---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-008977"
form_type: "8-K"
ticker: "MIRA"
cik: "0001904286"
company_name: "MIRA PHARMACEUTICALS, INC."
filed_at: "2025-03-04T23:59:59+00:00"
generated_at: "2026-05-25T15:53:32.148924+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# MIRA Pharma receives Israeli MoH approval to start Phase 1 trial for Ketamir-2 in neuropathic pain

## Summary
- Approval from Israeli Ministry of Health and IRB to initiate Phase 1 trial for Ketamir-2, an oral ketamine analog.
- Randomized, double-blind, placebo-controlled study evaluating safety, tolerability, and PK in healthy volunteers at Hadassah Medical Center.
- Subject recruitment begins Q1 2025; Phase 1 expected to conclude Q4 2025, followed by Phase 2a in neuropathic pain patients by year-end.
- Awaiting neurotoxicity study results from FDA, expected Q2 2025, to enable IND and U.S. patient dosing.

## SEC filing metadata
- accession: 0001493152-25-008977
- form_type: 8-K
- ticker: MIRA
- cik: 0001904286
- company_name: MIRA PHARMACEUTICALS, INC.
- filed_at: 2025-03-04T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1904286/000149315225008977/0001493152-25-008977-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1904286/000149315225008977/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-008977
- JSON: https://secwatch.observer/filing/0001493152-25-008977.json
- Plain text: https://secwatch.observer/filing/0001493152-25-008977.txt

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