Iron Deficiency and Inflammation
For patients with chronic inflammatory conditions, iron deficiency (ID) and iron deficiency anemia (IDA) can increase hospitalizations and contribute to higher rates of illness and death.53
A Comorbid Cycle That Compounds Patient Risk
Inflammation and ID are comorbidities that can create a harmful cycle where each condition worsens the other. When the body experiences inflammation, it systematically reduces iron levels. Conversely, ID can aggravate existing inflammatory diseases.49
Patients with the following conditions are at an increased risk of ID/IDA:
- Obesity and diabetes
- Chronic kidney disease
- Hypertension and cardiovascular disease
- Gastrointestinal disorders
- Lung disease
- Autoimmune diseases
- Cancer
Ferrous salts contribute to reactive oxygen species (ROS), heightening systemic inflammation risk.3,6,62
The ACCRUFeR Impact
ACCRUFeR® (ferric maltol) is backed by three pivotal studies demonstrating efficacy in patients with ID/IDA and chronic inflammation.
ACCRUFeR’s MALTOL SHIELD™ makes the difference, achieving the following benefits for patients with inflammation and malabsorption:
ACCRUFeR’s MALTOL SHIELDTM stays intact in the stomach, dissociating when it reaches the duodenum for optimal iron absorption, even in patients with inflammatory conditions.2
4.6% of patients taking ACCRUFeR (n=175) discontinued treatment due to adverse reactions, compared with 2.5% of patients taking a placebo (n=120).2,61
Clinical studies demonstrated that 86% of patients treated with ACCRUFeR maintained hemoglobin levels within the normal range for up to 64 weeks.1,2
In the 12-week double-blind phase of trials with patients with IBD, ACCRUFeR did not demonstrate worsening of inflammation.5,54
Proven Efficacy Across Co-Conditions
In clinical trials, ACCRUFeR demonstrated efficacy in treating ID/IDA, even in patients with serious, late-stage inflammatory conditions, including chronic kidney disease (CKD), inflammatory bowel disease (IBD), pulmonary hypertension (PH), and congestive heart failure (CHF).1,2,5,6,50,51
*Not actual patient.
ID/IDA Patients with CKD
| ACCRUFeR | Placebo | Endpoint |
|---|---|---|
|
+0.50 (0.12) |
-0.02 (0.16) |
Primary: |
|
+3.8 (0.6) |
0.9 (0.9) |
Secondary: |
Study Description:2,50
- 16-week, pivotal Phase 3 trial
- 167 adults with IDA and Stage 3 or 4 CKD
- Excluded patients taking erythropoiesis-stimulating agents
*Not actual patient.
ID/IDA Patients with IBD
| ACCRUFeR | Placebo | Endpoint |
|---|---|---|
|
+2.25 (0.12) |
+0.06 (0.13) |
Primary: |
|
+18.0 (20.2) |
-0.4 (7.8) |
Secondary: |
Study Description:2,62
- 12-week, pivotal Phase 3 trial
- 128 adults with ID/IDA and IBD
- All patients had previously failed treatment with an oral ferrous salt
*Not actual patient.
ID/IDA Patients with PH
| ACCRUFeR | Placebo | Endpoint |
|---|---|---|
|
12.8 (11.8 – 13.8) |
N/A |
Primary: |
|
29 (22 – 37) |
N/A |
Secondary: |
Study Description:51
- 12-week, open-label exploratory study
- 22 adults with IDA and PH
*Not actual patient.
ID/IDA Patients with CHF
| ACCRUFeR | Placebo | Endpoint |
|---|---|---|
|
12.8 (11.8 – 13.8) |
N/A |
Primary: |
|
29 (22 – 37) |
N/A |
Secondary: |
Study Description:51
- 16-week, open-label exploratory study
- 50 adults with IDA and CHF
References:
1. Schmidt C, Ahmad T, Tulassay Z, et al. Ferric maltol therapy for iron deficiency anaemia in patients with inflammatory bowel disease: long-term extension data from a phase 3 study. Aliment Pharmacol Ther. 2016;44(3):259-270. doi:10.1111/apt.13665
2. ACCRUFeR® full prescribing information. Shield Therapeutics, 2025.
3. Stallmach A, Büning C. Ferric maltol (ST10): a novel oral iron supplement for the treatment of iron deficiency anemia in inflammatory bowel disease. Expert Opin Pharmacother. 2015;16(18):2859-2867. doi:10.1517/14656566.2015.1096929
4. European Medicines Agency. Accessed March 17, 2021. https://www.ema.europa.eu/en/documents/variation-report/feraccru-h-c-2733-ii-0010-epar-assessment-report-variation_en.pdf
5. Gasche C, Ahmad T, Tulassay Z, et al. Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program. Inflamm Bowel Dis. 2015;21(3):579-588. doi:10.1097/mib.0000000000000314
49. Cappellini MD, Comin-Colet J, de Francisco A, et al. IRON CORE Group. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management. Am J Hematol. 2017 Oct;92(10):1068- 1078. doi: 10.1002/ajh.24820. Epub 2017 Jul 7. PMID: 28612425; PMCID: PMC5599965.
50. Kempf T, Geller W, Fuge J, et al. Oral ferric maltol improves iron deficiency anaemia in patients with chronic heart failure. Eur J Heart Fail 2025. https://doi.org/10.1002/ ejhf.3789
51. Olsson K, Fuge J, Brod T, et al. Oral iron supplementation with ferric maltol in patients with pulmonary hypertension. Eur Respir J. Nov 2020. 12;56(5): 2000616.
53. Quatredeniers M, Mendes-Ferreira P, Santos-Ribeiro D, et al. Iron deficiency in pulmonary arterial hypertension: A deep dive into the mechanisms. Cells. 2021;10(2) 477. https://doi.org/10.3390/cells10020477