A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients

The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing kidney transplantation. Participants aged 18 to 70 years who have low-to-moderate immunologic risk of graft rejection and receive their first kidney transplant are eligible if they meet all inclusion and no exclusion criteria. Study details include:
* The study and treatment duration will be up to approximately 5 years.
* The number of visits will be approximately 38.

开始日期2026-03-02

申办/合作机构

Sanofi

NCT07052370

/ Recruiting临床1期IIT

TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies

This is a phase I, prospective clinical trial studying the safety and feasibility of providing early memory T-cell DLI.
The primary objective is:
- To assess the safety and feasibility of early CD45RA-depleted DLI administration.
The secondary objectives are
* To assess the safety and feasibility of the addition of blinatumomab in the early post-transplant period in patients with CD19+ malignancy.
* To measure and describe the pharmacokinetics of rabbit ATG in HCT recipients on this study.

开始日期2025-09-25

申办/合作机构

St. Jude Children's Research Hospital, Inc.

NCT06872333

/ Recruiting临床2期IIT

Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders

A single center, open label, interventional, phase II trial for donor transplant for high risk hemoglobinopathies and other red cell transfusion dependent disorders utilizing allogeneic hematopoietic stem cell transplantation (HSCT) regimens.

开始日期2024-11-19

申办/合作机构

University of Minnesota Masonic Cancer Center

100 项与抗人胸腺细胞免疫球蛋白相关的临床结果

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100 项与抗人胸腺细胞免疫球蛋白相关的专利（医药）

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项与抗人胸腺细胞免疫球蛋白相关的文献（医药）

2026-04-01·BIOCHIMICA ET BIOPHYSICA ACTA-GENERAL SUBJECTS

Rapid in vivo loss of non-T-cell binding capacities of ATLG Grafalon® and ATG Thymoglobulin® explains selective effect on T-cell reconstitution after hematopoietic stem cell transplantation

Article

作者: Jansen-Hoogendijk, Anja M ; Lugthart, Gertjan ; van Ostaijen-Ten Dam, Monique M ; Jol-van der Zijde, Cornelia M ; van Tol, Maarten J D ; Vervat, Carly ; Schilham, Marco W ; Oostenbrink, Lisa V E ; Bredius, Robbert G M ; Lankester, Arjan C

Anti-thymocyte globulin (ATG Thymoglobulin®) and anti-T-lymphocyte globulin (ATLG Grafalon®) are commonly used in hematopoietic stem cell transplantation (HSCT) for in vivo T-cell depletion, aiming to reduce graft failure and graft-versus-host disease (GvHD). Despite their widespread use, the precise mechanisms by which ATG/ATLG affect immune recovery post-transplantation remain partially understood. In this study, in 289 pediatric HSCT patients treated with ATG (n = 213) or ATLG (n = 76), the relationship between longitudinal serum levels of the active T-lymphocyte-binding component of ATG/ATLG and immune reconstitution was evaluated. High levels of active ATG/ATLG did not prevent the recovery of neutrophils or NK-cells; however, T-cell recovery was delayed until active ATG/ATLG concentrations fell below 1 AU/mL. This is in apparent contradiction with the fact that ATG/ATLG are known not only to contain antibodies against antigens present on T-cells but also to antigens present on other immune and non-immune cells, including B-, NK-cells, granulocytes, monocytes and hematopoietic stem and progenitor cells (HSPC). To address this, we assessed the binding capacities of ATG and ATLG to immune cell subsets and HSPC both in vitro directly from the vial and in vivo from patients serum samples taken at multiple time points pre- and post-HSCT. Shortly after infusion, we observed a rapid reduction of ATG and ATLG binding to all cell types except for T-cells. This real-life specificity of ATG and ATLG explains their selective impact on T-cell reconstitution. These findings enhance our understanding of the mechanisms of action of ATG and ATLG and may contribute to optimization of these therapies.

2026-03-01·Cancer pathogenesis and therapy

Reduced cytomegalovirus reactivation and viremia without increasing GVHD after URD-PBSCT: A prospective study using targeted ATG dosing strategy

Article

作者: Gu, Zhenyang ; Wang, Lu ; Chen, Sheng ; Dou, Liping ; Du, Jishan ; Liu, Daihong ; Luan, Songhua ; Ge, Dongxue ; Wang, Haitao ; Wu, Yongli ; Li, Fei

Background:

Anti-thymocyte globulin (ATG) is widely used in allogeneic hematopoietic stem cell transplantation (allo-HCT) to prevent severe graft-versus-host disease (GVHD) and graft failure. Insufficient ATG exposure may reduce its effectiveness in GVHD prophylaxis, while excessive exposure can elevate the risk of viral reactivation, non-relapse mortality (NRM), and disease relapse. Based on monitoring ATG (Thymoglobulin, Sanofi, Lyon, France) concentrations, we developed an ATG-targeted dosing strategy and conducted a prospective, single-arm study on patients undergoing unrelated donor peripheral blood stem cell transplantation (URD-PBSCT) to evaluate its efficacy and safety.

Methods:

We enrolled 30 patients with malignant hematological diseases who underwent URD-PBSCT between January 2020 and June 2023. All patients received an ATG-targeted dosing strategy, involving a 4-day administration of ATG: 1.5 mg/kg on day -5, 2.5 mg/kg on day -4, with dose adjustments on day -3 and day -2 to achieve an optimal area under the concentration-time curve (AUC) for active ATG. Engraftment, viral infections, acute and chronic GVHD, relapse, and survival outcomes were statistically analyzed. A historical cohort of 38 patients who underwent URD-PBSCT between December 2014 and December 2020 was used for comparison. Patients in the historical cohort received a fixed total dose of 10 mg/kg ATG from day -5 to day -2.

Results:

All patients in the targeted dosing cohort achieved successful neutrophil and platelet engraftment with 100% donor chimerism. The cumulative incidence of cytomegalovirus (CMV) reactivation and persistent CMV viremia at 180 days post-transplantation was 30.0% and 16.7%, respectively. The cumulative incidences of Epstein-Barr virus (EBV) reactivation and persistent EBV viremia at 180 days were 46.7% and 23.3%, respectively. The cumulative incidences of grades II-IV and III-IV acute GVHD at 100 days were 49.4% and 9.3%, respectively. The 1-year cumulative incidence of relapse (CIR) was 10.0%, the 1-year NRM was 10.0%, the 1-year disease-free survival (DFS) was 80.0%, and the 1-year overall survival (OS) was 86.7%. Compared with the historical cohort, the targeted dosing cohort showed significantly lower the cumulative incidences of CMV reactivation (30.0% vs. 78.9%, P < 0.001) and persistent CMV viremia (16.7% vs. 42.1%, P = 0.026) on day 180. However, no significant differences were observed in EBV reactivation (46.7% vs. 68.4%, P = 0.170) or persistent EBV viremia (23.3% vs. 44.7%, P = 0.075) on day 180. Similarly, there were no statistically significant differences in the cumulative incidences of grade II-IV (49.4% vs. 50.3%, P = 0.700) or grade III-IV (9.3% vs. 18.8%, P = 0.390) acute GVHD on day 100, or 1-year chronic GVHD (10.0% vs. 13.2%, P = 0.680).

Conclusions:

Utilizing a targeted ATG dosing strategy in URD-PBSCT resulted in a lower incidence of CMV reactivation and viremia without increasing the risk of acute or chronic GVHD.

Trial registration:

www.clinicaltrials.gov, NCT06572462.

