Oxipurinol - XORTX Therapeutics
Alternative Names: Oxypurinol - XORTX; XORLO; XRx 101; XRx-008Latest Information Update: 22 Mar 2024
At a glance
- Originator XORTX Pharma
- Developer XORTX Therapeutics
- Class Anti-ischaemics; Antigouts; Antivirals; Pyrazoles; Pyrimidines; Small molecules; Urologics
- Mechanism of Action Xanthine oxidase inhibitors
-
Orphan Drug Status
Yes - Autosomal dominant polycystic kidney disease
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
- Available For Licensing Yes
Highest Development Phases
- Phase II/III Autosomal dominant polycystic kidney disease
- Phase II Acute lung injury
Most Recent Events
- 19 Mar 2024 XORTX Therapeutics plans a registrational trial for Autosomal dominant polycystic kidney disease in USA (PO),
- 03 Jan 2024 XORTX Therapeutics files for patent protection for Oxipurinol
- 31 Aug 2023 XORTX Therapeutics anticpates a feedback and a decision from the EMA, regarding submission of an Orphan Drug Designation (ODD) application for oxipurinol for the treatment of Autosomal dominant polycystic kidney disease, by December 2023
Development Overview
Introduction
A proprietary reformulation of oxipurinol (XRx 008), a xanthine oxidase inhibitor, is being developed by XORTX Therapeutics (previously XORTX Pharma) for the treatment of autosomal dominant polycystic kidney disease (ADPKD), and XRx-101 (a new formulation of oxypurinol) for acute kidney and lung injury accompanying coronavirus infection and specifically for the COVID-2019 infections. Other potential indications include hereditary hypouricaemia and diabetic nephropathy. XORTX’s approach is to use its product, called XORLO, to inhibit the excessive accumulation of serum uric acid (SUA), a key modulator in the pathology of these diseases. While uric acid is essential in the excretion of excess nutrients, SUA at high levels through a newly discovered mechanism can cause disease, such as accelerated kidney injury in patients with ADPKD. Additionally, excipients in the formulation such as L-arginine, a basic amino acid and nitric oxide source, can increase the aqueous solubility of uric acid, thereby also decreasing uric acid crystal formation associated with tumor lysis-like syndrome due to COVID-19 infection. L-arginine is also reported to protect against kidney injury, in the setting of ischemia reperfusion injury.The PKD Foundation is providing scientific expertise to XORTX for the treatment of ADPKD. The FDA approved the compassionate use of oxipurinol in patients with gout who could not tolerate allopurinol. There are currently no SUA lowering agents approved for treatment. Clinical development for autosomal dominant polycystic kidney disease is underway in USA and Canada and clinical development for acute lung injury is underway in the US. Clinical development is ongoing in the US for acute kidney injury.
XRx 101 is a new formulation of oxypurinol for the treatment of acute kidney injury and acute lung injury. XRx 101 can act to inhibit xanthine oxidase expression due to hypoxia, or tissue destruction, thereby preventing increased serum uric acid (SUA) concentration from reaching saturation levels at which uric acid crystals could trigger acute organ injury. In concept, XRx-101 may ameliorate the severity of COVID-19 infection comorbidity, mortality, and damage to kidneys. The company believes that XRx 101 has the potential to treat COVID-2019 infections based on its anti-viral properties.
In January 2018, APAC Resources merged with XORTX Pharma and subsequently changed its name to XORTX Therapeutics [1] .
Oxipurinol - XORTX Therapeutics is available for licensing as of 19 Jan 2021 [2] .
XORTX Therapeutics intends to file the approval of XRx 008 through the US FDA 505(b)2 marketing approval process [3] .
Company Agreements
In April 2020, XORTX Therapeutics entered into a manufacturing agreement with Lonza Pharma & Biotech for the active pharmaceutical ingredient for XRx-101 (Oxypurinol) and XRx-008. Stepwise manufacturing of Oxypurinol to support the drug development and clinical trial process is expected to commence in May 2020. LONZA will also perform formulation work and provide clinical supplies for future clinical trials in both programs. [4] [5]
Key Development Milestones
Autosomal dominant polycystic kidney disease
In August 2023, XORTX Therapeutics submitted an Orphan Drug Designation application for oxipurinol (XORLO™) to the European Medicines Agency (EMA), for the treatment of autosomal dominant polycystic kidney disease (ADPKD). Following discussion and guidance from EMA, XORTX will expand data package and resubmit to gain EMA Orphan Drug Designation [6] [7] .
In April 2023, XORTX Therapeutics announced that the US FDA granted Orphan Drug Designation for oxipurinol for treatment of autosomal dominant polycystic kidney disease [8] . XORTX Therapeutics submitted an Orphan Drug Designation (ODD) request with the US FDA for oxipurinol for the treatment of autosomal dominant polycystic kidney disease in February 2023 [9] [10] [11] [12] .
In February 2023, XORTX Therapeutics plans accelerated approval for NDA filing and plans to launch oxipurinol in the US in the year of 2025 [13] .
As of March 2024, XORTX Therapeutics is planning to initiate a registration clinical trial (XRX-OXY-201) that is designed to demonstrate the benefit of oxipurinol in slowing the progression of declining filtering capacity in ADPKD [6] [14] .
