AVEROA Secures UK MHRA Approval For XOANACYL®, A First-In-Class Oral Therapy Designed To Treat Major Complications Of Chronic Kidney Disease (CKD)

Averoa, a biopharmaceutical company dedicated to developing innovative therapeutic solutions for people with renal diseases, has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorization for XOANACYL, an oral therapy designed to treat two complications of Chronic Kidney Disease (CKD). The authorization was granted under the International Recognition Procedure (Route B) and follows XOANACYL’s European Marketing Authorization, which was received in June 2025. With approvals now secured in both the European Union and the United Kingdom, XOANACYL becomes the only approved treatment in Europe for adult CKD patients suffering from both elevated serum phosphorus and iron deficiency—two co-existing and often under-treated conditions.

Luc-André Granier, President and Medical Director at Averoa, highlighted the importance of this development, stating, “Receiving MHRA approval is a major milestone for Averoa and excellent news for one of the most important healthcare markets in Europe. With this authorization, we have now completed our European regulatory footprint—the UK approval marks the final major territory needed to bring XOANACYL to patients across Europe. The UK is a strategically significant market, and we are already seeing strong interest from leading nephrology experts eager to make it available to their patients. We remain committed to working with strategic partners to accelerate market access and unlock the full commercial potential of XOANACYL.”

XOANACYL (Ferric Citrate as Coordination Complex) is a single oral therapy that addresses two key and often co-occurring complications in adult CKD patients—iron deficiency and elevated serum phosphorus levels. Its unique mechanism of action enables it to effectively replenish ferric iron while simultaneously reducing phosphorus absorption. This dual functionality helps simplify treatment regimens and supports better disease management for CKD patients. By combining iron-replenishing and phosphate-binding properties in one oral medication, XOANACYL provides a multi-targeted approach that can improve treatment adherence, reduce therapy complexity, and enhance the quality of life for millions of individuals affected by CKD.

Professor Francesco Locatelli, Head of Nephrology and Dialysis at A. Manzoni Hospital in Lecco, emphasized the clinical potential of XOANACYL, stating that it can deliver effective iron deficiency anemia therapy while enabling early management of hyperphosphatemia. This early intervention can help prevent complications such as mineral bone disease, secondary hyperparathyroidism, bone fractures, and cardiovascular calcifications—all of which significantly affect CKD patients’ survival.

In the United Kingdom, it is estimated that over 3 million people are living with CKD, while across Europe, more than 10 million patients face the combined challenges of iron deficiency and phosphate imbalance. These complications are often inadequately treated—oral iron therapies frequently prove ineffective, and phosphate dysregulation tends to be addressed only in advanced stages of CKD, despite being detectable much earlier. 

If left unmanaged, these conditions accelerate disease progression and increase the risk of vascular calcification, cardiovascular disease, and mortality. With XOANACYL’s innovative dual-action therapy, Averoa offers a promising new approach to address these complications more effectively and improve outcomes for CKD patients across Europe.