Unicycive Resubmits NDA for Oxylanthanum Carbonate With Data From New Manufacturing Vendor
核心洞察
Unicycive Therapeutics has resubmitted its New Drug Application for oxylanthanum carbonate, an oral phosphate binder for hyperphosphatemia (搜索) in chronic kidney disease (搜索) patients on dialysis.
The resubmission adds chemistry, manufacturing and controls data from a new third-party drug product vendor, including 12-month stability data and in-vitro bridging data.
The FDA is expected to accept the NDA within 30 days, with a new PDUFA date anticipated six months from resubmission.
Unicycive Therapeutics announced on Sept. 29, 2026 that it has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC), its investigational oral phosphate binder for the treatment of hyperphosphatemia (搜索) in patients with chronic kidney disease (搜索) (CKD) on dialysis. The Mountain View, California-based company said it anticipates FDA acceptance of the NDA within 30 days of resubmission, with a new assigned PDUFA date expected six months from the date of resubmission.
The resubmission package includes Chemistry, Manufacturing, and Controls (CMC) data from a new third-party drug product manufacturing vendor. That facility was last inspected by the FDA in March 2024 and received "No Action Indicated" status, the agency's highest inspection classification, indicating the facility is in an acceptable state of current Good Manufacturing Practices (cGMP) compliance.
According to Unicycive, the new vendor's CMC data package contains technical specifications similar to those of the original third-party manufacturing vendor, and the new vendor has already produced OLC drug product and completed 12-month stability studies. The company also provided additional in-vitro bridging data between the two vendors, as recommended by the FDA in previous discussions.
Regulatory History
The resubmission follows two Complete Response Letters (CRLs) tied to manufacturing rather than clinical data. In June 2026, the company received a CRL regarding its first OLC NDA resubmission. That letter cited the same third-party manufacturing deficiencies identified in a CRL issued in June 2025 to the initial NDA submission, a result of the FDA not having conducted the reinspection of the original third-party manufacturing vendor. Unicycive stated that the FDA did not raise concerns regarding clinical efficacy or safety data and did not request additional data from the company.
The original third-party manufacturing vendor has received written notification from the FDA that its facility inspection has been assigned, but the inspection had not occurred as of Sept. 29, 2026. If that vendor is inspected in the near term and deemed cGMP-compliant, Unicycive plans to seek FDA alignment on a shorter approval timeline for the OLC NDA resubmission. The company intends to keep both drug product vendors to maintain supply chain redundancy.
"We believe this resubmission reflects an efficient path to potential approval and, if approved, a potentially faster path to bringing OLC to patients who need additional treatment options," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. "By adding an alternative primary manufacturing vendor, we are positioning the NDA for expedient review and potential approval. If the FDA's assigned inspection of the original vendor is completed favorably in the interim, that outcome could provide a potential timing benefit."
Clinical Data Package and Product Profile
The NDA is supported by 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, along with multiple preclinical studies and CMC data.
OLC is an investigational oral phosphate binder that uses proprietary nanoparticle technology intended to deliver high phosphate binding potency, reducing the number and size of pills patients must take to treat hyperphosphatemia (搜索) in CKD patients on dialysis. Unicycive states that its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options because it requires a lower pill burden. The company is seeking FDA approval of OLC through the 505(b)(2) regulatory pathway. OLC is protected by a global patent portfolio including issued composition-of-matter patents with exclusivity until 2031, with the potential for patent term extension until 2035.
Hyperphosphatemia Burden and Treatment Approach
Hyperphosphatemia (搜索) occurs in nearly all patients with End Stage Renal Disease (搜索) (ESRD). More than 450,000 individuals in the United States require medication annually to control their phosphate levels. Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis.
Treatment of hyperphosphatemia (搜索) aims to lower serum phosphate levels through two means: restricting dietary phosphorus intake, and using oral phosphate binding drugs daily with each meal to facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
Pipeline and Financial Position
Unicycive's second investigational treatment, UNI-494, is intended for conditions related to acute kidney injury (搜索). It has been granted orphan drug designation by the FDA for the prevention of Delayed Graft Function (搜索) (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers.
As of June 30, 2026, unaudited cash, cash equivalents and marketable securities totaled $61.4 million, which the company says supports continued OLC commercial launch preparation and an expected cash runway into the second half of 2027.