Optimization of Beta-lactam Dosing in Critically Ill Patients With Suspected or Documented Antimicrobial Resistant Gram-Negative Infections With Cystatin-C (OPTIMIZE-GNI)

The purpose of this study is to evaluate the abilities of Cystatin C (CysC) and CysC-based estimated Glomerular Filtration Rate (eGFR) equations to characterize the pharmacokinetics (PK) profiles of meropenem and cefepime relative to Serum Creatinine (SCR), Serum Creatinine based Equation (SCRE)and iohexol at the population and individual levels in critically ill adult patients with suspected or documented AMR Gram-negative infections. We hypothesize that CysC and CysC-based eGFR equations will characterize the PK profiles of meropenem and cefepime at the population and individual levels with greater accuracy and precision than SCR and SCREs. Iohexol will be administered to patients enrolled in the study and serve as the reference indicator of measured Glomerular Filtration Rate (mGFR), which is the gold standard assessment of kidney function. We hypothesize that the predictive performances of CysC and CysC-based eGFR equations in estimating the PK profiles of meropenem and cefepime at the population and individual levels will be comparable to iohexol. The information obtained in this study will be used to develop PK/pharmacodynamics (PD) optimized meropenem and cefepime dosing schemes based on the renal function biomarker population PK (PopPK) model with the best predictive performance for clinical use in the treatment of critically ill adult patients with suspected or documented AMR Gram-negative infections and varying degrees of renal function. The primary objective of this study is to compare the abilities of renal function biomarkers (CysC, CysC-based eGFR equations, SCR, SCREs) relative to iohexol to characterize the PK profiles of meropenem and cefepime in critically ill adult patients with suspected or documented AMR Gram-negative infections.

开始日期2025-01-17

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT05136963

/ Not yet recruiting临床1期IIT

Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance Using Limited Sample Strategy for the Evaluation of Kidney Donation Candidates.

In kidney transplantation, donor selection is based in part on the assessment of the functional capacity of the kidneys. For this purpose, it is recommended to measure the glomerular filtration rate (GFR) by a reference technique. To estimate GFR, several approaches are possible depending on the type of measurement (urinary or plasma) and the marker (exogenous or endogenous) used. Among these methods, the measurement of inulin clearance has long been considered the reference method. The occurrence of anaphylactic reactions led to its withdrawal from the market. Iohexol, an iodinated contrast agent, has characteristics similar to inulin. It is eliminated by glomerular filtration and its biological determination is simple.
Nevertheless, the techniques currently used to calculate plasma clearance of Iohexol have been imperfectly validated and are not always easy to implement in practice. the investigators propose to develop a Bayesian estimator for estimating Iohexol clearance applied to a population of healthy subjects, representative of potential kidney donors.

开始日期2024-06-01

申办/合作机构

Centre Hospitalier Universitaire de Saint-Etienne

NCT06259422

/ Not yet recruitingN/A

Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate

This study is a single centre intervention study to compare two methods of determining the measured glomerular filtration rate (mGFR). Subjects who receive radioactively labeled iothalamate (125I) and hippuran (131I) within the framework of routine clinical care, will be co-administered iohexol. The primary trial endpoint is the mGFR when administered 125I-iothalamate and 131I-hippuran versus iohexol. By determining the mGFR using both iohexol and iothalamate in the same patients, a direct comparison of the two methods can be made in terms of their accuracy and precision. This makes it possible to determine the potential use of the non-radioactive measurement method as an alternative to the radioactive method and thus lower the overall radioactive burden for patients and personnel.

开始日期2024-06-01

申办/合作机构

University Medical Center Groningen

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100 项与碘海醇相关的专利（医药）

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项与碘海醇相关的文献（医药）

2025-03-01·Journal of Pharmaceutical and Biomedical Analysis

Dried blood spot LC-MS/MS quantification of voclosporin in renal transplant recipients using volumetric dried blood spot sampling

Article

作者: Teng, Y K O ; Moes, D J A R ; de Vries, A P J ; Swen, J J ; Metscher, E ; Meziyerh, S ; Arends, E J

