The goal of this clinical trial is to compare the pharmacokinetic profile of the single intravenous injection of the test product and reference product in healthy subjects and to evaluate the bio-equivalence and safety of these two injections in healthy subjects. The main questions it aims to answer are:
[Question 1] Is there significant difference in the pharmacokinetic profile between the Iron Sucrose Injection (100 mg/5 mL [calculated by iron]) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. and the Iron Sucrose Injection (trade name: Venofer®, 100 mg/5 mL [calculated by iron]) held by Vifor France? [Question 2] Is it safe for the healthy subjects to take the test product (100 mg/5 mL [calculated by iron]) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. and the reference product held by Vifor France? Participants will be randomly divided into group I and group II, with equal number of subjects in each group. Each subject will receive only one dose of either the test product or the reference product in each period (two-sequence crossover study).

Start Date20 Nov 2024

Sponsor / Collaborator

Sichuan Huiyu Pharmaceutical Co., Ltd.

[+2]

CTR20244071 / Active, not recruitingNot Applicable

蔗糖铁注射液人体生物等效性研究

[Translation] Study on bioequivalence of iron sucrose injection in healthy volunteers

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Vifor France持证的蔗糖铁注射液（Venofer®，5 ml:100 mg铁）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 Vifor France's certified iron sucrose injection (Venofer®, 5 ml: 100 mg iron) as the reference preparation, 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 Date18 Nov 2024

Sponsor / Collaborator

Sichuan Huiyu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Iron sucrose

100 Translational Medicine associated with Iron sucrose

100 Patents (Medical) associated with Iron sucrose

1,190

Literatures (Medical) associated with Iron sucrose

01 Jan 2025·EUROPEAN JOURNAL OF HAEMATOLOGY

Infusion Reactions With Alternative Therapies During the National Shortage of Iron Dextran

Article

Author: Kuriakose, Philip ; Springer, Kylie ; Jamil, Maria ; Raslan, Shahm ; Nasser, Zeinab ; Jacob, Brigid

ABSTRACT:

Prior to the national shortage of iron dextran in early 2023, it was the most commonly administered intravenous iron infusion at our institution. After the shortage impacted the health system, alternatives such as iron sucrose and sodium ferric gluconate/sucrose were required that utilized lower doses given at more frequent patient visits. Coinciding with their more prevalent use, an increase in iron infusion reactions was observed. Our study analyzed 880 patients who received iron infusions in three Henry Ford Hospital clinics in metropolitan Detroit, Michigan, from July 2022–June 2023. The 74 reactions that occurred were most commonly associated with iron sucrose at the 500 mg dose (41/74, 55.41%, p < 0.0001). Most reactions observed across all iron formulations and doses were mild, with 83.7% being Grade 0 or 1 as defined by the United States Drug Allergy Registry (USDAR) grading scale for immediate reactions. Patients who experienced an infusion reaction were less likely to complete their infusion plans (OR 0.004 for iron dextran, OR 0.128 for iron sucrose, p < 0.0001), with infusions most commonly being completely discontinued thereafter, with a minority pursuing alternative options. More patients with lower number of doses scheduled for iron dextran completed their infusion schedules than those with more doses, but the opposite was seen for iron sucrose. We assessed the impact of the national shortage of iron dextran examining infusion reactions with various iron infusions and doses.

01 Dec 2024·EUROPEAN JOURNAL OF HAEMATOLOGY

Perinatal Outcomes Following Intravenous Iron for Treatment of Iron Deficiency With and Without Anemia

Article

Author: Deloughery, Thomas G. ; Hedges, Madeline A. ; Shatzel, Joseph J. ; Chobrutskiy, Boris I. ; Ryan, Kimberly S. ; Martens, Kylee L. ; Benson, Ashley E. ; Tuuli, Methodius G. ; Sabile, Jean M. G. ; Garg, Bharti ; Hagen, Olivia L. ; Lewkowitz, Adam K. ; Lo, Jamie O.

ABSTRACT:

Objective:

To determine maternal and neonatal outcomes in individuals with iron deficiency receiving antepartum intravenous (IV) iron supplementation, stratified by the degree of anemia.

Study Design:

Retrospective cohort study of iron‐deficient pregnant patients who received at least one IV infusion of iron (iron sucrose, low molecular weight iron dextran [LMWID], or ferric carboxymaltose) during their pregnancy from January 1, 2011 through June 16, 2022. Our primary outcomes included both neonatal composite morbidity and maternal composite morbidity in the context of maternal anemia.

