XORTX maps 2026 FDA path for $700M gout drug

XORTX maps out a funded-dependent path from a planned 2026 IND for XRx-026 to a targeted NDA submission aimed at a US$700 million U.S. gout market.

Rhea-AI Filing Summary

XORTX Therapeutics Inc. (XRTX) outlines a regulatory roadmap for its XRx-026 gout program, including a planned Investigational New Drug (IND) submission to the U.S. FDA in the fourth quarter of 2026 for its XORLO™ formulation of oxypurinol. The company describes a two-part XRX-OXY-102 clinical trial intended to generate pharmacokinetic and efficacy data to support a future New Drug Application (NDA) for XRx-026, along with plans to manufacture commercial supply for the first year of marketing.

Subject to sufficient funding and successful, timely completion of XRX-OXY-102, XORTX is targeting an NDA submission in approximately one year and estimates that XRx-026 could address an annual US$700 million U.S. gout market opportunity, based in part on prior peak net sales of febuxostat. The company positions XORLO™ as an alternative oral xanthine oxidase inhibitor for gout patients, particularly those who cannot tolerate allopurinol or are affected by febuxostat’s cardiovascular boxed warning, and highlights advancement of XRx-026 as a strategic priority within a broader pipeline of kidney and metabolic disease programs.

Key Figures

Estimated U.S. gout market opportunity for XRx-026: US$700 million per year Planned IND submission timing: Fourth quarter of 2026 Targeted NDA submission timing: Approximately one year +5 more

8 metrics

Estimated U.S. gout market opportunity for XRx-026 US$700 million per year Company estimate based on prior peak net sales for febuxostat

Planned IND submission timing Fourth quarter of 2026 Targeted submission of IND to U.S. FDA for XRx-026

Targeted NDA submission timing Approximately one year Subject to funding and successful completion of XRX-OXY-102 trial

U.S. individuals with hyperuricemia 44 million individuals Uric acid levels above normal range in the United States

U.S. individuals living with gout 9.2 million individuals Prevalence figure cited from published research

Projected global gout case increase 70% increase over 25 years Expected rise in global gout prevalence from cited literature

Prior peak annual sales of febuxostat Over US$450 million Used as reference point in sizing XRx-026 market opportunity

Allopurinol intolerance rate Approximately 3–5% of patients Share of patients who cannot tolerate allopurinol, current standard of care

Key Terms

Investigational New Drug application, New Drug Application, xanthine oxidase inhibitors, boxed warning, +2 more

6 terms

Investigational New Drug application regulatory

"Investigational New Drug application planned for submission to the U.S. FDA"

An investigational new drug application is a formal request made to regulatory authorities to begin testing a new medication in humans. It is a critical step in the drug development process, as approval indicates the drug has passed initial safety checks and can be studied further. For investors, this signals that a potential new treatment is progressing through its early testing stages, which can impact the company's future growth prospects.

New Drug Application regulatory

"its intention to file a New Drug Application ("NDA") with the FDA"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

xanthine oxidase inhibitors medical

"Oral xanthine oxidase inhibitors (XOIs) are the current standard of care"

Drugs that block the enzyme xanthine oxidase, which helps convert purines into uric acid; by slowing that chemical step they lower the amount of uric acid the body produces. Think of the enzyme as a factory machine and the inhibitors as controls that slow its output. They matter to investors because these medicines are central to treating gout and high uric acid, so regulatory approvals, patents, and market competition can affect pharmaceutical revenues and valuations.

boxed warning regulatory

"febuxostat, while once achieving >US$450 million in annual sales, now carries a boxed warning"

A boxed warning is the strongest safety alert a drug regulator places on a medication’s official label to highlight life‑threatening or very serious risks, similar to a bold red flag attached to a product. For investors, it matters because this warning can reduce sales, increase regulatory scrutiny, raise liability and monitoring costs, and change market perception of the drug’s future revenue and risk profile.

