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.49

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:24,38,49,51,63

  • Obesity and diabetes
  • Chronic kidney disease
  • Hypertension and cardiovascular disease
  • Gastrointestinal disorders
  • Lung disease
  • Autoimmune diseases
  • Cancer
ROS formation

Traditional iron treatments can worsen inflammation

Ferrous salts contribute to reactive oxygen species (ROS), heightening systemic inflammation risk.3,6

The ACCRUFeR impact

ACCRUFeR® (ferric maltol) is backed by three pivotal studies demonstrating efficacy in patients with ID/IDA and chronic inflammation.2 ACCRUFeR’s MALTOL SHIELD™ makes the difference, achieving the following benefits for patients with inflammation and malabsorption:

MALTOL SHIELD(TM) closed: Protects iron from oxidizing in the stomach MALTOL SHIELD (TM) opened: Releases iron only when ready for absorption in the small intestine Unused ACCRUFeR excreted: Stays protected, helping patients avoid free iron and irritation

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.2,6

4.6% of patients taking ACCRUFeR (n=175) discontinued treatment due to adverse GI reactions, compared with 2.5% of patients taking a placebo (n=120).2,7

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),2 inflammatory bowel disease (IBD),2 pulmonary hypertension (PH),51 and congestive heart failure (CHF).50

Hispanic man in front of a yellow background

*Not actual patient.

ID/IDA Patients with CKD2

Endpoint ACCRUFeR Placebo

Primary: Hb g/dL
LS mean (SE) change at Week 16

+0.50 (0.12)
Baseline (BL): 10.06 (0.77)

-0.02 (0.16)
BL: 10.03 (0.82)

Secondary: TSAT % 
LS mean (SE) change at Week 16

+3.8 (0.6)
BL: 15.7 (6.4)

-0.9 (0.9)
BL: 15.6 (5.9)

Study Description:2

  • 16-week, pivotal Phase 3 trial
  • 167 adults with IDA and Stage 3 or 4 CKD
  • Excluded patients taking erythropoiesis-stimulating agents
Woman smiling in front of a red background

*Not actual patient.

ID/IDA Patients with IBD2

Endpoint ACCRUFeR Placebo

Primary: Hb g/dL 
Primary LS mean (SE) change at Week 12

+2.25 (0.12)
BL: 11.0 (1.03)

+0.06 (0.13)
BL: 11.1 (0.85)

Secondary: TSAT %
Mean (SD) change at Week 12

+18.0 (20.2)
BL: 10.6 (11.7)

-0.4 (7.8) 
BL: 9.5 (7.5)

Study Description:2

  • 12-week, pivotal Phase 3 trial
  • 128 adults with ID/IDA and IBD
  • All patients had previously failed treatment with an oral ferrous salt
Older Hispanic woman featured in front of a yellow background

*Not actual patient.

ID/IDA Patients with PH51

Endpoint ACCRUFeR Placebo

Primary: Hb g/dL 
Median (interquartile range) at Week 16

12.8 (11.8 – 13.8)
BL: 11.4 (10.9 – 11.9)

N/A

Secondary: TSAT %
Median (interquartile range) at Week 16

29 (22 – 37)
BL: 14 (8 – 19)

N/A

Study Description:51

  • 12-week, open-label exploratory study
  • 20 adults with IDA and PH
Black man in front of a red background

*Not actual patient.

ID/IDA Patients with CHF50

Endpoint ACCRUFeR Placebo

Primary: Hb g/dL 
Median (interquartile range) at Week 16

12.8 (11.8 – 13.8)
BL: 11.4 (10.9 – 11.9)

N/A

Secondary: TSAT %
Median (interquartile range) at Week 16

29 (22 – 37)
BL: 14 (8 – 19)

N/A

Study Description:50

  • 16-week, open-label exploratory study
  • 41 adults with IDA and CHF

About ACCRUFeR

See how ACCRUFeR's MALTOL SHIELDTM helps minimize the risk of gastrointestinal side effects.2-4

Established Safety and Efficacy

ACCRUFeR is backed by a robust clinical profile. It has demonstrated both short- and long-term efficacy across three pivotal clinical studies.

References:
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
6. Pergola PE, Kopyt NP. Oral ferric maltol for the treatment of iron-deficiency anemia in patients with CKD: a randomized trial and open-label extension [published online ahead of print, May 21, 2021]. Am J Kidney Dis. 2021;S0272-6386(21)00624-7.
7. Data on file. Shield Therapeutics Inc. 2019.
24. Cappellini MD, Musallam KM, Taher AT. Iron deficiency anaemia revisited. J Intern Med. 2020;287(2):153-170. doi:10.1111/joim.13004
38. Kaitha S, Bashir M, Ali T. Iron deficiency anemia in inflammatory bowel disease. World J Gastrointest Pathophysiol. 2015;6(3):62-72. doi:10.4291/wjgp.v6.i3.62
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.
54. Data on File. Shield Therapeutics Inc. 2015
63. Busti F, Marchi G, Ugolini S, Castagna A, Girelli D. Anemia and Iron Deficiency in Cancer Patients: Role of Iron Replacement Therapy. Pharmaceuticals (Basel). 2018 Sep 30;11(4):94. doi: 10.3390/ph11040094. PMID: 30274354; PMCID: PMC6315653.