主要目的：本试验旨在研究健康受试者单次静脉注射四川汇宇制药股份有限公司研制、生产的蔗糖铁注射液（5 ml:100 mg铁和1.6 g蔗糖）在健康受试者体内的药代动力学特征；以AMERICAN REGENT, INC.持证的蔗糖铁注射液（Venofer®，100 mg铁/5 ml）为参比制剂，比较两制剂中药动学参数的差异，评价两制剂的人体生物等效性。次要目的：评估受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: This study aims to study the pharmacokinetic characteristics of a single intravenous injection of iron sucrose injection (5 ml: 100 mg iron and 1.6 g sucrose) developed and produced by Sichuan Huiyu Pharmaceutical Co., Ltd. in healthy subjects; using the iron sucrose injection (Venofer®, 100 mg iron/5 ml) certified by AMERICAN REGENT, INC. as the reference preparation, to compare the differences in pharmacokinetic parameters between the two preparations and evaluate the human bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy subjects.

Start Date21 Jun 2024

Sponsor / Collaborator

Sichuan Huiyu Pharmaceutical Co., Ltd.

ACTRN12624000410550 / RecruitingPhase 4

A Pilot Study of Post Operative Iron Infusion for the Treatment of Anaemia in Trauma Patients

Start Date14 Jun 2024

Sponsor / Collaborator-

100 Clinical Results associated with Iron sucrose

100 Translational Medicine associated with Iron sucrose

100 Patents (Medical) associated with Iron sucrose

1,176

Literatures (Medical) associated with Iron sucrose

01 Aug 2024·The Lancet Regional Health - Europe

Impact of a bundle of care (intravenous iron, erythropoietin and transfusion metabolic adjustment) on post-operative transfusion incidence in cardiac surgery: a single-centre, randomised, open-label, parallel-group controlled pilot trial

Article

Author: Mourad, Marc ; Saour, Marine ; Colson, Pascal H. ; Colson, Pascal H ; Gaudard, Philippe ; Picot, Marie-Christine ; Zeroual, Norddine ; Amico, Maïlis ; Blin, Cinderella

BackgroundRed blood cell (RBC) transfusions are frequent in patients after cardiac surgery. This study assessed whether a bundle of care including pre-operative and post-operative administration of erythropoietin (EPO) with intravenous iron supplementation, and restrictive transfusion adjusted for ScvO₂ could result in reduced postoperative transfusions.MethodsIn this single-centre, randomised, open-label, parallel-group controlled pilot study, patients undergoing elective cardiac surgery with high risk of transfusion in a University Hospital were enrolled by the investigator and the randomisation procedure using a central internet-based system was made by the clinical research assistant. Since the trial was open-label, no masking was used. Patients were assigned (1:1) to either the STOP group (40,000 IU subcutaneous EPO combined with 20 mg/kg intravenous ferric carboxymaltose if Hb < 13 g/dL the day before surgery or at ICU admission, and RBC transfusion if Hb ≤ 8 g/dL and ScvO₂ ≤ 65%, or additional EPO dose if 8 < Hb < 13 g/dL) or to the control group (RBC transfusion if Hb ≤ 8 g/dL, or, if 8 < Hb < 13 g/dL, intravenous iron sucrose 200 mg or 300 mg according to weight). Primary outcome was the incidence of postoperative RBC transfusion up to hospital discharge or postoperative day 28. The trial is registered with ClinicalTrials.gov, NCT04141631.FindingsBetween Jan 20, 2020, and Sept 6, 2022, among 128 patients enrolled, 123 (male, 54.4%, 67/123) were included in the full analysis set: 62 in the STOP group and 61 in the control group. Nine patients (14.5%, 9/62) in the STOP group required RBC transfusion vs 19 (31.2%, 19/61) in the control group (odds ratio 0.37 [95% CI: 0.15-0.91], p = 0.03). The median length of follow up to transfusion was 2.6 days (1.5; 4.6) and 3.3 (1.6; 4.2) in control and STOP groups respectively (p = 0.61).InterpretationThe bundle of care may reduce postoperative RBC transfusion. The findings should be taken with caution due to the unblinded and exploratory nature of the study.FundingUniversity of Montpellier Hospital and Vifor Pharma.