hyperuricemia medical

"Prevalence of Gout and Hyperuricemia in the US"

Hyperuricemia is a medical condition where uric acid builds up in the blood at higher-than-normal levels, similar to a sink that isn’t draining properly and allows residue to accumulate. It matters to investors because it is the underlying risk factor for gout and kidney stones and a target for drugs and diagnostics; changes in its prevalence, treatment options, or regulatory guidance can affect market size, company revenues, and healthcare spending.

metabolic syndrome medical

"It is also strongly associated with metabolic syndrome"

A cluster of common health problems—usually high blood pressure, high blood sugar, excess belly fat, and abnormal blood fats—that often occur together and raise the risk of heart disease, stroke and diabetes. Think of it like a car dashboard with several warning lights on at once: because the issues reinforce each other, they lead to bigger long-term healthcare needs and spending. Investors care because it drives demand for drugs, devices, diagnostics, chronic-care services and workplace health programs, shaping market size and regulatory attention.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What regulatory milestone is XORTX Therapeutics (XRTX) planning for the XRx-026 gout program?

XORTX plans to submit an Investigational New Drug (IND) application to the U.S. FDA for the XRx-026 gout program in the fourth quarter of 2026, outlining its clinical development plan and supporting studies for the XORLO™ formulation of oxypurinol.

When does XORTX (XRTX) aim to file an NDA for XRx-026?

Subject to sufficient funding and the timely, successful completion of the planned XRX-OXY-102 clinical trial, XORTX is targeting submission of a New Drug Application (NDA) in approximately one year after the steps described, following a pre-NDA meeting with the FDA.

How large is the U.S. market opportunity XORTX (XRTX) estimates for XRx-026?

Based on prior peak net sales for febuxostat, XORTX estimates that the XRx-026 program addresses an annual U.S. gout market opportunity of about US$700 million, reflecting its assessment of demand for alternative xanthine oxidase inhibitor therapies.

What is XORLO™ and how does it fit into XORTX’s XRx-026 program?

XORLO™ is XORTX’s proprietary formulation of oxypurinol being developed under the XRx-026 program to treat gout. It is designed as an oral xanthine oxidase inhibitor alternative, aiming to offer a differentiated safety and efficacy profile versus existing therapies.

What patient population is XORTX (XRTX) targeting with XRx-026?

XRx-026 targets individuals with gout, a condition affecting 9.2 million people in the U.S., within a broader group of about 44 million individuals with elevated uric acid levels. The company notes limitations of current xanthine oxidase inhibitors for some patients.

How is gout prevalence expected to change according to XORTX’s cited data?

XORTX notes literature indicating that global gout prevalence is increasing, with cases expected to rise by about 70% over the next 25 years, underscoring the potential long-term demand for new gout therapies like XRx-026.

What other development programs does XORTX (XRTX) report besides XRx-026?

XORTX reports three clinically advanced programs—XRx-026 for gout, XRx-008 for ADPKD, and XRx-101 for acute kidney and organ injury from respiratory virus infections—plus preclinical programs XRx-225 and VB4-P5 targeting diabetic nephropathy and various kidney diseases.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 09/18/2026 - 08:05 AM Accepted by SEC EDGAR 09/18/2026 - 08:05 AM Learn about SEC filing dates

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 
UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of September 2026

Commission File Number: 001-40858

XORTX Therapeutics Inc.

