構齋蓋淵 (顧糧糧齋選網憲願蓋憲, 70 ~ 90) 更多	积极	2024-02-01
NCT04930562 (phase II study of belumosudil, CTgov)	临床2期	慢性移植物抗宿主病	30	BN101	鑰餘範淵齋齋選範願蓋(製觸蓋選鬱鏇糧膚簾觸) = 選選選餘網鬱積淵淵膚觸鏇襯艱網窪艱膚齋醖 (網選構齋觸獵鹽膚夢廠, 壓鏇築顧醖窪廠壓齋糧 ~ 壓糧製鑰鬱蓋遞鑰壓範) 更多	-	2023-11-01
NCT03919799 (CTgov)	临床2期	弥漫性硬皮病	36	Placebo (DB Period: Placebo)	襯壓鹽鬱糧選範醖網廠(鑰窪糧艱顧壓鹽艱鏇衊) = 糧築鹽淵膚願糧齋鑰淵齋選餘簾淵衊艱膚廠壓 (廠範淵鏇製醖築廠齋顧, 淵夢遞齋顧構繭蓋網顧 ~ 蓋製鬱鑰廠範獵願齋蓋) 更多	-	2023-08-30
NCT03919799 (CTgov)	临床2期	弥漫性硬皮病	36	Belumosudil (KD025) (OLE Period: Placebo/Belumosudil QD)	憲醖衊遞蓋繭壓窪獵選(鹽壓鏇繭願鹹製範鑰構) = 鹽願窪築遞選鬱淵糧齋網繭範廠廠鑰廠衊繭遞 (獵蓋憲襯鏇積製鹹糧觸, 夢簾鬱膚淵鹽鏇鹹顧窪 ~ 遞選遞醖顧鑰壓窪鏇鹽) 更多	-	2023-08-30
NCT02841995 (KD025-208, CTgov)	临床2期	慢性移植物抗宿主病	54	Belumosudil (KD025) (Cohort 1: Belumosudil 200 mg QD)	鏇構網糧廠製餘積衊壓(糧衊網獵壓壓壓憲範夢) = 衊鏇鏇襯蓋獵艱網膚鹹獵遞範膚艱獵艱觸獵齋 (鏇願鹽獵廠衊醖鹹衊醖, 積齋鏇淵鹽淵鬱願壓簾 ~ 淵繭獵遞餘醖窪淵簾鬱) 更多	-	2023-06-28
NCT02841995 (KD025-208, CTgov)	临床2期	慢性移植物抗宿主病	54	Belumosudil (KD025) (Cohort 2: Belumosudil 200 mg BID)	鏇構網糧廠製餘積衊壓(糧衊網獵壓壓壓憲範夢) = 鏇觸鹽齋鏇構憲選鬱範獵遞範膚艱獵艱觸獵齋 (鏇願鹽獵廠衊醖鹹衊醖, 築襯襯積餘齋遞積艱鹽 ~ 選觸醖選夢壓選築夢窪) 更多	-	2023-06-28