UNI-494 Receives US Patent for Treatment of Chronic Kidney Disease

UNI-494 (Unicycive Therapeutics) was issued a US patent for the treatment of chronic kidney disease (CKD), according to a news release from the manufacturer. This patent follows the issuance of an earlier method of use patent for the treatment of acute kidney injury (AKI) with UNI-494.¹

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“While we are focused on seeking FDA approval of our lead product, oxylanthanum carbonate, we are pleased to announce the issuance of another patent for our second investigational drug, UNI-494,” Shalabh Gupta, MD, CEO of Unicycive Therapeutics, said in a news release. “This patent is part of a broader intellectual property portfolio for UNI-494, which supports potential partnership opportunities and future development efforts. We have completed a phase 1 clinical study in healthy volunteers and have received [an] orphan drug designation for the prevention of delayed graft function in patients undergoing kidney transplantation.”¹

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a significant role in the progression of both CKD and AKI, explained the manufacturers. UNI-494’s mechanism of action restores mitochondrial function, meaning it can be beneficial for the treatment of these diseases alongside other kidney-related conditions. Previously, UNI-494 received an orphan drug designation for the prevention of delayed graft function in patients who received kidney transplants. Of note, it completed a phase 1 dose-ranging safety study.^1,2

Further, prior research demonstrates that a single intravenous dose of 10 mg/kg of UNI-494 at 1 or 4 hours following ischemia significantly reduced kidney functional markers and tubular injury scores, suggesting that the therapy slows down—and possibly reverses—the progression of AKI in its established state.³

In addition, another study showed that a single dose of 10 to 160 mg of UNI-494 was safe and well-tolerated by healthy participants. It was rapidly converted to nicorandil, and exposure increased in a dose-proportional manner. Of note, therapeutic levels of nicorandil were observed to be achieved at 60 mg (area under curve: > 200 hour*ng/mL). With these findings, a phase 2 portion of the trial was initiated to determine the dose and schedule of UNI-494 when treating patients with AKI.⁴

“We are pleased to announce the successful completion of the UNI-494 phase 1 study that informs our next steps for advancement to a potential phase 2 clinical trial in patients with acute kidney injury,” said Gupta in a previous news release. “This is an important milestone for the clinical development of UNI-494, as it provides the necessary dosing and tolerability data to progress the program. We plan to request a meeting with the FDA before the end of the year to review these phase 1 results and a potential phase 2 study design. We would like to extend our gratitude to the trial investigator and participants who committed their time and effort to the study.”⁵

REFERENCES

1. Unicycive Therapeutics. Unicycive Therapeutics Granted New U.S. Patent for UNI-494 to Treat Chronic Kidney Disease. News release. August 18, 2025. Accessed August 18, 2025. https://ir.unicycive.com/news/detail/109/unicycive-therapeutics-granted-new-u-s-patent-for-uni-494

2. Unicycive Therapeutics. Innovative potential for renal disease and beyond with UNI-494. Accessed August 18, 2025. https://unicycive.com/uni-494/

3. Unicycive Therapeutics. EC Pharmacology and Toxicology: Evaluation of UNI-494 in Acute Kidney Injury Treatment Efficacy When Administered After Ischemia-Reperfusion in a Rat Model. News release. October 28, 2024. Accessed August 18, 2025. https://unicycive.com/evaluation-of-uni-494-in-acute-kidney-injury-treatment-efficacy/

4. Unicycive Therapeutics. UNI-494 Phase I Safety, Tolerability, and Pharmacokinetics. October 27, 2024. Accessed August 18, 2025. https://unicycive.com/uni-494-phase-1-safety-tolerability-and-pharmacokinetics/

5. GlobeNewswire. Unicycive Therapeutics Successfully Completes UNI-494 Phase 1 Study in Healthy Volunteers. News release. October 9, 2024. Accessed August 18, 2025. https://www.globenewswire.com/news-release/2024/10/09/2960387/0/en/Unicycive-Therapeutics-Successfully-Completes-UNI-494-Phase-1-Study-in-Healthy-Volunteers.html