XORTX Therapeutics Advances XORLO Toward FDA New Drug Application as Gout Prevalence Projected to Surge

Gout, a painful form of inflammatory arthritis, is projected to rise significantly over the next 25 years, driven by aging populations, obesity, and lifestyle factors. In the U.S. alone, over 9 million people have been diagnosed with gout, while 44 million people have uric acid levels above the normal range, placing them at risk. Current treatments, primarily oral xanthine oxidase inhibitors, carry boxed warnings for cardiovascular risk and can cause severe gastrointestinal issues, kidney toxicity, and initial flare-ups, leading to poor patient adherence.

XORTX Therapeutics Inc. (NASDAQ: XRTX) is developing XORLO™, a proprietary formulation of oxypurinol designed to overcome these limitations. According to XORTX, XORLO uses a liposomal delivery system to enhance oral absorption, enabling lower daily doses and reducing toxic-level exposure and gastrointestinal side effects associated with high-dose traditional therapies. The company recently announcing the launch of drug material and tablet manufacturing to support a planned two-part clinical study, XRX-OXY-102, based on positive prior results and FDA discussions.

The two-part study will characterize the pharmacokinetics and efficacy of XORLO and produce GMP drug supply representative of commercial batches. Contract production of pure oxypurinol has begun, and XORTX is working toward a new drug application submission to the FDA. The company has prepared a new Investigational New Drug application for submission in the fourth quarter of 2026 and intends to file an NDA once the trial is complete, targeting a submission in about one year. XORTX estimates a $700 million annual market opportunity for XORLO.

“Our planned IND submission to the FDA next quarter is a defining step for the XRx-026 program,” said Allen Davidoff, Co-CEO of XORTX. “It reflects the strength of our prior clinical results and moves us closer to potentially offering gout patients a differentiated treatment option.”

The implications are significant. With gout prevalence rising and existing therapies often falling short due to tolerability issues, a better-tolerated, effective treatment could improve adherence and outcomes for millions. XORTX's progress toward an NDA positions it to potentially fill this gap, offering a new option for patients who cannot tolerate current standard-of-care medications. As the company advances manufacturing and regulatory milestones, its success could reshape the gout treatment landscape. This content was originally published on Benzinga. Read further disclosures here. View the original release on www.newmediawire.com.