The FDA has started a review of Unicycive Therapeutics' drug for hyperphosphataemia in patients with chronic kidney disease (CKD) who need dialysis, which hopes to improve on 'onerous' phosphate binder therapy.The US regulator is due to deliver a verdict on Unicycive's oxylanthanum carbonate (OLC) candidate by 28th June, potentially giving the Los Altos, California-based company its first approved product.OLC is being developed as a more patient-friendly alternative to Takeda's phosphate binder Fosrenol (lanthanum carbonate), which is sold in a large chewable tablet formulation, while other drugs in the class can require patients to take as many as 12 pills per day.In contrast, Unicycive's drug requires fewer and smaller pills to be taken and can be swallowed whole with water, and according to the company's chief executive Shalabh Gupta that could offer 'meaningful patient adherence benefits.' The company hopes to get approval for a dose of one tablet – similar in size to a regular-strength aspirin – three times per day.In a survey commissioned by Unicycive that was conducted in 2022, kidney disease specialists said that the greatest unmet need in the treatment of hyperphosphataemia with phosphate binders is a lower pill burden and better patient compliance.A high phosphate level in the blood is a common complication of CKD, particularly affecting patients on dialysis.

FDA已经开始审查Uniycive Therapeutics治疗需要透析的慢性肾病（CKD）患者高磷血症的药物，希望改善“繁重”的磷酸盐粘合剂治疗。美国监管机构将于6月28日前对Unicycive的碳酸氧镧（OLC）候选产品做出裁决，这有可能使这家总部位于加利福尼亚州洛斯阿尔托斯的公司获得首个获批产品。OLC正在开发成为武田磷酸盐粘合剂Fosrenol（碳酸镧）的一种更利于患者的替代品，武田磷酸盐粘合剂Fosrenol（碳酸镧）以大型咀嚼片剂的形式销售，而该类其他药物可能要求患者每天服用多达12片药片。相比之下，Unicycive的药物需要服用的药片越来越少，可以用水整片吞咽，该公司首席执行官沙拉布·古普塔（ShalabhGupta）表示，这种药物可以提供“有意义的患者依从性益处”该公司希望获得批准，每天三次服用一片与常规剂量阿司匹林大小相似的片剂。在2022年由Unicycive委托进行的一项调查中，肾脏疾病专家表示，用磷酸盐结合剂治疗高磷血症的最大未满足需求是降低药丸负担和改善患者依从性。血液中的高磷酸盐水平是CKD的常见并发症，尤其影响透析患者。

In severe cases, it can cause bone and muscle problems as well as increase the risk of heart attacks and strokes.The global market for hyperphosphataemia therapies is around $2.5 billion, of which $1.1 billion comes from the US where there are more than half a million patients on dialysis and around 400,000 on phosphate binders.Despite the availability of six FDA-approved phosphate binders, around 75% of .

在严重的情况下，它会导致骨骼和肌肉问题，并增加心脏病发作和中风的风险。高磷血症治疗的全球市场约为25亿美元，其中11亿美元来自美国，美国有50多万透析患者，约40万磷酸盐结合剂患者。尽管有六种FDA批准的磷酸盐粘合剂，但约有75%。