Unicycive Therapeutics is a clinical-stage biotech focused on developing drugs for kidney disease. Its lead asset is oxylanthanum carbonate (OLC), a next-generation phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis. Excess phosphorus is a common and serious complication in dialysis patients, and current binders require patients to chew or swallow large numbers of chalky tablets daily — driving poor adherence. OLC uses a nanoparticle formulation to deliver lanthanum-based phosphate binding in a small, swallowable tablet, reducing pill burden. Unicycive submitted an NDA in late 2024, received a Complete Response Letter citing a manufacturing issue at a third-party vendor, resolved the issue, and resubmitted in December 2025. The FDA accepted the resubmission with a PDUFA date of June 29, 2026, and a commercial launch in the first half of 2027 is the base case. In the U.S., Unicycive plans to sell OLC directly via a lean specialty sales force targeting high-volume prescribers, with a key focus on securing formulary placement at DaVita and Fresenius, which together treat the majority of U.S. dialysis patients. OLC is expected to qualify for TDAPA, a CMS program that provides separate reimbursement on top of the standard Medicare bundle for at least two years post-approval. Unicycive has also licensed OLC rights in Greater China and certain Asian markets to regional partners in exchange for milestones and royalties. The company's second asset, UNI-494, targets acute kidney injury but is deprioritized pending OLC's launch.