Gout Treatments Need A Better Option: XORTX Therapeutics Is Betting XORLO Is It, Targets New Drug Application With FDA Next Year

By Meg Flippin, Benzinga

DETROIT, MICHIGAN - October 7, 2026 (NEWMEDIAWIRE) - Blame it on an aging population, obesity, lifestyle choices or a combination of all the above, but either way, the number of cases of gout globally is projected to rise significantly in the next twenty-five years. That’s tens of millions of people who will have to suffer a chronic disease that comes with severe pain, reduced quality of life, decreased physical function, increased healthcare costs and lost economic productivity.

As it stands, over 9 million people in the U.S. have been diagnosed with gout. But more worrisome, 44 million people have uric acid levels above the normal range, which could lead to this painful disease. While there are medicines on the market to treat it, they come with side effects that make patient adherence difficult.

For instance, some of the medicines can cause severe gastrointestinal issues, kidney toxicity and cardiovascular risks, particularly if the treatment is over a long term or the dosage is high. What’s more, with some of the treatments, initially it triggers more gout flare-ups, which prevents patients from taking the medication. Currently, 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.

Reimagining Gout Treatments For Sufferers

That’s where XORTX Therapeutics Inc. (NASDAQ: XRTX), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, comes in. The company has developed XORLO™, a proprietary formulation of oxypurinol that the company says provides high bioavailability and rapid absorption, allowing for the lowering of uric acid at substantially lower total daily doses. XORTX said XORLO is different from existing treatments because it overcomes the historically poor oral absorption of oxypurinol, minimizing the toxic-level exposure and severe gastrointestinal side effects associated with high-dose traditional therapies. XORTX said it is able to do this with XORLO by utilizing its proprietary liposomal delivery system to significantly increase oral absorption, enabling effective uric acid suppression with lower, better-tolerated dosing.

Hitting Milestones

While the drug is still in the development phase, XORTX is making inroads in potentially bringing it to market, with the company recently announcing the launch of drug material and tablet manufacturing to support a planned two-part clinical study of XORLO. XORTX said the clinical trial, XRX-OXY-102, is being advanced based on positive and supportive prior clinical trial results and discussions with the FDA.

The two-part clinical study requires the production of GMP drug and clinical supply tablets representative of what the company intends to submit to the FDA for marketing approval. Contract production of pure oxypurinol drug substance - the active pharmaceutical ingredient in XORLO - using the company’s proprietary synthetic pathway has already begun, and now XORTX is working with its contract manufacturing partner toward making commercial drug batches.

Working With The FDA

The company is also working toward a new drug application submission to the FDA for XORLO, focusing on meeting with the FDA, its two-part clinical study to characterize the pharmacokinetics and efficacy of the XORLO formulation of oxypurinol and manufacturing a commercial supply of XORLO for the first year of marketing.

To meet that end, the company has recently prepared a new IND for submission to the FDA in the fourth quarter of 2026 which describes its clinical development plan, and it intends to file the new drug application (NDA) with the FDA once its two-part clinical trial is complete. If the trial is completed successfully, XORTX said it will request a pre-NDA meeting with the FDA and prepare an NDA submission at the same time it is engaging in pre-commercialization activities. XORTX is targeting an NDA submission in about one year, and the company 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.”

Gout is a chronic disease that is expected to rise significantly in prevalence in the decades to come, but the current treatments can often fall short. The side effects can make patient adherence difficult, but XORTX is trying to change that. Its developmental drug XORLO promises to improve existing treatments. With tablet manufacturing underway and an NDA in its sights, XORTX is positioning itself to help. To learn more about XORTX, click here.

Featured image from Shutterstock.

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