In May 2023, XORTX Therapeutics announced the completion of a positive and constructive Type D meeting with the US FDA which resulted in the identification of additional clinical endpoints potentially available for accelerated approval and further understanding of the FDA expectations for the accelerated approval of oxipurinol for the treatment of autosomal dominant polycystic kidney disease. The US FDA confirmed the eligibility of oxipurinol for accelerated approval following review of March 14th submission of type D meeting [6] [15] . In March 2023, XORTX Therapeutics announced submission of a Type D meeting request to the US FDA and a response setting the date for a virtual meeting on May 1, 2023. Accompanying the Type D meeting request was a revised clinical trial protocol for XRX-OXY-301, a data update from the XRX-OXY-101 bridging pharmacokinetic clinical trial [see below] as well as a description of future clinical development program plans for oxipurinol (XORLOTM). Prior discussions with the FDA and existing agency guidance permits accelerated approval for specified validated endpoints such as total kidney volume in ADPKD. Submission of this revised clinical trial protocol, XRX-OXY-301, provides the opportunity for XORTX’s XRx-008 program to achieve earlier completion of its planned registration trial and importantly accelerate FDA marketing approval [16] . Earlier in September 2022, XORTX Therapeutics announced that it has successfully completed a Type B pre-phase 3 meeting which was previously scheduled with the US FDA [17] . In August 2022, XORTX Therapeutics announced that the US FDA has granted virtual meeting scheduled on September 16, 2022 for pre-phase III meeting. In advance of this meeting, XORTX has submitted a “pre-phase-III briefing package” to the FDA in July 2022. In July 2022, XORTX Therapeutics submitted a type B pre-phase III meeting request with the FDA and is and it is scheduled to take place in about 70 days [18] [19] .
As of May 2023, XORTX Therapeutics completed a clinical XRX-OXY-101 trial that characterized pharmacokinetics and bioavailability of oxipurinol in healthy volunteers. The trial initiated in May 2022 [15] . In same month, the US FDA notified that it reviewed and cleared the IND application together with a "study may proceed letter". Earlier in March 2022, XORTX Therapeutics had submitted an IND application of XRx 008 programme with the US FDA for the treatment of autosomal dominant polycystic kidney disease, for the bridging pharmacokinetics study – XRX-OXY-101. In October 2022, XORTX Therapeutics announced the further receipt of no objection letter (NOL) from Health Canada regarding XRX-OXY-101 clinical bridging pharmacokinetics study [20] [21] . Earlier, In March 2022, XORTX Therapeutics submitted a clinical trial application (CTA) and in April 2022, received No Objection Letter (NOL) from Health Canada for a XRX-OXY-101 bridging pharmacokinetics trial [3] . In August 2022, results from this trial were released by XORTX Therapeutics. In December 2022, the company announced completion of dosing in the XRX-OXY-101 pharmacokinetics bridging study [22] [23] [24] [25] [26] [27] [28] [29] [30] . In January 2023, the company released the positive clinical data from all the four parts of the trial [31] .
As of April 2018, XORTX Therapeutics is conducting a phase II/III trial for autosomal dominant polycystic kidney disease under a special protocol assessment (XORTX Therapeutics pipeline, April 2019) [32] [33] .
In July 2022, XORTX Therapeutics submitted request for “scientific advice review” to the European Medicines Agency and more specifically the Committee for Medicinal Products for Human Use regarding the XRx 008 program for autosomal dominant polycystic kidney disease, plans for its global phase III registration trial, and includes scientific advice pertaining to marketing approval in the EU. XORTX Therapeutics submission is based on topline results showing substantially increased bioavailability of XRx-008 formulation candidates in humans. These important milestones have positioned XORTX for the next important step for initiating a scientific review process with the EMA CHMP regarding its scientific status, developmental assumptions and plans for recruiting individuals in the upcoming phase III registration trial [34] .
In June 2018, XORTX Therapeutics in collaboration with Cato Research (also known as Cato Clinical Research) filed a pre-IND meeting request letter with the US FDA for the phase II trial of oxipurinol for the treatment of ADPKD. The request, supported by pre-IND documents, initiated a process for communication and discussion with the FDA regarding the phase II trial, defining the path for the clinical development and marketing approval of oxipurinol [35] . In August 2018, XORTX Therapeutics and Cato Clinical Research announced that the companies have submitted all the necessary pre-IND meeting documents with the FDA for the scheduled pre-IND meeting with US FDA on September 20th, 2018 [36] . In October 2018, the company reported a major revision in the development plan of oxipurinol which included manufacturing, formulation, non-clinical study plans and development strategy comprising of separate phase II and phase III clinical trials, followed by marketing application. The discussions with the FDA also suggested a substantially shorter path for marketing approval. The outcome of the pre-IND meeting with the US FDA included filing of an IND application, to characterise the bioavailability and pharmacokinetics of oxipurinol in advancing clinical studies in humans, to complete the orphan drug designation process and to conduct a single pivotal phase II/III clinical trial. The company intends to seek a special protocol assessment (SPA) from the US FDA to help in a design, endpoints and statistical analysis of a pivotal phase II/III trial to support the marketing approval [37] .
Earlier, XORTX Therapeutics had reported that phase II development of oxipurinol (XORLO) for the treatment of autosomal dominant polycystic kidney disease was planned for 2016 [38] . The company will investigate the first licensing or acquisition opportunity upon completion of the phase II development.
Several investigator-sponsored phase II trials showed that decreasing and maintaining SUA levels can suppress weight gain and decrease blood pressure, slow progression of blood vessel and kidney injury in patients with high SUA.
XORTX had planned to conduct a phase II trial of the product for the treatment of hereditary hypouricaemia in 2016.
Prior to February 2016, XORTX Pharma initiated a phase I study to evaluate oxipurinol for the treatment of patients with autosomal dominant polycystic kidney disease in the US (XORTX Pharma pipeline, February 2016 and June 2017).
In November 2022, XORTX release new proof of concept data from a mouse and rat models of polycystic kidney disease. Oxipurinol (XRx 008) formulation can substantially and significantly block the increase in kidney size associated with high circulating uric acid in a rodent model of polycystic kidney disease [39] .
Acute kidney injury, Acute lung injury associated with COVID-2019 infections
As of September 2021, XRx 101 is undergoing phase II trial for acute lung injury associated with COVID-19 infections (XORTX Therapeutics pipeline, September 2021) [40] .
In December 2021, XORTX Therapeutics, in collaboration with Altasciences, to conduct a pharmacokinetic bridging XRX-OXY-101 study of oxipurinol (XRx 101) for the treatment of acute kidney injury associated with COVID-2019 infections [24] [25] .