Voclosporin is a potent immunosuppressive agent currently approved for treating active lupus nephritis. Based on its potential antiviral activity, it has also been investigated as immunosuppressive agent in an investigator-initiated study in SARS-CoV2 positive kidney transplant recipients. As with many immunosuppressive agents, optimizing dosing regimens to achieve therapeutic efficacy while minimizing toxicity remains a critical challenge in clinical practice. To prevent organ rejection as well as infections, the prescribed immunosuppression needs to be well balanced. Dried blood spot (DBS) sampling has enabled development of remote voclosporin therapeutic drug monitoring. Here, we report on the development and analytical validation of a liquid chromatography tandem mass spectrometry (LC-MS/MS) assay for quantification of voclosporin in dried blood spots. Method development was based on previously developed assays for the quantification of tacrolimus, everolimus, sirolimus, cyclosporin, mycophenolic acid, creatinine and iohexol in DBS and voclosporin in whole blood using LC-MS/MS. HemaXis™ volumetric blood spot devices were used for sample collection. The sample purification was based on the extraction of voclosporin from the DBS samples. Stable isotopically labeled voclosporin-D4 was used as an internal standard prior to sample purification. Bland Altman and Passing bablok analysis were performed for cross validation between whole blood and DBS samples. The method was successfully validated following the current ICH M10 guidelines. The dynamic range for the analyte was 10-600 µg/L with an excellent mean coefficient of correlation of 0.9978. The within run and between run precision and accuracy were both within the acceptance criteria. The cross-validation against the whole blood method shows that the quantified voclosporin results are promising. This developed dried blood spot LC-MS/MS method was successfully validated and provides an easy, efficient workflow for therapeutic drug monitoring in kidney transplant patients or remote pharmacokinetic studies in lupus nephritis patients treated with voclosporin.

2025-03-01·Journal of Clinical and Experimental Hepatology

Comparison of Measured Glomerular Filtration Rate Versus Estimated Glomerular Filtration Rate in Indian Cirrhotic Patients: Report of a Pilot Study

Article

作者: Tiwari, Vaibhav ; Kekan, Kushal ; Verma, Nipun ; Duseja, Ajay K ; Premkumar, Madhumita ; Kashyap, Madhuri ; Gandotra, Akash ; Kaur, Jaskiran ; Aggarwal, Radhika ; Yadav, Ashok K ; Venkatasubramanian, Vaishnavi ; Patil, Amol N ; Safiq, Nusrat ; De, Arka ; Divyaveer, Smita ; Kohli, Harbir S ; Prajapati, Kanchan ; Bagur, Vishnuvardhan

BackgroundRenal impairment significantly affects morbidity and mortality rates of cirrhosis patients. Studies on glomerular filtration rate (eGFR) estimation did not include cirrhosis patients. These equations are erroneous and unreliable in cirrhosis due to sarcopenia. Further, the accuracy of eGFR equations varies across different ethnic groups. Measurement of GFR by iohexol clearance is a gold standard method of accurate determination of GFR. There is scarce data on iohexol GFR in cirrhosis and none in Indian population.MethodologyThis was prospective observational study. Consecutive adult patients with cirrhosis with stable renal function for prior 1 month were included. Iohexol weight-based dosage was given and timed blood samples were taken to measure iohexol clearance. Plasma iohexol levels was measured by high performance liquid chromatography (HPLC) and Cystatin-C was measured by ELISA in plasma samples.ResultsThirty-five patients were enrolled in the study. Hepatitis B (n = 5), hepatitis C (n = 4); alcoholic liver disease (n = 20), metabolic dysfunctional associated steatotic liver disease (n = 2), others/overlap (n = 3). The average eGFR by MDRD4, MDRD6, CKD-EPI Creat, CKD EPI Cys C, CKD EPI Creat-Cys C, RFHand GRAIL formulae were 105.24(24.2),104.75(23.5),102.14(15.9),68.91(16.5),82.91(15.21), 67.27 (14.08) and 112.9 (19.5) ml/min ml/min/1.73m², respectively. The average mGFR measured by iohexol method was 73.44 (16.8)ml/min/1.73 m². 30% agreement with mGFR was found with eGFR by MDRD4 in 38.2% (n = 13), MDRD6 38.2% ((n = 13), CKD-EPI Creat in 35.2% (n = 12), CKD EPI Cys C in 79.41% (n = 27), CKD EPI Creat-Cys C in 76.42% (n = 26), RFH 76.4% (n = 26) and GRAIL 20.5% (n = 7).ConclusionThe eGFR equations using creatinine are imprecise and less accurate in Indian patients with cirrhosis. All equations overestimate GFR. Equations especially developed for cirrhosis patients like MDRD6 are also not precise. Cystatin C based equations are better than creatinine-based equations. Further studies with large sample size are needed to establish an accurate method of GFR assessment in Indian patients with cirrhosis.

