Delving into the Latest Updates on Ferric Maltol with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Ferric maltol (USAN/INN), Iron (III) maltol, ASKC109

+ [6]

Target-

Action-

Mechanism

Iron preparation

Therapeutic Areas

Endocrinology and Metabolic DiseaseHemic and Lymphatic DiseasesNeoplasms+ [1]

Active Indication

Anemia, Iron-DeficiencyIron deficiencyAnemia+ [1]

Inactive Indication

Chronic Kidney DiseasesColitis, UlcerativeCrohn Disease

Originator Organization

Shield Therapeutics Plc

Active Organization

KYE Pharmaceuticals, Inc.

Norgine BVNorgine Ltd.

+ [8]

Inactive Organization-

License Organization

KYE Pharmaceuticals, Inc.

Shield Therapeutics Plc

Beijing Aosaikang Pharmaceutical Co., Ltd.

+ [4]

Drug Highest PhaseApproved

First Approval Date

European Union (18 Feb 2016),

Iron deficiency

Regulation-

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Structure/Sequence

Molecular FormulaC18H15FeO9

InChIKeyAHPWLYJHTFAWKI-UHFFFAOYSA-K

CAS Registry33725-54-1

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 4IIT

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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49

Literatures (Medical) associated with Ferric Maltol

01 May 2026·PEDIATRIC DRUGS

Ferric Maltol: Pediatric First Approval

Review

Author: Keam, Susan J

Ferric maltol (ACCRUFeR^®), is an oral iron replacement product being developed by Shield Therapeutics plc for the treatment of iron deficiency (ID). Ferric maltol was originally approved for the treatment of iron deficiency anemia (IDA) in adult patients with inflammatory bowel disease in 2016 (with an indication extension for ID/IDA in adults in 2018) in the EU, and in ID in adults in 2019 in the USA. In December 2025 the indication in the USA was extended to include pediatric patients aged ≥ 10 years. A similar indication extension in pediatric patients aged ≥ 12 years is being evaluated in the EU. This article summarizes the milestones in the development of ferric maltol leading to this first pediatric approval for the treatment of ID.

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: Peng Sun

01 Nov 2025·EUROPEAN JOURNAL OF HEART FAILURE

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

Letter

Author: Fuge, Jan ; Kempf, Tibor ; Bauersachs, Johann

9

News (Medical) associated with Ferric Maltol

27 Feb 2026

·shieldtherapeutics.com

Shield Therapeutics - Total Voting Rights

/ 0 Latest announcements Chinese NMPA Accepts MAA Submission for ACCRUFeR® (ferric maltol) Released 03 Mar 2026 Shield Therapeutics - FDA Grants additional Exclusivity for ACCRUFeR Released 09 Feb 2026 Shield Therapeutics - Total Voting Rights Released 30 Jan 2026 Ask a question Your question will be visible to everyone. Investor Q&As Start the conversation Ask Shield Therapeutics a question about this announcement. Likely Neutral Unlikely 0 responses

IND

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

21 Jan 2026

·shieldtherapeutics.com

Shield Therapeutics - Q4 2025 Trading Update

/ 0 Latest announcements Chinese NMPA Accepts MAA Submission for ACCRUFeR® (ferric maltol) Released 03 Mar 2026 Shield Therapeutics - Total Voting Rights Released 27 Feb 2026 Shield Therapeutics - FDA Grants additional Exclusivity for ACCRUFeR Released 09 Feb 2026 Ask a question Your question will be visible to everyone. Investor Q&As Start the conversation Ask Shield Therapeutics a question about this announcement. Likely Neutral Unlikely 0 responses

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100 Deals associated with Ferric Maltol

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External Link

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
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


ECCO2025	Not Applicable	Inflammatory Bowel Diseases	83	Feraccru 30 mg	zqptrtagze(amgckeogll) = A total of 8 AEs were reported which included: 64% stomach cramps (n=5), 12% (n=1) loose stools, 12% (n=1) constipation and 12% (n=1) rectal bleeding. fowmxgldio (uwsxekutnz )	Positive	19 Feb 2025
UEGW2023	Not Applicable	Anemia, Iron-Deficiency \| Inflammatory Bowel Diseases	-	Ferric Maltol	tvvotqkzyr(qbxsdiwylq) = 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. pvbffhwbnt (kuxqqrotll ) View more	-	15 Oct 2023
UEGW2021	Not Applicable	Anemia, Iron-Deficiency \| Inflammatory Bowel Diseases	-	Ferric Maltol	btnalspsba(ridtygmkds) = 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. aaabfhxykl (gpoedlzxal )	-	02 Oct 2021
				Ferric Carboxymaltose
NCT02680756 (ECCO2021)	Phase 3	-	125	ferric maltol (baseline Hb < 9.5 g/dL)	fcufpkyvpp(cqyxmufxso) = fewwvykjuy atwyyddhfl (uouergoqif ) View more	Positive	02 Jul 2021
				ferric maltol (baseline Hb ≥ 9.5 g/dL)	fcufpkyvpp(cqyxmufxso) = vkdhbsguel atwyyddhfl (uouergoqif ) View more
NCT02968368 (AEGIS-CKD, Pubmed \| Am J Kidney Dis)	Phase 3	Anemia, Iron-Deficiency	167	Oral ferric maltol 30 mg	fqstyxlbav(nxpyyzsbsc): P-Value = 0.01 View more	Positive	21 May 2021
				Placebo
NCT03181451 (CTgov)	Phase 1	Anemia, Iron-Deficiency	37	Ferric Maltol (30 mg Ferric Maltol)	tcinjwhzgo(cdedwnovsa) = tpqckpqnku veckgcajyu (qckqmmrjfu, 1.29590) View more	-	02 Jun 2020
				Ferric Maltol (16.6 mg Ferric Maltol)	tcinjwhzgo(cdedwnovsa) = citkzvsrxq veckgcajyu (qckqmmrjfu, 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)	fqhggrwfuh(tmppjzlkhn) = asbhuowigs lfbkmfmrbq (owyuqjkleq, 0.122) View more	-	01 May 2020
				Placebo (Oral Placebo)	fqhggrwfuh(tmppjzlkhn) = yteipqtedx lfbkmfmrbq (owyuqjkleq, 0.165) View more
NCT02680756 (CTgov)	Phase 3	Crohn Disease \| Anemia, Iron-Deficiency	250	Ferric Maltol (Oral Ferric Iron Compound)	kxdgsqmzcy: 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	rddlebhbsc(numtaogwvu) = ishnwqeqlk nuzgwaxjyq (cujwmpjxtc )	Positive	21 Oct 2019
				Intravenous ferric carboxymaltose	rddlebhbsc(numtaogwvu) = oxqqeyoajf nuzgwaxjyq (cujwmpjxtc )
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	mbiyzqjrol(nzctddtybj) = Two patients died (one in each group), both considered unrelated to study drug mfbewkunla (hxrhjfcgps ) View more	Positive	23 Oct 2018