secwatch.observer — SEC 8-K summary
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Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2025-10-23T23:59:59+00:00
Accession:  0001493152-25-019065
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000149315225019065/0001493152-25-019065-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000149315225019065/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-019065

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