2025-02-01·Diabetes, Obesity and Metabolism

Effect of dapagliflozin on renal haemodynamics in hyperfiltering T2D patients

Article

作者: DeFronzo, Ralph A. ; Triplitt, Curtis ; YueJuan, Qin ; Hansis‐Diarte, Andrea ; Barkhordarian, Maryam ; Chavez, Alberto ; Cersosimo, Eugenio ; Baskoy, Gozde

AbstractAimsTo investigate the effect of sodium‐glucose co‐transporter 2 inhibitor [SGLT‐2i] therapy on renal haemodynamics in T2D patients with glomerular hyperfiltration.Materials and MethodsSixty T2D patients with elevated [HYPER] and normal [NORMO] GFR were randomized to dapagliflozin 10 mg/day [DAPA/HYPER, n = 15; DAPA/NORMO, n = 15] or to metformin/glipizide [CONTROL/HYPER, n = 15; CONTROL/NORMO, n = 15] to reach similar glycaemic control after 4 months. GFR was measured with Iohexol and hyperfiltration was empirically defined as >125 mL/min/1.73 m2. GFR, renal plasma flow [RPF], mean arterial pressure [MAP], filtration fraction [FF], and renal vascular resistance [RVR] were determined before/after therapy.ResultsHbA1c decreased similarly in all 4 groups. GFR declined by ~18% in DAPA/HYPER and by ~7% in DAPA/NORMO and did not change in CONTROLS (p < 0.05 vs. DAPA). RPF remained unchanged in all four groups. Thus, FF (%) declined from 0.23 ± 0.01 to 0.18 ± 0.01 in DAPA/HYPER and from 0.17 ± 0.01 to 0.15 ± 0.01 in DAPA/NORMO and remained unchanged in CONTROLS (p < 0.05 vs. DAPA). MAP (mmHg) decreased from 95.4 ± 1.4 to 88.1 ± 1.3 in DAPA/HYPER and from 95.6 ± 1.3 to 91.8 ± 0.8 in DAPA/NORMO and remained unchanged in CONTROLS (p < 0.05 vs. DAPA). RVR [mmHg/L/min] declined in DAPA/HYPER (92.7 ± 7.8 to 80.4 ± 6.1) and DAPA/NORMO (90.1 ± 3.0 to 81.4 ± 2.1) but not in CONTROLS (p < 0.05 vs. DAPA).ConclusionsDespite comparable glycaemic control, dapagliflozin treatment, but not metformin and /or glipizide, reduced glomerular hyperfiltration in T2D patients and decreased both filtration fraction and renal vascular resistance. These findings suggest that a post‐glomerular vasodilatory action of SGLT2 inhibitors contributes to their renal protective effect in T2D.

项与碘海醇相关的新闻（医药）

2025-01-20

·赛柏蓝

原研药：集采影响有多大？

特约作者 | 张自然博士责任编辑 | 郑瑶近日，原研药和集采引起广泛热议。集采对原研药影响有多大？原研药在集采中表现如何？ 01 涉及品种数以前5批及第10批国采为例，涉及原研药≥2个的有16家外企。其中，涉及原研药数量最多的是辉瑞、阿斯利康，分别涉及27个和20个原研药。辉瑞连续十多年雄踞外企在华销售榜首，近三年被阿斯利康取代冠军宝座，所以，国采涉及这两家的原研药数量最多也就不足为奇了；其次是默沙东、诺华、勃林格殷格翰、葛兰素、拜耳和赛诺菲等6家知名外企，国采涉及原研药都超过10个，分别有15个、14个、13个、13个、12个和10个；礼来、强生和施贵宝都涉及8个原研药；日本的武田、第一三共和中外制药分别涉及5个、4个和2个原研药。 02 中选品种数国采已进行了10批，除第10批外，每批都有原研药中选。前十批国采，共22家外企有原研药中选。其中，中选原研药数量最多的是赛诺菲，共中选了4个，如波立维（硫酸氢氯吡格雷片）、安博诺（厄贝沙坦氢氯噻嗪片）、索里昂（氨磺必利片）、注射用奥沙利铂。中选2个原研药的外企有6家，即拜耳、德国贝朗医疗、勃林格殷格翰、辉瑞、默沙东和通用电气药业。如拜耳的拜糖平（阿卡波糖）、贝朗的ω-3鱼油中/长链脂肪乳注射液、勃林格殷格翰的优尼（美洛昔康片）、辉瑞的斯沃（利奈唑胺片）、默沙东的顺尔宁（孟鲁司特钠片）以及通用电气的碘海醇注射液等。其他如阿斯利康、费森尤斯、葛兰素、施贵宝等15家外企都各中选了1个原研药。 03 降幅因原研药还要叠加专利悬崖效应，一般要以较大的降价幅度才能中选。但也不尽然，也有降幅很小就中选的。在前十批国采中选的原研药中，降价幅度最小的是丹麦利奥（LEO）的依安凡。降幅＜40%的有2个原研药，即丹麦利奥（LEO）的依安凡（阿法骨化醇软胶囊）、博莱科的典比乐（碘帕醇注射液），分别只降了30%、32%即一举中选；降幅40～60%的有6个原研药，即意大利ALFASIGMA S.p.A.的左卡尼汀注射液49%、德国贝朗医疗的中/长链脂肪乳注射液C8~24Ve50%和ω-3鱼油中/长链脂肪乳注射液60%、默沙东的顺尔宁（孟鲁司特钠）54%和瑞美隆（米氮平片）57%、葛兰素的安福达（度他雄胺软胶囊）55%、礼来的力比泰（培美曲塞）60%；降幅60～70%的有4个原研药，即通用电气的欧乃派克（碘海醇注射液）61%、费森尤斯卡比的敏新（脂肪乳氨基酸17葡萄糖）66%、施贵宝的蒙诺（福辛普利钠）69%、辉凌的巧特欣（卡贝缩宫素注射剂）70%。 END 内容沟通：郑瑶（13810174402）左下角「关注账号」，右下角「在看」，防止失联

