预约演示
更新于：2026-04-15
Relmapirazin
瑞玛比嗪
更新于：2026-04-15
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2025-01-17), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C12H16N6O8 |
InChIKeyXHNJXRDGTITISI-QWWZWVQMSA-N |
CAS号1313706-17-0 |
关联
10
项与 瑞玛比嗪 相关的临床试验NCT07080008
A Single Center, Open Label Pilot Study to Assess the Feasibility and Safety of Lumitrace Injection for Intraoperative Ureter Visualization Comparing White Light (WL) Fluorescence (BLUE) in Participants Undergoing Minimally Invasive Abdominopelvic Surgeries
NCT04008121
A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium
NCT05777174
An Open Label, Multi-Center, Safety and Pharmacokinetic Bridging Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring in Normal and Renal Compromised Subjects for the Evaluation of Kidney Function
100 项与 瑞玛比嗪 相关的临床结果
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100 项与 瑞玛比嗪 相关的转化医学
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100 项与 瑞玛比嗪 相关的专利（医药）
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23
项与 瑞玛比嗪 相关的文献（医药）2026-04-01Kidney International Reports
Accuracy of Point-of-Care Transdermal GFR Methodology
Article
作者: Dorshow, Richard B ; Friedemann, Jochen ; Trelford, Lester Paul ; Goldstein, Stuart L ; Riley, I Rochelle ; Harr, James ; Debreczeny, Martin P ; Vitale, Laura ; Ross-Jones, Jesse ; Johnson, James R
Introduction:
Chronic kidney disease (CKD) is typically staged using population-derived empirical equations to estimate glomerular filtration rate (GFR) based on serum creatinine and/or cystatin C. However, these estimated GFR (eGFR) equations can be inaccurate for an individual patient. Although plasma-derived GFR using an exogenous agent is the preferred methodology, the requirement for multiple blood samples and laboratory analysis limits its practical clinical utility. We have shown that the fluorescent molecule, relmapirazin, is an exogenous GFR tracer agent and its transdermal fluorescence detection at the point-of-care can assess a clinically relevant range of GFR across all human skin colors. In the current study, transdermal GFR (tGFR) was compared with the plasma-derived indexed GFR (nGFR) in a multicenter pivotal clinical study.
Methods:
We evaluated 182 participants with normal eGFR to CKD stage 4 across all 6 Fitzpatrick Skin Scale (FSS) types. A sensor attached to the chest contained a light emitting diode and photodetector for transdermal fluorescence detection following i.v. administration of relmapirazin. The primary end point was percentage of tGFR values within 30% of nGFR (P30).
Results:
P30 of 94% (95% confidence interval [CI]: 89%-97%) was obtained for the entire cohort. P30 was 96% and 92% for participants with GFR > or < 60 ml/min per 1.73 m2, respectively. P30 of 96% was for participants with FSS I to III and 90% with IV to VI.
Conclusion:
The tGFR yielded a higher P30 value than creatinine-based eGFR equations reported in the current literature. For the cohort subsets of CKD strata and FSS, all P30 values observed were in the optimal range as established by the 2024 Kidney Disease: Improving Global Outcomes guideline.
2025-12-02EXPERT OPINION ON BIOLOGICAL THERAPY
Current status and future potential of CD123-based targeted therapies for acute leukemia
Review
作者: Aldoss, Ibrahim ; Arslan, Shukaib ; Stein, Anthony ; Aribi, Ahmed
INTRODUCTION:
Acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and blastic plasmacytoid dendritic cell neoplasm (BPDCN) are aggressive hematologic malignancies with poor outcomes, particularly in relapsed/refractory settings. CD123, the interleukin-3 receptor alpha chain, is highly expressed on leukemic blasts and leukemia stem cells, making it an attractive therapeutic target with limited expression on normal hematopoietic cells. CD123-directed therapies - including antibody-drug conjugates (ADCs), bispecific T-cell engagers (BiTEs), and CAR T-cell therapies - are under active investigation.
AREAS COVERED:
This review details the preclinical rationale, clinical development, efficacy, and toxicity of CD123-targeted therapies. It discusses completed and ongoing clinical trials for agents such as tagraxofusp, pivekimab sunirine, flotetuzumab, vibecotamab, and investigational CAR T-cell therapies (e.g. MB-102, UCART123v1.2). Toxicities, including myelosuppression, cytokine release syndrome (CRS), and hepatotoxicity - are characterized in detail, with attention to mitigation strategies. Future directions highlight combination regimens, switchable CAR designs, and biomarker-driven personalization.
EXPERT OPINION:
CD123-targeted therapy represents a promising yet challenging frontier in treating high-risk leukemias. While clinical activity has been demonstrated, especially in BPDCN, therapeutic durability and safety remain hurdles. Precision in antigen targeting, combination strategies, and toxicity management will be critical for successful integration of CD123-directed therapies into standard clinical practice.
2025-08-01JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY
GFR Measurement Using Transdermal Detection Methodology
Article
作者: Martin P. Debreczeny ; Richard B. Dorshow ; Stuart L. Goldstein
Key Points:
Transdermal fluorescence detection of GFR measurement at the point of care with the fluorescent GFR tracer agent relmapirazin was evaluated.Measurement over the entire range of clinically meaningful GFR and the entire range of human skin tones was demonstrated.
