Delving into the Latest Updates on Ferric Maltol with Synapse

An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioequivalence Study Comparing Ferric Maltol 30 mg Capsules Manufactured by BDR Pharmaceuticals International Private Limited India With Feraccru Ferric Maltol 30 mg Capsules Manufactured by Norgine B V Antonio Vivaldistraat 150 Amsterdam Netherlands 1083 Hp In Healthy Adult Human Subjects under Fasting Conditions - NIL

Start Date20 Oct 2025

Sponsor / Collaborator

BDR Pharmaceuticals International Pvt Ltd.

NCT05697211

/ CompletedPhase 4

A Pilot Study to Explore Safety, Tolerability and Efficacy of ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure

This is an open-label, single arm, multicenter pilot-study to explore the safety, tolerability and efficacy of oral iron supplementation with ferric maltol in treating iron deficiency and anaemia in patients with heart failure.

Start Date21 Feb 2023

Sponsor / Collaborator

Hannover Medical School

[+1]

NCT05456932

/ Unknown statusPhase 4IIT

Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease

Iron deficiency anemia is the most common systemic manifestation of Inflammatory Bowel Diseases (IBD)-Crohn's disease and ulcerative colitis. Iron deficiency with or without anemia poses a diagnostic and therapeutic challenge due to chronic gastrointestinal blood loss and the inflammatory nature of IBD. Recent illumination of iron metabolism has brought attention to the systemic iron regulator-hepcidin, a peptide hormone that regulates intestinal iron absorption and systemic iron availability. Elevated hepcidin is associated with oral iron malabsorption in IBD. This study aims to evaluate whether hepcidin concentration at baseline can predict response to oral and intravenous iron therapy in patients with IBD and concomitant iron deficiency with or without anemia.

Start Date19 Aug 2022

Sponsor / Collaborator

Leids Universitair Medisch Centrum

[+3]

100 Clinical Results associated with Ferric Maltol

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100 Translational Medicine associated with Ferric Maltol

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100 Patents (Medical) associated with Ferric Maltol

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55

Literatures (Medical) associated with Ferric Maltol

01 Nov 2025·EUROPEAN JOURNAL OF HEART FAILURE

Letter Regarding the Article ‘Oral Ferric Maltol Improves Iron Deficiency Anaemia in Patients with Chronic Heart Failure’

Letter

Author: Sun, Peng

06 Mar 2024·ACS applied materials & interfaces

Clinically Approved Ferric Maltol: A Potent Nanozyme with Added Effect for High-Efficient Catalytic Disinfection

Article

Author: Su, Zehui ; Feng, Jianxing ; Du, Ting ; Zhang, Wentao ; Wang, Jianlong

Nanozyme has been proven to be an attractive and promising candidate to alleviate the current pressing medical problems. However, the unknown clinical safety and limited function beyond the catalysis of the most reported nanozymes cannot promise an ideal therapeutic outcome in further clinical application. Herein, we find that ferric maltol (FM), a clinically approved iron supplement synthesized through a facile scalable method, exhibits excellent peroxidase-like activity than natural horseradish peroxidase-like (HRP) and commonly reported Fe-based nanozymes, and also shows high antibacterial performance for methicillin-resistant Staphylococcus aureus (MRSA) elimination (100%) and wound disinfection. In addition, with added effects inherited from contained maltol, FM can accelerate skin barrier recovery. Therefore, the exploration of FM as a safe and desired nanozyme provides a timely alternative to current antibiotic therapy against drug-resistant bacteria.

01 Jan 2024·BMJ open

Predicting response to iron supplementation in patients with active inflammatory bowel disease (PRIme): a randomised trial protocol

Article

Author: van der Meulen-de Jong, Andrea E ; Duijvestein, Marjolijn ; Loveikyte, Roberta ; Goetgebuer, Rogier L ; Mujagic, Zlatan ; Dijkstra, Gerard

Introduction:

Iron deficiency anaemia (IDA) is the most common systemic manifestation of inflammatory bowel disease (IBD) that has detrimental effects on quality of life (QoL) and disease outcomes. Iron deficiency (ID), with or without anaemia, poses a diagnostic and therapeutic challenge in patients with IBD due to the multifactorial nature of ID(A) and its frequent recurrence. Elevated hepcidin—a systemic iron regulator that modulates systemic iron availability and intestinal iron absorption—has been associated with oral iron malabsorption in IBD. Therefore, hepcidin could assist in therapeutic decision-making. In this study, we investigate whether hepcidin can predict response to oral and intravenous iron supplementation in patients with active IBD undergoing anti-inflammatory treatment.