带量采购核酸药物

2025-01-17

·PRNewswire

MediBeacon® Transdermal GFR System Receives FDA Approval to Assess Kidney Function

Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal or impaired renal function. The transdermal GFR (tGFR) methodology has been designed to be effective across the adult population without input of age, weight, sex, gender, race, or ethnicity. More than 800 million people have Chronic Kidney Disease (CKD), one of the world's leading causes of mortality worldwide, with associated deaths increasing over the past two decades.1 ST. LOUIS, Jan. 17, 2025 /PRNewswire/ -- MediBeacon Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the MediBeacon® TGFR for the assessment of kidney function in patients with normal or impaired renal function. The TGFR is comprised of the TGFR Sensor, TGFR Monitor, and Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR tracer agent, which together allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin. The TGFR Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the patient's bedside or in the outpatient setting. The TGFR is validated for use in the assessment of Glomerular Filtration Rate (GFR) in patients with stable kidney function at the point of care. The TGFR utilizes an intravenous Lumitrace injection but does not require blood draws or urine analysis, unlike current methodologies requiring multiple blood draws or urine samples. In addition, current clinical practice measured GFR (mGFR) assessment requires sophisticated clinical laboratory analysis away from the patient's point of care. "The development of a system such as the TGFR that assesses a patient's kidney function without the need to use estimating equations is an important milestone for the nephrology community," said Dr. Mitchell Rosner, chair of the Department of Medicine at University of Virginia and a highly regarded expert who has authored numerous articles on the challenges of assessing kidney function. "We are excited to explore applications of the transdermal GFR methodology in patients where current clinical practice is understood to be suboptimal." Dr. Pierre Galichon, an active kidney researcher at the Sorbonne Université and an attending physician in kidney transplantation at Pitié-Salpêtrière Hospital in Paris, said: "It has long been a challenge to understand kidney function in the context of its interaction with other vital organs, such as the heart and lungs. My experience with MediBeacon products in preclinical use, as relayed in Scientific Reports,2 has been exciting, and I look forward to evaluating how transdermal GFR can be applied in clinical practice." "The approval of the TGFR by the FDA demonstrates our proprietary system can provide an effective option for assessing kidney function," said Steve Hanley, CEO of MediBeacon. "According to the National Kidney Foundation, CKD causes more deaths each year than breast cancer or prostate cancer. It is the under-recognized public health crisis.3 The potential applications for the TGFR are numerous, and we look forward to exploring them with clinicians both in the hospital and outpatient settings." The timing of FDA approval aligns well with the Q4 2024 publication by MediBeacon's Chief Scientific Officer, Dr. Richard Dorshow, et al. in Kidney International4 with data that supports the utility of MediBeacon's patented agent Lumitrace®. The TGFR met its primary efficacy endpoint as per agreement with the FDA by demonstrating a P30 value of 94% while recruiting patients with a range of GFR values and skin tones. P30 is defined as the percentage of GFR estimation falling within +/- 30% of measured GFR (mGFR) values. In clinical studies no serious or severe adverse events have been observed. For more information, including the FDA Summary of Safety and Effectiveness Data, please refer to . About MediBeacon Inc. MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection. MediBeacon's use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable measurement of organ function. MediBeacon owns over 55 granted U.S. patents and over 215 granted patents worldwide that provide extensive coverage of the MediBeacon ® TGFR, including Lumitrace ® injection, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology. The TGFR is approved for human use. Potential technology applications in gastroenterology, ophthalmology and surgery are in various stages of clinical development. MediBeacon is based in St. Louis, Missouri, with additional operations in Mannheim, Germany. For more information, please visit: . About Lumitrace® (relmapirazin) injection Relmapirazin is a non-radioactive, non-iodinated pyrazine-based compound, which has been engineered to be inert, highly fluorescent, and have the clearance properties of a GFR tracer agent in the body. The unique photophysical characteristics of Lumitrace have been designed to enable the collection of fluorescence data via a photodetector sensor placed on the skin. Data collected by the sensor measures the change in the intensity of Lumitrace fluorescence over time and is converted into a transdermal GFR (tGFR) by proprietary algorithms. In a phase 2 investigational study mGFR deduced from Lumitrace matched that of mGFR deduced from iohexol over a range of GFR values. See the peer reviewed article published in the October 2024 issue of Kidney International by Dorshow et al. IMPORTANT SAFETY INFORMATION FOR TGFR Indication for Use: The MediBeacon® Transdermal GFR System (TGFR) is intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or normal renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent over time. This device has been validated in patients with stable renal function. The MediBeacon® TGFR is not approved for use in patients with GFR <15 ml/min/1.73 m2, GFR >120 ml/min/1.73m2, patients on dialysis, or anuric patients. The use of this device in patients with dynamic and rapidly changing renal function has not been validated. This device is not intended to diagnose acute kidney injury (AKI). The MediBeacon® TGFR Sensor and exogenous tracer agent, Lumitrace® injection, are single use and are only used with the MediBeacon® TGFR. The MediBeacon® TGFR Sensor is a single use device intended to attach to the patient's skin and excite fluorescence in Lumitrace® injection, the tracer agent, and measure the returning light intensity. The data is sent to the MediBeacon® TGFR Monitor. Lumitrace® is an injectable exogenous fluorescent tracer indicated for use with the MediBeacon® Transdermal GFR System (TGFR) for Glomerular Filtration Rate assessment. Contraindications: There are no known contraindications. Warnings and Precautions: See ifu.medibeacon.com for full instructions, warnings, and cautions. In clinical studies no serious or severe adverse events have been observed. Lumitrace® injection has light absorbance at 266nm and 435nm, and broad fluorescent emission at ~560nm when excited at ~440nm. Any drug activated at these wavelengths should not be used in conjunction with Lumitrace. Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally-impaired patients). The presence of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by around 20% in limited testing. Bolus infusions may impact the GFR assessment temporarily while the vasculature-tissue equilibrium is re-established. During a TGFR session, the patient should be as still as possible, especially during the "Establishing Baseline" stage. The current system is designed to compensate for light activity such as reading or eating after the Baseline stage. 1 Epidemiology of chronic kidney disease: an update 2022, Kidney International Supplement, 2022 Apr;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003., Csaba P Kovesdy 2 Pulmonary hypertension without heart failure causes cardiorenal syndrome in a porcine model, Scientific Reports (2023) 13:9130, Orieux et al, doi.org/10.1038/s41598-023-36124-1 3 National Kidney Foundation, Fast Facts (2024 Update), Updated as of 8/6/2024 4 Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102), Kidney International, Volume 106, Issue 4, P679-687, October 2024, DOI: 10.1016/j.kint.2024.06.012 SOURCE MediBeacon WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床2期

