ADV7103 is a combination product of potassium bicarbonate + potassium citrate extended release (i.e. the drug is released slowly over time). It is intended to treat distal renal tubular acidosis (dRTA) in adults, adolescents and children aged 6 months and older. DRTA disease occurs when the kidneys do not properly remove acids from the blood into the urine. As a result, too much acid remains in the blood (called acidosis). It can lead to many health problems and can vary in severity. Currently there are no approved treatments specifically for this condition.
ADV7103 is an innovative product with a prolonged-release formulation, designed to maintain sustained release over a twelve-hour period for dRTA treatment. As the combination is alkaline (pH greater than 7) and contains potassium, it is expected to neutralise excess acid in the blood and restore levels of potassium. The product was developed as a multi particulate formulation in 2mm granules that contains two active pharmaceutical ingredients. Bicarbonate + potassium citrate is tasteless and easy to administer, in small-size format that offer flexible, personalized dosing which makes it easier to take for patients of all ages. The ability of ADV7103 to normalize biological disorders caused by dRTA throughout the course of treatment has been shown in a Phase III extension study. If licensed, ADV7103 will offer a potentially curative treatment option for patients with dRTA, who currently have few approved therapies available.