A linear regression of transdermally derived GFR to plasma-derived GFR yielded an
r2
of 0.90 and P30 of 91.9%.
Background:
The well-known accuracy limitations of eGFR currently used in clinical practice present barriers to optimal care for patients with, or at risk of, decreased kidney function. A point-of-care GFR measurement methodology has the potential to address these limitations. We prospectively assessed transdermal detection of the novel fluorescent GFR tracer agent relmapirazin in participants having normal or impaired kidney function across all human skin colors on the Fitzpatrick Skin Scale (FSS).
Methods:
A multicenter study comprising 74 participants with eGFR from normal to stage 4 CKD was performed. Forty-six participants were FSS types 1–3, and 28 were FSS types 4–6. A module containing a light-emitting diode and photodetector to activate and collect transdermal relmapirazin fluorescence was attached adhesively to the upper chest of each participant. Relmapirazin (1.5 mg/kg) was administered by intravenous push, and fluorescence emission was acquired for 12 hours. A two-compartment pharmacokinetic model fit the fluorescent intensity versus time data, and fluorescence clearance rate (FCR) was extracted from the second (terminal) compartment. Plasma relmapirazin concentrations were measured contemporaneously, and the corresponding plasma GFR for each participant was determined. Linear regression analysis was used to compare the FCR with the indexed plasma GFR.
Results:
Participant age range was 23–80 years, with 59% female. The two-compartment pharmacokinetic behavior was observed in the fluorescence intensity versus time data, and a FCR was successfully deduced for every participant completing the 12-hour study. The FCR versus indexed plasma GFR yielded an excellent correlation over the range of GFR measured and for all skin colors with a
r2
of 0.90 (95% confidence interval, 0.85 to 0.94). No severe adverse events were reported.
Conclusions:
Point-of-care transdermal detection of the fluorescent GFR tracer agent relmapirazin was feasible in patients with normal to impaired kidney function and for a range of skin color types.
Clinical Trial registry name and registration number::
ClinicalTrials.gov, NCT02772276.
Podcast:
This article contains a podcast at https://dts.podtrac.com/redirect.mp3//www.asn-online.org/media/podcast/JASN/2025_12_10_KTS_December2025.mp3
100 项与 瑞玛比嗪 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 肾小球疾病 | 美国 | 2025-01-17 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 慢性肾病 | 临床3期 | 美国 | 2022-06-14 | |
| 慢性肾病 | 临床3期 | 中国 | 2022-06-14 | |
| 肾功能不全 | 临床3期 | 美国 | 2022-06-14 | |
| 肾功能不全 | 临床3期 | 美国 | 2022-06-14 | |
| 急性肾损伤 | 临床2期 | 美国 | 2016-05-11 | |
| 输尿管疾病 | 临床1期 | 美国 | 2026-01-30 | |
| 糖尿病性视网膜病变 | 临床1期 | 美国 | 2025-11-06 | |
| 黄斑变性 | 临床1期 | 美国 | 2025-11-06 | |
| 视网膜静脉阻塞 | 临床1期 | 美国 | 2025-11-06 | |
| 克罗恩病 | 临床1期 | 美国 | 2019-10-27 |
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临床结果
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适应症
分期
评价
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临床3期 | 149 | MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)+MB-102 (Participants With eGFR ≥ 70 mL/Min/1.73 m^2) | 構窪選蓋壓積糧衊獵艱 = 築觸膚鹹蓋積艱顧鏇壓 餘網鏇鏇醖鏇夢範鑰鑰 (積構遞築艱遞廠獵築獵, 糧膚鬱膚網構鏇餘鹹廠 ~ 膚築鑰鏇觸壓餘餘願鹹) 更多 | - | 2025-03-28 | ||
MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)+MB-102 (Participants With eGFR < 70 mL/Min/1.73 m^2) | 構窪選蓋壓積糧衊獵艱 = 壓願觸衊憲鹽廠願鏇鬱 餘網鏇鏇醖鏇夢範鑰鑰 (積構遞築艱遞廠獵築獵, 觸壓廠繭積鹽窪築鑰廠 ~ 壓顧獵鑰淵蓋憲積艱範) 更多 | ||||||
临床3期 | 249 | MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)+MB-102 (eGFR ≥ 70 mL/Min/1.73 m^2) | 選簾遞鹽壓顧鬱鬱鏇齋 = 網餘窪築襯襯餘構餘廠 鑰蓋鏇衊淵齋簾構艱網 (觸網製構願簾齋窪蓋膚, 夢襯憲鹽範鏇網餘衊醖 ~ 齋窪簾構築艱窪淵鑰獵) 更多 | - | 2024-04-18 | ||
MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)+MB-102 (eGFR < 70 mL/Min/1.73 m^2) | 選簾遞鹽壓顧鬱鬱鏇齋 = 簾鑰獵範獵膚繭鏇築衊 鑰蓋鏇衊淵齋簾構艱網 (觸網製構願簾齋窪蓋膚, 網觸選窪窪衊顧淵齋簾 ~ 鏇構選餘膚糧蓋憲艱鹽) 更多 |
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