(Potassium bicarbonate + potassium citrate) PR is under clinical development by Advicenne and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect (Potassium bicarbonate + potassium citrate) PR’s likelihood of approval (LoA) and phase transition for Kidney Disease (Nephropathy) took place on 06 May 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their (Potassium bicarbonate + potassium citrate) PR Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
(Potassium bicarbonate + potassium citrate) PR overview
Potassium citrate and potassium bicarbonate (Sibnayal) is a fixed dose combination, acts as an alkalizing and anti-urolithic agent. It is formulated as prolonged release granules for oral route of administration. Sibnayal is indicated for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older.
Potassium citrate and potassium bicarbonate combination (ADV-7103) is under development for the treatment of renal tubulopathy including cystinuria, distal renal tubular acidosis. The drug candidate is administered orally. ADV7103 is an innovative formula presented as micro-tablets.
Advicenne is a pharmaceutical company. It develops and provides pediatric products for rare diseases. The company offers product portfolio such as ADV6209, a liquid formulation of a benzodiazepine for moderate sedation and anesthetic premedication; ADV7103, a formulation in the form of micro-tablets for renal tubulopathies. It provides its products for the treatment of neurological diseases and renal disorders in children. Advicenne also offers products for the treatment epilepsy, anesthesia and dystonia. The company offers clinical research services by using statistical tools, approaches of meta-analysis and data modeling and simulation, among others. It works in partnership with other pharmaceutical companies. The company operates through its offices in Montbonnot and Paris. Advicenne is headquartered in Nimes, France.
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