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XORTX Therapeutics

XORTX Therapeutics is a late-stage clinical pharmaceutical company developing therapies for hyperuricemia-related disease, with a portfolio spanning gout and progressive kidney disease. Its lead program, XRx-026, is built on XORLO, a proprietary formulation of the xanthine oxidase inhibitor oxypurinol, and is aimed at gout patients who cannot tolerate or do not respond adequately to existing urate-lowering therapy: allopurinol is not tolerated by an estimated 3-5% of patients, and febuxostat carries a boxed warning for cardiovascular risk. The company has outlined a regulatory pathway in which an Investigational New Drug application for XRx-026 is targeted to the fourth quarter of 2026, followed by the two-part XRX-OXY-102 study to characterize pharmacokinetics and efficacy and commercial-scale manufacturing for a first year of launch, with an NDA submission targeted approximately one year out. Earlier-stage assets include XRx-008 for autosomal dominant polycystic kidney disease and XRx-101 for acute kidney injury associated with respiratory viral infection, including sepsis.

Company Info

Sector:Biotechnology / Nephrology and Metabolic Disease
Headquarters:Calgary, Alberta, Canada
Founded:2011

Upcoming Milestones & Key Dates

Q4 2026
Regulatory

Planned Investigational New Drug application submission to the U.S. FDA for the XRx-026 gout program

Clinical Development Pipeline

XRx-026 (XORLO formulation of oxypurinol)

Target: Xanthine oxidase inhibition via a proprietary oxypurinol formulation
Gout and hyperuricemia
Preclinical
Phase 1
Phase 2
Phase 3
Approved

XRx-008

Target: Xanthine oxidase inhibition in progressive kidney disease
Autosomal dominant polycystic kidney disease
Preclinical
Phase 1
Phase 2
Phase 3
Approved

XRx-101

Target: Xanthine oxidase inhibition in acute kidney injury
Acute kidney injury associated with respiratory viral infection, including sepsis
Preclinical
Phase 1
Phase 2
Phase 3
Approved

XRX-225

Target: Xanthine oxidase inhibition in diabetic kidney disease
Type 2 diabetic nephropathy
Preclinical
Phase 1
Phase 2
Phase 3
Approved

Recent News

No recent news updates available for this company.

Leadership Team

Allen Warren Davidoff, Ph.D.

Founder, Co-Chief Executive Officer, President and Director

Mika Grasso

Co-Chief Executive Officer (appointed June 2026)

Michael Scott Bumby, D.V.M., M.B.A.

Chief Financial Officer

Stephen Haworth, M.D., MRCP

Chief Medical Officer

Careers & Job Openings

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