3710 – 33rd Street NW, Calgary, Alberta, Canada T2L 2M1

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F [ X ]      Form 40-F [   ]

EXHIBIT INDEX

Exhibit		Description
99.1		News release dated September 18, 2026.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

		XORTX Therapeutics Inc.
Date: September 18, 2026		By:	/s/ Allen Davidoff
		Name:	Allen Davidoff
		Title:	Co-Chief Executive Officer

EXHIBIT 99.1

XORTX Announces Planned FDA IND Submission for XRx-026 Gout Program Using XORLO™, Targeting USD$700M+ U.S. Gout Market Opportunity

Investigational New Drug application planned for submission to the U.S. FDA in the fourth quarter of 2026, advancing the Company’s regulatory path toward NDA filing for gout program XRx-026

CALGARY, Alberta, Sept. 18, 2026 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, outlines its anticipated Investigational New Drug application (“IND”) submission to the U.S. Food and Drug Administration (the “FDA”) for the XRx-026 gout program. XORTX’s drug development plan is to seek FDA marketing approval for XRx-026 and provide patients with a new therapeutic option. The key steps the Company anticipates will be necessary to file a marketing application with the FDA include meetings with the agency, a two-part clinical study to characterize the pharmacokinetics and efficacy of the XORLO^™ formulation of oxypurinol, and manufacture of a commercial supply of XORLO^™ for the first year of marketing.

Recent drug development team activities include preparation of a new IND for submission to the FDA in the fourth quarter of 2026. The application describes the Company’s clinical development plan and its intention to file a New Drug Application (“NDA”) with the FDA following completion of the planned two-part XRX-OXY-102 clinical trial, which is being advanced based on positive and supportive prior clinical trial results and discussions with the FDA. The focus of the XRX-OXY-102 clinical trial is to characterize key information needed by the FDA in its evaluation of a future NDA filing by XORTX for marketing approval.

If the XRX-OXY-102 clinical trial is successfully completed, the Company anticipates requesting a pre-NDA meeting with the FDA and preparing an NDA submission, in parallel with pre-commercialization activities. Subject to the availability of sufficient funding and the timely completion of the XRX-OXY-102 clinical trial, XORTX is targeting an NDA submission in approximately one year. Based on prior peak net sales for febuxostat, XORTX estimates the XRx-026 program addresses an estimated US$700M market opportunity per annum.

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

This planned submission is one part of XORTX’s broader regulatory strategy for XRx-026, and the Company looks forward to providing further updates on its international development plans.

About Hyperuricemia and Gout

In the United States, approximately 44 million individuals have uric acid levels above the normal range, with 9.2 million individuals living with gout¹. Gout is associated with severe pain, reduced quality of life², decreased physical function³, increased healthcare costs⁴, and lost economic productivity⁵. It is also strongly associated with metabolic syndrome⁵, myocardial infarction^6,7, Type 2 diabetes mellitus⁸, chronic kidney disease⁹, and premature mortality^6,10,11. Importantly, the global prevalence of gout is increasing, with cases expected to increase 70% over the next 25 years^*.

About the XRx-026 Program and XORLO™

The XRx-026 program is developing XORLO™, the Company’s proprietary formulation of oxypurinol, to treat individuals with gout. Oral xanthine oxidase inhibitors (XOIs) are the current standard of care, but limitations remain: approximately 3–5% of patients cannot tolerate allopurinol, and febuxostat, while once achieving >US$450 million in annual sales, now carries a boxed warning for cardiovascular risk. XORLO™ is designed to address this unmet need by providing an alternative therapeutic option with a differentiated safety and efficacy profile. Advancement of XRx-026 through NDA filing is a strategic priority for XORTX.