2026-02-10·Blood Advances

Functional recovery of NK cells after T-cell replete haploidentical HSCT: delayed licensing and poor anti-acute myeloid leukemia activity

Article

作者: Le Bourgeois, Amandine ; Ferron, Enora ; Willem, Catherine ; David, Gaelle ; Peterlin, Pierre ; Vantyghem, Sophie ; Jullien, Maxime ; Guillaume, Thierry ; Retière, Christelle ; Bastien, Mathilde ; Garnier, Alice ; Gagne, Katia ; Duquesne, Alix ; Bouzy, Simon ; Legrand, Nolwenn ; Chevallier, Patrice

Abstract:

Haploidentical allogeneic hematopoietic stem cell transplantation (h-HSCT) is increasingly used in patients lacking an HLA-matched donor. In this context, the combination of posttransplant cyclophosphamide (PTCy) and antithymocyte globulin (ATG) effectively prevents graft-versus-host disease, but its impact on the reconstitution of peripheral blood natural killer (NK) cell subsets remains insufficiently characterized. In this study, NK cell subsets were analyzed in depth in 56 adult recipients of unmanipulated h-HSCT with PTCy and ATG. Peripheral blood samples were collected at days +30, +60, and +100 after transplant. NK cell immunophenotype and cytotoxic function were assessed using multiparameter flow cytometry with unsupervised clustering, and degranulation assays against lymphoid and myeloid targets. Data were compared with those from 200 healthy volunteers. In spite of early numerical reconstitution, NK cells exhibited an immature immunophenotype with a low expression of activation markers. Cytotoxic activity against lymphoid targets was preserved, but degranulation against acute myeloid leukemia cell lines was significantly impaired across all NK subsets, including phenotypically mature NK cells. Cytomegalovirus reactivation was associated with an expansion of memory-like NK subsets but did not enhance degranulation. Functional education via killer cell immunoglobulin–like receptors was lost by day +30 and progressively reacquired from day +60 onward, in a pattern primarily influenced by the HLA-C genotype of recipients. These results indicate that, after h-HSCT with PTCy and ATG, NK cell subsets recover in number but fail to achieve early functional competence, particularly against myeloid targets. Strategies aiming at restoring mature NK cell functions warrant prospective investigations, especially in high-risk myeloid malignancies.