In October 2020, XORTX Therapeutics received a positive response from the US FDA regarding its recent submission of a COVID-19 coronavirus pre-investigational new drug meeting package providing the Company with a clear development path forward for XRx 101. XORTX’s submission to the FDA summarised current data supporting the XRx 101 program. XORTX’s plans to rapidly advance into clinical trials and further included questions related to XORTX’s development program details including proposed manufacturing, non-clinical and clinical steps. The FDA response provided clear feedback on the proposed plan and outlined the critical steps to test XRx 101 in patients with COVID-19 infection to treat acute kidney injury [41] .
In August 2020, XORTX Therapeutics filed a pre-IND (Investigational New Drug) meeting request with the US FDA regarding development of oxypurinol for the treatment and prevention of acute kidney injury (AKI) associated with COVID-19 coronavirus infection. The request for a pre-IND meeting was accompanied by the complete pre-IND briefing document which includes discussion of the clinical development plan and requests for guidance regarding the novel formulation of oxypurinol specifically designed to treat individuals at risk of AKI associated with COVID-19 coronavirus infection [42] .
In May 2020, XORTX submitted Coronavirus Treatment Acceleration Program (CTAP), a development and data plan regarding a COVID-19 package and received guidance to submit a pre-IND package for review [5] .
XORTX has also initiated discussions with the US Medical Countermeasures Group associated with the U.S. Government’s Biomedical Advanced Research and Development Authority (BARDA) and separately with the National Institute of Health (NIH). These communications with BARDA and NIH are expected to further aid development of XORTX’s XRx-101 program [5] .
In December 2022, updated results from preclinical studies of XRx 008 produced by the XORTX's proprietary oral oxypurinol formulation released by XORTX Therapeutics [43] .
In March 2020, XORTX Therapeutics announced that it is developing the use of XRx 101 (a new formulation of oxypurinol) for the treatment of acute kidney injury, acute lung injury in COVID-2019 infections. The company believes that XRx 101 has the potential to treat COVID-2019 infections based on its anti-viral properties. The rationale was made based on various in vivo studies showing that xanthine oxidase inhibition may confer suppression of viral infection and decrease symptoms of coronavirus COVID-19 infection and importantly improve survivability, and most importantly to protect the kidneys from AKI. The company also announced that it has received an approval letter from the US FDA to accelerate the development of oxypurinol for the treatment of acute kidney injury and acute lung injury [5] [44] .
Financing information
In October 2021, XORTX Therapeutics announced the closing of an underwritten public offering of 2 906 000 units, with each unit consisting of one common share, no par value share, and one warrant to purchase one common share at a public offering price of $US4.13 per unit, for aggregate gross proceeds of approximately $US12 million. This financing will continue to advance clinical trial programs and regulatory filings in support of Oxipurinol [45] .
XORTX Therapeutics, in April 2021, reported the receipt of notification of intent to grant the patent “Compositions and Methods for Treatment and Prevention of Hyperuricemia Related Health Consequences", by the European Patent Office. The patent covers compositions and methods for the prevention and treatment of diabetic nephropathy, using uric acid lowering agent, specifically xanthine oxidase inhibitors. As at April 2021, the company had five granted in the US and/or EU, covering compositions and uses of uric acid lowering agents for the treatment of chronic progressing kidney disease, hypertension, insulin resistance, and diabetic nephropathy [46] .
In March 2021, XORTX Therapeutics announced that 4,286,438 warrants that were issued and exercised for aggregate proceeds of $US1,037,524. In February 2021, XORTX Therapeutics announced the it has further increased the private placement due to the high level of interest. The Company will issue 24,486,286 units (the “Units”), priced at $0.25 per Unit for total gross proceeds of $US6,121,572 (the “Upsized Offering”). In January 2021, XORTX Therapeutics the company has received significant interest in the non-brokered private placement. To respond to the interest received, the company has agreed to increase the private placement to raise between CDN $2,000,000 and CDN $5,000,000 through the issuance of between 8,000,000 and 20,000,000 common share and to adjust the terms to the warrants comprising a portion of the units being offered. Earlier, in the same month, January 2021, XORTX Therapeutics announced a non-brokered private placement to raise between CDN $2 million and CDN $3 million through the issuance of between 8,000,000 and 12,000,000 common share units of the Company at a price of CDN $0.25 per unit. The net proceeds from the sale of the units will be utilized by the Company for pre-clinical trials, IND (Investigative New Drug) filing for oxipurinol for polycystic kidney disease (a phase III ready program), advancing discussions with potential pharmaceutical development partners, R&D and for general corporate purposes [47] [48] [49] [50] .
In January 2020, XORTX Therapeutics announced the re-pricing of private placements previously announced in April 2019. The company intends to raise approximately $US5 million and the proceeds will be used to advance development of oxipurinol for polycystic kidney disease and XRx 221 [see Adis Insight Drug profile800045135] type 2 diabetic nephropathy (a phase IIb ready programme) including operations and ongoing licensing discussions [51] [52] .
XORTX raised $US1.5 million in Series A financing with proceeds allocated for the management of phase II development of XORLO.
Patent Information
In January 2024, XORTX Therapeutics announced submission of a new patent entitled “Oral and Sublingual Formulations of Xanthine Oxidase Inhibitors and Methods of Treating Disease” for the treatment of chronic kidney disease (CKD). This patent is designed to protect new discoveries and strategies for the treatment of individuals with varied degrees of kidney function in the setting of CKD [53]
In January 2023, XORTX Therapeutics announced the submission of a Patent Cooperation Treaty (PCT) patent application seeking international patent protection for the patent entitled “Compositions and Methods for Diagnosis, Treatment and Prevention of Kidney Disease”. The patent application builds upon new discoveries in polycystic disease and more specifically polycystic kidney disease (PKD) and proposes methods of diagnosing the risk associated with aberrant purine metabolism alone, or in combination with hyperuricemia in patients most at risk for accelerated kidney disease progression [54]
In April 2022, XORTX Therapeutics received notification that the patent “Formulations of Xanthine Oxidase Inhibitors” will be granted by the United States Patent Office (USPTO). The patent will cover compositions for, and methods of using XORTX’s proprietary formulations of xanthine oxidase inhibitors for renal and other diseases where aberrant purine metabolism has been implicated in disease progression [55] .