Methods and analysis:

PRIme is an exploratory, multicentre, open-label and randomised trial. All adult patients with active IBD and ID(A) will be assessed for eligibility. The participants (n=90) will be recruited at five academic hospitals within the Netherlands and randomised into three groups (1:1:1): oral ferrous fumarate, oral ferric maltol or intravenous iron. Clinical and biochemical data will be collected at the baseline and after 6, 14 and 24 weeks. Blood samples will be collected to measure hepcidin and other biomarkers related to iron status. In addition, patient-reported outcomes regarding QoL and disease burden will be evaluated. The primary outcome is the utility of hepcidin as a predictive biomarker for response to iron therapy, which will be assessed using receiver operating curve analysis.

Ethics and dissemination:

The study has been approved by the Institutional Review Board at the Leiden University Medical Center (IRB No. P21.109) and other study sites. All participants will provide written informed consent to enrol in the study. The findings will be published in a peer-reviewed journal and disseminated at scientific conferences; the dataset will be available on reasonable request.

Trial registration:

Prospectively registered in the https://clinicaltrials.gov/ and the Eudra registries. First submitted on 10 May 2022 to the ClinicalTrials.gov (ID: NCT05456932 ) and on 3 March 2022 to the European Union Drug Regulating Authorities Clinical Trials Database (ID: 2022-000894-16).

6

News (Medical) associated with Ferric Maltol

17 Feb 2026

·www.prnewswire.com

Shield Therapeutics Announces FDA Approval of ACCRUFeR®, the First and Only Prescription Oral Iron Therapy Approved for Children Age 10 and Older

LONDON, Feb. 17, 2026 /PRNewswire/ -- Shield Therapeutics plc announced that ACCRUFeR® (ferric maltol) is the first and only prescription oral iron treatment approved by the U.S. Food and Drug Administration for the treatment of iron deficiency in children age 10 and older. ACCRUFeR® has been FDA-approved and prescribed for adults with iron deficiency since 2019. Iron deficiency affects about 2.4 million children in the United States, with adolescents at a particularly high risk. Up to 40% of females age 12-21 may be affected due to menstruation and increased iron needs during puberty. Other common risk factors include not eating enough iron-rich foods, high-intensity athletic training, obesity, and growth spurts. Early treatment of iron deficiency in children is critical. Unnoticed or untreated iron deficiency can lead to developmental delays, difficulty with learning and concentration, decreased academic performance, behavioral issues, and a weakened immune system. Common signs of low iron in children include unusual fatigue, paleness, irritability, or difficulty keeping up in school or activities. If parents have concerns surrounding iron deficiency they should speak with their child's doctor who may recommend performing blood tests to diagnose iron deficiency or iron deficiency anemia. Many families have experienced challenges with traditional iron supplements, which can cause stomach upset, nausea, or constipation – side effects that make it difficult for children to stick with treatment. ACCRUFeR® was designed with tolerability in mind. For children ages 10 and up, ACCRUFeR® is a new option that can help restore iron levels while minimizing the risk of GI side effects. For Important Safety Information and full Prescribing Information for ACCRUFeR®, visit About ACCRUFeR® /FeRACCRU® ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral therapy for adults and children age 10 and older with ID/IDA. The drug has a novel mechanism of absorption compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. More information about ACCRUFeR®/FeRACCRU®, including the product label, can be found at: and . SOURCE Shield Therapeutics 21% more press release views with Request a Demo

