Advicenne Submits FDA Registration Application for Sibnayal® in Rare Kidney Disease Treatment
Key Insights
Advicenne has submitted a registration application to the US FDA (search) for Sibnayal® (ADV7103), a fixed-dose combination of potassium citrate and potassium bicarbonate for treating distal renal tubular acidosis (search).
The FDA evaluation process is expected to take approximately 12 months, with the PDUFA date to be announced within weeks.
Sibnayal® has already received marketing approval in the EU and GB for dRTA treatment and has been designated as an orphan drug in the USA.
Advicenne, a Paris-based specialty pharmaceutical company focused on rare kidney diseases, has submitted its registration application to the US Food and Drug Administration (FDA) for Sibnayal® in the treatment of distal renal tubular acidosis (search) (dRTA). The November 4, 2025 submission marks a significant regulatory milestone for the company's lead product, which has already secured orphan drug designation in the United States.
Regulatory Timeline and Process
The FDA evaluation of the registration dossier is expected to take approximately 12 months. Advicenne anticipates receiving the Prescription Drug User Fee Act (PDUFA) date, which will specify the FDA's target decision timeline, within the coming weeks. The company has committed to providing updates on major evaluation milestones throughout the review process.
Clinical Foundation and Data Package
The registration application is built upon extensive clinical data from a pivotal European study that followed dRTA patients for more than six years. These long-term results were recently published in the Orphanet Journal of Rare Diseases, providing comprehensive clinical follow-up data that enhances understanding of the natural history of this rare disease.
The clinical dataset from this extended study forms the core of the clinical section of ADV7103's US registration dossier, demonstrating the drug's long-term safety and efficacy profile in treating dRTA patients.
Product Profile and Market Position
Sibnayal® is formulated as a fixed-dose combination of potassium citrate and potassium bicarbonate specifically designed for dRTA treatment. The product has already achieved significant regulatory success in international markets, having received marketing approval for distal renal tubular acidosis (search) in both the European Union and Great Britain.
Beyond its current dRTA indication, ADV7103 is advancing through late-stage development for cystinuria (search) treatment in Europe, as well as for both dRTA and cystinuria indications in the United States and Canada, potentially expanding its therapeutic applications across multiple rare kidney conditions.
Company Background
Founded in 2007, Advicenne specializes in developing innovative nephrology treatments for patients with rare kidney diseases. The company has been publicly traded since 2017, initially on Euronext Paris before transferring to Euronext Growth Paris in March 2022. Advicenne's focused approach on rare kidney diseases positions it as a specialized player in the orphan drug development space.