01 Aug 2024·International Journal of Hematology

Clinical management of iron deficiency anemia in Japan: iron prescription patterns, treatment effectiveness, and assessments

Article

Author: Ikuta, Katsuya ; Tsuchikawa, Masaru ; Kosugi, Miyako ; Takezawa, Ryo ; Shiota, Shun

AbstractIron deficiency anemia is one of the most common types of anemia, but real-world clinical management practices in Japan are unclear. This study retrospectively explored iron prescription patterns, treatment effectiveness, and assessments. Patients with at least one treatment period between September 2020 and September 2022 were included and classified into three groups (ferric carboxymaltose [FCM]: 7437 patients, saccharated ferric oxide [SFO]: 98,648 patients, and oral iron: 359,547 patients). Iron-related laboratory values over time and testing proportions were evaluated. Median baseline hemoglobin levels were lowest with FCM (FCM: 8.10 g/dL, SFO: 8.70 g/dL, oral iron: 9.70 g/dL), but changes in hemoglobin levels by 12 weeks were greatest with FCM (FCM: 3.20 g/dL, SFO: 2.60 g/dL, oral iron: 1.70 g/dL). The median serum ferritin level at 8 weeks after FCM treatment was 43.70 ng/mL for ≤500 mg, versus 123.30 ng/mL for >500 to ≤1500 mg. All groups had a low proportion of serum ferritin and transferrin saturation (TSAT) testing at diagnosis (<38%), which decreased further for post-treatment assessment (<24%). This study suggests the importance of prescribing an appropriate total iron cumulative dose per the package insert, along with diagnosis and assessments based on serum ferritin/TSAT.

01 Aug 2024·Environmental Pollution

Ferruginous components of particulate matters in subway environments, α-Fe2O3 or Fe3O4, exacerbates allergies

Article

Author: Honda, Akiko ; Okuda, Tomoaki ; Takano, Hirohisa ; Matsuda, Tomonari ; Qiu, Binyang ; Miyasaka, Natsuko ; Wang, Zaoshi ; Nagao, Megumi ; Ichinose, Takamichi ; Ishikawa, Raga ; Higaki, Yuya ; Owokoniran, Oluwatoyin Hannah ; Liu, Wei ; Watanabe, Hikari

The respiratory effects of particulate matter (PM) in subway station platforms or tunnels have attracted considerable research attention. However, no studies have characterized the effects of subway PM on allergic immune responses. In this study, iron oxide (α-Fe₂O₃ and Fe₃O₄) particles-the main components of subway PM-were intratracheally administered to BALB/c mice where ovalbumin (OVA) induced allergic pulmonary inflammation. Iron oxide particles enhanced OVA-induced eosinophil recruitment around the bronchi and mucus production from airway epithelium. The concentrations of type 2 cytokines, namely, interleukin (IL)-5 and IL-13, in bronchial alveolar lavage fluids were increased by iron oxide particles. Iron oxide particles also increased the number of type 2 innate lymphoid cells and CD86⁺ cells in the lung. Moreover, phagocytosis of particles in lung cells was confirmed by Raman spectroscopy. In a subsequent in vitro study, bone marrow-derived antigen-presenting cells (APCs) isolated from NC/Nga mice were exposed to iron oxide particles and OVA. They were also exposed to outdoor ambient PM: Vehicle Exhaust Particulates (VEP) and Urban Aerosols (UA) as references. Iron oxide particles promoted the release of lactate dehydrogenase, C-X-C motif chemokine ligand 1 and IL-1α from APCs, which tended to be stronger than those of VEP. These results suggest that iron oxide particles enhance antigen presentation in the lungs, promoting allergic immune response in mice; iron oxide particles-induced death and inflammatory response of APCs can contribute to allergy exacerbation. Although iron oxide particles do not contain various compounds like VEP, iron oxide alone may have sufficient influence.

