secwatch.observer — SEC 8-K summary
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Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2026-05-13T20:01:30+00:00
Accession:  0001493152-26-022704
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01
LLM model:  deepseek-v4-flash:cloud@v2

Mira Pharmaceuticals announces positive Phase 1 results for Ketamir-2; plans Phase 2a in CIPN
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- Phase 1 trial in 57 healthy volunteers; all completed with no withdrawals or serious adverse events.
- Ketamir-2 half-life 2.5–7 hours; active metabolite nor-Ketamir-2 half-life 7–9 hours; supports once-daily dosing.
- DEA classified Ketamir-2 as not a controlled substance, eliminating scheduling barriers.
- Company preparing Phase 2a protocol for chemotherapy-induced peripheral neuropathy (CIPN) for FDA submission.
- Preclinical data showed Ketamir-2 superior efficacy vs. ketamine, pregabalin, and gabapentin in neuropathic pain models.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000149315226022704/0001493152-26-022704-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000149315226022704/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-022704

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