Delving into the Latest Updates on Fermagate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Alpharen, Macrosorb MD

Target

Phosphates

Mechanism

Phosphates modulators(Phosphates modulators)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Hypophosphatemia

Inactive Indication

HyperphosphatemiaKidney Failure, Chronic

Originator Organization

Ineos Healthcare Ltd.

Active Organization

Prolor Biotech Ltd.

Inactive Organization

Ineos Healthcare Ltd.OPKO Renal LLC

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaCH20Fe2Mg4O19

InChIKeyVESOWWBEYMMDFG-UHFFFAOYSA-A

CAS Registry119175-48-3

View All Structures (2)

Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.
The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring haemodialysis, compared with a marketed phosphate binder, sevelamer hydrochloride.

Start Date01 Jul 2009

Sponsor / Collaborator

Ineos Healthcare Ltd.

NCT00436683

/ CompletedPhase 2

An Open Label, Dose-Ranging Study to Establish the Tolerability of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia.

Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.
The purpose of this study is to determine how well a range of different doses of fermagate are tolerated by the subjects in the trial.

Start Date01 Feb 2007

Sponsor / Collaborator

Ineos Healthcare Ltd.

100 Clinical Results associated with Fermagate

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100 Translational Medicine associated with Fermagate

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100 Patents (Medical) associated with Fermagate

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3

Literatures (Medical) associated with Fermagate

01 Sep 2021·International Urology and NephrologyQ4 · MEDICINE

Using iron-based phosphate binders in phosphate reduction and anemia improvement in patients receiving dialysis: a meta-analysis of randomized controlled trials

Q4 · MEDICINE

Article

Author: Zhu, Yan ; Rao, Jinlan ; Liao, Xueling ; Li, Wei ; Xue, Chao ; Ou, Jihong

PURPOSEA study was conducted to determine whether iron-based phosphate binders (IBPBs) need to be preferred for hyperphosphatemia and anemia management in patients on dialysis.METHODSFor this meta-analysis, we searched PubMed, Embase, and Cochrane Central Register of Controlled Trials for randomized controlled trials that evaluated the efficacy and safety of IBPBs in decreasing phosphate and correcting anemia in dialysis patients.RESULTSNineteen trials comprising 4719 participants were included. Compared with placebo, serum phosphate decreased significantly after treatment with ferric citrate (FC), fermagate (one study), and SBR759 (one study). Hemoglobin increased significantly after treatment with FC and sucroferric oxyhydroxide (PA21). In addition, FC and PA21 reduced serum intact parathyroid hormone (iPTH) and increased ferritin and transferrin saturation, but SBR759 did not. Compared with active treatment, the non-inferiority of IBPBs in reducing serum phosphate and iPTH was demonstrated. FC significantly improved serum hemoglobin and iron-related parameters and decreased the use of intravenous iron and erythropoiesis-stimulating agent, whereas PA21 did not increase serum hemoglobin level. The incidences of infection and hospitalization were similar between the two groups, with FC having a higher risk of diarrhea than the placebo and active treatments.CONCLUSIONFC was associated with the control of hyperphosphatemia and the improvement of anemia. However, PA21 did not show superiority for alleviating anemia compared with the active treatment. Other IBPBs, such as fermagate and SBR759, remained poorly understood due to the limited number of studies. Further trials are required to assess the effect of IBPBs on the risk of cardiovascular events and all-cause mortality.

01 Jun 2014·DrugsQ1 · MEDICINE

Next-Generation Phosphate Binders: Focus on Iron-Based Binders

Q1 · MEDICINE

Review

Author: Alberto Ortiz ; Emilio González-Parra ; Liliana González-Espinoza ; Dimitra Nastou ; Beatriz Fernández-Fernández ; Maria D. Sanchez-Niño ; Usama Elewa

