Xoanacyl
Authorised
This medicine is authorised for use in the European Union
ferric citrate coordination complex
Medicine
Human
Authorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Xoanacyl is a medicine used to treat high levels of phosphate in the blood and iron deficiency (lack of iron) in adults with chronic kidney disease.
Xoanacyl contains the active substance ferric citrate coordination complex.
Xoanacyl is available as tablets to be taken by mouth three times a day with or immediately after meals.
Xoanacyl can only be obtained with a prescription and it should be started under the supervision of a doctor experienced in treating patients with kidney disease.
For more information about using Xoanacyl, see the package leaflet or contact your doctor or pharmacist.
Patients with chronic kidney disease have difficulty removing phosphate from their body and may also have low levels of iron. The active substance in Xoanacyl, ferric citrate coordination complex, contains iron. When taken by mouth, part of the iron is absorbed by the cells in the gut. The iron then enters the bloodstream and is taken to cells that store or use iron. The iron that is not absorbed binds to phosphate from food in the gut, forming a compound that is then eliminated in the stools. As a result, Xoanacyl helps to restore normal levels of iron and keep down phosphate levels in the blood.
Two main studies compared Xoanacyl with placebo (a dummy treatment) in adults with chronic kidney disease who did not need dialysis. Dialysis is a technique for removing unwanted substances and excess fluid from the blood when the kidneys do not work well enough.
In the first study involving 149 patients with iron deficiency and high levels of phosphate in the blood, the amount of iron stored in the body (measured as transferrin saturation) after 12 weeks of treatment increased by around 10% in people treated with Xoanacyl and decreased by around 1% in those given placebo. At the same time, phosphate levels in the blood decreased by 0.7 mg/dl in patients given Xoanacyl compared with 0.2 mg/dl in those given placebo.
In the second study involving 234 patients mainly with iron deficiency, the level of haemoglobin (the protein in red blood cells that carries oxygen around the body) increased by at least 1 g/dl at any point during 16 weeks of treatment in around 52% of patients given Xoanacyl (61 out of 117) compared with around 19% of those given placebo (22 out of 115).
A third main study involved 441 adults with chronic kidney disease who needed dialysis and had high levels of phosphate in the blood. Xoanacyl was at least as effective at reducing phosphate levels in the blood after 12 weeks of treatment as sevelamer carbonate (another medicine used to lower phosphate levels in the blood), with a reduction of around 2.0 mg/dl with Xoanacyl and 2.2 mg/dl with sevelamer carbonate.
For the full list of side effects and restrictions with Xoanacyl, see the package leaflet.
The most common side effects with Xoanacyl (which may affect more than 1 in 10 people) include diarrhoea and discoloured stools.
Xoanacyl must not be used in patients who have an active severe stomach or intestinal disorder or conditions that lead to iron accumulation in the body such as haemochromatosis (an inherited condition in which iron builds up gradually in the body and can cause damage to joints and organs).
The Agency considered that Xoanacyl is effective at reducing phosphate levels in the blood of adults with chronic kidney disease and that it also has a positive effect on iron deficiency. The safety profile of Xoanacyl is manageable.
The European Medicines Agency therefore decided that Xoanacyl’s benefits are greater than its risks and that it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xoanacyl have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Xoanacyl are continuously monitored. Suspected side effects reported with Xoanacyl are carefully evaluated and any necessary action taken to protect patients.
Xoanacyl received a marketing authorisation valid throughout the EU on 11 June 2025.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Xoanacyl
- Active substance
- ferric citrate coordination complex
- International non-proprietary name (INN) or common name
- ferric citrate coordination complex
- Therapeutic area (MeSH)
- Iron Deficiencies
- Renal Insufficiency, Chronic
- Hyperphosphatemia
- Anatomical therapeutic chemical (ATC) code
- V03AE08
Pharmacotherapeutic group
All other therapeutic productsTherapeutic indication
Xoanacyl is indicated for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).
News on Xoanacyl
This page was last updated on