Unicycive Therapeutics Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology
Unicycive Therapeutics (Nasdaq: UNCY) announced the publication of pivotal trial data for oxylanthanum carbonate (OLC) in the Clinical Journal of the American Society of Nephrology. The Phase 2 clinical trial demonstrated that OLC effectively controlled serum phosphate levels in over 90% of chronic kidney disease (CKD) patients on dialysis with hyperphosphatemia.
The study, involving 86 patients, showed that two-thirds of participants achieved target phosphate levels with three or fewer tablets daily. The treatment demonstrated minimal to no systemic absorption and was well-tolerated, with only 4% of patients discontinuing due to treatment-related adverse events. The most common side effects were gastrointestinal, including diarrhea (9%) and vomiting (6%).
Unicycive Therapeutics (Nasdaq: UNCY) ha annunciato la pubblicazione dei dati dello studio fondamentale sull'oxilanthanum carbonate (OLC) nel Clinical Journal of the American Society of Nephrology. Lo studio di Fase 2 ha dimostrato che l'OLC controlla efficacemente i livelli sierici di fosfato in oltre il 90% dei pazienti con malattia renale cronica (CKD) in dialisi affetti da iperfosfatemia.
Lo studio, che ha coinvolto 86 pazienti, ha evidenziato che due terzi dei partecipanti hanno raggiunto i livelli target di fosfato assumendo tre o meno compresse al giorno. Il trattamento ha mostrato un'assorbimento sistemico minimo o nullo ed è stato ben tollerato, con solo il 4% dei pazienti che ha interrotto la terapia a causa di eventi avversi correlati al trattamento. Gli effetti collaterali più comuni sono stati di natura gastrointestinale, tra cui diarrea (9%) e vomito (6%).
Unicycive Therapeutics (Nasdaq: UNCY) anunció la publicación de los datos del ensayo pivotal para oxilanthanum carbonate (OLC) en el Clinical Journal of the American Society of Nephrology. El ensayo clínico de Fase 2 demostró que el OLC controló eficazmente los niveles séricos de fosfato en más del 90% de los pacientes con enfermedad renal crónica (ERC) en diálisis con hiperfosfatemia.
El estudio, que involucró a 86 pacientes, mostró que dos tercios de los participantes alcanzaron los niveles objetivo de fosfato con tres o menos tabletas diarias. El tratamiento presentó una absorción sistémica mínima o nula y fue bien tolerado, con solo el 4% de los pacientes que interrumpió debido a eventos adversos relacionados con el tratamiento. Los efectos secundarios más comunes fueron gastrointestinales, incluyendo diarrea (9%) y vómitos (6%).
Unicycive Therapeutics (나스닥: UNCY)는 Clinical Journal of the American Society of Nephrology에 옥실란타늄 카보네이트(OLC)의 중추 임상시험 데이터를 발표했다고 밝혔다. 2상 임상시험에서 OLC는 투석 중인 만성 신장 질환(CKD) 환자 중 90% 이상에서 혈청 인 수치를 효과적으로 조절하는 것으로 나타났다.
총 86명의 환자가 참여한 이 연구에서 참가자의 3분의 2가 하루 3정 이하 복용으로 목표 인 수치에 도달했다. 이 치료는 전신 흡수가 거의 없거나 전혀 없었으며, 치료 관련 부작용으로 인해 4%의 환자만 치료를 중단했다. 가장 흔한 부작용은 위장 관련으로 설사(9%)와 구토(6%)였다.
Unicycive Therapeutics (Nasdaq : UNCY) a annoncé la publication des données de l'essai pivot concernant l'oxylanthanum carbonate (OLC) dans le Clinical Journal of the American Society of Nephrology. L'essai clinique de phase 2 a démontré que l'OLC contrôlait efficacement les niveaux sériques de phosphate chez plus de 90 % des patients atteints de maladie rénale chronique (MRC) sous dialyse présentant une hyperphosphatémie.
L'étude, impliquant 86 patients, a montré que deux tiers des participants atteignaient les niveaux cibles de phosphate avec trois comprimés ou moins par jour. Le traitement a présenté une absorption systémique minimale voire nulle et a été bien toléré, avec seulement 4 % des patients ayant arrêté le traitement en raison d'effets indésirables liés au traitement. Les effets secondaires les plus courants étaient gastro-intestinaux, incluant diarrhée (9 %) et vomissements (6 %).
Unicycive Therapeutics (Nasdaq: UNCY) gab die Veröffentlichung der entscheidenden Studiendaten zu Oxylanthanumcarbonat (OLC) im Clinical Journal of the American Society of Nephrology bekannt. Die Phase-2-Studie zeigte, dass OLC bei über 90 % der Dialysepatienten mit chronischer Nierenerkrankung (CKD) und Hyperphosphatämie die Serumphosphatwerte effektiv kontrollierte.
Die Studie mit 86 Patienten ergab, dass zwei Drittel der Teilnehmer mit drei oder weniger Tabletten täglich die Zielphosphatwerte erreichten. Die Behandlung zeigte eine minimale bis keine systemische Absorption und wurde gut vertragen, wobei nur 4 % der Patienten die Therapie aufgrund behandlungsbedingter Nebenwirkungen abbrachen. Die häufigsten Nebenwirkungen waren gastrointestinale Beschwerden, darunter Durchfall (9 %) und Erbrechen (6 %).