In March 2022, XORTX Therapeutics announced the submission of a Patent Cooperation Treaty (PCT) patent application seeking international patent protection for the patent entitled “Compositions and Methods for Enhancing Anti-Viral Therapies”. This patent is based on retrospective clinical data from XORTX scientific partners which suggest an important therapeutic opportunity in addressing aberrant purine metabolism combined with hyperuricemia, in patients most at risk to severe COVID-19 outcome [56] .
In December 2021, XORTX Therapeutics filed a provisional patent application with the US Patent Office entitled, "Compositions and Methods for Diagnosis, Treatment of and Prevention of Kidney Disease". The patent application contains claims to new methods of diagnosing aberrant purine metabolism in polycystic kidney disease, compositions and formulations of agents capable of modulating aberrant purine metabolism in the kidney and claims new compositions including molecular iRNA and siRNA methods for preventing and treating progression of chronic kidney disease [57] .
As at April 2021, XORTX Therapeutics had five granted in the US and/or EU, covering compositions and uses of uric acid lowering agents for the treatment of chronic progressing kidney disease, hypertension, insulin resistance, and diabetic nephropathy [46] .
In March 2021, XORTX Therapeutics filed a new provisional patent application with the US Patent Office entitled, “compositions and methods for enhancing anti-viral therapies” [58] .
In January 2021, The European Patent Office received notice of grant for the patent entitled "Formulations of Xanthine Oxidase Inhibitors”. This patent covered compositions and methods of using XORTX’s proprietary formulations of xanthine oxidase for, renal and other diseases where aberrant purine metabolism has been implicated in disease progression [59] .
In December 2020, XORTX Therapeutics reported the receipt of notification that the patent “Formulations of Xanthine Oxidase Inhibitors” will be granted by the European Patent Office European Patent Office. The patent will cover compositions and methods of using XORTX’s proprietary formulations of xanthine oxidase inhibitors, including oxipurinol for, renal and other diseases where aberrant purine metabolism has been implicated in disease progression. The patent is expected to be protected for 20 years [60] .
In March 2020, XORTX Therapeutics filed new intellectual property rights for oxipurinol for the treatment of respiratory and kidney disease due to viral infetions [44] .
In 2014, XORTX Therapeutics filed a patent application with Patent Coorperation Treaty (PCT) for a formulation of Oxypurinol [4] .
Drug Properties & Chemical Synopsis
- Route of administration PO
- Formulation Tablet, unspecified
- Class Anti-ischaemics, Antigouts, Antivirals, Pyrazoles, Pyrimidines, Small molecules, Urologics
- Target Xanthine oxidase
- Mechanism of Action Xanthine oxidase inhibitors
-
WHO ATC code
J05A-X (Other antivirals)
M04A-A (Preparations inhibiting uric acid production)
R07A (Other Respiratory System Products)
-
EPhMRA code
J5B9 (Antivirals, others)
M4A (Anti-Gout Preparations)
R7X (All Other Respiratory System Products)
- Chemical name 1H-Pyrazolo[3,4-d]pyrimidine-4,6-diol
- Molecular formula C5 H4 N4 O2
- SMILES C1(NC2=C(C(N1)=O)C=NN2)=O
-
Chemical Structure
- CAS Registry Number 2465-59-0
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Acute lung injury | associated with coronavirus / COVID-19 infection | - | Phase II | USA | unspecified / unspecified | XORTX Therapeutics | 02 Sep 2021 |
| Autosomal dominant polycystic kidney disease | - | - | Phase II/III | USA | PO / Tablet | XORTX Therapeutics | 03 May 2019 |
| Autosomal dominant polycystic kidney disease | - | In volunteers | Clinical Phase Unknown | Canada | PO / Tablet | XORTX Therapeutics | 03 May 2022 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Coronavirus Treatment Acceleration Program | USA | Acute kidney injury |
Orphan Status
| Indication | Patient Segment | Country | Organisation | Event Date |
|---|---|---|---|---|
| Autosomal dominant polycystic kidney disease | - | USA | XORTX Therapeutics | 21 Apr 2023 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| XORTX Pharma | Originator | Canada |
| XORTX Therapeutics | Owner | Canada |
| PKD Foundation | Collaborator | USA |
| Cato Research | Collaborator | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| XORTX Therapeutics | - | Unspecified | - | 19 Jan 2021 |
Scientific Summary
Pharmacokinetics
Data from the XRX-OXY-101 – Bridging Pharmacokinetics clinical trial, demonstrated that in part 1, the oral formulation of oxipurinol increased bioavailability of 100%, compared with non-formulated oxypurinol alone. In part 2 of the trial, an average increase of exposure of ~40% in oxypurinol was observed when taken with food, compared with the fasted taste. A substantial improvement in dose related exposure across the range of doses was observed in part 3 of the trial, compared with oxypurinol alone. In part 4 of the trial, steady state concentrations of oxypurinol at the relevant therapeutic range were achievable within several days of administration of oral oxipurinol and the food effect on exposure under steady state was minimal. The highest systemic exposure of oxypurinol was observed in healthy normal individuals using an oral oxypurinol-based drug product [31] [26] [30] .
