Lanthanum carbonate
- Generic Name
- Lanthanum carbonate
- Brand Names
- Fosrenol
- Drug Type
- Small Molecule
- Chemical Formula
- C3La2O9
- CAS Number
- 587-26-8
- Unique Ingredient Identifier
- 0M78EU4V9H
- Background
Lanthanum carbonate is a phosphate binder commonly used in clinical practice. It is marketed under the trade name Fosrenol by Shire Pharmaceuticals. It is the largest of all pills filled in community pharmacies. Sometimes patients forget that Fosrenol is not swallowed whole, but instead should be chewed. This has led to severe choking. It is prescribed for treating high phosphate levels, mainly found in patients with chronic kidney disease. Lanthanum should be taken with meals and binds to phosphate in the diet, preventing phosphate absorption in the intestine.
- Indication
Used to reduce serum phosphate in patients with end stage renal disease (ESRD).
- Associated Conditions
- Hyperphosphataemia
Unicycive and ORIC Pharmaceuticals Receive Buy Ratings Based on Promising Clinical Data
• Unicycive Therapeutics' OLC shows promise in treating hyperphosphatemia by reducing pill burden and adverse events, potentially gaining FDA approval by June 2025.
• ORIC Pharmaceuticals' ORIC-944, combined with apalutamide, demonstrates significant PSA level decreases in metastatic castration-resistant prostate cancer patients.
• Durability of ORIC-944 responses, with some patients maintaining PSA90 responses for 38 weeks, supports confidence in Oric Pharmaceuticals' strategic advancements.
• H.C. Wainwright analyst Ed Arce maintains a Buy rating on Unicycive with a $4.00 price target, while Robert Burns reiterates a Buy rating on Oric with a $21.00 target.
Unicycive's Hyperphosphatemia Drug, Oxylanthanum Carbonate, Awaits FDA Decision in June
• Unicycive Therapeutics' oxylanthanum carbonate (OLC) is under FDA review for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
• OLC aims to improve patient adherence with fewer, smaller, and easier-to-swallow pills compared to existing phosphate binders like Takeda's Fosrenol.
• Clinical trial data showed that 69% of evaluable patients achieved target serum phosphate levels with OLC at a dose of 500mg three times daily.
• The FDA is expected to make a decision on OLC by June 28, potentially marking Unicycive's first approved product in a market with significant unmet needs.
Unicycive's OLC Receives FDA Acceptance for Hyperphosphatemia NDA
• The FDA has accepted Unicycive Therapeutics' New Drug Application for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis.
• The FDA has set a PDUFA target action date of June 28, 2025, for OLC, a next-generation lanthanum-based phosphate binding agent.
• OLC aims to reduce pill burden and improve patient compliance, potentially offering a more convenient treatment option compared to existing therapies.
• Clinical data supports OLC's safety and bioequivalence, with Unicycive preparing for a commercial launch in the second half of 2025, pending approval.
Unicycive Submits NDA to FDA for Oxylanthanum Carbonate to Treat Hyperphosphatemia in CKD Patients on Dialysis
• Unicycive Therapeutics has submitted an NDA to the FDA for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
• The NDA is supported by data from three clinical studies, multiple preclinical studies, and CMC specifications, seeking approval via the 505(b)(2) regulatory pathway.
• OLC, a next-generation lanthanum-based phosphate binder, aims to reduce pill burden and improve patient compliance compared to existing treatments.
• The FDA granted a waiver for the NDA application Prescription Drug User Fee Act (PDUFA) fees, resulting in significant savings of approximately $4 million.
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