XORTX starts clinical and commercial manufacturing for gout drug XORLO

XORTX Therapeutics announced on September 10, 2026 that it has begun production of drug material and tablet manufacturing to support the company's XRx-026 program for the treatment of gout.¹

The work is meant to supply a planned two-part clinical study of XORLO, the company's proprietary formulation of oxypurinol, a xanthine oxidase inhibitor.¹ XORTX said the study, known as XRX-OXY-102, follows earlier trial results the company described as favorable, and comes after discussions with the FDA.

According to the release, the two-part study will require GMP drug and clinical supply tablets meant to represent material intended for FDA marketing approval.¹ XORTX said contract production of pure oxypurinol drug substance, the active ingredient in XORLO, using its own proprietary synthetic pathway, has already begun.¹

The company also said it is now working with its contract manufacturing partner toward producing commercial-scale drug batches.¹ XORTX said the resulting validation and stability testing is meant to support a future FDA marketing submission, according to Co-CEO Allen Davidoff, who called the manufacturing work "a foundational step toward bringing XORLO to patients"¹ and said it "builds the validation and stability record that we expect will support our NDA filing."

XORTX said this manufacturing effort is one part of a broader plan to advance XRx-026 toward FDA marketing approval, and stated it expects to share further updates on its regulatory and clinical strategy in the coming weeks.¹

The company describes itself as having three clinically advanced products in development: the XRx-026 gout program, the XRx-008 program for ADPKD, and XRx-101 for acute kidney and other organ injury tied to respiratory virus infections.¹