References

1. Chen-Xu M, et al. Prevalence of Gout and Hyperuricemia in the US. Arthritis Rheumatol. 2019;71(6):991–999.
2. Singh JA. Quality of life and quality of care for patients with gout. Curr Rheumatol Rep. 2009;11(2):154–60.
3. Burke BT, et al. Physical Function, Hyperuricemia, and Gout in Older Adults. Arthritis Care Res. 2015;67(12):1730–8.
4. Rai SK, et al. The economic burden of gout: a systematic review. Semin Arthritis Rheum. 2015;45(1):75–80.
5. Choi HK, et al. Prevalence of the metabolic syndrome in individuals with hyperuricemia. Am J Med. 2007;120(5):442–7.
6. Choi HK, Curhan G. Independent impact of gout on mortality and risk for coronary heart disease. Circulation. 2007;116(8):894–900.
7. Liu S-C, et al. Gout and Risk of Myocardial Infarction: A Systematic Review. PLoS ONE. 2015;10(7):e0134088.
8. Choi HK, et al. Gout and the risk of type 2 diabetes among men with high cardiovascular risk profile. Rheumatology. 2008;47(10):1567–70.
9. Roughley MJ, et al. Gout and risk of chronic kidney disease and nephrolithiasis: meta-analysis. Arthritis Res Ther. 2015;17(1).
10. Kuo C-F, et al. Gout: an independent risk factor for all-cause and cardiovascular mortality. Rheumatology. 2010;49(1):141–6.
11. Fisher MC, et al. Premature mortality gap in gout: a general population-based study. Ann Rheum Dis. 2017;76(7):1289–94.
    
    

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our lead XRx-026 program for the treatment of gout; 2) XRx-008 program for ADPKD; and 3) XRx-101 for acute kidney and other acute organ injury associated with respiratory virus infections. In addition, the Company is developing XRx-225, a pre-clinical stage program for Type 2 diabetic nephropathy, and the recently acquired VB4-P5 program, which is currently at the pre-IND stage of development and targets both rare and prevalent forms of kidney disease. XORTX is working to advance products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.

For more information, please contact:

Allen Davidoff, Co-CEO	Mika Grasso, Co-CEO
adavidoff@xortx.com	mgrasso@xortx.com
+1 403 455 7727	+1 949 244 6011

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as well as "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "expect," "estimate," "plan," "intend," "will," "designed to," "positions," and similar expressions, and include all statements that are not statements of historical fact. These forward-looking statements include, but are not limited to, statements regarding the timing and content of the Company's planned IND submission to the FDA for the XRx-026 program; the design, initiation, conduct, and completion of the planned XRX-OXY-102 clinical trial; the timing of a pre-NDA meeting and the preparation and submission of an NDA, including the Company's target of submitting an NDA in approximately one year; the manufacture of commercial supply of XORLO™; the Company's estimate of the size of the U.S. market opportunity for XRx-026; the Company's international development plans; and the advancement of the Company's XRx-026 program, its other development programs, and its strategy.

Forward-looking statements are based on the Company's current expectations and assumptions and are subject to known and unknown risks, uncertainties, and other factors that could cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, among others: the Company's need for, and ability to obtain, additional capital to fund its development programs and operations; the risk that the Company's IND submission is delayed or, once submitted, is placed on clinical hold or otherwise not permitted to proceed by the FDA; the Company's ability to initiate, conduct, and complete the planned XRX-OXY-102 clinical trial on the timelines currently anticipated, or at all, and the risk that the results of that trial are not positive or do not support an NDA submission; the risk that the FDA does not agree with the Company's proposed clinical development plan or regulatory pathway, or requires additional studies or data; the Company's reliance on third-party contract research organizations and contract manufacturers; the risk that the Company's estimates of market size, which are based on third-party data and the historical sales of other products, prove to be inaccurate; competition from existing and future therapies for gout; the Company's ability to advance, and obtain regulatory approval for, the XRx-026 program and its other product candidates on the timelines currently anticipated, or at all; the evolving regulatory environment applicable to the Company's business in the United States and Canada; and the Company's ability to attract and retain qualified personnel.

For a more detailed discussion of these and other risks and uncertainties, investors should review the disclosures contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2025, and in the Company's subsequent Reports of Foreign Private Issuer on Form 6-K, each as filed with or furnished to the SEC and available at www.sec.gov, as well as in the Company's continuous disclosure documents filed with the Canadian securities regulatory authorities and available at www.sedarplus.ca.

The forward-looking statements in this press release speak only as of the date hereof. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned not to place undue reliance on these forward-looking statements.

__________________________
* https://pubmed.ncbi.nlm.nih.gov/38996590/

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