XORTX Announces Receipt of FDA Orphan Drug Designation for ADPKD Treatment
On April 21, 2023, XORTX Therapeutics Inc., a clinical-stage biopharmaceutical company, announced that it has received the Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate XRx-101 for the treatment of autosomal dominant polycystic kidney disease (ADPKD). This designation is given to drugs that are intended to treat rare diseases or disorders affecting fewer than 200,000 people in the United States.
ADPKD is a genetic disorder characterized by the growth of cysts in the kidneys, which can lead to kidney failure and other serious complications. Currently, there are limited treatment options for ADPKD, and XRx-101 has shown promising results in preclinical studies.
The Orphan Drug Designation provides XORTX Therapeutics with various benefits, including tax credits for clinical research costs, waiver of certain FDA fees, and a period of market exclusivity upon regulatory approval. This designation is a significant milestone for XORTX Therapeutics and underscores the company’s commitment to developing innovative therapies for rare and serious diseases.
XORTX is a pharmaceutical company developing two clinically advanced products: 1) our lead program, XRx-008, for ADPKD, and 2) our secondary program, XRx-101, for acute kidney and other acute organ injury associated with Coronavirus / COVID-19 infection.
XRx-225 is also a pre-clinical stage program for Type 2 Diabetic Nephropathy. XORTX is working to advance the clinical development stage of its products that target abnormal purine metabolism and xanthine oxidase to reduce or inhibit uric acid production. At XORTX, we are committed to developing medications that will improve patients’ quality of life and future health.
For more information, please visit: XORTX’s ADPKD Treatment
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