Gout, a painful form of inflammatory arthritis, is set to become more common in the coming decades. According to projections, the number of gout 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 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 the disease.
Current treatments for gout, while effective for some, are not without problems. Oral xanthine oxidase inhibitors (XOIs) 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 cardiovascular risks, especially with long-term or high-dose use. Additionally, some treatments initially trigger more gout flare-ups, which discourages patients from sticking with their medication. These limitations highlight a clear need for better options.
XORTX Therapeutics Inc. (NASDAQ: XRTX), a late-stage clinical pharmaceutical company focused on gout and progressive kidney disease, is working to fill that gap. The company has developed XORLO™, a proprietary formulation of oxypurinol that uses a liposomal delivery system to overcome the historically poor oral absorption of oxypurinol. This allows for effective uric acid lowering at substantially lower total daily doses, potentially minimizing toxic-level exposure and severe gastrointestinal side effects associated with high-dose traditional therapies.
XORTX is making steady progress 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 called XRX-OXY-102. This study is being advanced based on positive prior clinical results and discussions with the FDA. Contract production of pure oxypurinol drug substance has already begun, and XORTX is now working with its contract manufacturing partner toward making commercial drug batches.
In addition, the company is working toward a new drug application submission to the FDA for XORLO. XORTX has prepared a new Investigational New Drug (IND) application for submission in the fourth quarter of 2026, describing its clinical development plan. If the two-part clinical trial is successful, the company intends to request a pre-NDA meeting with the FDA and prepare an NDA submission while engaging in pre-commercialization activities. XORTX is targeting an NDA submission in about one year and estimates a market opportunity of $700 million annually 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 of XORTX’s progress are significant for patients and the healthcare industry. With gout prevalence on the rise, a better-tolerated treatment could improve adherence and outcomes, reducing the burden of a chronic disease that causes severe pain, reduced quality of life, and increased healthcare costs. For the industry, XORLO’s novel delivery approach could set a new standard for uric acid-lowering therapies. Investors and industry watchers can find more information on XORTX and follow updates via NEWMEDIAWIRE. This content was originally published on Benzinga.