Adverse Events
Pharmacodynamics
Summary
Results from preclinical studies of oral XRx 008 oxypurinol formulation demosnatred that, aberrant purine metabolism is substantially and significantly increased, as indicated by an increased kidney tissue expression of XO and increased activity of the enzyme in ADPKD tissue is present. With increased circulating serum uric acid in mouse ADPKD models, accompanied increase of kidney volume and decreased filtering capacity reported. The formulation attenuated the mechanism of injury associated with chronically increased uric acid [43] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Jan 2025 | Regulatory Status | XORTX Therapeutics announces intention to launch Oxipurinol in the year of 2025 [13] | 20 Feb 2023 |
| 31 Jan 2025 | Regulatory Status | XORTX Therapeutics announces intention to submit accelerated approval for NDA filing in USA in the year of 2025 [13] | 20 Feb 2023 |
| 01 Jan 2025 | Regulatory Status | XORTX Therapeutics announces intention to submit regulatory filings to EMA and FDA by 2025 [59] | 09 May 2023 |
| 31 Dec 2023 | Trial Update | XORTX Therapeutics plans the registrational phase III XRX-OXY-301 trial for Autosomal dominant polycystic kidney disease in US, EU and other countries in globally in the second half of 2023 [61] | 09 May 2023 |
| 31 Dec 2023 | Regulatory Status | XORTX Therapeutics anticpates a feedback and a decision from the EMA, regarding submission of an Orphan Drug Designation (ODD) application for oxipurinol for the treatment of Autosomal dominant polycystic kidney disease, by December 2023 (9397264) | 31 Aug 2023 |
| 01 May 2023 | Regulatory Status | XORTX Therapeutics plans a Type D virtual meeting with the US FDA to discuss planned phase III clinical program [8] | 09 May 2023 |
| 31 Dec 2022 | Trial Update | XORTX plans to initiate a late-stage clinical study for XRx-101 in 2022. [62] | 29 Nov 2021 |
| 31 Dec 2022 | Trial Update | XORTX Therapeutics plans the bridging pharmacokinetics XRX-OXY-101 trials for Autosomal dominant polycystic kidney disease and Acute kidney injury in the first half of 2022 (9344572) [59] | 06 May 2022 |
| 16 Sep 2022 | Regulatory Status | A type B pre-Phase III meeting is expected to be held in September 2022 [18] | 28 Sep 2022 |
| 30 Jun 2022 | Regulatory Status | XORTX Therapeutics announces intention to submit IND application to the US FDA for Autosomal dominant polycystic kidney disease in the first half of 2022 [59] | 04 Apr 2022 |
| 31 Dec 2021 | Regulatory Status | XORTX Therapeutics plans to file for orphan drug designation of oxipurinol (XRx 008) for autosomal dominant polycystic kidney disease in 2021 [2] | 03 Feb 2023 |
| 31 Dec 2021 | Regulatory Status | XORTX Therapeutics plans to Complete regulatory filings with FDA and EMA in 2021 [2] | 21 Jan 2021 |
| 29 Feb 2020 | Trial Update | XORTX Therapeutics plans a pivotal phase III trial for Autosomal dominant polycystic kidney disease in February 2020 [32] | 03 May 2019 |
| 10 Sep 2018 | Regulatory Status | XORTX Therapeutics plans a pre-IND meeting with US FDA for discussions related to a phase II trial of oxipurinol for treatment of Autosomal-dominant polycystic kidney disease in September 2018 [35] | 30 Oct 2018 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 19 Mar 2024 | Trial Update | XORTX Therapeutics plans a registrational trial for Autosomal dominant polycystic kidney disease in USA (PO), [6] Updated 22 Mar 2024 |
| 03 Jan 2024 | Patent Information | XORTX Therapeutics files for patent protection for Oxipurinol [53] Updated 05 Jan 2024 |
| 31 Aug 2023 | Regulatory Status | XORTX Therapeutics anticpates a feedback and a decision from the EMA, regarding submission of an Orphan Drug Designation (ODD) application for oxipurinol for the treatment of Autosomal dominant polycystic kidney disease, by December 2023 [7] Updated 31 Aug 2023 |
| 29 Aug 2023 | Regulatory Status | XORTX Therapeutics submits an Orphan Drug Designation application to the EMA, for Autosomal dominant polycystic kidney disease [7] Updated 31 Aug 2023 |
| 04 May 2023 | Regulatory Status | XORTX Therapeutics completes a Type D meeting with US FDA which conducted to discuss planned phase III clinical programme [15] Updated 09 May 2023 |
| 04 May 2023 | Trial Update | XORTX Therapeutics competes XRX-OXY-101 bridging pharmacokinetics trial in Autosomal dominant polycystic kidney disease (In volunteers) (PO) (before May 2023) [15] Updated 09 May 2023 |
| 21 Apr 2023 | Regulatory Status | XORTX Therapeutics plans a Type D virtual meeting with the US FDA to discuss planned phase III clinical program [8] Updated 09 May 2023 |
| 21 Apr 2023 | Regulatory Status | Oxipurinol - XORTX Therapeutics receives Orphan Drug status for Autosomal dominant polycystic kidney disease in USA [8] Updated 24 Apr 2023 |
| 14 Mar 2023 | Regulatory Status | XORTX Therapeutics submits a Type D meeting request to the US FDA and a response [16] Updated 16 Mar 2023 |
| 07 Feb 2023 | Regulatory Status | XORTX Therapeutics announces intention to submit accelerated approval for NDA filing in USA in the year of 2025 [13] Updated 23 Feb 2023 |
| 07 Feb 2023 | Regulatory Status | XORTX Therapeutics announces intention to launch Oxipurinol in the year of 2025 [13] Updated 23 Feb 2023 |
| 01 Feb 2023 | Regulatory Status | XORTX Therapeutics submits an Orphan Drug Designation request to the US Food and Drug Administration for oxipurinol for autosomal dominant polycystic kidney disease [9] Updated 03 Feb 2023 |
| 19 Jan 2023 | Scientific Update | Adverse events and updated pharmacokinetics data from the XRX-OXY-101 – Bridging Pharmacokinetics Clinical Trial in Autosomal dominant polycystic kidney disease (In volunteers) released by XORTX Therapeutics [31] Updated 27 Jan 2023 |