- None.
- 9% of patients experienced diarrhea as a treatment-related adverse event
- 6% of patients experienced vomiting as a treatment-related adverse event
Insights
Unicycive's OLC shows strong efficacy and reduced pill burden for dialysis patients with hyperphosphatemia, advancing toward potential FDA approval.
The pivotal Phase 2 trial results for oxylanthanum carbonate (OLC) represent a significant clinical advancement in hyperphosphatemia management. The study demonstrated that over 90% of chronic kidney disease patients on dialysis achieved target serum phosphate levels (≤5.5 mg/dL), compared to only 59% at screening. This substantial improvement in phosphate control addresses a critical need in nephrology care.
What stands out most is the reduced pill burden - two-thirds of patients required ≤3 tablets daily, with most needing just one tablet per meal. This is remarkably lower than current phosphate binders that often require 9-12 pills daily, which directly impacts long-term adherence and effectiveness. The minimal systemic absorption demonstrated in pharmacokinetic analysis suggests a favorable safety profile for long-term use.
The adverse event profile appears manageable, with primarily gastrointestinal side effects (9% diarrhea, 6% vomiting) and only 4% discontinuation rate due to treatment-related events. These tolerability metrics compare favorably to existing phosphate binders, which often cause significant GI distress.
From a clinical perspective, hyperphosphatemia remains one of the most challenging aspects of managing dialysis patients, contributing to cardiovascular complications, mineral bone disorders, and increased mortality. OLC's high efficacy combined with simplified dosing could significantly improve clinical outcomes by enhancing medication adherence - a persistent problem with current treatments requiring high pill counts.
This publication represents a critical regulatory milestone for Unicycive's lead asset. The company explicitly states these results constitute "the final clinical evidence needed for our NDA package," indicating they're pursuing FDA approval based on this Phase 2 data rather than conducting a larger Phase 3 trial - a potential accelerated pathway to market.
The competitive positioning appears strong: OLC demonstrates >90% efficacy with substantially fewer pills than market leaders. Current phosphate binders like sevelamer and lanthanum carbonate typically require multiple pills with each meal, creating a clear differentiation opportunity for OLC with its 1-3 daily pill regimen.
The reference to "outstanding manufacturing questions" with the FDA suggests the company is already in late-stage regulatory discussions. While manufacturing challenges could potentially delay approval, the company's language indicates these are addressable issues rather than fundamental concerns about efficacy or safety.
For this
Publication in the prestigious Clinical Journal of the American Society of Nephrology provides important validation for OLC's clinical profile. The endorsement from Dr. Pergola, a recognized key opinion leader in nephrology, further strengthens the clinical narrative and potential for favorable reception among prescribers if approved.
OLC was well-tolerated and enabled serum phosphate control in over
LOS ALTOS, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the publication of pivotal trial data describing the safety and tolerability of oxylanthanum carbonate (OLC) in chronic kidney disease (CKD) patients on dialysis in the Clinical Journal of the American Society of Nephrology.
The publication, entitled “A Phase 2 Clinical Trial of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia,” examines the safety and tolerability of OLC at clinically effective doses with a goal serum phosphate concentration of ≤5.5 mg/dL. Eighty-six patients were treated with OLC in this open-label single arm Phase 2 study. At screening, only
“With the favorable tolerability, strong efficacy and low pill burden highlighted in this prestigious publication, we continue to believe that OLC has the potential to offer patients a new option that could help improve adherence to treatment over time,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This pivotal study was the final clinical evidence needed for our NDA package. We continue to collaborate closely with the U.S. Food and Drug Administration as we address their outstanding manufacturing questions and align on a path forward to bring OLC to this underserved patient population as quickly as possible.”
Key Findings:
- More than
90% of patients with hyperphosphatemia taking OLC achieved effective phosphate control. - Two-thirds of patients required three or fewer OLC tablets per day to achieve target serum phosphate levels, with most requiring no more than one tablet with each meal.
- OLC was well tolerated in CKD patients on dialysis. The most common treatment-related adverse events were gastrointestinal (
9% diarrhea;6% vomiting) and only4% of patients discontinued treatment due to treatment-related adverse events.
“Despite the various treatment options available, there remains a significant need in managing hyperphosphatemia, which heavily impacts people with chronic kidney disease on dialysis,” said Dr. Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator of the trial. “These data add to the growing body of clinical evidence supporting the potential of OLC as an innovative treatment option, demonstrating effective phosphate control and reducing pill burden. OLC’s unique profile offers a promising alternative with favorable tolerability, potentially transforming the standard of care for patients.”
The full publication can be accessed here and on the Presentations & Research page of Unicycive’s website.
About Oxylanthanum Carbonate (OLC)
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145. Epub 2023 Jun 29. PMID: 37229723; PMCID: PMC10371371.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted Orphan Drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contacts:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Media Contact:
Rachel Visi
Real Chemistry
redery@realchemistry.com
SOURCE: Unicycive Therapeutics, Inc.
FAQ
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