Phosphate excess is associated with increased mortality in patients with chronic kidney disease (CKD) and has recently been linked to accelerated aging. Oral phosphate binders are prescribed to patients with CKD to prevent absorption of dietary phosphate. Currently available binders have been associated with impaired outcomes (calcium-based binders) or are expensive (non-calcium-based binders). Iron-based phosphate binders represent a new class of phosphate binders. Four iron-based phosphate binders have undergone testing in clinical trials. The development of fermagate and SBR759 is currently on hold due to suboptimal and adverse effect profiles in at least some clinical trials. Ferric citrate and sucroferric oxyhydroxide (PA21) are at different stages of application for regulatory approval after being found safe and efficacious in decreasing serum phosphate. Iron from ferric citrate is more readily absorbed than that from sucroferric oxyhydroxide. Sucroferric oxyhydroxide was launched in the USA in 2014 for the treatment of hyperphosphatemia in adult dialysis patients. Ferric citrate may be more suited for chronic treatment of hyperphosphatemia in CKD patients requiring iron supplements but its use may have to be limited in time because of potential for iron overload in patients not needing iron or not receiving erythropoiesis-stimulating agents. In contrast, sucroferric oxyhydroxide may be more suited for hyperphosphatemic CKD patients not requiring iron supplements.

01 Feb 2009·Clinical Journal of the American Society of NephrologyQ1 · MEDICINE

Iron-Magnesium Hydroxycarbonate (Fermagate)

Q1 · MEDICINE

Article

Author: Hutchison, Alastair J. ; McIntyre, Christopher W. ; Toft, Alex J. ; Warwick, Graham ; Pai, Pearl ; Wilkie, Martin

BACKGROUND AND OBJECTIVESThis phase II study tested the safety and efficacy of fermagate, a calcium-free iron and magnesium hydroxycarbonate binder, for treating hyperphosphatemia in hemodialysis patients.DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTSA randomized, double-blind, three-arm, parallel-group study compared two doses of fermagate (1 g three times daily or 2 g three times daily with placebo). Sixty-three patients who had been on a stable hemodialysis regimen for > or =3 mo were randomized to the treatment phase. Study medication was administered three times daily just before meals for 21 d. The primary endpoint was reduction in serum phosphate over this period.RESULTSIn the intention-to-treat analysis, mean baseline serum phosphate was 2.16 mmol/L. The fermagate 1- and 2-g three-times-daily treatment arms were associated with statistical reductions in mean serum phosphate to 1.71 and 1.47 mmol/L, respectively. Adverse event (AE) incidence in the 1-g fermagate arm was statistically comparable to the placebo group. The 2-g arm was associated with a statistically higher number of patients reporting AEs than the 1-g arm, particularly gastrointestinal AEs, as well as a higher number of discontinuations, complicating interpretation of this dose's efficacy. Both doses were associated with elevations of prehemodialysis serum magnesium levels.CONCLUSIONSThe efficacy and tolerability of fermagate were dose dependent. Fermagate showed promising efficacy in the treatment of hyperphosphatemia in chronic hemodialysis patients as compared with placebo in this initial phase II study. The optimal balance between efficacy and tolerability needs to be determined from future dose-titration studies, or fixed-dose comparisons of more doses.

100 Deals associated with Fermagate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Fermagate	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Kidney Failure, Chronic	Phase 2	US	Ineos Healthcare Ltd.	01 Jul 2009
Kidney Failure, Chronic	Phase 2	SK	Ineos Healthcare Ltd.	01 Jul 2009
Kidney Failure, Chronic	Phase 2	EE	Ineos Healthcare Ltd.	01 Jul 2009
Kidney Failure, Chronic	Phase 2	IL	Ineos Healthcare Ltd.	01 Jul 2009
Kidney Failure, Chronic	Phase 2	MX	Ineos Healthcare Ltd.	01 Jul 2009
Kidney Failure, Chronic	Phase 2	RS	Ineos Healthcare Ltd.	01 Jul 2009
Kidney Failure, Chronic	Phase 2	HU	Ineos Healthcare Ltd.	01 Jul 2009
Kidney Failure, Chronic	Phase 2	ZA	Ineos Healthcare Ltd.	01 Jul 2009
Kidney Failure, Chronic	Phase 2	GB	Ineos Healthcare Ltd.	01 Jul 2009
Kidney Failure, Chronic	Phase 2	BR	Ineos Healthcare Ltd.	01 Jul 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2018	Not Applicable	Chronic Kidney Diseases	23	Fermagate	fzsqxjzmen(solfifkfoi) = fftmljzrkc yvyyziwvbf (skbljaatrw, 79%/65%inCONvs.35%FER(0.75%P)and13%FER(0.5-1%P) - p<0.001)	Positive	23 Oct 2018