Oxylanthanum carbonate FDA Approval Status
Last updated by Judith Stewart, BPharm on Sep 4, 2024.
FDA Approved: No
Generic name: oxylanthanum carbonate
Company: Unicycive Therapeutics, Inc.
Treatment for: Hyperphosphatemia of Renal Failure
Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent in development for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.
- Hyperphosphatemia is a serious medical condition characterized by high serum phosphate levels. It is often a symptom of chronic kidney disease (CKD). If left untreated, hyperphosphatemia can lead to secondary hyperparathyroidism, which can cause renal osteodystrophy, and cardiovascular disease with associated hardening of arteries and atherosclerosis.
- Oxylanthanum carbonate works in the treatment of hyperphosphatemia by binding to phosphate to facilitate fecal elimination of dietary phosphate, rather than absorption from the gastrointestinal tract into the bloodstream.
- A New Drug Application has been submitted to the U.S. Food and Drug Administration (FDA) for oxylanthanum carbonate for the treatment of hyperphosphatemia in patients with CKD on dialysis. Unicycive is seeking FDA approval of oxylanthanum carbonate via the 505(b)(2) regulatory pathway.
- If approved, oxylanthanum carbonate will share substantially the same product label and prescribing information as the reference-listed drug Fosrenol (lanthanum carbonate), with the exception that oxylanthanum carbonate tablets are smaller in size and swallowed whole with water and not chewed.
Development timeline for oxylanthanum carbonate
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.