项与抗人胸腺细胞免疫球蛋白相关的新闻（医药）

2026-02-12

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Drug Testing and Analysis. 2025 17:6 (825-833)比较不同胰岛素类型的疗效：健康受试者葡萄糖钳夹效应的PK-PD建模Comparing the Efficacy of Various Insulin Types: Pharmacokinetic and Pharmacodynamic Modeling of Glucose Clamp Effects in Healthy VolunteersChang Y.C., Jusko W.J. Journal of Clinical Pharmacology. 2025 65:8 (999-1010)评估多重插补算法对PK模型性能的影响：一项基于模拟的研究Assessing the Impact of Multiple Imputation Algorithms on Pharmacokinetic Model Performance: A Simulation-Based StudyDuflot T., Fayette L., Konecki C., Seurat J., Feliu C., Scala-Bertola J., Djerada Z.AAPS Journal. 2025 27:4 Article Number 77量化影响常染色体显性肾小管间质肾病进展速度和严重程度的临床及遗传因素Quantifying clinical and genetic factors influencing rate and severity of autosomal dominant tubulointerstitial kidney disease progressionRamesh S.S., Rogge M., Kidd K.O., Williams A.H., Yoon D.Y., Roignot J., Blakeslee K., Bleyer A.J., Kim S. Journal of Pharmacokinetics and Pharmacodynamics. 2025 52:4 Article Number 41甲氨蝶呤的治疗药物监测、PopPK建模及在儿童急性淋巴细胞白血病患者高剂量给药的外部验证Therapeutic Drug Monitoring, Population Pharmacokinetics Models, and External Validation of High-Dose Methotrexate in Pediatric Acute Lymphoblastic LeukemiaMaximova N., Calabrò P.F., Cangialosi A., Di Paolo A. Chemotherapy. 2025 70:3 (109-118)危重症儿童尿液生物标志物与头孢吡肟治疗目标达成的关联研究Urinary Biomarkers and Attainment of Cefepime Therapeutic Targets in Critically Ill ChildrenDownes K.J., Sharova A., Amajor V., Gianchetti L., Himebauch A.S., Fitzgerald J.C., Zuppa A.F. Pediatric Infectious Disease Journal. 2025 44:8 (749-754)Andalusian马体内静脉注射对乙酰氨基酚及其代谢物后的群体药代动力学和临床评估研究Population pharmacokinetics and clinical evaluation of intravenous acetaminophen and its metabolites in Andalusian horses预测妊娠期间他克莫司的游离浓度Predicting Unbound Tacrolimus Concentrations during PregnancyLeino A., Wilson N.K., Kataria A.D., Hebert M.F. American Journal of Transplantation. 2025 25:8 Supplement 1 (S204-)AEROfen：一项 I 期临床、开放标签、随机交叉研究方案，通过PK模型评估健康受试者中雾化芬太尼的给药效率—比较面部与鼻内给药途径AEROfen: protocol for a phase I, open-label, randomised crossover study evaluating the efficiency of nebulised fentanyl in healthy volunteers - comparing facial versus intranasal administration via pharmacometric modellingFollet C., Dumont A., Roussel M., Gillibert A., Boedard C., Quillard M., Ruault S., Vallin F., Donnadieu N., Nunes Ferreira D., Pereira T., Joly L.-M., Lvovschi V., Duflot T. BMJ Open. 2025 15:7 Article Number e091125超越线性模型的浓度- QT 分析Beyond the linear model in concentration‑QT analysisGéraldine Cellière, Andreas Krause, Guillaume Bonnefois, Jonathan Chauvin. Journal of Pharmacokinetics and Pharmacodynamics. (2025) 52:311型干扰素介导的系统性红斑狼疮炎症的综合机制模型An Integrative Mechanistic Model of Type 1 IFN-Mediated Inflammation in Systemic Lupus ErythematosusVolkova A., Sokolov V., Tettamanti F., Verma M., Ugolkov Y., Peskov K., Tang W., Kimko H. CPT: Pharmacometrics and Systems Pharmacology. 2025 14:7 (1225-1235)PK/PD建模与蒙特卡洛模拟预测接受（缬）更昔洛韦治疗的儿科移植受者的巨细胞病毒载量Pharmacokinetic/Pharmacodynamic Modelling and Monte Carlo Simulations to Predict Cytomegalovirus Viral Load in Pediatric Transplant Recipients Treated with (val) GanciclovirKoloskoff K., Franck B., Benito S., Welzel J., Autmizguine J., Theoret Y., Briand A., Ovetchkine P., Woillard J.-B. Clinical Pharmacokinetics. 2025 64:7 (1061-1069)沙特阿拉伯儿童肝移植术后早期他克莫司药代动力学的一项回顾性分析A retrospective analysis of tacrolimus pharmacokinetic in Saudi paediatric patients in early post-liver transplantation periodAlghanem A., Joharji H., Garaween N., Alenazi H., Alsaleh N.A., Broering D., Alshagrani M., Alhassan F., Albassam A.A., Alsultan A., Alsmari A. Pediatrics and Neonatology. 2025 66:4 (368-374)利用纵向患者报告结局轨迹预测非小细胞肺癌生存期Leveraging Longitudinal Patient-Reported Outcome Trajectories to Predict Survival in Non–Small Cell Lung Cancer理解与优化剂量探索：从剂量模拟到剂量估算Understanding and Streamlining Dose Finding: From Dose Simulation to Dose EstimationBräm D., Bachmann F., Schropp J., Gotta V., Steffens B., van den Anker J., Pfister M., Koch G. Journal of Clinical Pharmacology. 2025 65:6 (731-741)基于模型的方法评估抗药物抗体对生物制剂药物暴露的影响：以 CD3 T 细胞双特异性抗体赛必妥单抗为例A Model-Based Approach to Evaluate Anti-Drug Antibody Impact on Drug Exposure With Biologics: A Case Example With the CD3 T-Cell Bispecific CibisatamabSanchez J., Pierrillas P.B., Frey N., Lotz G.P., Jönsson S., Friberg L.E., Frances N. CPT: Pharmacometrics and Systems Pharmacology. 2025 14:6 (1065-1076)基于治疗药物监测, 考察阿米卡星在教学医院患者中的群体药代动力学Therapeutic Drug Monitoring-Based Population Pharmacokinetics of Amikacin in Patients at a Teaching HospitalSteffens N.A., Zimmermann E.S., Azeredo F.J., Linden R., Finatto L.J., Hahn R.Z., Schwarzbold A.V., Pacheco L.S., Brucker N. Antibiotics. 2025 14:6 Article Number 531辅助靶点的药效学评估：低分子量 PBP7/8 对β-内酰胺类药物抗碳青霉烯耐药鲍曼不动杆菌活性的影响Pharmacodynamic Evaluation of Adjuvant Targets: Low Molecular Weight PBP7/8 Effects on β-Lactam Activity Against Carbapenem-Resistant Acinetobacter BaumanniiHo B.M., Jin J., Sanborn J.T., Nguyen T.D., Singh N., Cheng C., Nasief N.N., Carlino-MacDonald U., Tsuji B.T., Zhao Y., Chen L., Moya B., Russo T.A., Smith N.M.Pharmaceuticals. 2025 18:6 Article Number 918WS02.06 Elexacaftor/tezacaftor/ivacaftor在 2 至 5 岁儿童中的药代动力学及行为障碍发生情况WS02.06Elexacaftor/tezacaftor/ivacaftor pharmacokinetics and occurrence of behavioural disorders in children aged 2 to 5 years oldTruong N.H., Benaboud S., Chouchana L., Bonnel A.-S., Barboura M., Bouazza N., Gautier S., Rouillon S., Froelicher-Bournaud L., Bihouee T., Bui S., Treluyer J.-M., Gaudelus I.S., Foissac F., Modul-CF research group. Journal of Cystic Fibrosis. 2025 24 Supplement 1 (S5-)老年群体中皮下注射与静脉注射头孢曲松的药代动力学：PhASAge 研究Pharmacokinetics of Subcutaneous and Intravenous Ceftriaxone in an Older Population: The PhASAge StudyRoubaud-Baudron C., Fauchon H., Stanke-Labesque F.,et al. Open Forum Infectious Diseases. 