---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-024731"
form_type: "8-K"
ticker: "MIRA"
cik: "0001904286"
company_name: "MIRA PHARMACEUTICALS, INC."
filed_at: "2025-08-19T23:59:59+00:00"
generated_at: "2026-05-17T11:35:08.574882+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# MIRA Pharmaceuticals completes Phase 1 SAD for Ketamir-2; no safety issues, advances to MAD

## Summary
- Completed SAD phase with 32 participants across 4 cohorts (50-600 mg); no severe adverse effects observed.
- Advancing to MAD phase with 3 cohorts (150, 300, 600 mg daily for 5 days) in up to 24 participants.
- FDA IND clearance for neuropathic pain already received; U.S. Phase 2a trial planned for Q4 2025.
- Safety monitored via C-SSRS, Bowdle VAS, and KSET scales; no clinically significant safety concerns.

## SEC filing metadata
- accession: 0001641172-25-024731
- form_type: 8-K
- ticker: MIRA
- cik: 0001904286
- company_name: MIRA PHARMACEUTICALS, INC.
- filed_at: 2025-08-19T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1904286/000164117225024731/0001641172-25-024731-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1904286/000164117225024731/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-024731
- JSON: https://secwatch.observer/filing/0001641172-25-024731.json
- Plain text: https://secwatch.observer/filing/0001641172-25-024731.txt

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