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+ [2]

Active Indication

Anemia, Iron-DeficiencyIron deficiencyColitis, Ulcerative+ [4]

Inactive Indication

Chronic Kidney Diseases

Originator Organization

Shield Therapeutics Plc

Active Organization

KOREA PHARMA Co., Ltd.KYE Pharmaceuticals, Inc.

Hangzhou QIANYUAN Pollen Pharmaceutical Co., Ltd.

+ [9]

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

Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD) and impairs quality of life. Hepcidin, the regulator of systemic iron homeostasis, may predict response to iron therapy; however, its utility in IBD remains unclear. This study evaluated whether baseline hepcidin predicts response to oral and intravenous (IV) iron in active IBD to guide personalised treatment.

Methods:

Ninety adults with active IBD and iron deficiency (with or without anaemia) from two randomised trials received IV iron, oral ferrous fumarate (FF) or oral ferric maltol (FM). Response at 12 weeks was defined as haemoglobin increase ≥ 1.2 mmol/L (19.3 g/L) or normalisation in IDA or ferritin > 100 μg/L and transferrin saturation > 20% in iron deficient patients. Baseline iron indices including ferritin, hepcidin, and soluble transferrin receptor (sTfR) were measured. Logistic regression and receiver operating curve analyses evaluated predictive performance.

Results:

Baseline hepcidin strongly predicted response to iron therapy: AUC (FF) : 0.86, 95% CI: 0.71–1.00 and AUC (IV) : 0.63, 95% CI: 0.30–0.96. Hepcidin > 2.68 μg/mL identified non‐responders to FF with 89% sensitivity and 77% specificity. Each twofold increase in baseline hepcidin or ferritin reduced the odds of response [log 2 (hepcidin) OR: 0.71, 95% CI: 0.56–0.89; log 2 (ferritin) OR: 0.38, 95% CI: 0.21–0.69]. Higher transferrin/log 10 (ferritin) (OR: 2.95, 95% CI: 1.38–6.30) and sTfR/log 10 (ferritin) ratios (OR: 1.29, 95% CI: 1.05–1.59) increased likelihood of response.

Conclusion:

Baseline hepcidin supports route selection for iron therapy: higher levels favour IV iron, while lower levels indicate likely oral response. Ferritin‐based indices, notably transferrin/log 10 (ferritin), offer pragmatic alternatives where hepcidin testing is unavailable.

Trial Registration:

ClinicalTrials.gov identifier: NCT05581420 and NCT05456932

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

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

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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	Medius 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
Inflammatory Bowel Diseases	Phase 3	China	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	01 Sep 2021
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


ORION-HF (ESC2026)	Phase 2	Anemia, Iron-Deficiency	41	Oral ferric maltol (NYHA class II)	dfliqxiewv(npbnhjoupw) = tmzvqxonze ksfcxvomus (waptvdrweg ) View more	Positive	28 Aug 2026
				Oral ferric maltol (NYHA class III-IV)	dfliqxiewv(npbnhjoupw) = jumjrqrbxk ksfcxvomus (waptvdrweg ) View more
NCT05581420 \| NCT05456932 (Pubmed \| Aliment Pharmacol Ther)	Phase 4	Inflammatory Bowel Diseases hepcidin \| ferritin \| sTfR	90	Intravenous (IV) iron	dnoeukvsmp(parlrwqhxf) = Hepcidin > 2.68 µg/mL identified non‐responders to FF with 89% sensitivity and 77% specificity. rmvsmtjxpz (yuwixgssgt ) View more	Positive	01 Jul 2026
ECCO2025	Not Applicable	Inflammatory Bowel Diseases	83	Feraccru 30 mg	xtgkryyzpv(amnvxilnny) = 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. ixhoviulew (gpzzhrmapm )	Positive	19 Feb 2025
UEGW2023	Not Applicable	Anemia, Iron-Deficiency \| Inflammatory Bowel Diseases	-	Ferric Maltol	lvgwiemomb(hjywhxvriq) = 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. sthcfxicbk (tdfycselxg ) View more	-	15 Oct 2023
UEGW2021	Not Applicable	Anemia, Iron-Deficiency \| Inflammatory Bowel Diseases	-	Ferric Maltol	bqxqtkoowv(urycijdipi) = 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. tbqlqlnicf (ykbaehhufb )	-	02 Oct 2021
				Ferric Carboxymaltose
NCT02680756 (ECCO2021)	Phase 3	-	125	ferric maltol (baseline Hb < 9.5 g/dL)	vofcjbvuml(qgwihbfcnr) = nevrdxqnpq jmmczmpjux (zufsruuday ) View more	Positive	02 Jul 2021
				ferric maltol (baseline Hb ≥ 9.5 g/dL)	vofcjbvuml(qgwihbfcnr) = roberpwqug jmmczmpjux (zufsruuday ) View more
NCT02968368 (AEGIS-CKD, Pubmed \| Am J Kidney Dis)	Phase 3	Anemia, Iron-Deficiency	167	Oral ferric maltol 30 mg	kxmeiexqao(yhnoxhakpt): 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)	shntighxvt(jpmqphlefs) = bsspdrmfap nztyhamehe (uzgthnimlw, 1.29590) View more	-	02 Jun 2020
				Ferric Maltol (16.6 mg Ferric Maltol)	shntighxvt(jpmqphlefs) = gjcojnoelb nztyhamehe (uzgthnimlw, 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)	dqpcmfoabu(tphdrilngg) = ealukvgbaa owffhsfmck (rdjkbeffrx, 0.122) View more	-	01 May 2020
				Placebo (Oral Placebo)	dqpcmfoabu(tphdrilngg) = cjojhvmbfb owffhsfmck (rdjkbeffrx, 0.165) View more
NCT02680756 (CTgov)	Phase 3	Crohn Disease \| Anemia, Iron-Deficiency	250	Ferric Maltol (Oral Ferric Iron Compound)	jhlnliupkh: 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)