2025 12:6 Article Number ofaf313感染后期植入的 SIV 前病毒存在于寿命较短的 CD4+ T 细胞中SIV proviruses seeded later in infection are harbored in short-lived CD4+ T cells一箭多雕：用于多适应症的肠溶型霉酚酸钠的PopPK模型及贝叶斯估算Killing several birds with one stone: A multi-indication population pharmacokinetic model and Bayesian estimator for enteric-coated mycophenolate sodiumFromage Y., Sayadi H., Koloskoff K., Marquet P., Labriffe M., Monchaud C., Woillard J.-B. British Journal of Clinical Pharmacology. 2025 91:5 (1396-1408)通过PopPL分析优化 1-3 级肥胖患者静脉注射利多卡因的给药方案Dosing optimisation of intravenous lidocaine in patients with class 1–3 obesity by population pharmacokinetic analysisTognolini A.R., Liu X., Pandey S., Roberts J.A., Wallis S.C., Jackson D., Eley V.A. Anaesthesia. 2025 80:5 (511-521)用于考察阿替洛尔与美托洛尔在营养不良大鼠体内吸收的迷你PBPK模型Minimal Physiologically-Based Pharmacokinetic Modeling of Atenolol and Metoprolol Absorption in Malnourished RatsKir F., Sahin S., Jusko W.J. European Journal of Drug Metabolism and Pharmacokinetics. 2025 50:3 (251-263) Article Number e115Elexacaftor/Tezacaftor/Ivacaftor在囊性纤维化儿科患者中的群体药代动力学研究Elexacaftor/Tezacaftor/Ivacaftor Population Pharmacokinetics in Pediatric Patients With Cystic FibrosisTruong N.H., Benaboud S., Bouazza N., Barboura M.,et al. Clinical and Translational Science. 2025 18:5 Article Number e70245比较妊娠妇女在惊厥前期使用 75 mg与 150 mg阿司匹林的效果Comparing 75mg vs 150mg aspirin in pregnancy women at risk of preeclampsiaVinogradov R., Kavanagh O.N., Kamali F., Robson S. American Journal of Obstetrics and Gynecology. 2025 232:5 (e189-e190)克林霉素与利福平联合用药的剂量及给药途径Dosing and route of administration of clindamycin given in combination with rifampicinMagréault S., Berrah R., Kerroumi Y., Mimram L., Salmon D., Goulenok T., de la Selle A., Lefort A., Marmor S., Helali N.H., Zeller V., Jullien V. Clinical Microbiology and Infection. 2025 31:5 (832-838)舒更葡糖或新斯的明逆转维库溴铵诱导犬神经肌肉阻滞的速度：随机临床试验与药理学建模Speed of reversal by sugammadex or neostigmine after vecuronium-induced neuromuscular block in dogs: Randomized clinical trial and pharmacological modelingMartin-Flores M., Lorenzutti A.M., Markmann A.D., Araos J., Campoy L. Veterinary Anaesthesia and Analgesia. 2025 52:3 (328-337)阿昔洛韦及其主要代谢产物 9-羧甲氧基甲基鸟嘌呤在早期肝移植受者中的群体药代动力学及伐昔洛韦的安全性评估Population pharmacokinetics of aciclovir and its major metabolite 9-carboxymethoxymethylguanine and safety profile of valaciclovir in early liver transplant recipientsKably B., Briard M., Francoz C., Roux O., Houhou N., Mackiewicz V., Peytavin G., Durand F., Lê M.P. Journal of Antimicrobial Chemotherapy. 2025 80:5 (1302-1308)一种用于治疗慢性乙型肝炎的衣壳蛋白装配调节剂作用的多尺度模型A multiscale model of the action of a capsid assembly modulator for the treatment of chronic hepatitis B左乙拉西坦药代动力学在真实世界中的患者间变异性Real-world interpatient variability in the pharmacokinetics of levetiracetamChykharivska A., Kagan L., Wagner M., Brunetti L. Fundamental and Clinical Pharmacology. 2025 39:2 Article Number e13059接受连续性肾脏替代治疗的危重患者是否需要调整头孢洛林给药剂量？基于回顾性数据的头孢洛林PopPK模型及目标达成概率分析的剂量模拟Do Critically Ill Patients Undergoing Continuous Renal Replacement Therapy Require Ceftaroline Dosage Adjustments? 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European Journal of Hospital Pharmacy. 2024 31:3 (253-258)万古霉素在越南儿科患者治疗药物监测中的PopPK建模及中点浓度便捷采样Population Pharmacokinetic Modeling and Convenient Sampling of Midpoint Concentration for Therapeutic Drug Monitoring of Vancomycin in Vietnamese Pediatric PatientsHai L.B., Kien P.C., Dua N.T., Hao N.T., Hung V.M., Hai N.T., Le J., Huong N.T.L. Pharmaceutical Sciences Asia. 2024 51:3 (241-249)影响万古霉素谷浓度的因素：沙特非重症监护患者的PopPK模型Factors Affecting Vancomycin Trough Concentration; a Population Pharmacokinetic Model in Non-Critical Care Saudi PatientsOrvacabtagene Autoleucel, 一种自体 BCMA 导向的CAR-T 细胞产品在治疗复发/难治性多发性骨髓瘤患者中的PopPK研究Population Pharmacokinetics of Orvacabtagene Autoleucel, an Autologous BCMA-Directed Chimeric Antigen Receptor T-cell Product, in Patients with Relapsed/Refractory Multiple MyelomaHu H., Li Y., Piasecki J., Hosseyni D., Yan Z., Liu X., Ogasawara K., Zhou S., Cheng Y. Clinical Cancer Research. 2025 31:6 (1163-1171)建模分析表明，奈玛特韦-利托那韦治疗后出现的 SARS-CoV-2 病毒反弹，是由靶细胞得以保留与病毒清除不彻底共同导致的Modeling suggests SARS-CoV-2 rebound after nirmatrelvir-ritonavir treatment is driven by target cell preservation coupled with incomplete viral clearancePhan T., Ribeiro R.M., Edelstein G.E., Boucau J., et al.Journal of Virology. 2025 99:3用于癌症药物PK-PD建模与模拟的多器官芯片Multiorgan-on-a-chip for cancer drug pharmacokinetics-pharmacodynamics (PK-PD) modeling and simulationsMohammed A.E., Kurucaovalı F., Okvur D.P. Journal of Pharmacokinetics and Pharmacodynamics. 2025 52:1 Article Number 1NX210c多肽在健康老年受试者中的安全性、耐受性及PK-PD关系研究：一项随机、安慰剂对照、双盲、多剂量递增试验Safety, Tolerability and Pharmacokinetic-Pharmacodynamic Relationship of NX210c Peptide in Healthy Elderly Volunteers: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study卡泊芬净在接受体外膜氧合治疗的危重患者中的PopPK研究——ASAP ECMO 研究Population pharmacokinetics of caspofungin in critically ill patients receiving extracorporeal membrane oxygenation—an ASAP ECMO studyAbdul-Aziz M.H., Diehl A., Liu X., Cheng V., Corley A., Gilder E., Levkovich B., McGuinness S., Ordonez J., Parke R., Pellegrino V., Wallis S.C., Fraser J.F., Shekar K., Roberts J.A. Antimicrobial Agents and Chemotherapy. 2025 69:2肾功能不全患者中哌拉西林剂量调整：无论是否接受肾脏替代治疗, 均需增加达到目标暴露量Dosing of Piperacillin in Altered Renal Function with and without Renal Replacement Therapy for Required Increased ExpositionSurat G., Dohmann E., Scherf-Clavel O., Kurlbaum M., Hagel S. Open Forum Infectious Diseases2025 12 Supplement 1 (S798-)重症成人鲍曼不动杆菌感染患者口服米诺环素的PK模型Phamacokinetic Model of Oral Minocycline in Critically Ill Adult Patients with Acinetobacter baumannii InfectionKoumaki V., Athanassa Z., Valsami G., Papakyriakopoulou P., Saitani E.