2025-01-08

·echemi

80 batches of drugs recalled urgently! A major decision by the National Medical Products Administration

Recently, the National Medical Products Administration announced an important decision to stop the production, sale, and use of Hyoscine Butylbromide Tablets, and to revoke its drug registration certificate. According to the announcement issued by the National Medical Products Administration on January 3, titled “Announcement on the Revocation of the Drug Registration Certificate for Hyoscine Butylbromide Tablets (2025 No. 2)”, Hyoscine Butylbromide Tablets, an antibacterial drug also known as Loperamide, will no longer circulate in the market of our country. This decision is effective immediately, and the products already on the market will be recalled by the marketing authorization holder and supervised by provincial drug regulatory authorities for destruction or other harmless disposal measures. A total of 80 batches of Hyoscine Butylbromide Tablets are involved. In addition, in another announcement issued by the National Medical Products Administration on December 2, 2024, it was also announced that 58 drug registration certificates, including 11 batches of Hyoscine Butylbromide Tablets, have been revoked. Based on Article 83 of the Drug Administration Law of the People's Republic of China and other relevant regulations, these drugs have been required to stop production and sale due to unclear efficacy, serious adverse reactions, or other hazards to human health. Hyoscine Butylbromide Tablets are a compound preparation, with the main active ingredients including Hyoscine Tincture, Sulfamethoxazole, and Trimethoprim, primarily used to treat dysentery caused by Shigella and other sensitive pathogenic bacteria causing enteritis. However, with the withdrawal of this drug from the market, other drugs such as Montmorillonite Powder will take on the responsibility for treating diarrhea. According to data from Miiine, the incidence of gastrointestinal diseases is on the rise and is becoming more prevalent among younger populations. In the first three quarters of 2022, the sales of anti-diarrheal drugs and intestinal anti-inflammatory/infection drugs in public hospitals in key provinces and cities in China exceeded 1.2 billion yuan, a year-on-year increase of 6.30%. The sales scale of Montmorillonite Powder in the three major terminal markets in China has exceeded 1 billion yuan, with the outpatient market being the main sales channel, rising by 60%, making it the Top 2 product in anti-diarrheal and intestinal anti-inflammatory/infection drugs. Statistics from Cyborg Blue show that 145 drug registration certificates were revoked in 2024. In the announcement on December 2, 2024, in addition to Hyoscine Butylbromide Tablets, it also included 3 batches of Losartan Potassium Tablets, 2 batches of Phenazone Tablets, 2 batches of Amlodipine Besylate Tablets, 2 batches of Entecavir Tablets, 2 batches of Compound Snake Gall and Chuan Bei Powder, and 2 batches of Rifampicin Capsules. Phenazone, as a pyrazolone analgesic and antipyretic, was launched early in our country, but its injection and nasal drops have severe adverse reactions, with risks outweighing benefits, and alternative medications are available, leading to its registration certificate being revoked in 2020. Although oral preparations like Phenazone Tablets still have certain clinical value, the National Medical Products Administration has implemented risk control measures by revising the instructions to add safety warnings, restricting applicable populations and indications. In the domestic market for antipyretic and analgesic drugs, Phenazone has a low market share and is declining. Data from Cyborg Blue shows that there are 861 approvals for "Phenazone Tablets," involving many companies and intense market competition. As related drug approvals are revoked, this market will face further fragmentation. Finally, according to the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, the National Medical Products Administration decided on April 11, 2024, to revoke the registration certificates for 87 drugs, including Pancreatin Injection. Cyborg Blue’s analysis found that drugs such as 7 batches of Iohexol Injection, 6 batches of Insulin Glargine Injection, 4 batches of Detemir Insulin Injection, 4 batches of Vardenafil Hydrochloride Tablets, and 3 batches of Brain Protein Hydrolysate Injection were also revoked. Please note that the number of drugs counted in the text has not been deduplicated. No. Marketing Authorization Holder Approval Number 1 Shijiazhuang Lesheng Pharmaceutical Co., Ltd. SFDA H13023949 2 Jiangzhong Pharmaceutical Co., Ltd. SFDA H36022316 3 Shijiazhuang Fourth Pharmaceutical Co., Ltd. SFDA H13023932 4 Shijiazhuang Grey Pharmaceutical Co., Ltd. SFDA H13023934 5 Handan Bailin Pharmaceutical Co., Ltd. SFDA H13023945 6 Hebei Yongfeng Pharmaceutical Co., Ltd. SFDA H13023943 7 China National Pharmaceutical Group Wuhan Zhonglian Fourth Pharmaceutical Co., Ltd. SFDA H42022497 8 Jiangsu Enhua Pharmaceutical Co., Ltd. SFDA H32025932 9 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022013 10 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022244 11 Jiangsu Chenpai Pharmaceutical Group Co., Ltd. SFDA H32025935 12 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024102 13 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024073 14 Hebei Hengli Group Pharmaceutical Co., Ltd. SFDA H13024253 15 Hebei Tianzhi Pharmaceutical Co., Ltd. SFDA H13024245 16 Hebei Dongfeng Pharmaceutical Co., Ltd. SFDA H13024170 17 Hebei Jinzhuan Pharmaceutical Co., Ltd. SFDA H13024269 18 Tianjin Baihai Pharmaceutical Co., Ltd. SFDA H12021099 19 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41024876 20 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41025013 21 Shanxi Xinxing Pharmaceutical Co., Ltd. SFDA H14023068 22 Jiangxi Jiminke Pharmaceutical Co., Ltd. SFDA H36022305 23 Suzhou Hongsun Pharmaceutical Co., Ltd. SFDA H32025897 24 Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd. SFDA H32026256 25 Guangxi Tiantianle Pharmaceutical Co., Ltd. SFDA H45021319 26 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021120 27 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021117 28 Shanghai Modern Harsen (Shangqiu) Pharmaceutical Co., Ltd. SFDA H41024989 29 Tianjin Pacific Pharmaceutical Co., Ltd. SFDA H12021100 30 Hebei Guojin Pharmaceutical Co., Ltd. SFDA H13023940 31 Hebei Kaiwei Pharmaceutical Co., Ltd. SFDA H13023920 32 Hebei Sanshi Pharmaceutical Co., Ltd. SFDA H13023928 33 Yuanda Pharmaceutical (China) Co., Ltd. SFDA H42022649 34 Shanxi Tongda Pharmaceutical Co., Ltd. SFDA H14023309 35 Shanxi Guorun Pharmaceutical Co., Ltd. SFDA H14023402 36 Shanxi Fenhe Pharmaceutical Co., Ltd. SFDA H14023200 37 Shanxi Wanhui Pharmaceutical Co., Ltd. SFDA H14023333 38 Jilin Wantong Pharmaceutical Co., Ltd. SFDA H22025288 39 Changchun Overseas Pharmaceutical Group Co., Ltd. SFDA H22026726 40 Shijiazhuang Xiehe Pharmaceutical Co., Ltd. SFDA H13024084 41 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023541 42 Kuihua Pharmaceutical Group (Hengshui) Defier Co., Ltd. SFDA H13023979 43 Shijiazhuang Kanghewai Pharmaceutical Co., Ltd. SFDA H13024261 44 Shandong Xinhua Pharmaceutical Co., Ltd. SFDA H37023523 45 Hebei Yuzhilin Pharmaceutical Co., Ltd. SFDA H13024426 46 Xinhai Yansheng Pharmaceutical Co., Ltd. SFDA H41024907 47 Fu'an Pharmaceutical Group Yantai Zhichu Pharmaceutical Co., Ltd. SFDA H37023543 48 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025139 49 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025174 50 Changchun Changqing Pharmaceutical Group Co., Ltd. SFDA H22025234 51 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41024840 52 Changzhou Kangpu Pharmaceutical Co., Ltd. SFDA H32025910 53 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41025575 54 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41024862 55 Hebei Ruicen Pharmaceutical Co., Ltd. SFDA H13023953 56 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020588 57 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020604 58 Yaodu Pharmaceutical Group Co., Ltd. SFDA H13023951 59 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023939 60 Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. SFDA H13023952 61 Tianfang Pharmaceutical Co., Ltd. SFDA H41024887 62 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41025576 63 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022412 64 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022411 65 Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. SFDA H41024834 66 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41024896 67 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41025009 68 Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. SFDA H13023994 69 Handan Furong Pharmaceutical Co., Ltd. SFDA H13024077 70 Hebei Tiancheng Pharmaceutical Co., Ltd. SFDA H13024056 71 Hebei Kangtai Pharmaceutical Co., Ltd. SFDA H13024041 72 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44025328 73 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44024963 74 Zhengzhou Furuitang Pharmaceutical Co., Ltd. SFDA H41025579 75 Chongqing Kerui Pharmaceutical (Group) Co., Ltd. SFDA H50021730 76 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41024872 77 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41024895 78 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41025012 79 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41025008 80 Tianfang Pharmaceutical Co., Ltd. SFDA H41025010

