FDA Accepts Oxylanthanum Carbonate NDA Resubmission for Hyperphosphatemia in CKD Dialysis
The FDA has accepted the resubmitted New Drug Application for oxylanthanum carbonate (OLC), a high-potency lanthanum-based phosphate binder formulated as a small, swallowable pill, advancing it toward potential approval for hyperphosphatemia in dialysis patients with CKD.
What changed
This is a regulatory milestone: the FDA accepted the NDA resubmission for oxylanthanum carbonate as a treatment for hyperphosphatemia in patients with CKD on dialysis, moving the agent through the review pathway toward a possible approval decision. Acceptance of a resubmission indicates the application addressed prior review issues and is again under active FDA consideration.
Background
Hyperphosphatemia is nearly universal in dialysis-dependent CKD and is managed with dietary restriction plus oral phosphate binders, but existing binders suffer from high pill burden, large or chewable tablets, and gastrointestinal side effects that undermine adherence. OLC uses nanoparticle technology to deliver lanthanum — the highest phosphate-binding capacity among available binders — in a smaller pill that is swallowed whole rather than chewed, with minimal systemic lanthanum absorption.
Why it matters
In an open-label phase 2 trial of 86 maintenance hemodialysis patients, OLC was well tolerated and enabled serum phosphate control (target ≤5.5 mg/dL) in over 90% of patients, with most achieving this on three or fewer tablets per day; the most common treatment-related adverse events were gastrointestinal (diarrhea 9%, vomiting 6%) and only 4% discontinued for adverse events. If approved, OLC's low pill burden and swallowable formulation could improve adherence relative to existing phosphate binders, addressing a longstanding practical barrier in dialysis care.
Category
Regulatory
Source
FDA
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