---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-028992"
form_type: "8-K"
ticker: "MIRA"
cik: "0001904286"
company_name: "MIRA PHARMACEUTICALS, INC."
filed_at: "2026-06-17T12:00:39+00:00"
generated_at: "2026-06-17T12:11:11.336491+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# MIRA submits Phase 2a protocol to FDA for Ketamir-2 in CIPN

## Summary
- Phase 2a protocol (Mira-002) for oral NMDA receptor modulator Ketamir-2 in chemotherapy-induced peripheral neuropathy.
- Randomized, double-blind, placebo-controlled, three-period crossover trial with 300 mg and 600 mg doses.
- No FDA-approved therapies exist for CIPN; study targets 30–40% of chemo patients affected.
- Phase 1 showed clean safety: no serious AEs or dose-limiting toxicities in 56 volunteers.
- Trial to run at a leading U.S. cancer center; FDA acknowledged receipt of submission.

## SEC filing metadata
- accession: 0001493152-26-028992
- form_type: 8-K
- ticker: MIRA
- cik: 0001904286
- company_name: MIRA PHARMACEUTICALS, INC.
- filed_at: 2026-06-17T12:00:39+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1904286/000149315226028992/0001493152-26-028992-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1904286/000149315226028992/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-028992
- JSON: https://secwatch.observer/filing/0001493152-26-028992.json
- Plain text: https://secwatch.observer/filing/0001493152-26-028992.txt

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