| 03 Jan 2023 | Patent Information | XORTX Therapeutics files for patent protection for oxipurinol [54] Updated 05 Jan 2023 |
| 08 Dec 2022 | Scientific Update | Pharmacodynamics data from a preclinical trial in Autosomal dominant polycystic kidney disease released by XORTX Therapeutics [43] Updated 12 Dec 2022 |
| 28 Nov 2022 | Trial Update | XORTX Therapeutics competes enrolment in its XRX-OXY-101 bridging pharmacokinetics trial in Autosomal dominant polycystic kidney disease (In volunteers) (PO) [23] Updated 30 Nov 2022 |
| 16 Nov 2022 | Trial Update | XORTX Therapeutics plans the registrational phase III XRX-OXY-301 trial for Autosomal dominant polycystic kidney disease in US, EU and other countries in globally in the second half of 2023 [61] Updated 09 May 2023 |
| 26 Oct 2022 | Regulatory Status | XORTX Therapeutics announced the further receipt of no objection letter (NOL) from Health Canada regarding XRX-OXY-101 trial in Autosomal dominant polycystic kidney disease [20] Updated 01 Nov 2022 |
| 19 Sep 2022 | Trial Update | The XORTX plans the phase 3 registration clinical trial design in advance of initiation of a Special Protocol Assessment (SPA) discussion [17] Updated 28 Sep 2022 |
| 19 Sep 2022 | Regulatory Status | XORTX announces competeion of pre phase III meeting with US FDA for oxipurinol for Autosomal dominant polycystic kidney disease [17] Updated 22 Sep 2022 |
| 22 Aug 2022 | Scientific Update | Pharmacokinetics data from bridging XRX-OXY-101 trial in Autosomal dominant polycystic kidney disease released by XORTX Therapeutics [26] Updated 29 Aug 2022 |
| 04 Aug 2022 | Regulatory Status | A type B pre-Phase III meeting is expected to be held in September 2022 [18] Updated 28 Sep 2022 |
| 28 Jul 2022 | Regulatory Status | XORTX has submitted a pre-phase-III briefing package to the US FDA [18] . Updated 09 Aug 2022 |
| 19 Jul 2022 | Regulatory Status | XORTX Therapeutics submitted of a request for “scientific advice review” to the European Medicines Agency and more specifically the Committee for Medicinal Products for Human Use Request [34] Updated 21 Jul 2022 |
| 05 May 2022 | Regulatory Status | US FDA approves IND application for oxipurinol in Autosomal dominant polycystic kidney disease [27] Updated 09 May 2022 |
| 03 May 2022 | Phase Change - Clinical | Clinical trials in Autosomal dominant polycystic kidney disease (In volunteers) in Canada (PO) [26] Updated 29 Aug 2022 |
| 03 May 2022 | Trial Update | XORTX Therapeutics initiates a bridging pharmacokinetics XRX-OXY-101 trial in Autosomal dominant polycystic kidney disease (In volunteers) (PO) Updated 06 May 2022 |
| 12 Apr 2022 | Regulatory Status | XORTX Therapeutics announced the receipt of no objection letter (NOL) from Health Canada regarding XRX-OXY-101 trial in Autosomal dominant polycystic kidney disease [21] Updated 19 Apr 2022 |
| 07 Apr 2022 | Patent Information | XORTX Pharma receives notification of intent to grant from the United States Patent Office for a patent covering xanthine oxidase inhibitors [55] Updated 11 Apr 2022 |
| 31 Mar 2022 | Regulatory Status | XORTX Therapeutics files an IND application with the US FDA in USA for Autosomal dominant polycystic kidney disease [29] Updated 04 Apr 2022 |
| 23 Mar 2022 | Patent Information | XORTX Therapeutics files for patent protection for oxipurinol [56] Updated 25 Mar 2022 |
| 14 Mar 2022 | Trial Update | XORTX Therapeutics submits a clinical trial application with Health Canada for a XRX-OXY-101 bridging pharmacokinetics trial [3] . Updated 16 Mar 2022 |
| 31 Jan 2022 | Regulatory Status | XORTX Therapeutics announces intention to submit regulatory filings to EMA and FDA by 2025 [59] Updated 09 May 2023 |
| 31 Jan 2022 | Trial Update | XORTX Therapeutics plans the bridging pharmacokinetics XRX-OXY-101 trials for Autosomal dominant polycystic kidney disease and Acute kidney injury in the first half of 2022 [24] [59] Updated 06 May 2022 |
| 31 Jan 2022 | Regulatory Status | XORTX Therapeutics announces intention to submit IND application to the US FDA for Autosomal dominant polycystic kidney disease in the first half of 2022 [59] Updated 04 Apr 2022 |
| 21 Dec 2021 | Patent Information | XORTX Therapeutics files for patent protection with the US Patent Office for compositions and methods for diagnosis, treatment of and prevention of kidney disease [57] Updated 25 Dec 2021 |
| 15 Nov 2021 | Trial Update | XORTX plans to initiate a late-stage clinical study for XRx-101 in 2022. [62] Updated 29 Nov 2021 |
| 02 Sep 2021 | Phase Change - II | Phase-II clinical trials in Acute lung injury in USA (unspecified route) (XORTX Therapeutics pipeline, September 2021) [40] Updated 07 Sep 2021 |
| 06 Apr 2021 | Patent Information | XORTX Pharma has patent protection for the use of uric acid lowering agents to treat chronic progressing kidney disease, hypertension, insulin resistance, and diabetic nephropathy, in USA and Europe Union [46] Updated 14 May 2021 |
| 10 Mar 2021 | Patent Information | XORTX Therapeutics files for patent protection with the US Patent Office for compositions and methods for enhancing anti-viral therapies [58] Updated 10 Mar 2021 |
| 19 Jan 2021 | Regulatory Status | XORTX Therapeutics plans to file for orphan drug designation of oxipurinol (XRx 008) for autosomal dominant polycystic kidney disease in 2021 [2] Updated 03 Feb 2023 |
| 19 Jan 2021 | Licensing Status | Oxipurinol - XORTX Therapeutics is available for licensing as of 19 Jan 2021. 9313682 Updated 21 Jan 2021 |
| 19 Jan 2021 | Regulatory Status | XORTX Therapeutics plans to Complete regulatory filings with FDA and EMA in 2021 [2] Updated 21 Jan 2021 |