News (Medical) associated with Iron sucrose

26 Apr 2024

·www.prnewswire.com

Renibus Therapeutics Announces Oral Presentations on RBT-1 at AATS and SCA Medical Conferences

SOUTHLAKE, Texas, April 26, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced its participation at two prestigious medical conferences: the American Association for Thoracic Surgery (AATS) 104th Annual Meeting and the Society of Cardiovascular Anesthesiologists (SCA) 46th Annual Meeting, both taking place in Toronto, Canada, April 27-30, 2024. "We are pleased to present additional clinical data on RBT-1 at the AATS and SCA meetings in collaboration with key opinion leaders in our field, Drs. Charles Mack and Andrew Shaw," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "These presentations are critical to advancing the understanding of our preconditioning approach with RBT-1, and we thank the meeting organizers and principal investigators for their partnership. Our Phase 3 PROTECT study is enrolling well and we remain on track to report top-line data in the third quarter of 2025." RBT-1 (stannic protoporfin / iron sucrose) is a single dose, multi-organ, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing cardiac surgery.Renibus Therapeutics is actively enrolling its PROTECT Phase 3 pivotal trial evaluating RBT-1's potential to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. RBT-1 has received both FDA Breakthrough and Fast Track Designations. Details of the oral presentations at AATS: Title: RBT-1 Reduces Incidence of Blood Product Utilization in Patients Undergoing Non-Emergent Coronary Artery Bypass Grafting and/or Valve Surgery Date and Time: Sunday, April 28th at 9:44 am ET Location: Room 714 Presenter: Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine Title: RBT-1 Reduces the Number of Post-Operative Complications Associated with Cardiac Surgery Date and Time: Sunday, April 28th at 4:03 pm ET Location: Theater 2, Exhibit Hall Presenter: Bhupinder Singh, MD, Chief Medical Officer, Renibus Details of the oral presentation at SCA: Title: RBT-1 Improves Clinical Outcomes in Patients Requiring Prolonged Intensive Care Unit Stay Following Non-Emergent Cardiac Surgery Date and Time: Sunday, April 28th at 3:00 pm ET Session: Best of Meeting Oral Presenter: Andrew Shaw, MD, FRCA, FCCM, FFICM, Professor and Chair, Department of Intensive Care and Resuscitation, Cleveland Clinic About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory andantioxidant pathways currently in Phase 3 [NCT # 06021457] for its lead indication to reduce post-operative complications following cardiothoracic surgery. Renibus completed the Phase 2 study of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this study in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal study. RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics

Phase 3Fast TrackPhase 2Breakthrough Therapy

18 Apr 2024

·www.prnewswire.com

Renibus Therapeutics Announces Oral Presentation on RBT-1 at the European Association for Cardio-Thoracic Surgery (EACTS) 2nd Innovation Summit

