---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-049377"
form_type: "8-K"
ticker: "MIRA"
cik: "0001904286"
company_name: "MIRA PHARMACEUTICALS, INC."
filed_at: "2024-12-10T23:59:59+00:00"
generated_at: "2026-05-29T05:18:47.333393+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Mira Pharma completes Ketamir-2 GLP safety program; no adverse findings, IND submission by year-end 2024

## Summary
- Successful completion of GLP preclinical safety program for Ketamir-2; no adverse findings across cardiovascular, CNS, respiratory, and toxicology studies.
- Key results: cardiovascular safety in dogs, CNS assessment in rats (transient high-dose effects), 14-day dog tox up to 200 mg/kg, Ames test non-mutagenic.
- Plan to submit IND by end of 2024; Phase I trial start Q1 2025 for safety, tolerability, PK/PD, and pain evaluation.
- Early Phase I data expected Q2 2025; focus on neuropathic pain and psychosis.

## SEC filing metadata
- accession: 0001493152-24-049377
- form_type: 8-K
- ticker: MIRA
- cik: 0001904286
- company_name: MIRA PHARMACEUTICALS, INC.
- filed_at: 2024-12-10T23:59:59+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/1904286/000149315224049377/0001493152-24-049377-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1904286/000149315224049377/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-049377
- JSON: https://secwatch.observer/filing/0001493152-24-049377.json
- Plain text: https://secwatch.observer/filing/0001493152-24-049377.txt

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