-M., Marques S., Manioudaki S., Sakagianni A., Dokoumatzidis A., Tsakris A. Open Forum Infectious Diseases. 2025 12 Supplement 1 (S801-)使用容积吸收微量采样法研究多器官功能障碍综合征危重患儿中的万古霉素群体药代动力学Vancomycin Population Pharmacokinetics Using Volumetric Absorptive Microsampling in Critically Ill Children with Multiple Organ Dysfunction SyndromeShiau J., Amajor V., Rhodes N.J., Zuppa A., Downes K.J., Takyi-Williams J., Wen B., Scheetz M.H. Open Forum Infectious Diseases. 2025 12 Supplement 1 (S788-S789)粒细胞集落刺激因子的群体PK-PD建模以优化 CD34+细胞采集的给药剂量与给药时机Population Pharmacokinetic–Pharmacodynamic Modeling of Granulocyte Colony-Stimulating Factor to Optimize Dosing and Timing for CD34+ Cell HarvestingXu Jiang, Jun Seok Cha, Byung Hak Jin, Choon Ok Kim, Dongwoo Chae. Clinical and Translational Science, 2025; 18:e70121基于PopPK模型，为接受血液透析的肥胖患者群体制定万古霉素负荷剂量个体化给药方案Vancomycin loading dose individualization in a population of obese patients undergoing haemodialysis based on population pharmacokinetic modelPolášková L., Hartinger J.M., Murínová I., Michálek P., Slanař O., Šíma M. Journal of Chemotherapy. 2025 37:2 (121-129)考虑个体间变异的低维神经常微分方程在 Monolix 和 NONMEM 中的实现Low-dimensional neural ordinary differential equations accounting for inter-individual variability implemented in Monolix and NONMEMBräm D.S., Steiert B., Pfister M., Steffens B., Koch G. CPT: Pharmacometrics and Systems Pharmacology. 2025 14:1 (5-16)瑞德西韦及其代谢物在健康受试者和肾功能不全患者中的药代动力学模拟Pharmacokinetic simulations for remdesivir and its metabolites in healthy subjects and patients with renal impairment群体PK/PD分析证实 SB16 与参比药物地舒单抗具有生物相似性Population pharmacokinetics/pharmacodynamics analysis confirming biosimilarity of SB16 to reference denosumab肠溶阿司匹林胶囊与片剂在健康受试者群体中的PK-PD研究Population Pharmacokinetic and Pharmacodynamic Modeling of Enteric-Coated Aspirin Capsule and Tablet Formulations in Healthy Subjects结核病治疗中剂量精准的重要性The importance of getting the dose right in the treatment of tuberculosis瑞舒伐他汀和依折麦布联合用药导致肠肝循环的群体PK-PD研究Population Pharmacokinetics and Pharmacodynamics with Enterohepatic Recirculation of Co-Medication of Rosuvastatin and Ezetimibe在美国未感染 HIV 的成人中单独使用抗HIV-1 单克隆抗体 PGT121.414.LS，及与VRC07-523LS 联合给药的安全性、耐受性、药代动力学及中和活性研究（项目编号HVTN 136/HPTN 092）：一项首次人体、开放标签、随机对照的 1 期临床试验Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trialEdupuganti S., Hurt C.B., Stephenson K.E., Huang Y., et al.The Lancet HIV. 2025 12:1 (e13-e25)恩诺沙星在治疗肉鸡大肠杆菌病中的PK、PD预测指标及蒙特卡洛模拟研究Pharmacokinetics, pharmacodynamic efficacy prediction indices, and Monte Carlo simulations of enrofloxacin for the treatment of colibacillosis in broiler chickens卡铂在犬类中的PopPK建模及其临床剂量调整Population pharmacokinetics modelling for clinical dose adjustment of carboplatin in dogsBéguin J., Mahfoudhi S., Uzel M., Rostang A., Ibish C., Ferran A.A., Pelligand L., Hulin A., Kohlhauer M. BMC Veterinary Research. 2024 20:1 Article Number 575Development of a Population Pharmacokinetic Gabapentin Model Leveraging Therapeutic Drug Monitoring ConcentrationsAl-Zubaydi F., Wassef A., Kagan L., Brunetti L. Pharmaceutics. 2024 16:12 Article Number 1514阿莫西林对犬类假中间葡萄球菌PK-PD评价Pharmacokinetics and Pharmacodynamics Evaluation of Amoxicillin Against Staphylococcus pseudintermedius in DogsJeong J.-S., Kim J.-W., Kim J.-H., Kim C.-Y., Chung E.-H., Boo S.-Y., Lee S.-H., Ko J.-W., Kim T.-W. Pathogens. 2024 13:12 Article Number 1121膳食和制剂对耐药性发育性及癫痫性脑病患儿体内大麻二酚全身暴露的影响Impact of food and formulation on cannabidiol systemic exposure in children with drug-resistant developmental and epileptic encephalopathiesBrstilo L., Reyes G., Ibarra M., Cáceres Guido P., Bressan I., Marin M.N., Delaven S.F., Agostini S., Pérez Montilla C., López M.E., Cresta A., García Bournissen F., Schaiquevich P., Caraballo R. Epilepsia. 2024 65 Supplement 1 (492-)基于模型荟萃分析建立复方口服避孕药突破性出血模型Development of breakthrough bleeding model of combined-oral contraceptives utilizing model-based meta-analysisChen H., Chun D., Lingineni K., Guzy S., Cristofoletti R., Hoechel J., Jiao T., Cicali B., Vozmediano V., Schmidt S. CPT: Pharmacometrics and Systems Pharmacology. 2024 13:11 (2016-2025)静脉注射免疫球蛋白在治疗各类免疫系统疾病患者中的PopPK模型Population Pharmacokinetic Model of Intravenous Immunoglobulin in Patients Treated for Various Immune System DisordersLee J.L., Mohamed Shah N., Makmor-Bakry M., Islahudin F., Alias H., Mohd Saffian S. Clinical Therapeutics. 2024 46:12 (e25-e37)持续输注哌拉西林/他唑巴坦可优化择期盆腔摘除术患者术中抗生素暴露水平Continuous infusion of piperacillin/tazobactam optimizes intraoperative antibiotic exposure in patients undergoing elective pelvic exenteration surgeryJackson D., Ulldemolins M., Liu X., Harris C., Tognolini A., Wallis S.C., Sumi C., Parker S.L., Eley V., Roberts J.A. Antimicrobial Agents and Chemotherapy. 2024 68:12接受单倍体相合干细胞移植并采用移植后环磷酰胺/环孢素 A 为基础的移植物抗宿主病预防方案的患者中，霉酚酸暴露量降低—需加强剂量调整Lower Mycophenolic Acid Exposure in Patients Undergoing Haploidentical Stem Cell Transplantation with Post-Transplant Cyclophosphamide/ Cyclosporine a-Based GvHD Prophylaxis - Need for Dose IntensificationPai A.A., Panetta J.C., Bijukumar N., Renji R.M., A M., Jayaraman A., Karumathil S., Korula A., Selvarajan S., Srivastava A., Abraham A., Mathews V., George B., Kulkarni U., Balasubramanian P. Blood. 2024 144 Supplement 1 (2150-)不同剂量的甲氨蝶呤在类风湿关节炎患者中的PK-PD建模与模拟Pharmacokinetic-pharmacodynamic modelling and simulation of methotrexate dosing in patients with rheumatoid arthritis研究丙泊酚作为单一药物对 2-12 岁儿童双频谱指数峰值效应时间的影响Understanding time to peak effect of propofol as sole agent on bispectral index in children aged 2–12 yearsGavel G., Koch G., Terrier A., Atkinson A., Pfister M., Erb T. Paediatric Anaesthesia. 2024 34:10 (1019-1028)替扎帕林（一种皮下注射普通肝素的替代药物）用于重度及终末期肾功能不全患者的回顾性单中心观察性研究Tinzaparin, an alternative to subcutaneous unfractionated heparin, in patients with severe and end-stage renal impairment: a retrospective observational single-center study麦考酚酸酯在印度狼疮性肾炎患者群体中的PopPK及有限采样策略研究Population Pharmacokinetics and Limited Sampling Strategy of Mycophenolate Mofetil for Indian Patients With Lupus NephritisKoloskoff K., Panwar R., Rathi M., Mathew S., Sharma A., Marquet P., Benito S., Woillard J.