SOUTHLAKE, Texas, April 18, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced an oral presentation on RBT-1 at the prestigious, invitation only, European Association for Cardio-Thoracic Surgery (EACTS) 2nd Innovation Summit, taking place in Paris, France, April 18-20, 2024. Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery and Vice Chairman of Quality and Patient Safety, New York-Presbyterian Hospital, Weill Cornell Medicine, will be presenting on behalf of Renibus. RBT-1 (stannic protoporfin / iron sucrose) is a single dose, multi-organ, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing elective cardiac surgery. RBT-1 is actively enrolling in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. RBT-1 has received FDA Breakthrough and Fast Track Designations. "Presenting at EACTS enables Renibus to share our promising RBT-1 results with the global cardiothoracic surgery community," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "In a completed Phase 2 clinical trial, RBT-1 demonstrated the potential to improve outcomes in the post-cardiac surgery setting, including reductions in 30-day hospital readmission rates, time in the ICU, as well as time on ventilator. We continue to advance RBT-1 through the Phase 3 PROTECT study, with top-line data expected in the third quarter of 2025." Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine, added, "RBT-1 is an exciting pre-conditioning agent and I am honored to showcase its results at EACTS. While RBT-1 has demonstrated its potential benefit across multiple cardiac surgery types in its Phase 2 clinical trial, I look forward to presenting data demonstrating RBT-1's potential to have a greater impact on patients undergoing more complex procedures combining both CABG and valve surgeries where the risk of post-operative complications is greatest." Details of the oral presentation at EACTS 2nd Innovation Summit: Title: RBT-1: A Pharmacologic Approach to Reducing the Risk of Post-Operative Complications in Patients Workshop Group: Future of Extracorporeal circulation. Hypothermia in CT surgery Date and Time: Friday, April 19, 2024, 15:55 Presenter: Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine About RBT-1 RBT-1 (stannic protoporfin/iron sucrose) is a potent inducer of anti-inflammatory and antioxidant pathways currently in Phase 3 [NCT # 06021457] for its lead indication to reduce post-operative complications following cardiothoracic surgery. Renibus completed the Phase 2 study of RBT-1 (NCT04564833) in February 2023 and announced positive final results from this study in May 2023. In October 2023, Renibus initiated enrollment and administration of RBT-1 in its PROTECT Phase 3 pivotal study. RBT-1 was granted Breakthrough Therapy designation status from the U.S. FDA to reduce the risk of complications in patients undergoing cardiothoracic surgery. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics

Phase 2Phase 3Fast TrackBreakthrough Therapy

02 Apr 2024

·www.prnewswire.com

Renibus Announces Participation at the 23rd Annual Needham Virtual Healthcare Conference

SOUTHLAKE, Texas, April 2, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal and metabolic diseases, today announced its participation in the 23rd Annual Needham Virtual Healthcare Conference, being held in a virtual format, April 8-11, 2024. Company management will meet with investors in one-on-one meetings during the conference. About Renibus Therapeutics Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases. Renibus' first-in-a-new class lead program is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery. It is in a Phase 3 pivotal trial to reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. The drug has received FDA Breakthrough and Fast Track Designations. Veverimer is an oral, non-absorbed hydrochloric acid binder that was acquired from Tricida. We are currently evaluating veverimer in preclinical models and analyzing historical data to further our understanding of its clinical profile with a goal of identifying an indication for evaluation in clinical trials. Renibus has three additional assets at earlier stages of development. For more information, please visit the Company's website at and engage with us on LinkedIn. Investor and Media Contact: Amy Conrad Juniper Point [email protected] 858-914-1962 Business Development Contact Jamie Donadio CFO, Renibus [email protected] SOURCE Renibus Therapeutics

Phase 3Fast Track

100 Deals associated with Iron sucrose

External Link

KEGG	Wiki	ATC	Drug Bank
D04616	Iron sucrose	B03AB02	DB09146

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperphosphatemia	JP	Kissei Pharmaceutical Co., Ltd.	28 Sep 2015
Chronic Kidney Diseases	US	American Regent, Inc.	06 Nov 2000
Iron deficiency	US	Allergan Sales LLC	29 Apr 1974
Anemia, Iron-Deficiency	CH	Vifor Pharma AG	02 Jun 1949

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hyperphosphatemia	NDA/BLA	CN	Vifor Fresenius Medical Care Renal Pharma Ltd.	18 Jan 2022
Hyperphosphatemia	NDA/BLA	CN	Vifor SA	18 Jan 2022
Chronic Kidney Diseases	Preclinical	GB	Vifor Pharma AG	01 Mar 2011
Chronic Kidney Diseases	Preclinical	PL	Vifor Pharma AG	01 Mar 2011
Chronic Kidney Diseases	Preclinical	DE	Vifor Pharma AG	01 Mar 2011
Chronic Kidney Diseases	Discovery	PL	Vifor Pharma AG	01 Mar 2011
Chronic Kidney Diseases	Discovery	DE	Vifor Pharma AG	01 Mar 2011
Chronic Kidney Diseases	Discovery	GB	Vifor Pharma AG	01 Mar 2011
Neoplasms	Discovery	-	American Regent, Inc.	01 Feb 2003
Anemia	Discovery	-	American Regent, Inc.	01 Jul 2002

