Drugs / Ferric maltol
Ferric maltol
also known as
Feraccru · Accrufer · Ferracru · Iron maltol · Maltol ferrico · Maltol ferrique · ST10 · ST10-021
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed iron deficiency anemia 3 milestones | |||||
| Filed | China (NMPA) | ACCRUFeR® | iron deficiency anemia | 2026-03-03 | “Chinese NMPA Accepts MAA Submission for ACCRUFeR® (ferric maltol)” shieldtherapeutics.com ↗ |
| Filed | EU (EMA) | FeRACCRU® | iron deficiency anemia | — | “filed a regulatory submission to the EMA in Q2 2025 for the approval of FeRACCRU® (ferric maltol) in the adolescent population.” shieldtherapeutics.com ↗ |
| Filed | US (FDA) | Accrufer®/Feraccru® | iron deficiency anemia | — | “Shield submitted a clinical supplement application to the FDA in June 2025 for the approval of ACCRUFeR®/FeRACCRU® in the pediatric population.” shieldtherapeutics.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 37 trials · 3 met primary | ||||||
| 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 Stop: Enrollment |
| Phase 3 | NCT02968368 | Dec 2016 → Jan 2018 | chronic kidney disease, iron deficiency anemia | Shield Therapeutics | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01340872 | Aug 2011 → Oct 2013 | iron deficiency anemia, ulcerative colitis | Shield Therapeutics | Completed | Met primary |
| 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 Stop: Enrollment |
| Comparator or background therapy3 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 4 | NCT07308769 Comparator | Dec 2025 → Oct 2026 expected | iron deficiency anemia | Pharmanutra S.p.a. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-07-28 | Shield Therapeutics | Results Shield Therapeutics - ACCRUFeR® Phase 3 pediatric trial published shieldtherapeutics.com ↗ |
| 2026-03-31 | Shield Therapeutics | Regulatory Shield Therapeutics - EMA approves extension - to include adolescents shieldtherapeutics.com ↗ |
| 2026-03-03 | Shield Therapeutics | Regulatory Chinese NMPA Accepts MAA Submission for ACCRUFeR® (ferric maltol) shieldtherapeutics.com ↗
Chinese NMPA Accepts MAA Submission for ACCRUFeR® (ferric maltol) |
| 2026-02-09 | Shield Therapeutics | Regulatory Shield Therapeutics - FDA Grants additional Exclusivity for ACCRUFeR shieldtherapeutics.com ↗
Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that the US Food and Drug Administration (FDA) has granted to Shield an additional 3 years of Data Exclusivity for ACCRUFeR® (ferric maltol). |
| 2025-12-22 | Shield Therapeutics | Regulatory Shield Therapeutics - FDA approves extension for ACCRUFeR® shieldtherapeutics.com ↗
ACCRUFeR® is now indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. |
| 2025-11-11 | Shield Therapeutics | Results Shield Therapeutics - ACCRUFeR Pediatric PK Results to be Presented shieldtherapeutics.com ↗
The PK profile in children and adolescents demonstrated ferric maltol's suitability for iron replacement in all age groups |
| 2025-11-07 | Shield Therapeutics | Regulatory Shield Therapeutics - ACCRUFeR receives Authorisation by Korean Ministry shieldtherapeutics.com ↗
Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company focused on addressing iron deficiency, is pleased to announce that the Korean Ministry of Food and Drug Safety (MFDS) has granted regulatory approval for ACCRUFeR® (Ferric Maltol) in the Republic of Korea (South Korea) for the treatment of iron deficiency in adult subjects. |
| 2025-10-01 | Shield Therapeutics | Results Shield Therapeutics - Positive efficacy and tolerance in pediatric trial shieldtherapeutics.com ↗
Clinically and statistically significant Hb improvements vs. baseline were observed across all groups (ferric maltol arms and ferrous sulfate arm (P<0.0001) |
| 2025-09-04 | Shield Therapeutics | Regulatory Shield Therapeutics - ACCRUFeR® assigned Priority Review in US by FDA shieldtherapeutics.com ↗
FDA has granted Priority Review for the supplement as it supports the extension of the label to a pediatric population based on a final agreed pediatric study report. |
| 2025-08-27 | Shield Therapeutics | Results Shield Therapeutics - Data published -European Journal of Heart Failure shieldtherapeutics.com ↗
Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces positive efficacy and safety results in the ORION-HF study showing improvements in haemoglobin and other iron markers, exercise capacity, and quality of life (QoL) in patients with heart failure (HF) and iron deficiency anemia (IDA), after 16 weeks of treatment with FeRACCRU® (ferric maltol). |
| 2024-09-25 | Shield Therapeutics | Results Shield Therapeutics - Results from Phase 3 paediatric study shieldtherapeutics.com ↗ |
| 2024-08-27 | Shield Therapeutics | Regulatory Shield Therapeutics - ACCRUFeR® Approved by Health Canada shieldtherapeutics.com ↗
Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company that delivers ACCRUFeR®/FeRACCRU® (ferric maltol), an innovative and differentiated specialty pharmaceutical product, to address a significant unmet need for patients suffering from iron deficiency (with or without anaemia), today announces that Health Canada has approved ACCRUFeR® (ferric maltol) as a prescription drug for the treatment of adults with iron deficiency anemia (IDA). |
| 2024-05-28 | Shield Therapeutics | Regulatory Shield Therapeutics - New Drug Application for Accrufer® in South Korea shieldtherapeutics.com ↗
Korea Pharma Co., Ltd (Korea Pharma) has submitted a New Drug Application (NDA) to the Korean Ministry of Food and Drug Safety (MFDS) for the review and approval of Accrufer® to treat patients with iron deficiency anaemia in Korea. |
| 2022-10-31 | Shield Therapeutics | Regulatory Shield Therapeutics - Republic of Korea update shieldtherapeutics.com ↗
We are delighted that the pathway to regulatory approval for commercialisation of Accrufer® in Korea has been established, and that our partner, Korea Pharma, is now ready to commence the study required to support the NDA submission. |
| 2022-10-27 | Shield Therapeutics | Regulatory Shield Therapeutics - Shelf-life for Accrufer® extended to 48 months shieldtherapeutics.com ↗ |
| 2022-07-14 | Shield Therapeutics | Regulatory Shield Therapeutics - New Drug Submission accepted by Health Canada shieldtherapeutics.com ↗ |
| 2022-03-21 | Shield Therapeutics | Regulatory Shield Therapeutics - KYE Pharmaceuticals Files Accrufer® NDS in Canada shieldtherapeutics.com ↗
KYE Pharmaceuticals Inc. ('KYE') has submitted a New Drug Submission ('NDS') to Health Canada for the regulatory review and approval of Accrufer®. |
| 2021-08-09 | Shield Therapeutics | Results Shield Therapeutics - AEGIS-CKD study results published in AJKD shieldtherapeutics.com ↗
Ferric maltol demonstrates statistically significant (16 weeks) and sustained (up to 52 weeks) increase in haemoglobin, compared to placebo, in subjects with chronic kidney disease (CKD) and iron deficiency anaemia (ID) |
All press releases naming this drug 27 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ferric maltol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05177484 ↗ |
| 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 ↗ |