---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-014393"
form_type: "8-K"
ticker: "MIRA"
cik: "0001904286"
company_name: "MIRA PHARMACEUTICALS, INC."
filed_at: "2025-09-22T23:59:59+00:00"
generated_at: "2026-05-17T06:00:42.623480+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# MIRA Pharma Phase 1 SAD of Ketamir-2 safe, well tolerated; positive PK

## Summary
- Phase 1 SAD study in 32 healthy volunteers (50-600 mg doses) showed no severe or serious adverse events.
- Dose-proportional exposure (Cmax, AUC); median Tmax 1-2 h; half-life 2-5 h; metabolite nor-Ketamir half-life 6.5-8.5 h.
- Company to initiate MAD portion of Phase 1, followed by Phase 2a trial in neuropathic pain patients.
- DEA concluded Ketamir-2 is not a controlled substance under the Controlled Substances Act.

## SEC filing metadata
- accession: 0001493152-25-014393
- form_type: 8-K
- ticker: MIRA
- cik: 0001904286
- company_name: MIRA PHARMACEUTICALS, INC.
- filed_at: 2025-09-22T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1904286/000149315225014393/0001493152-25-014393-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1904286/000149315225014393/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-014393
- JSON: https://secwatch.observer/filing/0001493152-25-014393.json
- Plain text: https://secwatch.observer/filing/0001493152-25-014393.txt

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