---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-043051"
form_type: "8-K"
ticker: "MIRA"
cik: "0001904286"
company_name: "MIRA PHARMACEUTICALS, INC."
filed_at: "2026-09-17T12:30:40+00:00"
generated_at: "2026-09-17T12:35:12.195790+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# MIRA advances Ketamir-2 Phase 2a for CIPN; IRB submission after FDA review, site initiation targeted Q1 2027

## Summary
- Phase 2a protocol for Ketamir-2 in CIPN submitted for IRB review after incorporating FDA feedback; site initiation targeted Q1 2027.
- Randomized, double-blind, placebo-controlled three-period crossover; Ketamir-2 300 mg and 600 mg vs placebo; 7-day periods with 13-day washouts.
- Builds on completed Phase 1 in healthy volunteers with favorable safety/PK profile; no serious adverse events or dose-limiting toxicities.
- No FDA-approved therapies specifically indicated for CIPN; Ketamir-2 is not a DEA-controlled substance.
- MIRA to present Ketamir-2 data at Tokyo conference Oct 5-6, 2026 and attend BioJapan for licensing discussions.

## SEC filing metadata
- accession: 0001493152-26-043051
- form_type: 8-K
- ticker: MIRA
- cik: 0001904286
- company_name: MIRA PHARMACEUTICALS, INC.
- filed_at: 2026-09-17T12:30:40+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1904286/000149315226043051/0001493152-26-043051-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1904286/000149315226043051/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-043051
- JSON: https://secwatch.observer/filing/0001493152-26-043051.json
- Plain text: https://secwatch.observer/filing/0001493152-26-043051.txt

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