-B., Pattanaik S. Therapeutic Drug Monitoring. 2024 46:5 (567-574)通过建模与模拟确定儿科重症监护室中美罗培南的最佳给药策略Identifying optimal dosing strategies for meropenem in the paediatric intensive care unit through modelling and simulation给药剂量是否得当？重症儿童患者中头孢吡肟的PopPK研究Are We Dosing Correctly? Population Pharmacokinetics of Cefepime in Critically Ill Pediatric PatientsRolsma S., Blackman M., Beck C., Dbouk A., Morovia F., Glover F., Ess G., Dohler K., Bridges B., Choi L., Creech C.B. Journal of the Pediatric Infectious Diseases Society. 2024 13 Supplement 4 (S9-S10)评估高加索健康受试者中与体重相关的协变量对利福平PK的影响Assessment of body mass-related covariates for rifampicin pharmacokinetics in healthy Caucasian volunteersBilal M., Ullah S., Jaehde U., Trueck C., Zaremba D., Wachall B., Wargenau M., Scheidel B., Wiesen M.H.J., Gazzaz M., Chen C., Büsker S., Fuhr U., Taubert M., Dokos C. European Journal of Clinical Pharmacology. 2024 80:9 (1271-1283)采用非线性混合效应模型对肥胖血液透析患者庆大霉素个体药代动力学参数进行估算Individual pharmacokinetic parameter estimation of gentamicin in an obese hemodialysis patient using non-linear mixed effect modelLee H., Yoon S., Chung J.Y. Translational and Clinical Pharmacology. 2024 32:3 (150-158)利用定量药理学评估患者友好的伊维菌素 CHILD-IVITAB 在体重≥15 kg 和 <15 kg 儿童中的给药剂量Pharmacometrics to Evaluate Dosing of the Patient-Friendly Ivermectin CHILD-IVITAB in Children ≥ 15 kg and <15 kgGolhen K., Buettcher M., Huwyler J., van den Anker J., Gotta V., Dao K., Rothuizen L.E., Kobylinski K., Pfister M. Pharmaceutics. 2024 16:9 Article Number 1186Elexacaftor/tezacaftor/ivacaftor 药代动力学与 2 至 5 岁儿童行为障碍的发生情况的研究Elexacaftor/tezacaftor/ivacaftor pharmacokinetics and occurance of behavioral disorders in children aged 2 to 5Truong N., Benaboud S., Chouchana L., Bonnel A., Barboura M., Bouazza N., Gautier S., Rouillon S., Froelicher-Bournaud L., Bihouee T., Bui S., Treluyer J., Sermet-Gaudelus I., Foissac F. Journal of Cystic Fibrosis. 2024 23 Supplement 2 (S277-S278)重症患者需增加头孢哌酮负荷剂量：一项采用PK建模评估推荐负荷剂量的回顾性研究Loading Dose of Ceftazidime Needs to Be Increased in Critically Ill Patients: A Retrospective Study to Evaluate Recommended Loading Dose with Pharmacokinetic ModellingLaunay M., Ollier E., Kably B., Le Louedec F., Thiery G., Lanoiselée J., Perinel-Ragey S. Antibiotics. 2024 13:8 Article Number 756达沙替尼在健康受试者中的PopPK研究Population Pharmacokinetics of Dasatinib in Healthy SubjectsHassouneh W.B., Al-Ghazawi M.A., Saleh M.I., Najib N. Pharmaceuticals. 2024 17:6 Article Number 671WS15.03 Elexacaftor/tezacaftor/ivacaftor 在囊性纤维化儿科患者中的PopPK研究WS15.03 Elexacaftor/tezacaftor/ivacaftor population pharmacokinetics in paediatric patients with cystic fibrosisTruong N.H., Benaboud S., Bardin E., et al. Journal of Cystic Fibrosis. 2024 23 Supplement 1 (S28-)慢性髓性白血病患者体重指数与血浆中伊马替尼浓度的关系，并采用PK引导的给药策略减轻其临床影响Relationship of body mass index and plasma imatinib levels in CML patients and mitigation of clinical impact using PK-guided dosing strategyMaroselli P., Fanciullino R., Colle J., Farnault L., Rocher P., Venton G., Costello R., Ciccolini J. Journal of Clinical Oncology. 2024 42:16 Supplement延长纳武利尤单抗给药间隔：在未筛选癌症患者中开展基于模型的模拟Extending the dosing intervals of nivolumab: model-based simulations in unselected cancer patientsPuszkiel A., Bianconi G., Pasquiers B., Balakirouchenane D., Arrondeau J., Boudou-Rouquette P., Bretagne M.-C., Salem J.-E., Declèves X., Vidal M., Kramkimel N., Guegan S., Aractingi S., Huillard O., Alexandre J., Wislez M., Goldwasser F., Blanchet B. British Journal of Cancer. 2024 130:11 (1866-1874)RPEM：随机蒙特卡洛参数期望最大化算法RPEM: Randomized Monte Carlo parametric expectation maximization algorithmChen R., Schumitzky A., Kryshchenko A., Nieforth K., Tomashevskiy M., Hu S., Garreau R., Otalvaro J., Yamada W., Neely M.N. CPT: Pharmacometrics and Systems Pharmacology. 2024 13:5 (759-780)肺移植受者进行伊沙康唑治疗药物监测的理论依据The Rationale for Therapeutic Drug Monitoring of Isavuconazole in a Lung Transplant RecipientZajacova A., Sima M., Havlin J., Klapkova E., Lischke R., Slanar O., Dvorackova E. Journal of Heart and Lung Transplantation. 2024 43:4 Supplement (S644-S645)Lumacaftor/Ivacaftor 在囊性纤维化儿科患者中的PopPK：迈向个体化治疗的第一步Lumacaftor/Ivacaftor Population Pharmacokinetics in Pediatric Patients with Cystic Fibrosis: A First Step Toward Personalized TherapyBouazza N., Urien S., Foissac F., Choupeaux L., et al. Clinical Pharmacokinetics. 2024 63:3 (333-342)赖诺普利在高血压的儿童和正常至轻度肾功能受损的青少年的PopPK研究Population pharmacokinetics of lisinopril in hypertensive children and adolescents with normal to mildly reduced kidney functionSandra L., Degraeuwe E., De Bruyne P., De Baere S., Croubels S., Van Bocxlaer J.F.P., Raes A., Vande Walle J., Gasthuys E., Vermeulen A. British Journal of Clinical Pharmacology. 2024 90:2 (504-515)基于模型的临床前试验心血管安全性评估与转化教程A tutorial for model-based evaluation and translation of cardiovascular safety in preclinical trialsKulesh V., Vasyutin I., Volkova A., Peskov K., Kimko H., Sokolov V., Alluri R. CPT: Pharmacometrics and Systems Pharmacology2024 13:1 (5-22)提高奥拉帕利的药物暴露量以优化不良反应管理Improving olaparib exposure to optimize adverse effects managementSterlé M., Puszkiel A., Burlot C., Pereira E., Bellesoeur A., De Percin S., Beinse G., Fumet J.-D., Favier L., Niogret J., Blanchet B., Royer B., Bengrine-Lefevre L., Schmitt A. Therapeutic Advances in Medical Oncology. 2024 16疑似急性肾移植排斥反应：甲基泼尼松龙治疗下他克莫司的药代动力学研究Suspicious of Acute Kidney Graft Rejection: Tacrolimus Pharmacokinetics Under Methylprednisolone TherapyBidu N.S., Mattoso R.J.C., Santos O.A.C.O., Alves I.A., Fernandes B.J.D., Couto R.D. Current Drug Research Reviews. 2024 16:3 (403-411)►►►往年MonolixSuite文献汇总返回搜狐，查看更多

