Carbonate ion

Unicycive Therapeutics announced FDA accepted its NDA for Oxylanthanum Carbonate (OLC), setting a PDUFA action date of June 28, 2025. OLC aims to improve treatment burden for hyperphosphatemia patients with CKD on dialysis, potentially offering better adherence benefits. The company is preparing for a 2025 commercial launch if approved.

USFDA accepted Unicycive's NDA for Oxylanthanum Carbonate (OLC), targeting a PDUFA date of June 28, 2025. OLC aims to reduce pill burden for CKD dialysis patients with hyperphosphatemia, potentially improving adherence. Unicycive plans to commercialize OLC in the US in H2 2025, partnering with Shilpa Medicare for supply.

Unicycive Therapeutics announces FDA acceptance of OLC NDA with PDUFA date of June 28, 2025, and plans for 2025 commercial launch. Successful completion of UNI-494 Phase 1 trial and progress on OLC commercial planning highlighted.

The FDA is reviewing Unicycive Therapeutics' oxylanthanum carbonate (OLC) for hyperphosphataemia in CKD dialysis patients, aiming to improve on current phosphate binder therapy. OLC requires fewer and smaller pills, potentially enhancing patient adherence. A survey highlighted the need for lower pill burden and better compliance. The global hyperphosphataemia market is $2.5 billion, with 75% of patients failing to meet serum phosphorus targets. Unicycive filed OLC under the 505(b)(2) pathway, requiring only three clinical trials.

Unicycive Therapeutics announced FDA acceptance of Oxylanthanum Carbonate (OLC) NDA, targeting PDUFA date of June 28, 2025. OLC aims to improve hyperphosphatemia treatment for CKD dialysis patients, with potential commercial launch in H2 2025. The NDA is based on clinical, preclinical, and CMC data, and OLC is protected by patents until 2031, extendable to 2035. The FDA waived NDA PDUFA fees, saving Unicycive ~$4M.

Unicycive Therapeutics announced FDA acceptance of the NDA for Oxylanthanum Carbonate (OLC) for hyperphosphatemia treatment in CKD patients on dialysis, with a PDUFA action date of June 28, 2025. OLC, offering a lower pill burden and better patient compliance, could significantly improve treatment. Unicycive is preparing for a 2025 commercial launch, pending approval.

Unicycive Therapeutics announced the FDA acceptance of their New Drug Application for Oxylanthanum Carbonate (OLC) to treat hyperphosphatemia in CKD dialysis patients, with a PDUFA target action date of June 28, 2025. OLC aims to reduce pill burden and improve patient compliance, potentially addressing a $2.5 billion global market.

Unicycive Therapeutics announced FDA acceptance of its NDA for Oxylanthanum Carbonate (OLC), targeting hyperphosphatemia in CKD patients on dialysis, with a PDUFA date of June 28, 2025. OLC offers a lower pill burden, potentially improving patient adherence. The company prepares for a 2025 commercial launch, supported by a strong patent portfolio and significant PDUFA fee savings.

Unicycive Therapeutics' FDA application for oxylanthanum carbonate, targeting hyperphosphatemia in chronic kidney disease patients on dialysis, was accepted with a June 28, 2025, action date. The drug aims to reduce pill burden, with commercialization planned for late 2025.

Unicycive Therapeutics announced FDA acceptance of its NDA for Oxylanthanum Carbonate (OLC), targeting hyperphosphatemia in CKD patients on dialysis, with a PDUFA action date of June 28, 2025. OLC, protected by patents until at least 2031, could launch in late 2025 if approved. The FDA waived $4M in PDUFA fees.