Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
Unicycive Therapeutics announced FDA acceptance of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA set a PDUFA target date of June 28, 2025. OLC aims to reduce treatment burden by requiring fewer and smaller pills that can be swallowed rather than chewed. The NDA submission includes data from three clinical studies and is seeking approval via the 505(b)(2) pathway. The company received an FDA fee waiver, saving approximately $4 million, and is preparing for commercial launch in second half of 2025 if approved.
Unicycive Therapeutics ha annunciato l'accettazione da parte della FDA della sua Domanda di Nuovo Farmaco (NDA) per Oxylanthanum Carbonate (OLC) per il trattamento dell'iperfosfatemia nei pazienti con malattia renale cronica in dialisi. La FDA ha fissato una data obiettivo PDUFA per il 28 giugno 2025. OLC punta a ridurre l'onere del trattamento richiedendo meno pillole, di dimensioni più piccole, che possano essere ingerite invece di masticate. La submission dell'NDA include dati provenienti da tre studi clinici e cerca approvazione attraverso il percorso 505(b)(2). L'azienda ha ricevuto un'esenzione dalle tasse dalla FDA, risparmiando circa 4 milioni di dollari, e si sta preparando per il lancio commerciale nella seconda metà del 2025, se approvata.
Unicycive Therapeutics anunció la aceptación de su solicitud de nuevo fármaco (NDA) por parte de la FDA para Oxylanthanum Carbonate (OLC) para tratar la hiperfosfatemia en pacientes con enfermedad renal crónica en diálisis. La FDA estableció una fecha objetivo PDUFA del 28 de junio de 2025. OLC busca reducir la carga del tratamiento al requerir menos pastillas y de menor tamaño que pueden ser tragadas en lugar de masticadas. La presentación de la NDA incluye datos de tres estudios clínicos y busca aprobación a través de la vía 505(b)(2). La empresa recibió una exención de tarifas de la FDA, ahorrando aproximadamente 4 millones de dólares, y se está preparando para un lanzamiento comercial en la segunda mitad de 2025, si se aprueba.
유니사이브 테라퓨틱스가 FDA로부터 옥실란타늄 탄산염(OLC)의 신약 신청(NDA) 승인을 받았다고 발표했습니다. 이는 투석 중인 만성 신장 질환 환자의 고인산혈증을 치료하기 위한 것입니다. FDA는 PDUFA 목표 날짜를 2025년 6월 28일로 정했습니다. OLC는 소량의 작은 알약을 씹는 대신 삼키도록 요구하여 치료 부담을 줄이는 것을 목표로 하고 있습니다. NDA 제출에는 세 가지 임상 연구의 데이터가 포함되어 있으며, 505(b)(2) 경로를 통해 승인을 요청하고 있습니다. 회사는 약 400만 달러를 절감한 FDA 수수료 면제를 받았으며, 승인이 된다면 2025년 하반기에 상업 출시를 준비하고 있습니다.
Unicycive Therapeutics a annoncé l'acceptation de sa Demande de Nouveau Médicament (NDA) par la FDA pour l'Oxylanthane Carbonate (OLC) afin de traiter l'hyperphosphatémie chez les patients atteints de maladie rénale chronique sous dialyse. La FDA a fixé une date cible PDUFA au 28 juin 2025. L'OLC vise à réduire le fardeau du traitement en nécessitant moins de pilules plus petites qui peuvent être avalées plutôt que mastiquées. La soumission de la NDA comprend des données de trois études cliniques et recherche une approbation par le biais de la voie 505(b)(2). L'entreprise a reçu une exonération des frais de la FDA, économisant environ 4 millions de dollars, et se prépare à un lancement commercial dans la seconde moitié de 2025 si elle est approuvée.
Unicycive Therapeutics hat die Akzeptanz ihrer Zulassungsanträge für ein neues Arzneimittel (NDA) durch die FDA für Oxylanthanum Carbonate (OLC) zur Behandlung der Hyperphosphatämie bei Patienten mit chronischer Nierenerkrankung in Dialyse bekannt gegeben. Die FDA hat ein Zieltermin für PDUFA auf den 28. Juni 2025 festgelegt. OLC zielt darauf ab, die Behandlungsbelastung zu reduzieren, indem weniger und kleinere Tabletten erforderlich sind, die geschluckt anstatt gekaut werden können. Die NDA-Einreichung umfasst Daten aus drei klinischen Studien und strebt eine Genehmigung über den 505(b)(2) Weg an. Das Unternehmen erhielt eine Befreiung von der FDA-Gebühr, wodurch etwa 4 Millionen Dollar gespart wurden, und bereitet sich auf die kommerzielle Einführung in der zweiten Hälfte des Jahres 2025 vor, sofern genehmigt.
- FDA accepted NDA for OLC with PDUFA date set for June 28, 2025
- FDA granted PDUFA fee waiver, saving approximately $4 million
- Strong patent protection until 2031, with potential extension to 2035
- Product offers competitive advantages: lower pill burden and swallowable vs. chewable tablets
- None.
Insights
The FDA's acceptance of Unicycive's NDA for Oxylanthanum Carbonate (OLC) represents a significant regulatory milestone in the hyperphosphatemia treatment landscape. The drug's potential market advantage lies in its reduced pill burden and swallowable format, addressing a critical adherence challenge in dialysis patients who currently take up to 12 pills daily.
The 505(b)(2) pathway choice is strategically sound, potentially reducing development costs and time to market. The robust patent protection until 2031 (extendable to 2035) provides a substantial commercialization window. The PDUFA fee waiver of
Key success factors include:
- Three completed clinical studies demonstrating safety and efficacy
- Comprehensive CMC data package
- Strong intellectual property protection
- Clear competitive advantage in patient compliance
This regulatory milestone significantly derisks Unicycive's lead asset and provides a clear pathway to commercialization. For a company with a market cap of only
The hyperphosphatemia market represents a substantial commercial opportunity, with current treatments generating hundreds of millions in annual sales. OLC's potential market entry in H2 2025 could capture significant market share due to its improved compliance profile. The strong patent protection ensures a lengthy period of market exclusivity, critical for ROI potential.
– FDA sets PDUFA Action Date of June 28, 2025
– Company Preparing for 2025 Commercial Launch –
LOS ALTOS, Calif., Nov. 11, 2024 (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 that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If approved, OLC has the potential to meaningfully improve the treatment burden for hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis.
“We are thrilled with the FDA acceptance of our first NDA, a significant milestone towards our efforts to bring this important treatment option to patients with kidney disease if approved,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “CKD patients on dialysis with hyperphosphatemia are often saddled with an onerous treatment regimen that includes having to take as many as 12 pills per day. OLC may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of the number and size of pills per dose, and the pills are swallowed instead of chewed for added convenience. With our NDA now under review, we are preparing to commercialize and launch OLC in the second half of 2025, if approved.”
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.
As previously announced, the FDA granted a waiver for the NDA application PDUFA fees, representing a significant savings of approximately
About Oxylanthanum Carbonate (OLC)
Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. OLC has over thirty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is expected to exceed
1Reason Research, LLC 2022 survey. Results here.
2Fortune Business InsightsTM, Hyperphosphatemia Treatment Market, 2021-2028
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over
Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. 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.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.
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, 2023, 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.
FOR MORE INFORMATION, PLEASE CONTACT:
Investors:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com
SOURCE: Unicycive Therapeutics, Inc.
FAQ
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