---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-008988"
form_type: "8-K"
ticker: "CING"
cik: "0001862150"
company_name: "Cingulate Inc."
filed_at: "2025-03-04T23:59:59+00:00"
generated_at: "2026-05-25T15:39:06.196556+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Cingulate reports Phase 3 safety data for ADHD drug CTx-1301; no serious adverse events in final trials

## Summary
- No serious treatment-emergent adverse events, deaths, or clinically relevant trends in two pediatric Phase 3 studies and one food-effect study.
- Food-effect study with 50mg dose shows CTx-1301 can be taken with or without food, consistent with prior 25mg study.
- Final combined adult and pediatric safety and efficacy analysis expected mid-2025 for NDA submission.
- Pre-NDA in-person meeting with FDA scheduled for April 2, 2025.
- Company had 3,647,655 shares of common stock outstanding as of March 4, 2025.

## SEC filing metadata
- accession: 0001493152-25-008988
- form_type: 8-K
- ticker: CING
- cik: 0001862150
- company_name: Cingulate Inc.
- filed_at: 2025-03-04T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1862150/000149315225008988/0001493152-25-008988-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1862150/000149315225008988/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-008988
- JSON: https://secwatch.observer/filing/0001493152-25-008988.json
- Plain text: https://secwatch.observer/filing/0001493152-25-008988.txt

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