---
schema_version: "secwatch.filing_event.v1"
accession: "0001013762-23-005659"
form_type: "8-K"
ticker: "UNCY"
cik: "0001766140"
company_name: "Unicycive Therapeutics, Inc."
filed_at: "2023-10-23T23:59:59+00:00"
generated_at: "2026-06-09T17:01:26.026547+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Unicycive reaches FDA alignment on NDA path for OLC; pivotal trial to start by end of 2023

## Summary
- FDA agreed on full NDA package requirements: clinical, preclinical, and CMC data for Oxylanthanum Carbonate (OLC).
- Pivotal open-label trial to enroll 60 CKD dialysis patients; 4-week evaluation after dose titration.
- Top-line data expected Q2 2024; no statistical analysis required; efficacy referenced from prior bioequivalence study.
- Cash of $18.8M as of June 30, 2023 expected to fund trial and operations into H2 2024.
- NDA to be filed via 505(b)(2) pathway referencing Fosrenol; only one clinical study required.

## SEC filing metadata
- accession: 0001013762-23-005659
- form_type: 8-K
- ticker: UNCY
- cik: 0001766140
- company_name: Unicycive Therapeutics, Inc.
- filed_at: 2023-10-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1766140/000101376223005659/0001013762-23-005659-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1766140/000101376223005659/ea187125-8k_unicycive.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001013762-23-005659
- JSON: https://secwatch.observer/filing/0001013762-23-005659.json
- Plain text: https://secwatch.observer/filing/0001013762-23-005659.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.