AVEROA Receives UK MHRA Approval for XOANACYL®, an Oral Therapy Targeting Key Complications of Chronic Kidney Disease (CKD)

• The MHRA (Medicines and Healthcare products Regulatory Agency) granted UK Marketing Authorisation for XOANACYL via the International Recognition Procedure (Route B) recognising its prior EU approval (June 2025)

• XOANACYL is an oral therapy designed to address two major unmet needs in CKD - Iron deficiency and elevated serum phosphorus – in a single drug

• AVEROA is now actively engaging strategic partners and investors to accelerate European market access and unlock XOANACYL’s full commercial potential

Grenoble, France, 05 November 2025 - Averoa, a biopharmaceutical company bringing innovative therapeutic solutions to people with renal diseases, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorization for XOANACYL, an oral therapy for the treatment of two complications of Chronic Kidney Disease (CKD). The authorisation was granted under the International Recognition Procedure (Route B), following the product’s European Marketing Authorisation received in June 2025. With regulatory authorisations now in both the EU and UK, XOANACYL is currently the only approved treatment for concomitant elevated serum phosphorus and iron deficiency in adult patients with CKD - a significant unmet need in the European market.

Luc-André Granier, President and Medical Director at Averoa, said: “Receiving MHRA approval is a major milestone for Averoa and excellent news for one of the most important healthcare markets in Europe. With this authorisation, 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 key opinion leaders who are 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 common and co-occurring complications in adult patients with chronic kidney disease (CKD): iron deficiency and elevated serum phosphorus levels. Its novel mechanism of action allows for effective ferric iron supplementation while simultaneously reducing phosphorus absorption, helping to simplify treatment regimens and improve outcomes for patients with CKD.

By combining iron-replenishing and phosphate-binding mechanisms in a single oral drug, XOANACYL offers a multi-factor approach and has the potential to reduce treatment complexity, improve adherence and enhance quality of life for millions of CKD patients.

Prof. Francesco Locatelli, Head of Nephrology and Dialysis at A. Manzoni Hospital, Lecco, added: "Xoanacyl can deliver effective IDA therapy in these patients as well as allow for early intervention in managing hyperphosphataemia to prevent later complications of ‘mineral bone disease’ in CKD patients, including secondary hyperparathyroidism with the associate risk of bone fractures and cardiovascular calcifications heavily affecting patients' survival.”

In the UK, more than 3 million people are estimated to be living with CKD, and across Europe, more than 10 million CKD patients suffer from iron deficiency and phosphate dysregulation - two under-treated complications that drive disease progression and poor outcomes. Oral iron therapies are often ineffective while elevated serum phosphate is often addressed only at advanced CKD stages, despite phosphate dysregulation being detectable much earlier in the disease. If not appropriately treated, these complications significantly worsen clinical outcomes, contributing to vascular calcification, cardiovascular disease and increased mortality. XOANACYL offers a novel opportunity to address both complications earlier and more effectively.

For background on the European authorisation, see Averoa’s EU Marketing Authorisation announcement (June 2025).

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About CKD
Chronic Kidney Disease (CKD) describes the gradual loss of kidney function. It is a major public health problem resulting in an important burden for patients and healthcare systems. It affects millions of people with an estimated prevalence ranging from 3% to 17% in Europe. It is one of the ten leading causes of death in developed countries and can be due to multiple causes, including: high blood pressure, diabetes, high cholesterol, kidney infections, glomerulonephritis, polycystic kidney disease, genetic conditions, autoimmune diseases, kidney stones, smoking, age, and use of certain medicines.

CKD induces two common debilitating disorders, Iron Deficiency Anemia (IDA) and Mineral Bone Disorders (MBD) which in turn are linked to an increase of FGF23 as a compensatory mechanism. Depending on the stage of the disease, CKD can induce cardiovascular diseases. CKD can progress to end-stage kidney failure, which is fatal without dialysis or a kidney transplant.

About XOANACYL®
Akebia Therapeutics granted to Averoa an exclusive license to develop and commercialize XOANACYL® in the European Economic Area, Switzerland, the United Kingdom, Turkey, Israel and additional selected countries in eastern Europe.

Ferric citrate has been approved and is being commercialized in different regions: in the United States (US) under the brand name Auryxia® (ferric citrate) by Akebia Therapeutics, Inc.; in Japan as Riona® (ferric citrate hydrate) by Japan Tobacco Inc.; in Taiwan as Nephoxil® by Panion & BF Biotech Inc.; and in South Korea as Nephoxil® by Kyowa Kirin Korea Co. Ltd.

About Averoa
Averoa is a biopharmaceutical company, founded in December 2021, bringing innovative therapeutic solutions to people with renal diseases. Averoa’s goal is to build, advance and commercialize a strong pipeline of products to meet significant unmet medical needs of patients with kidney or metabolic diseases.

More information is available on our website www.averoa-pharma.org and on our LinkedIn page

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