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100 项与碘海醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01817	碘海醇	V08AB02	DB01362

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
肿瘤	美国	GE Healthcare, Inc.	1995-10-24
造影剂	美国	GE Healthcare, Inc.	1985-12-26

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
造影剂	临床前	美国	Interpharma Praha as	2015-03-26
法布里病	临床前	英国	-	2013-05-01
法布里病	临床前	挪威	-	2013-05-01
法布里病	临床前	比利时	-	2013-05-01
法布里病	临床前	巴西	-	2013-05-01
法布里病	临床前	波兰	-	2013-05-01
法布里病	临床前	奥地利	-	2013-05-01
法布里病	临床前	西班牙	-	2013-05-01
急性肾损伤	药物发现	-	Ligand Pharmaceuticals, Inc.	2021-03-01

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临床结果

适应症

分期

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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


ACAAI2024	N/A	急性泛发性发疹性脓疱病	-	Iohexol	衊壓醖鹹淵糧憲艱憲鏇(夢積廠膚窪膚鹹鏇壓窪) = She developed a morbilliform rash after 3 days that progressed to pink edematous plaques with pinpoint pustules on day 6 範簾襯構窪齋壓齋襯艱 (繭艱醖壓淵廠廠衊齋壓 ) 更多	-	2024-10-24
ISN WCN2021	N/A	-	208	iohexol (CKD-EPIcr)	築壓鏇構壓鑰餘齋顧餘(獵觸鏇糧鬱夢淵淵廠蓋) = 糧艱構鑰網醖醖鹹選鹽範選顧窪範襯遞憲願網 (淵製艱簾網鬱憲窪築鑰 ) 更多	-	2021-04-01
				iohexol (CKD-EPIcys)	築壓鏇構壓鑰餘齋顧餘(獵觸鏇糧鬱夢淵淵廠蓋) = 簾遞網艱糧範鹹遞艱醖範選顧窪範襯遞憲願網 (淵製艱簾網鬱憲窪築鑰 ) 更多
ASN2020	N/A	-	-	HK-2 cells treated with iohexol for 6hrs	(蓋齋襯壓鑰遞蓋願廠蓋) = 範繭壓顧襯醖鏇獵積鹹壓膚糧艱簾構範鬱選獵 (製夢鏇廠構範夢蓋襯蓋 ) 更多	-	2020-10-19
				HK-2 cells treated with iohexol for 12hrs	(蓋齋襯壓鑰遞蓋願廠蓋) = 顧蓋積醖觸齋選醖簾繭壓膚糧艱簾構範鬱選獵 (製夢鏇廠構範夢蓋襯蓋 ) 更多
NCT02884089 (CTgov)	临床1期	-	40	Placebo+Metformin (Placebo + 1000 mg Metformin)	憲鑰遞襯積製窪糧廠築(齋鹽憲範鹽艱鏇鬱簾構) = 醖繭憲鹹鹽襯憲觸廠鬱窪齋廠構積憲顧鹽鑰憲 (壓鹹構廠網齋膚觸選鏇, 蓋顧願憲窪壓鏇齋淵淵 ~ 襯積築襯夢窪鏇蓋獵繭) 更多	-	2018-08-07
