Feraccru (ferric maltol) / Shield Therap - LARVOL DELTA

ACCRUFeR (ferric maltol) is now available in Canada as a prescription oral treatment for iron deficiency anemia (Canada Newswire) - "Kye Pharmaceuticals, Inc...announced today that ACCRUFeR (ferric maltol) is now available across Canada. ACCRUFeR is approved as a prescription medicine in Canada for adults with iron deficiency anemia (IDA) who are unresponsive or intolerant to other oral iron preparations."

Launch Canada • Anemia

ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure (ORION-HF) (clinicaltrials.gov) - P4 | N=50 | Completed | Sponsor: Hannover Medical School | Recruiting ➔ Completed

Trial completion • Anemia • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders

Exploring Ferric Maltol: A Promising Alternative to IV Iron for Managing Chronic Iron Deficiency Anaemia in Inflammatory Bowel Disease Patients (ECCO-IBD 2025) - "Only 23% of patients required IV iron, reducing the risk of adverse events, lowering costs, and avoiding the logistical challenges of hospital-based treatments. Feraccru should be considered as an option for IBD patients prior to referring for IV iron."

Clinical • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

FORTIS: 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 (clinicaltrials.gov) - P3 | N=65 | Completed | Sponsor: Shield Therapeutics | N=98 ➔ 65 | Recruiting ➔ Completed

Enrollment change • Trial completion • Anemia • Hematological Disorders

ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients With Heart Failure (ORION-HF) (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Hannover Medical School | Trial completion date: Oct 2024 ➔ Jan 2025 | Trial primary completion date: Sep 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Anemia • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders

The Importance and Essentiality of Natural and Synthetic Chelators in Medicine: Increased Prospects for the Effective Treatment of Iron Overload and Iron Deficiency. (PubMed, Int J Mol Sci) - "Similarly, the mainstay treatments of the most common diseases of iron metabolism, namely iron deficiency anaemia and iron overload, involve many iron-chelator complexes and the iron-chelating drugs deferiprone (L1), deferoxamine (DF) and deferasirox...Recent advances in the treatment of iron deficiency anaemia with effective iron complexes such as the ferric iron tri-maltol complex (feraccru or accrufer) and the effective treatment of transfusional iron overload using L1 and L1/DF combinations have decreased associated mortality and morbidity and also improved the quality of life of millions of patients. Many other chelating drugs such as ciclopirox, dexrazoxane and EDTA are used daily by millions of patients in other diseases. Similarly, many other drugs or their metabolites with iron-chelation capacity such as hydroxyurea, tetracyclines, anthracyclines and aspirin, as well as dietary molecules such as gallic acid, caffeic acid, quercetin, ellagic acid, maltol and many..."

Journal • Review • Alzheimer's Disease • CNS Disorders • Diabetic Nephropathy • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Movement Disorders • Nephrology • Oncology • Parkinson's Disease • Renal Disease

FORTIS: 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 (clinicaltrials.gov) - P3 | N=98 | Recruiting | Sponsor: Shield Therapeutics | Trial completion date: Sep 2023 ➔ Jul 2024 | Trial primary completion date: May 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders

Iron Uptake from Ferric Maltol in Patients with Iron Deficiency with or without Anemia: Post Hoc analysis of a Multicenter, Open-Label, Randomized, Phase 1 Clinical Study (ASH 2023) - "These data demonstrate similar iron uptake from ferric maltol in patients with iron deficiency with or without anemia. Given the adverse impact of iron deficiency, even without anemia, iron-replacement therapy should be considered in anyone with an indication of low iron availability (e. g."

Clinical • P1 data • Retrospective data • Alzheimer's Disease • Anemia • Cognitive Disorders • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Pain • Restless Legs Syndrome

Deferiprone and Iron-Maltol: Forty Years since Their Discovery and Insights into Their Drug Design, Development, Clinical Use and Future Prospects. (PubMed, Int J Mol Sci) - "The prospects of the application of these two drugs in many other diseases are discussed under the light of competing drugs from other academic and commercial centers and also different regulatory authorities. The underlying scientific and other strategies, as well as the many limitations in the present global scene of pharmaceuticals, are also highlighted, with an emphasis on the priorities for orphan drug and emergency medicine development, including the roles of the academic scientific community, pharmaceutical companies and patient organizations."

Journal • Review • Genetic Disorders • Hematological Disorders

PRIme: Predicting Response to Iron Supplementation in Patients With Inflammatory Bowel Disease During Induction Therapy (clinicaltrials.gov) - P4 | N=90 | Recruiting | Sponsor: Leiden University Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • IL6

Iron Maltol Versus Ferrous Sulphate in IBD-related Anemia: Does Choice of Iron Compound Make a Difference to Serum Hepcidin Levels? (AIBD 2022) - "Iron absorption capacity was determined in 2 oral absorption tests conducted 2 weeks apart: at the first visit, iron(II)-glycine-sulphate complex (Ferro sanol) was administered; at the second visit, patients received iron(III)-maltol (Feraccru); or vice-versa...Thirty patients with IBD were enrolled (17 f/13 m; 13 CD/17 UC; 37.6 ± 13.6 y). Of these, 5/30(%) had inflammatory disease activity. The first administration of both ferrous sulphate and iron maltol led to a significant increase in plasma iron compared to baseline (P < 0.001), regardless of the presence of inflammation."

Immunology • Inflammation • Inflammatory Bowel Disease • CRP

A Pooled Analysis of Early and Sustained Response in Patients With IBD With Iron Deficiency Anemia Who Were Treated With Ferric Maltol (ACG 2022) - "In 301/2, the mean age was 39.3 years and 65% were female; 55% had CD and 45% had UC. In 304 the mean age was 40.2 years and 58% were female; 62% had CD and 37% had UC. At Week 4, the 301/2 population (n=59) had a mean improvement in Hb from BL of 1.08 g/dL (95% confidence interval [CI], 0.91–1.25) and the 304 population (n=125) had a mean increase of 1.27 g/dL (95% CI, 1.10–1.44)."

Retrospective data • Anemia • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

"Ferric Maltol (Feraccru) can be given in the higher doses and has a significantly reduced side effect profile." (@Kyalimers)

Adverse events

ORAL IRON THERAPY WITH IRON MALTOL VERSUS FERROUS SULPHATE IN INFLAMMATORY BOWEL DISEASE: INTRA-INDIVIDUAL COMPARISON INDICATES LEVEL PEGGING ON INCREASE IN PLASMA HEPCIDIN LEVELS (UEGW 2022) - "To evaluate iron absorption capacity, patients took two oral absorption tests two weeks apart: at the first study visit, with iron(II)-glycine-sulphate complex (Ferro sanol®) and at the second visit, with iron(III)-maltol (Feraccru®), or vice-versa... Both ferrous sulphate and iron maltol resulted in an increase in plasma hepcidin levels, thus impairing iron absorption after the second daily dose. In IDA, the intake of oral iron supplements leads to an acute hepcidin increase for 24 hours - regardless of whether ferric(III) or ferrous(II) iron is ingested, and even if hepatic hepcidin expression is strongly suppressed by iron deficiency and erythropoietic drive. Alternate day dosing of oral iron supplements in anaemic IBD patients may be preferable."

Clinical • Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease

PRIme: Predicting Response to Iron Supplementation in Patients With Inflammatory Bowel Disease During Induction Therapy (clinicaltrials.gov) - P4 | N=90 | Not yet recruiting | Sponsor: Leiden University Medical Center

New P4 trial • Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • IL6

Predicting the effect of iron therapy in Inflammatory Bowel Disease Voorspellen van het effect van ijzerbehandeling bij ontstekingsziekten van de darmen (clinicaltrialsregister.eu) - P4 | N=90 | Ongoing | Sponsor: Leiden University Medical Center

New P4 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

FORTIS: 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 (clinicaltrials.gov) - P3; N=110; Recruiting; Sponsor: Shield Therapeutics

Clinical • New P3 trial • Anemia • Hematological Disorders

New Era in the Treatment of Iron Deficiency Anaemia Using Trimaltol Iron and Other Lipophilic Iron Chelator Complexes: Historical Perspectives of Discovery and Future Applications. (PubMed, Int J Mol Sci) - "Trimaltol iron, sold as Feraccru or Accrufer, was recently approved for clinical use in IDA patients in many countries, including the USA and in EU countries, and was shown to be effective and safe, with a better therapeutic index in comparison to other iron formulations...The interactions of the KHP iron complexes with natural chelators, drugs, metal ions, proteins, and other molecules appear to affect the pharmacological and metabolic effects of both iron and the KHP chelators. A new era in the treatment of IDA and other possible clinical applications, such as theranostic and anticancer formulations and metal radiotracers in diagnostic medicine, are envisaged from the introduction of maltol, KHP, and similar lipophilic chelators."

Journal • Review • Anemia • Hematological Disorders • Oncology

Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Shield Therapeutics

Clinical • New P1 trial • Anemia • Hematological Disorders