---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-019065"
form_type: "8-K"
ticker: "MIRA"
cik: "0001904286"
company_name: "MIRA PHARMACEUTICALS, INC."
filed_at: "2025-10-23T23:59:59+00:00"
generated_at: "2026-05-17T02:34:10.617958+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# MIRA Pharmaceuticals starts MAD Phase 1 of oral Ketamir-2; selects CIPN for Phase 2a

## Summary
- Initiated multiple ascending dose (MAD) portion of Phase 1 trial for oral Ketamir-2 in healthy volunteers.
- Selected chemotherapy-induced peripheral neuropathy (CIPN) as lead indication for planned Phase 2a study.
- In SAD portion, no serious or dose-limiting adverse events; no clinically significant safety concerns.
- Ketamir-2 is a non-scheduled oral analog of ketamine designed for once-daily dosing without psychoactive effects.
- Preclinical data showed Ketamir-2 outperformed ketamine, gabapentin, and pregabalin in neuropathic pain models.

## SEC filing metadata
- accession: 0001493152-25-019065
- form_type: 8-K
- ticker: MIRA
- cik: 0001904286
- company_name: MIRA PHARMACEUTICALS, INC.
- filed_at: 2025-10-23T23:59:59+00:00
- event_type: other_material
- 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/1904286/000149315225019065/0001493152-25-019065-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1904286/000149315225019065/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-019065
- JSON: https://secwatch.observer/filing/0001493152-25-019065.json
- Plain text: https://secwatch.observer/filing/0001493152-25-019065.txt

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