Drugs / Ferric maltol

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) ACCRUFER 2025-12-19 fda.gov
Approved US (FDA) ACCRUFER 2019-07-25 fda.gov
Approved EU (EMA) Feraccru 2016-02-18 europa.eu

Trials 10 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 37 trials
Phase 3 NCT05177484 May 2022 → Jan 2024 colorectal cancer The Royal Wolverhampton Hospitals NHS Trust Completed No outcome recorded
Phase 3 NCT05126901 Nov 2021 → Jun 2024 iron deficiency anemia Shield Therapeutics Completed No outcome recorded
Phase 3 NCT03371173 Mar 2018 → Mar 2020 iron deficiency anemia, pulmonary hypertension Hannover Medical School Terminated No outcome recorded
Phase 3 NCT02968368 Dec 2016 → Jan 2018 chronic kidney disease, iron deficiency anemia Shield Therapeutics Completed No outcome recorded
Phase 3 NCT02680756 Jan 2016 → Oct 2018 Crohn disease, iron deficiency anemia Shield Therapeutics Completed No outcome recorded
Phase 3 NCT01352221 Aug 2011 → Oct 2013 Crohn disease, iron deficiency anemia Shield Therapeutics Completed No outcome recorded
Phase 3 NCT01340872 Aug 2011 → Oct 2013 iron deficiency anemia, ulcerative colitis Shield Therapeutics Completed No outcome recorded
Phase 43 trials
Phase 4 NCT05697211 Feb 2023 → Jan 2025 iron deficiency anemia, left ventricular failure Hannover Medical School Completed No outcome recorded
Phase 4 NCT05456932 Aug 2022 → Aug 2023 disorder of iron metabolism and transport, inflammatory bowel disease, iron deficiency anemia Leiden University Medical Center Unknown No outcome recorded
Phase 4 NCT03774615 Mar → Nov 2019 iron deficiency anemia, left ventricular failure Hannover Medical School Terminated No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT04626414 Comparator Sep → Nov 2020 iron deficiency anemia Shield Therapeutics Completed No outcome recorded
Phase 1 NCT03181451 Comparator Mar 2017 → Mar 2018 iron deficiency anemia Shield Therapeutics Completed No outcome recorded
Phase 41 trial
Phase 4 NCT07308769 Comparator Dec 2025 → May 2026 overdue iron deficiency anemia Pharmanutra S.p.a. Recruiting No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as Ferric Maltol ClinicalTrials.gov intervention name — accepted as the source's own label NCT02680756
10

NCT03371173

NCT05177484

NCT05126901

NCT03774615

NCT03181451

NCT05697211

NCT02968368

NCT05456932

NCT04626414

NCT07308769

Known as Accrufer ChEMBL registry synonym — accepted as the source's own label CHEMBL4298110
Known as Feraccru “Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg).” NCT05697211
3

“Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg).” NCT03371173

“Ferric Maltol (Feraccru®), 30 mg elemental iron per capsule” NCT07308769

Feraccru® 30 mg hard capsules will be used.” NCT03774615

Known as Ferracru “a newer oral iron preparation - ferric maltol (Ferracru) has been found to be better tolerated and more efficacious than ferrous iron.” NCT05177484
Known as Iron maltol ChEMBL registry synonym — accepted as the source's own label CHEMBL4298110
Known as Maltol ferrico ChEMBL registry synonym — accepted as the source's own label CHEMBL4298110
Known as Maltol ferrique ChEMBL registry synonym — accepted as the source's own label CHEMBL4298110
Known as ST10 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01352221
Known as ST10-021 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01340872
Modality Small molecule CHEMBL4298110
Route Oral “30 mg capsules to be taken orally twice a day for 12 weeks” NCT01340872