J & D Pharmaceuticals LLC Receives Orphan Drug Designation for Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

MONMOUTH, N.J., Sept. 18, 2025 /PRNewswire/ -- J & D Pharmaceuticals LLC has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's investigational therapy, JD-004, for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD), a rare and life-threatening genetic disorder that affects approximately 600,000 individuals in the United States.

ADPKD is characterized by the progressive development of numerous fluid-filled cysts in the kidneys, often leading to kidney failure and the need for dialysis or transplantation. Despite being one of the most common inherited kidney diseases, effective therapeutic options remain limited.

"Receiving Orphan Drug Designation is a significant milestone for J & D Pharmaceuticals," said Lenard Lichtenberger, PhD, Chief Scientific Officer. "This designation underscores the urgent need for innovative therapies for ADPKD patients and strengthens our commitment to developing solutions that can transform the lives of those affected by this debilitating condition."

J & D Pharmaceuticals plans to advance its ADPKD program into clinical development and will continue working closely with the FDA and the nephrology community to accelerate progress toward delivering an anti-inflammatory treatment option to patients in need. JD-004 has been safely tested in patients with osteoarthritis and rheumatoid arthritis.

About J & D Pharmaceuticals LLC
J & D Pharmaceuticals LLC is a biopharmaceutical company dedicated to developing therapies for inflammatory disease including common and rare diseases. The company's mission is to discover, rediscover, develop and deliver safe and effective therapies for serious diseases. For more information, please visit: https://jdpharmaceuticals.com/ 

Michael Murphy
Business Development Lead
J & D Pharmaceuticals LLC
732 859 9829
[email protected] 

SOURCE J & D Pharmaceuticals LLC