11 completed, 2 terminated, 2 unknown, 1 recruiting. 8 Phase 3, 4 Phase 4, 2 Phase 1, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 7, Terminated 1 |
| Phase 4 | 4 | Completed 1, Recruiting 1, Terminated 1, Unknown 1 |
| Phase 1 | 2 | Completed 2 |
| Not applicable | 1 | Unknown 1 |
Follow ferric maltol: new trials by email Literature Review of ferric maltol trials Research Report on ferric maltol
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women Sucrosomial® Iron (Sideral® Forte), Ferric Maltol (Feraccru®) - Anemia, Iron Deficiency Anemia (IDA) | Phase 4 | Recruiting | Pharmanutra S.p.a. | 146 | 2025-12-11 | 2026-09-03 |
| Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults Oral Sucrosomial iron, Oral Ferric maltol - Iron Deficiency, Iron Deficiency Anemia | Not applicable | Unknown | Liaquat University of Medical & Health Sciences | 59 | 2023-07-17 | 2025-04-16 |
| ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure (ORION-HF) Ferric maltol 30 mg (Feraccru®) - Heart Failure, Left-sided, Anemia, Iron Deficiency | Phase 4 | Completed | Hannover Medical School | 50 | 2023-02-21 | 2025-03-07 |
| Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease Intravenous iron, Ferric maltol, Ferrous fumarate - Inflammatory Bowel Diseases, Iron-deficiency | Phase 4 | Unknown | Leiden University Medical Center | 90 | 2022-08-19 | 2023-03-31 |
| Perioperative Iron for Colorectal Cancer (PICoC Study) oral ferric maltol - Cancer Colon | Phase 3 | Completed | The Royal Wolverhampton Hospitals NHS Trust | 40 | 2022-05-30 | 2026-01-30 |
| Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years Ferric Maltol, Ferrous sulfate - Anemia, Iron-deficiency | Phase 3 | Completed | Shield Therapeutics | 65 | 2021-11-03 | 2025-11-10 |
| Safety and Efficacy Study of Ferric Maltol To Treat Iron Deficiency Anaemia in Chinese Patients With Inflammatory Bowel Disease Ferric Maltol, Placebo Oral Capsule - Iron Deficiency Anaemia | Phase 3 | Completed | Jiangsu Aosaikang Pharmaceutical Co., Ltd. | 122 | 2021-09-01 | 2026-07-31 |
| Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers Ferric maltol capsule, Ferric maltol suspension - Anemia, Iron Deficiency | Phase 1 | Completed | Shield Therapeutics | 32 | 2020-09-28 | 2025-08-24 |
| ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices Ferric maltol 30 mg (Feraccru®) - Heart Failure, Left Sided, Anemia, Iron Deficiency | Phase 4 | Terminated | Hannover Medical School | 11 | 2019-03-18 | 2020-04-21 |
| ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1) Ferric maltol 30 mg (Feraccru®) - Hypertension, Pulmonary, Anemia, Iron Deficiency | Phase 3 | Terminated | Hannover Medical School | 22 | 2018-03-27 | 2020-04-21 |
| EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations Iron Supplement - Iron-deficiency | Completed | GWT-TUD GmbH | 51 | 2018-01-16 | 2019-07-02 | |
| Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency Ferric Maltol - Iron Deficiency, Anaemia in Children, Iron-Deficiency | Phase 1 | Completed | Shield Therapeutics | 37 | 2017-03-14 | 2021-10-06 |
| Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease Ferric maltol, Placebo - Renal Insufficiency, Chronic, Iron-Deficiency Anemia | Phase 3 | Completed | Shield Therapeutics | 167 | 2016-12-01 | 2020-11-02 |
| Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD Ferric Maltol, Ferric Carboxy Maltose - Anemia, Iron-Deficiency, Inflammatory Bowel Disease | Phase 3 | Completed | Shield Therapeutics | 250 | 2016-01-01 | 2020-11-02 |
| Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2) ST10, Placebo oral capsule - Iron Deficiency Anaemia, Inflammatory Bowel Disease | Phase 3 | Completed | Shield Therapeutics | 128 | 2011-08-01 | 2020-10-30 |
| Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1) ST10-021, Placebo Comparator - Iron Deficiency Anaemia, Inflammatory Bowel Disease | Phase 3 | Completed | Shield Therapeutics | 128 | 2011-08-01 | 2020-10-30 |
Anemia, Iron-Deficiency (15) · Iron Deficiencies (10) · Anemia (5) · Inflammatory Bowel Diseases (4) · Crohn Disease (3) · Colitis, Ulcerative (2) · Heart Failure (2) · Colonic Neoplasms (1) · Deficiency Diseases (1) · Hypertension, Pulmonary (1) · Intestinal Diseases (1) · Renal Insufficiency, Chronic (1)
Shield Therapeutics (7) · Hannover Medical School (3) · GWT-TUD GmbH (1) · Jiangsu Aosaikang Pharmaceutical Co., Ltd. (1) · Leiden University Medical Center (1) · Liaquat University of Medical & Health Sciences (1) · Pharmanutra S.p.a. (1) · The Royal Wolverhampton Hospitals NHS Trust (1)
Germany (5) · United States (4) · United Kingdom (3) · Spain (2) · Belgium (1) · China (1) · France (1) · Hungary (1) · Netherlands (1) · Pakistan (1) · Puerto Rico (1)
Nicholas Mallard, PhD (2) · David Pittrow, MD, PhD (1) · Jackie Mitchell, DPhil (1) · Jackie Mitchell, PhD (1) · Jan Schmitto, Prof. MD (1) · Johann Bauersachs, Prof. Dr. (1) · Marius Hoeper, Prof. Dr. (1) · Mark Sampson, MBChB (1) · Nuha Yassin (1) · Stefan Schreiber, MD, PhD (1)
PMID 25545376, PMID 27237709, PMID 32444411, PMID 34029682, PMID 38296290, PMID 42261111
2025 (1)