UNCY
Oxylanthanum carbonate (OLC)
FDA PDUFA Target Action Date · Unicycive Therapeutics, Inc.
Monday, June 29, 2026
Complete Response Letter
Complete Response Letter Note: SECOND CRL for OLC, announced by company press release on 2026-06-30 at 7:05am EDT (one day after the 2026-06-29 PDUFA target action date). No approval, no brand name. FDA acted 2026-06-30 (target was 2026-06-29). Source: https://ir.unicycive.com/news/detail/123/unicycive-therapeutics-receives-complete-response-letter
Drug Information
- Drug Name
- Oxylanthanum carbonate (OLC) (CT.gov)
- Application Type
- NDA
- Indication
- hyperphosphatemia in patients with CKD on dialysis
- Approved As
- Oxylanthanum carbonate (OLC)
Filing Details
- Company
- Unicycive Therapeutics, Inc.
- Stock Ticker
- UNCY
- SEC CIK
- 0001766140
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue