FDA Issues CRL for Oxylanthanum Carbonate - Report - MDSpire

FDA Issues CRL for Oxylanthanum Carbonate

The action relates to previously identified third-party manufacturing deficiencies rather than concerns about the clinical efficacy or safety data, according to the company.

  • By

  • Kathryn Wighton

  • June 30, 2026

  • 2 min

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Clinical Report: FDA Issues CRL for Oxylanthanum Carbonate

Overview

The FDA has issued a Complete Response Letter for Unicycive Therapeutics' oxylanthanum carbonate, an investigational oral phosphate binder for hyperphosphatemia in dialysis patients. The CRL cites manufacturing deficiencies.

Background

Hyperphosphatemia is a common complication in patients with chronic kidney disease (CKD) receiving dialysis, necessitating effective phosphate-lowering therapies. Oral phosphate binders are a key component of managing elevated serum phosphate levels.

Data Highlights

No numerical data or trial results are provided in the source material.

Key Findings

  • The FDA issued a Complete Response Letter (CRL) for oxylanthanum carbonate due to manufacturing deficiencies.
  • The CRL does not indicate any concerns regarding clinical efficacy or safety data.
  • The same manufacturing deficiencies were noted in a previous CRL issued in June 2025.
  • The FDA did not inspect the third-party manufacturing facility during the review of the resubmitted NDA.
  • Unicycive believes that the third-party vendor has made progress in addressing the cited deficiencies.
  • Labeling discussions with the FDA are ongoing, focusing on carton and container labeling.

Clinical Implications

The issuance of a CRL highlights the importance of manufacturing quality in the approval process for new therapies. Ongoing discussions regarding labeling may impact the eventual market introduction of oxylanthanum carbonate.

Conclusion

The FDA's Complete Response Letter for oxylanthanum carbonate underscores the challenges faced in the regulatory pathway for new phosphate binders in CKD management.

Related Resources & Content

  1. Unicycive Therapeutics Inc., Press Release, 2025 -- FDA Issues CRL for Oxylanthanum Carbonate
  2. conexiant — FDA Cites Manufacturing Issues for Cytisinicline
  3. conexiant — FDA Clears Olastrocel Trial Expansion
  4. Open Forum Infectious Diseases — Stability and Recovery Assessment of Crushed 150-mg Omadacycline Tablets Mixed with Food or Water for Nasogastric Tube Administration
  5. Drugs - Real World Outcomes — Analysis of Unintentional Dosing Mistakes with Immediate-Release Sodium Oxybate: Insights from the FDA Adverse Event Reporting Database
  6. FDA Cites Manufacturing Issues for Cytisinicline
  7. FDA Clears Olastrocel Trial Expansion
  8. Stability and Recovery Assessment of Crushed 150-mg Omadacycline Tablets Mixed with Food or Water for Nasogastric Tube Administration
  9. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD)
  10. Efficacy and Safety of Phosphate-Lowering Agents for Adult Patients with CKD Requiring Dialysis: A Network Meta-Analysis
  11. Safety and Phosphate‐Binding Capacity of Oxylanthanum Carbonate in Healthy Volunteers

Original Source(s)

FDA Issues CRL for Oxylanthanum Carbonate

  • by Kathryn Wighton

  • June 30, 2026

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