Gout, a painful form of inflammatory arthritis, is projected to become more common in the coming decades. According to one estimate, the number of cases globally could rise significantly by 2050, driven by aging populations, obesity, and lifestyle factors. In the U.S. alone, over 9 million people have been diagnosed with gout, and an additional 44 million people have uric acid levels above the normal range, putting them at risk.
Current treatments, primarily oral xanthine oxidase inhibitors, are effective for many but come with significant drawbacks. Some cause severe gastrointestinal issues, kidney toxicity, and cardiovascular risks, and they carry boxed warnings for cardiovascular events. Approximately 3% to 5% of patients cannot tolerate these drugs. Moreover, some therapies initially trigger more gout flare-ups, discouraging adherence.
XORTX Therapeutics Inc. (NASDAQ: XRTX), a late-stage clinical pharmaceutical company focused on gout and progressive kidney disease, believes it has a better option. The company has developed XORLO, a proprietary formulation of oxypurinol that uses a liposomal delivery system to overcome the historically poor oral absorption of the drug. This allows for effective uric acid suppression 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 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, XRX-OXY-102. The study is based on positive prior clinical results and discussions with the FDA. Contract production of pure oxypurinol, the active ingredient in XORLO, has begun using XORTX’s proprietary synthetic pathway, and the company is working with a contract manufacturing partner toward commercial drug batches.
The company is also 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 and submit an NDA, targeting a submission in about one year. XORTX expects XORLO to have a market opportunity of $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.”
With tablet manufacturing underway and an NDA in its sights, XORTX is positioning itself to address a growing patient population. The company’s efforts could provide a more tolerable alternative for those who cannot take existing gout medications. For more information, visit XORTX. This content was originally published on Benzinga. View the original release on www.newmediawire.com.
