Gout, a painful form of inflammatory arthritis, is set to become far more common in the coming decades. According to projections, the number of cases globally is expected to rise significantly over the next twenty-five years, driven by aging populations, obesity, and lifestyle factors. In the United States alone, over 9 million people have already been diagnosed with gout, and an even larger group—44 million people—have uric acid levels above the normal range, putting them at risk for developing the disease.
Current treatments for gout, while effective for some, are far from ideal. Oral xanthine oxidase inhibitors are the standard of care, but approximately 3% to 5% of patients cannot tolerate them, and they carry boxed warnings for cardiovascular risk. Other medications can cause severe gastrointestinal issues, kidney toxicity, and even trigger more gout flare-ups initially, making patient adherence difficult. This leaves a significant unmet need for better-tolerated therapies that can effectively lower uric acid levels over the long term.
XORTX Therapeutics Inc. (NASDAQ: XRTX), a late-stage clinical pharmaceutical company, is aiming to fill that gap with its proprietary formulation XORLO™. The company reports that XORLO, a formulation of oxypurinol, overcomes the historically poor oral absorption of the drug by using a liposomal delivery system. This allows for high bioavailability and rapid absorption, enabling effective uric acid suppression at substantially lower total daily doses. As a result, XORLO may minimize the toxic-level exposure and severe gastrointestinal side effects associated with high-dose traditional therapies. Investors and patients can follow the company’s progress through resources like XORTX.
XORTX is making tangible strides toward bringing XORLO to market. The company recently announcing the launch of drug material and tablet manufacturing to support a planned two-part clinical study, XRX-OXY-102. This study is based on positive prior clinical results and discussions with the FDA. Contract production of pure oxypurinol, the active ingredient in XORLO, has already begun using XORTX’s proprietary synthetic pathway, and the company is now working with its manufacturing partner to produce commercial drug batches.
Regulatory progress is also underway. XORTX is working toward a new drug application submission to the FDA for XORLO. The company has prepared a new Investigational New Drug (IND) application for submission in the fourth quarter of 2026, describing its clinical development plan. Once the two-part clinical trial is complete, XORTX intends to file a New Drug Application (NDA) with the FDA, targeting a submission in about one year. If successful, XORLO could address a market opportunity estimated at $700 million annually.
“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.”
As gout prevalence climbs, the need for safer, more tolerable treatments becomes increasingly urgent. XORTX’s efforts with XORLO represent a potential breakthrough for patients who struggle with existing therapies. The company’s progress toward an NDA, combined with its manufacturing scale-up, positions it as a notable player in the gout treatment landscape. This story was originally published on Benzinga and featured on www.newmediawire.com. For full disclosures, readers can refer to the partner disclosure page here.