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2024	Not Applicable	Anemia, Iron-Deficiency	-	Ferric Carboxymaltose	kngikvvzfc(uiraowzzdm): RR = 2.75 (95% CI, 2.29 - 3.3), P-Value = <0.0001 View more	Negative	14 May 2024
				Iron Sucrose
ASN2022	Not Applicable	sP \| sCa \| iPTH	100	Sucroferric oxyhydroxide	npsprnydxt(vnmyupfquy) = jtihfbfkzu shpisrtlan (qpouwxzxnq )	Positive	03 Nov 2022
NCT04046263 (CTgov)	Phase 4	Hyperphosphatemia \| Peritoneal dialysis complication \| Hypoalbuminemia	17	Sucroferric Oxyhydroxide Chewable Tablet	jvnehlzoru(lbqtthleuq) = bmadcjujmm tubxiapqog (hgbnrhobdq, uplqivqfue - dmluwgueny) View more	-	31 Aug 2022
MO814 (ERA2022)	Not Applicable	Chronic Kidney Diseases skeletal plasma clearance of tracer (K i ) \| bone volume/tissue volume (BV/TV)	-	Sucroferric oxyhydroxide	feggzecvxp(yoayqhifwy) = BV/TV (volume) was significantly lower after SO treatment than after CC treatment eynmzvtgfq (ccozbbtlqr )	-	03 May 2022
				Calcium carbonate
MO809 (ERA2022)	Not Applicable	Hyperphosphatemia	92	Sucroferric Oxyhydroxide	(rcyjiccoww) = The drug was well tolerated hsrjqyubyg (eomfhkhywt ) View more	Positive	03 May 2022
ERA2022	Not Applicable	Bone Diseases FGF23 \| soluble Klotho \| c-reactive protein (CRP) ... View more	50	Sucroferric oxyhydroxide	xjgjsqqvcl(pqkdzglhkh) = bhejunmujm hsssmkhcko (nzidwdhymm ) View more	Positive	03 May 2022
				Sevelamer	bjomjoxyws(gcobbbkcpo) = gytmuokozw jmksinbmid (ohewsbdrbh )
ASN2021	Not Applicable	Maintenance	115	Ferric Citrate	wrlblyimnt(outgyapnph) = irytafzsug zkbkquuaqx (xbndgkiyeh ) View more	Positive	27 Oct 2021
				Sucroferric Oxyhydroxide	wrlblyimnt(outgyapnph) = tpikvgidyp zkbkquuaqx (xbndgkiyeh, 5.2) View more
ASN2021	Not Applicable	serum phosphorus \| serum calcium \| iPTH	841	Sevelamer	(kevwolqxth) = Mean iPTH and serum calcium (Ca) decreased progressively after SO conversion epvjgcilhm (apeywxmgzl )	Positive	27 Oct 2021
				Sucroferric Oxyhydroxide
NCT01414075 (CTgov)	Phase 2	Anemia	60	Roxadustat (Arm A + E (Participants on HD): Roxadustat Only, No Iron)	iqwrqcjwhm(kqmjqjubpy) = itsqammctn gmrfknikbz (xrfmikasjn, hwfdivhskh - jjyaurywqu) View more	-	01 Oct 2021
				Oral Iron+Roxadustat (Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg)	iqwrqcjwhm(kqmjqjubpy) = xpimeyopoe gmrfknikbz (xrfmikasjn, ondkzupliu - vkkfhlkvts) View more
NCT02707757 (PRIME, CTgov)	Phase 4	Anemia	197	Iron sucrose (Iron Sucrose)	msavmjouae(daspyfulce) = oeaxclgtbp teytxlwyfj (xhhuwzaork, pbbeqcmcgs - rldvyguhdq) View more	-	09 Mar 2021
				Erythopoietin stimulating agent (Neorecormon)	msavmjouae(daspyfulce) = zzyzeoarud teytxlwyfj (xhhuwzaork, sxntnjfdhi - nltfxcwzfk) View more

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Iron sucrose

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