Drug Approval

22 Dec 2025

·www.einpresswire.com

FDA approves first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older

Action The U.S. Food and Drug Administration (FDA) approved Accrufer (ferric maltol) capsules to treat pediatric patients ages 10 and older with iron deficiency. Accrufer was initially approved in 2019 for adults with iron deficiency. Disease or Condition Iron deficiency is the most common cause of anemia and occurs if there is not enough iron in the blood. Without enough iron, the body cannot make sufficient hemoglobin, a protein inside red blood cells that carries oxygen throughout the body. Iron deficiency anemia can result in symptoms such as fatigue, pale skin, and dizziness. Causes can include blood loss from gastrointestinal conditions, menstruation, food malabsorption, and insufficient iron in the diet. Data Supporting Accrufer The efficacy of Accrufer to treat iron deficiency in pediatric patients ages 10-17 was assessed in the FORTIS trial (NCT05126901). The trial treated 24 patients with age-based dosing of Accrufer twice daily, and showed a clinically meaningful average increase in hemoglobin of 1.1 g/dL at Week 12. This, on average, would be the expected increase in hemoglobin with one blood transfusion. Safety Information Patients should not take Accrufer if they are allergic to Accrufer or any of its excipients, have hemochromatosis and other iron overload syndromes, or receive repeated blood transfusions. In addition, patients should avoid Accrufer if they are experiencing an inflammatory bowel disease flare and should be aware of the risks of iron overload. The most common side effects of Accrufer are flatulence, diarrhea, constipation, discolored feces, abdominal pain, nausea, vomiting, and abdominal discomfort/distension. Content current as of: 12/22/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultDrug Approval

21 Jun 2021

·www.globenewswire.com

Shield Therapeutics PLC (“Shield”) to Webcast Live at Life Sciences Investor Forum June 24th

LONDON, June 21, 2021 (GLOBE NEWSWIRE) -- Shield Therapeutics PLC (STX.L), based in Newcastle-upon-Tyne, UK, focused on addressing iron deficiency with its lead product Feraccru®/Accrufer® (ferric maltol), today announced that Greg Madison, Chief Executive Officer, will present live at LifeSciencesInvestorForum.com on June 24th. DATE: Thursday, June 24th TIME: 10.00 am ETLINK: This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event. It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. Learn more about the event at . About ShieldShield is a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru® /Accrufer® (ferric maltol), a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia. Shield’s lead product, Feraccru®/Accrufer®, has been approved for use in the United States, European Union, UK and Switzerland and has exclusive IP rights until the mid-2030s. The Group plans to launch Accrufer® in the US during 2021 through a highly experienced sales and marketing team. Feraccru® is already being commercialised in the UK and European Union by Norgine B.V., who also have the marketing rights in Australia and New Zealand. Shield also has an exclusive licence agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the development and commercialisation of Feraccru®/Accrufer® in China, Hong Kong, Macau and Taiwan. For more information, please visit . Follow Shield on Twitter @ShieldTx About Life Sciences Investor ForumLife Sciences Investor Forum is the leading proprietary investor conference series that provides an interactive forum for Life Sciences companies to meet with and present directly to investors. A real-time solution for investor engagement, Life Sciences Investor Forum is powered by Intrado Digital Media and specifically designed for more efficient investor access. Replicating the look and feel of on-site investor conferences, Life Sciences Investor Forum combines leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.

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100 Deals associated with Ferric Maltol

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KEGG	Wiki	ATC	Drug Bank
D10833	Ferric Maltol	B03AB10	DB15598

