---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-021155"
form_type: "8-K"
ticker: "MIRA"
cik: "0001904286"
company_name: "MIRA PHARMACEUTICALS, INC."
filed_at: "2025-07-28T23:59:59+00:00"
generated_at: "2026-05-18T00:26:47.103670+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# MIRA Pharma receives FDA IND clearance for Ketamir-2, advancing neuropathic pain program

## Summary
- FDA cleared IND for Ketamir-2, an oral NMDA antagonist for neuropathic pain, enabling U.S. clinical trials.
- Preclinical head-to-head data showed superior efficacy to gabapentin and pregabalin with no ketamine-related neurotoxicity.
- Phase 1 single ascending dose portion nearing completion; U.S. Phase 2a efficacy trial planned for Q4 2025.
- Acquisition of SKNY Pharmaceuticals on track; SKNY-1 shows efficacy in obesity and nicotine craving models.
- MIRA-55 oral cannabinoid analog demonstrated comparable efficacy to morphine in inflammatory pain models.

## SEC filing metadata
- accession: 0001641172-25-021155
- form_type: 8-K
- ticker: MIRA
- cik: 0001904286
- company_name: MIRA PHARMACEUTICALS, INC.
- filed_at: 2025-07-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1904286/000164117225021155/0001641172-25-021155-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1904286/000164117225021155/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-021155
- JSON: https://secwatch.observer/filing/0001641172-25-021155.json
- Plain text: https://secwatch.observer/filing/0001641172-25-021155.txt

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