---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-001113"
form_type: "8-K"
ticker: "CING"
cik: "0001862150"
company_name: "Cingulate Inc."
filed_at: "2025-01-07T23:59:59+00:00"
generated_at: "2026-05-28T09:09:49.007147+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Cingulate completes final FDA-required food effect study for CTx-1301; NDA submission targeted mid-2025

## Summary
- Completed food effect study for CTx-1301 (dexmethylphenidate) in 26 healthy adults using 50mg dose.
- No serious adverse events reported; data readout on bioavailability with/without food expected Q2 2025.
- Final FDA-required study before NDA submission, which is planned for mid-2025.
- 2022 study with 25mg dose already showed CTx-1301 can be taken with or without food.
- CTx-1301 designed as once-daily stimulant for ADHD covering entire active day.

## SEC filing metadata
- accession: 0001493152-25-001113
- form_type: 8-K
- ticker: CING
- cik: 0001862150
- company_name: Cingulate Inc.
- filed_at: 2025-01-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1862150/000149315225001113/0001493152-25-001113-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1862150/000149315225001113/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-001113
- JSON: https://secwatch.observer/filing/0001493152-25-001113.json
- Plain text: https://secwatch.observer/filing/0001493152-25-001113.txt

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