2026-01-15

·PRNewswire

Hemophagocytic Lymphohistiocytosis Market Poised for Phenomenal Expansion in the US at a CAGR of 24.5% During the Forecast Period (2025-2034) | DelveInsight

The hemophagocytic lymphohistiocytosis market is expected to increase due to the launch of emerging therapies, such as plonmarlimab (TJ Biopharma), ELA026 (Electra Therapeutics), MAS825 (Novartis), tadekinig alfa (r-hIL-18BP) (AB2 Bio), and others, as well as label expansions of current therapies. This is because of the higher patient burden, approval of newer therapies with high cost, and broader acceptance and availability of newly approved therapies. LAS VEGAS, Jan. 15, 2026 /PRNewswire/ -- DelveInsight's Hemophagocytic Lymphohistiocytosis Market Insights report includes a comprehensive understanding of current treatment practices, hemophagocytic lymphohistiocytosis emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Hemophagocytic Lymphohistiocytosis Market Summary The market size for hemophagocytic lymphohistiocytosis was found to be USD 140 million in the United States in 2024. The HLH market remains highly unmet, with conventional therapies leading to high mortality (20–30% before HSCT) and only about 60% long-term survival due to toxicity, treatment failure, and relapse risk. Among the 7MM countries, there were 5,100 incident cases of HLH in the US in 2024. Leading hemophagocytic lymphohistiocytosis companies, such as TJ Biopharma, AB2 Bio, Electra Therapeutics, Novartis, and others, are developing new hemophagocytic lymphohistiocytosis treatment drugs that can be available in the hemophagocytic lymphohistiocytosis market in the coming years. The promising hemophagocytic lymphohistiocytosis therapies in clinical trials include Plonmarlimab (TJM2/TJ003234), Tadekinig alfa (r-hIL-18BP), ELA026, MAS 825, and others. Discover the new hemophagocytic lymphohistiocytosis treatment @ Key Factors Driving the Growth of the Hemophagocytic Lymphohistiocytosis Market Rising HLH Incidence: The increasing incidence of HLH, often triggered by underlying infections, autoimmune diseases, malignancies, or immuno-oncology treatments, has expanded the pool of patients needing diagnosis and therapy. Advances in Diagnostics and Early Detection: Improvements in diagnostic technologies, including genetic testing, immunologic profiling, and next-generation sequencing, enable earlier and more accurate detection of HLH. This allows timely intervention, which is critical given the rapid, life-threatening course of HLH. GAMIFANT Maintains First-in-Class Position in HLH: GAMIFANT (Sobi) remains the only approved therapy for primary HLH (since 2018) and has recently expanded its label, gaining US FDA approval in June 2025 for MAS associated with Still's disease. Following this approval, GAMIFANT has demonstrated stronger-than-projected market uptake, with double-digit growth in Constant Exchange Rates (CER). The company plans to pursue EU regulatory submission in 2026, indicating continued strategic expansion of its HLH and MAS portfolio. Launch of Emerging HLH Drugs: The dynamics of the HLH market are expected to change in the coming years due to the launch of emerging therapies such as plonmarlimab (TJ Biopharma), ELA026 (Electra Therapeutics), MAS825 (Novartis), tadekinig alfa (r-hIL-18BP) (AB2 Bio), and others. Hemophagocytic Lymphohistiocytosis Market Analysis Management of HLH necessitates a comprehensive, multimodal strategy that integrates immunosuppressive, cytotoxic, and targeted therapies to control hyperinflammation, limit pathological immune activation, and restore immune homeostasis. Therapeutic decisions are guided by disease severity and the underlying trigger, with early, aggressive intervention essential to prevent irreversible organ damage. High-dose corticosteroids, particularly dexamethasone, constitute a foundational component of HLH treatment due to their potent anti-inflammatory effects and ability to suppress cytokine-mediated tissue injury. Etoposide-based regimens remain a cornerstone of first-line therapy, as they effectively eradicate cytotoxic lymphocytes and macrophages that are excessively activated and drive disease pathology. Immunosuppressive agents such as cyclosporine are commonly employed to suppress T-cell activation and reduce cytokine release, thereby dampening immune overactivation. Targeted biologic therapies, including rituximab for EBV-associated HLH and monoclonal antibodies such as alemtuzumab or antithymocyte globulin in refractory disease, enable more selective immune modulation. When infections serve as triggering factors, concurrent antimicrobial therapy, including antivirals and antibiotics, is critical to address both the precipitating cause and the downstream inflammatory cascade. Collectively, these treatment approaches aim to achieve disease stabilization and control, allowing eligible patients to proceed to definitive curative options such as hematopoietic stem cell transplantation (HSCT). GAMIFANT demonstrated strong commercial momentum in Q3 2025, generating USD 66.6 million in revenue, a 98% year-over-year increase. Revenue growth was driven by rising patient adoption, a favorable product mix, and the successful U.S. launch for macrophage activation syndrome (MAS) in Still's disease, making GAMIFANT the first approved therapy for both pediatric and adult patients. This milestone highlights GAMIFANT's broader applicability across the HLH–MAS disease spectrum and reinforces its long-term growth potential. Regulatory momentum remains positive, while active compassionate-use programs in Europe continue to reflect sustained clinician demand. Looking ahead, GAMIFANT revenues are expected to grow at a low double-digit CAGR at constant exchange rates, supported by global market expansion, improved patient access, and continued uptake across both MAS and HLH indications. Hemophagocytic Lymphohistiocytosis Competitive Landscape The pipeline of HLH is very scarce, with only three emerging therapies: plonmarlimab (TJ Biopharma), ELA026 (Electra Therapeutics), MAS825 (Novartis), and tadekinig alfa (r-hIL-18BP) (AB2 Bio). Despite all being in late-stage development, this underscores the scarcity of therapeutic innovation in this space. AB2 Bio's Tadekinig alfa is an innovative recombinant human IL-18 binding protein (IL-18BP) that neutralizes IL-18, a key pro-inflammatory cytokine. Under normal physiological conditions, endogenous IL-18BP is present in excess, maintaining circulating free IL-18 at undetectable levels. In certain autoinflammatory disorders, this regulatory balance is disrupted, leading to elevated systemic free IL-18 and severe pathological hyperinflammation. Tadekinig alfa re-establishes this balance by sequestering excess free IL-18, thereby attenuating inflammatory responses. This mechanism represents a novel and promising therapeutic strategy for autoimmune and inflammatory diseases characterized by elevated systemic IL-18 levels. The therapy is currently being evaluated in a Phase III clinical trial. Electra Therapeutics' ELA026 is a monoclonal antibody developed to treat severe inflammatory diseases driven by dysregulated myeloid cells and T-lymphocytes. It selectively and rapidly depletes the circulating inflammatory myeloid cells and T cells responsible for disease pathology, while preserving the CD47/SIRPα immune checkpoint pathway. ELA026 is presently in Phase II/III clinical development. The anticipated launch of these emerging therapies are poised to transform the hemophagocytic lymphohistiocytosis market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the hemophagocytic lymphohistiocytosis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about the hemophagocytic lymphohistiocytosis drugs @ Hemophagocytic Lymphohistiocytosis Drugs Market Recent Developments in the Hemophagocytic Lymphohistiocytosis Market In October 2025, Electra Therapeutics announced that the first patients had been dosed in the SURPASS study, a pivotal Phase II/III clinical trial evaluating ELA026, the first investigational therapy designed to broadly treat secondary HLH. In June 2025, Sobi announced that the US FDA approved emapalumab for the treatment of adult and pediatric (newborn and older) patients with HLH/MAS in known or suspected Still's disease, including sJIA, with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. What is Hemophagocytic Lymphohistiocytosis? Hemophagocytic lymphohistiocytosis is a rare, life-threatening immune system disorder characterized by extreme and uncontrolled immune activation. In HLH, immune cells, particularly macrophages and lymphocytes, become overactive and release excessive amounts of inflammatory cytokines, leading to a "cytokine storm" that causes widespread tissue damage and organ failure. The condition can be inherited (primary HLH) due to genetic defects affecting immune regulation, or acquired (secondary HLH) and triggered by infections, malignancies, autoimmune diseases, or other immune challenges. Clinically, HLH often presents with persistent high fever, enlarged liver and spleen, cytopenias, liver dysfunction, and markedly elevated inflammatory markers. Without prompt diagnosis and treatment, HLH can rapidly progress and is frequently fatal. Hemophagocytic Lymphohistiocytosis Epidemiology Segmentation The hemophagocytic lymphohistiocytosis epidemiology section provides insights into the historical and current hemophagocytic lymphohistiocytosis patient pool and forecasted trends for the leading markets. The commonest single disease entities were lymphoma, SLE, and sJIA. There has been evidence of clinically diagnosed HIV, EBV, or CMV infection either in the health record or on the death certificate in 2.3%, 8.9%, and 3.3%, respectively. The hemophagocytic lymphohistiocytosis treatment market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into: Total Incident Cases of HLH Total Incident Cases of HLH by Type Incident Cases of HLH by Gender Incident Cases of Familial HLH by Mutation Incident Cases of Acquired HLH by Etiology Total Treated Cases of HLH Scope of the Hemophagocytic Lymphohistiocytosis Market Report Therapeutic Assessment: Hemophagocytic Lymphohistiocytosis current marketed and emerging therapies Hemophagocytic Lymphohistiocytosis Market Dynamics: Key Market Forecast Assumptions of Emerging Hemophagocytic Lymphohistiocytosis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Hemophagocytic Lymphohistiocytosis Market Access and Reimbursement Download the report to understand what is the latest research on hemophagocytic lymphohistiocytosis @ New Hemophagocytic Lymphohistiocytosis Medication Table of Contents Related Reports Hemophagocytic Lymphohistiocytosis Clinical Trial Analysis Hemophagocytic Lymphohistiocytosis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HLH companies, including Chia Tai Tianqing Pharmaceutical Group, Bellicum Pharmaceuticals, Atara Biotherapeutics, Incyte Corporation, Alpine Immune Sciences, Expression Therapeutics, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Clinical Trial Analysis Systemic Lupus Erythematosus Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key SLE companies, including Roche, Biogen, Viatris Inc., Novartis, Qilu Pharmaceutical, ImmuPharma, Beijing Mabworks Biotech Co., Ltd., Zenas Biopharma, AbbVie, Beijing InnoCare Pharma Tech Co., Ltd., Alumis Inc., Galapagos NV, Palleon Pharmaceuticals, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Johnson & Johnson, Merck KGaA, Resolve Therapeutics, ILTOO Pharma, Argenx, Cartesian Therapeutics, Keymed Biosciences Co.Ltd, BioSenic, Eisai, Vertex Pharmaceuticals, Kyverna Therapeutics, Miltenyi Biomedicine, Astrazeneca, Otsuka Pharmaceutical, Fresh Tracks Therapeutics, among others. Macrophage Activation Syndrome Market Macrophage Activation Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key MAS companies, including Electra Therapeutics, TJ Biopharma, AB2 Bio, Novartis, Deepcure, Sobi, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

上市批准免疫疗法临床3期

2025-11-07

·Firstwordpharma

Eledon pursues Phase III bid for kidney transplant drug despite mid-stage failure

Eledon Pharmaceuticals said its anti-CD40 ligand antibody tegoprubart, fell short on the main efficacy goal in a mid-stage trial for preventing organ rejection in de novo kidney transplant recipients. Notwithstanding the setback, the company plans to discuss a potential Phase III study with regulatory agencies, citing encouraging efficacy and safety signals.The Phase II BESTOW study enrolled 127 kidney transplant recipients — who were randomised to receive either tegoprubart-based immunosuppression or tacrolimus-based therapy — in addition to rabbit antithymocyte globulin induction and maintenance treatment with mycophenolate mofetil and corticosteroids. The trial’s primary efficacy endpoint was change in estimated glomerular filtration rate (eGFR) at 12 months post-transplant.Results presented Thursday at the American Society of Nephrology's Kidney Week meeting, showed the tegoprubart arm achieved a mean eGFR of 69 mL/min/1.73 m² at 12 months versus 66 mL/min/1.73 m² for tacrolimus, missing statistical significance but attaining what the company touts as the highest mean eGFR level reported to date in this trial setting. Additionally, a key secondary endpoint of composite efficacy failure rate — comprising death, graft loss and biopsy-proven acute rejection — was 22% for tegoprubart versus 17% for tacrolimus, demonstrating non-inferiority using a 20% margin.The biotech noted the biologic’s safety profile to be largely favourable. New-onset diabetes was recorded in one in 47 patients receiving tegoprubart compared with one in six on tacrolimus, while tremor occurred in 1.6% versus 25.0% of patients, respectively. Tegoprubart also fared better than the comparator on cardiovascular events, including hypertension, hypertensive crisis and heart failure. Additionally, delayed graft function requiring dialysis was less frequent with tegoprubart at 14.3% versus 25.0% for tacrolimus."By pairing strong immunosuppressive efficacy with a differentiated safety profile…tegoprubart represents a promising next-generation option for kidney transplant immunosuppression as we advance into Phase III," said CEO David-Alexandre Gros.Besides renal allograft transplantation, the therapy is also being investigated in xenotransplantation and amyotrophic lateral sclerosis. As of September 30, the company held cash reserves worth approximately $93.4 million, enough to fund operations till late next year.

临床结果临床3期临床2期ASH会议

100 项与抗人胸腺细胞免疫球蛋白相关的药物交易

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适应症	国家/地区	公司	日期
器官移植排斥	日本	Sanofi KK	2011-04-22
细菌感染	澳大利亚	Sanofi-Aventis Australia Pty Ltd.	2008-07-18
移植物抗宿主病	日本	Sanofi KK	2008-07-16
再生障碍性贫血	韩国	Sanofi-Aventis Korea Co., Ltd.	1993-01-19
心脏移植排斥反应	韩国	Sanofi-Aventis Korea Co., Ltd.	1993-01-19
肾移植排斥反应	韩国	Sanofi-Aventis Korea Co., Ltd.	1993-01-19

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适应症	最高研发状态	国家/地区	公司	日期
心源性猝死	临床3期	英国	Genzyme Corp.	2011-01-01
再灌注损伤	临床3期	英国	Genzyme Corp.	2011-01-01
慢性移植物抗宿主病	临床3期	加拿大	Genzyme Corp.	2010-04-01
白血病	临床3期	加拿大	Genzyme Corp.	2010-04-01
急性髓性白血病	临床3期	美国	Genzyme Corp.	2007-08-01
肺移植排斥反应	临床3期	美国	Genzyme Corp.	2006-01-01
原发性移植物功能障碍	临床3期	美国	Genzyme Corp.	2006-01-01
免疫系统疾病	临床2期	荷兰	-	2015-01-26
1型糖尿病	临床2期	美国	Genzyme Corp.	2010-04-01
终末期肾脏病	临床2期	美国	Sanofi	2010-03-01

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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


Tandem Meetings ASTCT and CIBMTR2026	N/A	再生障碍性贫血	17	Fludarabine+Cyclophosphamide+Anti-Thymocyte Globulin (ATG)	獵觸鏇鏇鏇網膚顧鏇壓(窪衊鑰簾鑰製餘簾齋遞) = 遞壓齋網醖醖餘範觸衊選網獵築鹽鏇襯網繭鬱 (鑰齋鑰構鑰憲壓餘衊鑰 ) 更多	积极	2026-02-04
EBMT 2024 (ASCO2025)	N/A	absolute lymphocyte	30	Split-dose rATG	壓衊積蓋鏇築鬱鹽積獵(壓餘獵構醖憲製鑰簾淵) = 構鑰顧鑰襯範糧觸願鬱願鹹顧鹽鑰鬱範鹹醖築 (蓋觸廠鑰艱顧願衊製蓋 ) 更多	积极	2025-05-30
PF1188 (EHA2025)	N/A	输血依赖性地中海贫血	51	F-BMT conditioning regimen	鑰廠選觸鹹襯遞觸構選(製製顧顧壓衊夢襯夢廠) = 壓夢襯襯糧壓網齋觸鹹網繭鑰鹹鏇壓選艱壓願 (襯衊淵廠餘糧衊醖廠簾 ) 更多	积极	2025-05-14
NCT05634915 (S263, EHA2025)	临床4期	MRD+	119	Optimal AUC (55-75 AU/mL/day)	範夢獵顧網廠糧網醖鹽(鏇顧鏇遞壓願鹽齋蓋艱) = 糧膚構蓋網獵淵衊積構範積鹽餘積淵淵蓋壓範 (壓鑰觸簾齋憲憲願壓獵 ) 更多	积极	2025-05-14
				Non-optimal AUC	範夢獵顧網廠糧網醖鹽(鏇顧鏇遞壓願鹽齋蓋艱) = 簾齋網襯蓋築網積願觸範積鹽餘積淵淵蓋壓範 (壓鑰觸簾齋憲憲願壓獵 ) 更多
EHA2025	N/A	急性淋巴细胞白血病	943	ATLG (20 mg/kg)	糧醖衊繭壓膚憲淵鬱遞(顧窪餘願願積鑰醖選壓) = 簾齋選艱糧顧夢淵鬱鹽網顧餘獵衊鬱膚齋築鏇 (遞蓋廠壓願鑰鏇淵艱膚 ) 更多	-	2025-05-14
				ATG-T (5-6.75 mg/kg)	糧醖衊繭壓膚憲淵鬱遞(顧窪餘願願積鑰醖選壓) = 膚鬱糧繭醖顧繭鹽衊鬱網顧餘獵衊鬱膚齋築鏇 (遞蓋廠壓願鑰鏇淵艱膚 ) 更多
ASH2024	N/A	慢性移植物抗宿主病	-	Anti-thymocyte globulin (ATG)	鏇蓋網蓋糧遞鏇構窪願(鹹膚範齋夢壓壓獵糧廠) = AGVHD was reported in 15 and 6 patients in Arms A and BE respectively, of which 6 and 3 had grades II-IV and 3 and 0 had grades III-IV. At 100 days, 3 patients in Arm A and 3 patients in Arm BE were receiving systemic corticosteroids. 繭鏇構憲鹹糧醖衊製鹽 (淵鹹願繭醖製製鹽夢艱 ) 更多	-	2024-12-08
				ATG plus Post Transplant Cyclophosphamide (PTCy)
3537 (ASH2024)	N/A	Sveinsson脉络膜视网膜萎缩 CMV \| EBV	406	rATG	糧壓衊積餘艱窪獵窪築(襯鹹醖構壓鹹願網獵鹽) = 製選餘夢網簾夢範網糧醖積餘製夢鏇壓鑰獵鬱 (願糧齋衊窪顧觸壓窪製, 0.71 ~ 0.81) 更多	积极	2024-12-08
				ATLG	糧壓衊積餘艱窪獵窪築(襯鹹醖構壓鹹願網獵鹽) = 壓鹽壓壓齋鏇鏇獵艱鏇醖積餘製夢鏇壓鑰獵鬱 (願糧齋衊窪顧觸壓窪製, 0.65 ~ 0.83) 更多
TBI-ATG-BASED CONDITIONING REGIMEN (EHA2024)	N/A	外周T细胞淋巴瘤	-	TBI-ATG-based conditioning regimen	糧積選醖鑰製窪衊積範(餘鹹壓顧餘鑰齋壓廠繭) = 網艱鑰製艱遞餘鬱艱鏇窪衊鑰選鏇夢網築鬱餘 (獵餘襯膚鑰鹹網範願鑰, 57.55% ~ 77.79%) 更多	积极	2024-05-14
EHA2024	N/A	血液肿瘤	211	ATG-Genzyme (ATG-G) ≤6 mg/kg	鹽蓋築廠壓鹹醖廠獵衊(鹽築繭鏇壓鹹觸積鬱壓) = 糧鑰衊艱範憲夢願壓觸鏇繭願選構範積衊獵製 (構壓鑰窪構構範鑰獵艱, 40.8% ~ 56.3) 更多	-	2024-05-14
				ATG-Fresenius (ATG-F) 20mg/kg	繭繭範構獵醖觸鑰製蓋(選艱窪餘憲蓋觸鹽繭遞) = 糧襯積襯繭鏇衊廠餘觸糧簾繭製鬱製齋蓋獵範 (鹽鹹築鏇窪遞窪顧網糧, 15.7% ~ 26.8) 更多
Tandem Meetings ASTCT and CIBMTR2024	N/A	镰状细胞血症	28	Thiotepa, Fludarabine, Thymoglobulin, Low Dose Cyclophosphamide, 200 Cgy TBI and Post-Transplant Cyclophosphamide	構築蓋壓襯糧構範製鑰(鏇淵醖鏇艱願範廠衊窪) = 選遞積積遞選膚鑰願膚鏇製鹽鬱構遞範簾衊膚 (夢醖衊簾餘鏇窪鹽餘範 ) 更多	积极	2024-02-01