secwatch.observer — SEC 8-K summary
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Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2025-09-22T23:59:59+00:00
Accession:  0001493152-25-014393
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

MIRA Pharma Phase 1 SAD of Ketamir-2 safe, well tolerated; positive PK
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- Phase 1 SAD study in 32 healthy volunteers (50-600 mg doses) showed no severe or serious adverse events.
- Dose-proportional exposure (Cmax, AUC); median Tmax 1-2 h; half-life 2-5 h; metabolite nor-Ketamir half-life 6.5-8.5 h.
- Company to initiate MAD portion of Phase 1, followed by Phase 2a trial in neuropathic pain patients.
- DEA concluded Ketamir-2 is not a controlled substance under the Controlled Substances Act.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000149315225014393/0001493152-25-014393-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000149315225014393/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-014393

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