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FDA Issues CRL to Oxylanthanum Carbonate for Hyperphosphatemia in CKD, Dialysis
The CRL cited deficiencies previously identified at a third-party manufacturing vendor unrelated to OLC, and the Company plans to request a Type A meeting.
The US Food and Drug Administration (FDA) has issued a Complete Response Letter to Unicycive Therapeutics’ New Drug Application for oxylanthanum carbonate for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.1
According to a June 30, 2025, press release from the company, the CRL cites deficiencies previously identified at a third-party manufacturing vendor unrelated to oxylanthanum carbonate with no other concerns stated, including pre-clinical, clinical, or safety data.1
“We plan to immediately seek a Type A meeting with the Agency to gain alignment on the best strategy to ensure rapid resolution of the CRL,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive, in a statement.1 “With a second manufacturing vendor identified that has produced OLC drug product, we remain optimistic about our ability to bring this promising new treatment option to patients with CKD on dialysis who are managing hyperphosphatemia, and we plan to provide an update as soon as we have additional clarity on next steps from the FDA.”
As referenced by Gupta and as part of its overall manufacturing strategy, the Company had previously identified a back-up third-party manufacturing vendor to build redundancy into its supply chain. According to Unicycive, the second vendor has a long history of successful FDA and international regulatory inspections and has already produced OLC drug product, which could also be used to support the resolution of the CMC issues identified in the CRL.1
Of note, following the NDA submission and as a part of the application review and routine information requests, the FDA notified the Company that a third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) was cited for deficiencies following a cGMP inspection. The vendor was one of Unicycive’s CDMO's third-party subcontractors and not its Drug Substance vendor, and the citation was unrelated to oxylanthanum carbonate. Unicycive also noted that as part of the NDA review, the FDA has not highlighted any other technical concerns related to the submitted CMC documentation or testing of oxylanthanum carbonate itself.1
At the time of the notification from the FDA, Unicycive indicated it had responded to all FDA information requests and did not anticipate any delays in a final decision from the Agency beyond the original PDUFA target action date of June 28, 2025.2
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 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 for patients in terms of number and size of pills per dose that are swallowed instead of chewed.1
The NDA submission package was based on data from 3 clinical studies, including a phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of oxylanthanum carbonate in CKD patients on dialysis, as well as multiple preclinical studies, and the CMC data.1
In April 2025, Unicycive announced patient-reported outcomes data from its phase 2 study of oxylanthanum carbonate for hyperphosphatemia in patients with CKD on dialysis as well as findings from a survey on top barriers to phosphate binder adherence among patients undergoing dialysis. The data were presented during poster sessions at the National Kidney Foundation (NKF) Spring Clinical Meetings and highlighted patients’ satisfaction with oxylanthanum carbonate compared to their prior phosphate lowering therapy as well as patient perspectives on the barriers phosphate binder pill size and count pose to consistent medication use.3
Looking ahead, the second manufacturing vendor has already produced the oxylanthanum carbonate drug product and could also be used to support the resolution of the CMC issues identified in the CRL. Additionally, the company indicated plans to immediately request a Type A meeting with the FDA to align on next steps.1
References
Unicycive Therapeutics. Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis. June 30, 2025. Accessed June 30, 2025. https://ir.unicycive.com/news/detail/104/unicycive-therapeutics-announces-receipt-of-complete.
Unicycive Therapeutics. Unicycive Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis. June 10, 2025. Accessed June 26, 2025. https://ir.unicycive.com/news/detail/102/unicycive-provides-update-on-new-drug-application-for.
Brooks A. Oxylanthanum Carbonate May Offer Desirable Alternative to Current Phosphate Binders. HCPLive. April 10, 2025. Accessed June 26, 2025. https://www.hcplive.com/view/oxylanthanum-carbonate-may-offer-desirable-alternative-current-phosphate-binders.