| 12 Jan 2021 | Patent Information | XORTX Pharma receives notification of intent to grant from the European patent office for a patent covering xanthine oxidase inhibitors [59] Updated 02 Feb 2022 |
| 29 Dec 2020 | Patent Information | European Patent Office receives notification for patent for oxipurinol in Europe [60] Updated 31 Dec 2020 |
| 08 Oct 2020 | Regulatory Status | XORTX Therapeutics receives a positive response from the US FDA regarding its submission of a pre-investigational new drug meeting package related to Acute kidney injury (associated with COVID-2019 infections) [41] Updated 12 Oct 2020 |
| 08 Oct 2020 | Trial Update | XORTX Therapeutics plans late-stage clinical trials in Acute kidney injury (associated with COVID-2019 infections) [41] Updated 12 Oct 2020 |
| 07 Oct 2020 | Regulatory Status | XORTX Therapeutics submits pre-investigational new drug meeting package for Acute kidney injury (associated with COVID-2019 infections) to the US FDA before October 2020 [41] Updated 12 Oct 2020 |
| 19 May 2020 | Regulatory Status | XORTX Therapeutics plans to submit IND Application for XRx-101 for Acute kidney injury associated with COVID-2019 infections [5] Updated 26 May 2020 |
| 18 May 2020 | Regulatory Status | XORTX Therapeutics submits Coronavirus Treatment Acceleration Programme (CTAP) to the US FDA for XRx 101 and receives guidance to submit a pre-IND package for Acute kidney injury (associated with COVID-2019 infections) [5] Updated 04 Jan 2021 |
| 16 Mar 2020 | Phase Change - Preclinical | Preclinical trials in Acute kidney injury in USA (unspecified route) [44] Updated 08 May 2020 |
| 16 Mar 2020 | Phase Change - Preclinical | Preclinical trials in Acute lung injury (associated with COVID-2019 infections) in USA (unspecified route) [44] Updated 08 May 2020 |
| 16 Mar 2020 | Patent Information | XORTX Therapeutics files new intellectual property rights for XRx 101 for the treatment of respiratory and kidney disease due to viral infection [44] Updated 18 Mar 2020 |
| 16 Mar 2020 | Regulatory Status | XORTX Therapeutics plans to submit IND Application for XRx-008 for phase III trial in Autosomal dominant polycystic kidney disease [44] Updated 18 Mar 2020 |
| 16 Mar 2020 | Regulatory Status | XORTX Therapeutics receives approval letter from the US FDA for accelerating development of XRx 101 associated with COVID-2019 infections [44] Updated 18 Mar 2020 |
| 31 Jan 2020 | Licensing Status | Oxipurinol is available for licensing as of 31 Jan 2020 [52] . Updated 11 Feb 2020 |
| 03 May 2019 | Regulatory Status | XORTX Therapeutics plans to submit New Drug Application for XRx-008 for Autosomal dominant polycystic kidney disease [32] Updated 03 May 2019 |
| 30 Apr 2019 | Phase Change - II/III | Phase-II/III clinical trials in Autosomal dominant polycystic kidney disease in USA (unspecified route) (XORTX Therapeutics pipeline, May 2019) [32] Updated 03 May 2019 |
| 29 Apr 2019 | Trial Update | XORTX Therapeutics plans a pivotal phase III trial for Autosomal dominant polycystic kidney disease in February 2020 [32] Updated 03 May 2019 |
| 28 Mar 2019 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Autosomal-dominant-polycystic-kidney-disease in USA Updated 28 Mar 2019 |
| 26 Nov 2018 | Regulatory Status | XORTX Therapeutics received response letter from the US FDA for the orphan drug designation application for oxipurinol in Autosomal dominant polycystic kidney disease [11] Updated 28 Nov 2018 |
| 26 Nov 2018 | Trial Update | XORTX Therapeutics plans a phase II/III trial for Autosomal dominant polycystic kidney disease [11] Updated 28 Nov 2018 |
| 23 Oct 2018 | Regulatory Status | XORTX Therapeutics announces intention to submit NDA to the US FDA for Autosomal dominant polycystic kidney disease (ADPKD) [37] Updated 30 Oct 2018 |
| 23 Oct 2018 | Regulatory Status | XORTX Therapeutics intends to seek a special protocol assessment (SPA) from the FDA for its pivotal phase II/III trial for Autosomal dominant polycystic kidney disease (ADPKD) [37] Updated 30 Oct 2018 |
| 23 Oct 2018 | Regulatory Status | XORTX Therapeutics intends to file an IND application with the US FDA for Autosomal dominant polycystic kidney disease (ADPKD) [37] Updated 30 Oct 2018 |
| 10 Sep 2018 | Regulatory Status | XORTX applies for Orphan Drug status in Autosomal dominant polycystic kidney disease in USA [12] Updated 11 Sep 2018 |
| 08 Jun 2018 | Regulatory Status | XORTX Therapeutics plans a pre-IND meeting with US FDA for discussions related to a phase II trial of oxipurinol for treatment of Autosomal-dominant polycystic kidney disease in September 2018 [35] Updated 30 Oct 2018 |
| 08 Jun 2018 | Trial Update | XORTX Therapeutics plans a phase II trial of oxipurinol for treatment of Autosomal-dominant polycystic kidney disease [35] Updated 24 Jul 2018 |
| 08 Jun 2018 | Regulatory Status | XORTX Therapeutics and Cato Research file a pre-IND meeting request letter with the US FDA for Autosomal-dominant polycystic kidney disease [35] Updated 13 Jun 2018 |
| 10 Jan 2018 | Company Involvement | APAC Resources merged with XORTX Pharma and subsequently changed its name to XORTX Therapeutics Updated 16 Jan 2018 |
| 15 Feb 2016 | Phase Change - I | Phase I trials in Autosomal-dominant polycystic kidney disease in USA (unspecified route) Updated 15 Feb 2016 |
| 31 Dec 2014 | Patent Information | XORTX Therapeutics files for patent protection with Patent Cooperation Treaty (PCT) for XRx 008 [4] Updated 07 May 2020 |
References
-
APAC Resources Inc. and XORTX Pharma Corp. Announce Closing of Reverse Take-over, Financing, Consolidation and Name Change.
Media Release -
XORTX Provides Corporate Update.