Results:

Patients who received LMWID had fewer infusion visits, received higher total doses of iron and had a more substantial correction of hemoglobin compared to those who received iron sucrose (p < 0.01). Maternal anemia at the time of admission was not associated with neonatal composite morbidity. However, there was a significant association between anemia status and maternal composite outcome (p = 0.05). Anemia at time of delivery was associated with the likelihood of requiring a blood transfusion (p = 0.01).

Conclusion:

This study reinforces previous findings emphasizing the adverse effects of iron deficiency on maternal health and the role of IV iron in reducing these risks.

01 Dec 2024·TOXICOLOGY IN VITRO

Go with the flow: An in vitro model of a mature endothelium for the study of the bioresponse of IV injectable nanomedicines

Article

Author: Rippl, Alexandra ; Alston, Amy Barton ; Wick, Peter ; Hoch, Tobias ; Eitner, Stephanie ; Diener, Liliane ; Barton Alston, Amy ; Ayala-Nunez, Vanesa ; Digigow, Reinaldo ; Nikravesh, Niusha ; Chortarea, Savvina

The first exposure of intravenously (IV) administered nanomedicines in vivo is to endothelial cells (ECs) lining blood vessels. While it is known that in vitro endothelium models to assess responses to circulating nanoparticles require shear stress, there is no consensus on when and how to include it in the experimental design. Our experimental workflow integrates shear stress by featuring a flow-induced mature endothelium (14 days) and a flow-mediated nanoparticle treatment. The mature endothelium model exhibited distinct features that indicated a structurally stable and quiescent monolayer. Upon treatment with iron sucrose under dynamic conditions, there was a lower nanoparticle uptake, lower cytotoxicity, and decreased expression of activation markers compared to the static control. This response was attributed to glycocalyx expression, predominantly observed on the mature endothelium. In conclusion, our proposed in vitro endothelium model can be leveraged to understand the dynamics of IV injectable nanomedicines at the initial nano-bio interface in veins immediately post-injection.

News (Medical) associated with Iron sucrose

09 Oct 2024

·www.prnewswire.com

Renibus Therapeutics Announces Oral Presentation on RBT-1 at the 38th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting

- Renibus is actively enrolling a Phase 3 pivotal trial to reduce the risk of post-operative complications and improve outcomes following cardiac surgery - SOUTHLAKE, Texas, Oct. 9, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardiac, renal, and metabolic diseases, today announced that an oral presentation will be delivered on RBT-1 at the 38th EACTS Annual Meeting, taking place October 9-12, 2024, in Lisbon, Portugal. Charles 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 is a single-dose, preconditioning agent that is administered intravenously 24-48 hours prior to patients undergoing non-emergent cardiac and/or valve surgery. Renibus is actively enrolling a Phase 3 pivotal trial of RBT-1 to reduce the risk of post-operative complications and improve outcomes following cardiac surgery. RBT-1 has received Breakthrough and Fast Track Designations from the US FDA. "We are thrilled that EACTS has recognized RBT-1 with an oral presentation to share our promising results with the global cardiothoracic surgery community," stated Jeffrey Keyser, RPh, JD, PhD, President and CEO of Renibus. "Enrollment in the RBT-1 Phase 3 PROTECT study is ahead of schedule, and we remain on track to report top-line data in the second quarter of 2025." "RBT-1 has shown great potential in our Phase 2, multi-center, randomized, double-blind, placebo-controlled study," said Charles A. Mack, MD, FACS, Associate Professor of Cardiothoracic Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine. "I am excited to present new data from a post-hoc analysis, which included all patients regardless of surgery delay, showing that the improvement in clinical outcomes in response to RBT-1 treatment was maintained." Details of the oral presentation at EACTS Annual Meeting: Title: Effect of RBT-1 on Clinical Outcomes the Safety Population of a Phase 2 Study in Cardiac Surgery Date and Time: Friday, October 11, 2024, 9:15 am Presenting Author: Charles Mack, MD Authors: C. Mack (New York, USA), M. Jessen (Dallas, USA), A. Shaw (Cleveland, USA), S. Ruiz (Southlake, USA), C. Wang (Piscataway, USA), S. Snapinn (Seattle, USA), B. Singh (Southlake, USA), A. Lamy (Ontario, Canada) 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3Fast TrackBreakthrough Therapy

24 Sep 2024

·www.prnewswire.com

Renibus Therapeutics Announces Participation at Upcoming Investor Conferences

SOUTHLAKE, Texas, Sept. 24, 2024 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio, renal and metabolic diseases, today announced participation in the following upcoming investor conferences: Oppenheimer Private Life Sciences Company Showcase, October 1, 2024, New York, NY 4th Annual Needham Private Biotech Company Virtual 1x1 Forum, October 8-9, 2024 Renibus management will be available to meet with investors one-on-one during these events. 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Fast TrackAcquisition

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

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.

to view more data

Indication	Country/Location	Organization	Date
Kidney Failure, Chronic	CA	Vifor Fresenius Medical Care Renal Pharma Ltd.	05 Jan 2018
Hyperphosphatemia	JP	Kissei Pharmaceutical Co., Ltd.	28 Sep 2015
Chronic Kidney Diseases	US	American Regent, Inc.	06 Nov 2000
Iron deficiency	US	Sanofi-Aventis U.S. LLC	25 Apr 1957
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
Neoplasms	Phase 3	-	American Regent, Inc.	01 Feb 2003
Anemia	Phase 3	-	American Regent, Inc.	01 Jul 2002
Inflammatory Bowel Diseases	Phase 2	US	American Regent, Inc.	01 Nov 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04485039 (CTgov)	Phase 4	Smallpox	44	Tecovirimat (TPOXX: Oral Antiviral)	txroxqcknv(heapljkfap) = yobohtacqo amaxayidgy (gpwnavmmhj, zijwhkumgp - lqpapbzzde) View more	-	09 Oct 2024
				Tecovirimat+sevelamer carbonate oral tablet (TPOXX: Oral Antiviral and Sevelamer Carbonate)	ealrivincg(squysslhsn) = uafvldspgd bdzprssqxk (ibdhbrmvzn, lpzuqlqsqv - agxglpwuqb) View more
SOHO2024	Not Applicable	Hypophosphatemia	-	Ferric hydroxide-sucrose	moaxnpyljo(xdzocbqsac) = pxtiyrhohh jubftjfpio (osheqgarpb )	-	04 Sep 2024
SOHO2023	Not Applicable	-	-	Ferric Carboxymaltose (FCM)	xivslknlrk(cvgybzxkmb): risk ratio = 0.97 (95% CI, 0.62 - 1.51), P-Value = 0.86 View more	-	01 Sep 2023
				Iron Sucrose (IS)
DaVita Biorepository (ASN2022)	Not Applicable	iron sucrose	950	Iron Sucrose administration	ckruhshwlo(hyztmmhcco) = fslgtbtjpl aefsdjqhkl (xnmisoymal )	Positive	05 Nov 2022
				No Iron Sucrose administration	-
ASN2022	Not Applicable	sP \| sCa \| iPTH	100	Sucroferric oxyhydroxide	lufeomrhge(xbnwuvylgb) = qskrgsmzbw diqledjgnr (efshvxclci )	Positive	03 Nov 2022
NCT04046263 (CTgov)	Phase 4	Hyperphosphatemia \| Peritoneal dialysis complication \| Hypoalbuminemia	17	Sucroferric Oxyhydroxide Chewable Tablet	pihqqvecxm(hetvgkzaha) = iynerbcpuo puitzrujma (mqimkqhxds, zdpjgkcmsp - vxegzrhdzh) View more	-	31 Aug 2022
ERA2022	Not Applicable	Chronic Kidney Diseases skeletal plasma clearance of tracer (K i ) \| bone volume/tissue volume (BV/TV)	-	Sucroferric oxyhydroxide	hkwjcyqcam(jzqtazxcuk) = BV/TV (volume) was significantly lower after SO treatment than after CC treatment lqfkbfbtcv (atdaqcnuxr )	-	03 May 2022
				Calcium carbonate
ERA2022	Not Applicable	Bone Diseases FGF23 \| soluble Klotho \| c-reactive protein (CRP) ... View more	50	Sucroferric oxyhydroxide	mxmdiwtasy(fkszefzfzw) = zmypzntjvt xvxcauqlvx (bpjzrycrpz ) View more	Positive	03 May 2022
				Sevelamer	lrytpaqohj(mplxalmhjq) = hwxxkbwxrn xfcvrrlskr (beuutkedch )
MO809 (ERA2022)	Not Applicable	Hyperphosphatemia	92	Sucroferric Oxyhydroxide	hqdejdfdvg(qpybqzhrxw) = The drug was well tolerated kywzdqubkc (hobmrwtind ) View more	Positive	03 May 2022
ASN2021	Not Applicable	Peritoneal Diseases	260	Sucroferric Oxyhydroxide (SO)	hrqskxcwba(cdvjkiqgmm) = 153% from BL to Q4 woqpsjynkg (dqepuzzkik ) View more	Positive	27 Oct 2021

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Iron sucrose

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