				Abemaciclib+Metformin (400 mg Abemaciclib + 1000 mg Metformin)	憲鑰遞襯積製窪糧廠築(齋鹽憲範鹽艱鏇鬱簾構) = 鹽鹹選鹽壓築蓋鬱製選窪齋廠構積憲顧鹽鑰憲 (壓鹹構廠網齋膚觸選鏇, 憲蓋壓廠膚範窪網願艱 ~ 鬱簾夢艱膚壓壓齋繭鹹) 更多
NCT02246998 (CTgov)	临床4期	HIV感染	72	STB+iohexol (STB + Iohexol)	製鹽齋構齋願製選鹽築(築廠積膚壓襯淵築鹹鹹) = 鏇觸願製願顧顧願積鑰蓋觸齋壓鏇鬱願繭顧範 (淵積廠遞選網淵膚範淵, 構製遞窪窪願鬱選繭繭 ~ 衊網觸齋鏇網淵齋繭繭) 更多	-	2018-01-03
				ATV+iohexol+TVD+RTV (TVD + ATV/r + Iohexol)	製鹽齋構齋願製選鹽築(築廠積膚壓襯淵築鹹鹹) = 鑰窪壓觸鬱糧齋鹽範齋蓋觸齋壓鏇鬱願繭顧範 (淵積廠遞選網淵膚範淵, 選選網齋糧築淵範鏇膚 ~ 糧廠選鑰餘積壓膚醖鑰) 更多
ASN2016	N/A	-	-	Iohexol (Single Sample Method)	遞醖鑰壓淵鹽網衊範鬱(鑰壓廠積廠廠獵淵願鏇) = 鑰餘顧夢鬱構窪鹽範鏇範淵艱鹹鹹齋積窪網艱 (鏇願艱網廠選網獵憲艱 )	积极	2016-11-15
				Iohexol (Multiple Samples Method)	遞醖鑰壓淵鹽網衊範鬱(鑰壓廠積廠廠獵淵願鏇) = 夢遞壓鹽觸鹽製範鹽壓範淵艱鹹鹹齋積窪網艱 (鏇願艱網廠選網獵憲艱 )
FP243 (ERA2015)	N/A	-	-	Iohexol	鹹構齋觸廠獵願淵醖鏇(醖範窪餘選積鹹齋窪鹹) = 積壓膚艱選顧衊壓壓選醖製廠蓋獵襯鹹壓憲艱 (構餘願襯網壓願築築窪 ) 更多	积极	2015-05-21
Berlin Initiative Study (BIS) (ASN2013)	N/A	-	61	Iohexol (mGFR 300)	醖構選糧鬱窪糧選醖夢(窪鬱觸淵壓鑰膚醖鏇願) = 獵衊構積鹹簾願積範網觸鹽艱範壓遞鹽膚齋襯 (築遞襯膚壓構獵顧衊願 )	积极	2013-11-05
				Iohexol (mGFR 1400)	醖構選糧鬱窪糧選醖夢(窪鬱觸淵壓鑰膚醖鏇願) = 願餘積窪構積繭網夢艱觸鹽艱範壓遞鹽膚齋襯 (築遞襯膚壓構獵顧衊願 )
ASN2012	N/A	cysC	12	Iohexol (Protein Shake)	艱鹽鏇廠顧鹹鑰鑰蓋糧(夢網淵艱餘糧網窪鏇製) = 衊蓋衊獵憲遞蓋遞網鹽網製艱餘觸繭壓築廠獵 (齋艱衊簾鑰築鹹構顧憲, 14.5) 更多	不佳	2012-10-30
				Iohexol (Hamburger)	艱鹽鏇廠顧鹹鑰鑰蓋糧(夢網淵艱餘糧網窪鏇製) = 獵衊鏇夢糧製繭餘築網網製艱餘觸繭壓築廠獵 (齋艱衊簾鑰築鹹構顧憲, 7.6) 更多
188: Re-DTPA- (EANM2007)	N/A	甲状腺功能亢进症	43	Iohexol Group	廠糧鏇襯憲夢鏇糧遞衊(獵襯觸醖選觸願憲簾鏇) = 淵餘膚遞憲醖積膚淵廠獵顧願膚簾襯齋夢餘獵 (淵窪構蓋鹹遞艱襯窪醖, 9)	-	2007-10-15
				iohexol (Control Group)	廠糧鏇襯憲夢鏇糧遞衊(獵襯觸醖選觸願憲簾鏇) = 鏇鬱鬱鏇膚網醖衊襯獵獵顧願膚簾襯齋夢餘獵 (淵窪構蓋鹹遞艱襯窪醖, 12)