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia, Iron-Deficiency	Switzerland	Ewopharma AG	22 Sep 2017
Iron deficiency	European Union	Norgine BV	18 Feb 2016
Iron deficiency	Iceland	Norgine BV	18 Feb 2016
Iron deficiency	Liechtenstein	Norgine BV	18 Feb 2016
Iron deficiency	Norway	Norgine BV	18 Feb 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anemia	Phase 3	United Kingdom	Norgine Ltd.	30 May 2022
Colonic Cancer	Phase 3	United Kingdom	Norgine Ltd.	30 May 2022
Chronic Kidney Diseases	Phase 3	United States	Shield Therapeutics Plc	01 Dec 2016
Inflammatory Bowel Diseases	Phase 3	Germany	Shield TX (UK) Ltd.	02 Dec 2015
Colitis, Ulcerative	Phase 3	-	Shield Therapeutics Plc	01 Aug 2011
Crohn Disease	Phase 3	-	Shield Therapeutics Plc	01 Aug 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2023	Not Applicable	Anemia, Iron-Deficiency \| Inflammatory Bowel Diseases	-	Ferric Maltol	rcfzlwpjka(phivoczthx) = At the time of the current analysis, all 27 completed pregnancies proceeded without complications and ended with healthy neonatal infants without abnormalities. Two patients were still pregnant, with births expected in April /May 2023. hjijxagszs (avtusiifvr ) View more	-	15 Oct 2023
UEGW2021	Not Applicable	Anemia, Iron-Deficiency \| Inflammatory Bowel Diseases	-	Ferric Maltol	xfdyhjdreg(eugcnermaz) = Drug-related treatment emergent adverse events were similar between < 9.5 g/dL and ≥ 9.5 g/dL Hb groups (15.8% vs. 21.3%, respectively); all non-serious. trccjgkskr (lfjnxrmziu )	-	02 Oct 2021
				Ferric Carboxymaltose
NCT02968368 (AEGIS-CKD, Pubmed \| Am J Kidney Dis)	Phase 3	Anemia, Iron-Deficiency	167	Oral ferric maltol 30 mg	ggqdtkyzzm(yqxmbtwcxr): P-Value = 0.01 View more	Positive	21 May 2021
				Placebo
NCT03181451 (CTgov)	Phase 1	Iron deficiency \| Anemia, Iron-Deficiency	37	Ferric Maltol (30 mg Ferric Maltol)	nzryfsxnsb(jaqdvruhbr) = ducdmavuat tloecdodxc (ahphlwkrmm, 1.29590) View more	-	02 Jun 2020
				Ferric Maltol (16.6 mg Ferric Maltol)	nzryfsxnsb(jaqdvruhbr) = axyhavfigc tloecdodxc (ahphlwkrmm, 0.18435) View more
NCT02968368 (AEGIS-CKD \| phase 3 multicenter double-blind, randomized controlled trial, CTgov)	Phase 3	Anemia, Iron-Deficiency \| Chronic Kidney Diseases	167	Ferric maltol (Oral Ferric Maltol)	yewwmshkst(ugeoeqkxla) = kexrkecujf ekrusroyqr (vafvimgjqc, 0.122) View more	-	01 May 2020
				Placebo (Oral Placebo)	yewwmshkst(ugeoeqkxla) = zyngehcbao ekrusroyqr (vafvimgjqc, 0.165) View more
NCT02680756 (CTgov)	Phase 3	Crohn Disease \| Anemia, Iron-Deficiency	250	Ferric Maltol (Oral Ferric Iron Compound)	ltdanuuxan: Risk Difference (RD) = -0.17 (95% CI, -0.28 to -0.06), P-Value = 0.298 View more	-	24 Feb 2020
				Ferric Carboxy Maltose (Intravenous Iron)
EUCTR2015-002496-26-BE (UEGW2019)	Phase 3	Inflammatory Bowel Diseases haemoglobin \| ferritin \| transferrin saturation	-	Oral ferric maltol 30 mg twice daily	lurrrqcfsl(kntbvxuziv) = ymyzfokzqd cohnjlpufh (sgkhgxrada )	Positive	21 Oct 2019
				Intravenous ferric carboxymaltose	lurrrqcfsl(kntbvxuziv) = sndhfwcegi cohnjlpufh (sgkhgxrada )
NCT02968368 (ASN2018)	Phase 3	Inflammation \| Chronic Kidney Diseases high-sensitivity C-reactive protein (hsCRP)	-	Ferric Maltol 30 mg	gmcvottnfo(rovzzzdzer) = zvqcdtttou uxxuuurgte (efxtspavsb ) View more	Positive	23 Oct 2018
				Placebo	gmcvottnfo(rovzzzdzer) = ztoizmwahz uxxuuurgte (efxtspavsb ) View more
NCT02968368 (phase 3 multicenter double-blind, randomized controlled trial, ASN2018)	Phase 3	Anemia, Iron-Deficiency \| Chronic Kidney Diseases	167	Oral Ferric Maltol (FM) 30 mg	btdlyrgjvk(mwpllqmgbx) = Two patients died (one in each group), both considered unrelated to study drug ocasgkcsjs (vnmllexyss ) View more	Positive	23 Oct 2018
NCT01340872 (AEGIS-1, CTgov)	Phase 3	Anemia, Iron-Deficiency \| Colitis, Ulcerative	128	ST10-021 (ST10)	ixeovwtjgf(qyyfmgnjxn) = tsliohtxrb rfxrnetkvk (gkyytdgdph, 1.184) View more	-	03 Aug 2018
				Placebo Comparator (Placebo)	ixeovwtjgf(qyyfmgnjxn) = vydengrxqt rfxrnetkvk (gkyytdgdph, 0.764) View more