EUTEGRA has administered more than 200 treatments and advances towards new therapeutic indications.
The biological therapy based on human fecal microbiota, developed by Mikrobiomik and authorized in Spain under the European SoHO framework, has been used in more than 40 public and private hospitals.
EUTEGRA®, the biological therapy based on human fecal microbiota developed by Mikrobiomik, has surpassed 200 treatments administered, including its use in clinical development and hospital practice. It is currently indicated for the treatment of recurrent Clostridioides difficile infection (CDI), one of the leading causes of antibiotic-associated diarrhea.
In 2025, EUTEGRA became the first therapy of its kind to be authorized in Spain under the European framework for Substances of Human Origin (SoHO), following technical assessment by the Spanish National Transplant Organisation (ONT) and the SoHO Innovation Assessment Committee (CEI-SoHO).
Its clinical journey began with the Phase III ICD-01 trial, conducted at 21 hospitals in Spain. Subsequently, the therapy was made available to certain patients through compassionate use program, subject to authorization by the Spanish Agency of Medicines and Medical Devices (AEMPS). To date, healthcare professionals at more than 40 hospitals have used EUTEGRA, also known as MBK-01 during its development.
The therapy is manufactured through a standardized process encompassing donor selection and screening, microbiota processing, analytical quality controls and traceability from donor to patient.
“Clinical evidence, safety and traceability are fundamental to microbiota-based therapies. EUTEGRA brings these three elements together: clinical trials have demonstrated its efficacy and a favorable safety profile, and it follows a standardized process that ensures control from donor selection through to administration to the patient,” says Patricia del Río, Executive Director of Mikrobiomik.
Mikrobiomik is currently working with Spain’s autonomous communities to support the gradual introduction of EUTEGRA into hospitals within the Spanish National Health System. The company is also continuing to investigate its potential in other indications, with clinical trials in areas including recurrent diverticulitis, decompensated liver cirrhosis and immune-mediated colitis.
The clinical experience accumulated to date and ongoing research into new applications reflect Mikrobiomik’s commitment to developing microbiota-based therapies and generating clinical evidence to explore their potential in other conditions.