Media Release -
XORTX Therapeutics Announces Submission of Clinical Trial Application to Conduct Bridging Pharmacokinetics Study.
Media Release -
XORTX Appoints Lonza for GMP Manufacturing and Formulation of XRx-101 (Oxypurinol) for Coronavirus / COVID-19 Clinical Trials.
Media Release -
XORTX Provides Program Update Regarding XRx-008 for ADPKD and XRx-101 for Coronavirus / COVID-19 Programs.
Media Release -
XORTX Highlights Achievements of 2023 and Preparation for Registration Clinical Trial.
Media Release -
XORTX Submits Orphan Drug Designation Application to the European Medicines Agency (EMA) to Treat Progressive Kidney Disease.
Media Release -
XORTX Announces Receipt of FDA Orphan Drug Designation to Treat Autosomal Dominant Kidney Disease.
Media Release -
XORTX Announces Submission of Orphan Drug Designation Request for XRx-008 Program to Treat Autosomal Dominant Kidney Disease.
Media Release -
XORTX Provides Overview and Update of Key Activities.
Media Release -
XORTX Receives FDA Response onOrphan Drug Designation Application.
Media Release -
XORTX Announces Submission of Orphan Drug Designation Application.
Media Release -
XORTX Provides Update on 2022 Achievements and 2023 Planned Milestones.
Media Release -
Registrational trial of XRx-008
ctiprofile -
FDA Confirms Eligibility of XORLO(Tm) for Accelerated Approval.
Media Release -
XORTX Announces Type D Meeting with FDA to be held May 1, 2023.
Media Release -
XORTX Completes Positive Pre-Phase 3 Meeting with the US Food and Drug Administration.
Media Release -
XORTX Announces Pre-Phase 3 Meeting Date with US Food and Drug Administration.
Media Release -
XORTX Announces Pre-Phase 3 Meeting Request with US Food and Drug Administration (FDA).
Media Release -
XORTX Receives Further No Objection Letter from Health Canada.
Media Release -
XORTX Receives No Objection Letter from Health Canada.
Media Release -
XORTX Announces Completion of Dosing in XRX-OXY-101 Clinical Study.
Media Release -
XORTX Announces Completion of Screening and Enrollment in Bridging Pharmacokinetics Study.
Media Release -
Altasciences Chosen by XORTX Therapeutics, Inc. to Conduct Pharmacokinetic Bridging Study XRX-OXY-101 in Support of Developing New Therapies for Progressive Kidney Disease and Acute Kidney Injury.
Media Release -
XORTX Therapeutics Appoints Altasciences as CRO for Clinical Study.
Media Release -
XORTX Announces Positive Topline Results from Part 2 Pharmacokinetics Bridging Study.
Media Release -
XORTX Opens an IND for XRx-008 Program for Autosomal Dominant Polycystic Kidney Disease.
Media Release -
Verona Pharma Completes Enrollment in ENHANCE-1 48-week Subset.
Media Release -
XORTX Files IND with US FDA.
Media Release -
Bridging pharmacokinetics study of XRx-008 for autosomal dominant polycystic kidney disease
ctiprofile -
XORTX Announces Positive Topline Results from XRX-OXY-101 Clinical Trial.
Media Release -
XORTX Provides Overview and Announces $5 Million Financing to Advance Clinical Trials.
Media Release -
A Phase III trial of XRx-008 in autosomal dominant polycystic kidney disease patients
ctiprofile -
XORTX Announces Submission to European Medicines Agency.
Media Release -
XORTX Announces Filing of FDA pre-IND Meeting Request Letter.
Media Release -
XORTX Submits FDA pre-IND Meeting Documents.
Media Release -
XORTX Announces Revision to Polycystic Kidney Disease Clinical Development Plan.
Media Release -
A phase II trial of oxipurinol in autosomal dominant polycystic kidney disease
ctiprofile -
XORTX Presents New Proof of Concept Data at American Society of Nephrology.
Media Release -
XORTX Therapeutics Reports Special Meeting Results.
Media Release -
XORTX Receives Positive Feedback from FDA on COVID-19 Related Acute Kidney Injury.
Media Release -
XORTX Files U.S. FDA Pre-IND Meeting Request for XRx-101 (Oxypurinol) COVID-19 Program and Pre-IND Meeting Submission.
Media Release -
XORTX Announces New Proof of Concept Data in Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Media Release -
XORTX Launches XRx-101, A New Program to Treat Coronavirus COVID-19 Infection.
Media Release -
XORTX Therapeutics Announces Closing of US$12 Million Public Offering.
Media Release -
XORTX Announces Notice to Grant European Patent.
Media Release -
XORTX Confirms $1 Million in Warrant Exercise Proceeds.
Media Release -
XORTX Announces Over Subscribed Private Placement.
Media Release -
XORTX Announces Increase to Private Placement.
Media Release -
XORTX Announces Private Placement.
Media Release -
XORTX Announces First Tranche Closing of Non-Brokered Private Placement.
Media Release -
XORTX Announces Re-Pricing of Private Placement.
Media Release -
XORTX Submits a New Patent for the Treatment of Chronic Kidney Disease.
Media Release -
XORTX Files New Provisional Patent to Diagnose and Treat Individuals Most at Risk of Polycystic Kidney Disease Progression.
Media Release -
XORTX Announces Grant of US Patent.
Media Release -
XORTX Files New PCT Patent to Treat and Protect Individuals Most at Risk to Severe Viral Infection.
Media Release -
XORTX Therapeutics Announces Filing of Provision Patent for Polycystic Kidney Disease.
Media Release -
XORTX Files New Provisional Patent to Treat and Protect Individuals Most at Risk to Severe Viral Infection.
Media Release -
XORTX Provides Corporate Update: 01-Feb-2022.
Media Release -
XORTX Announces Grant of European Patent.
Media Release -
XORTX Therapeutics Appoints Stacy Evans, M.D., MBA as Chief Business Officer.
Media Release -
Argus Research Initiates Equity Research Report Coverage on XORTX Therapeutics Inc. (Nasdaq: XRTX).
Media Release
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG