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MIRA Pharmaceuticals Initiates Multiple Ascending Dose (MAD) Phase 1 Study of Oral Ketamir-2 and Selects Chemotherapy-Induced Neuropathic Pain as Lead Phase 2a Indication

Key Takeaway: MIRA Pharmaceuticals has launched a multiple ascending dose Phase 1 study for its oral Ketamir-2, targeting chemotherapy-induced neuropathic pain. This condition currently lacks approved treatments, highlighting the significance of the study. The company is also considering FDA Fast Track designation to expedite development.
Price reaction · baseline $1.55 (2025-10-23 close) · hit pre-market · clean, no other MIRA news in the window
day 0 close · peak
-3.2%

Market Sentiment Analysis

POSITIVE FACTORS

  • Initiation of Phase 1 study for oral Ketamir-2.
  • Focus on chemotherapy-induced neuropathic pain, an unmet medical need.
  • Potential for FDA Fast Track designation.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+5%
120-day peak, hindsight
Typical move
0.6%
average across 2 past catalysts
Cash runway
~21 mo
Low dilution risk

Full Press Release Details

Advancing toward Phase 2a clinical evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track consideration MIAMI, FLORIDA / ACCESS Newswire / October 24, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) (“MIRA” or the “Company”), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the initiation of the multiple ascending dose (MAD) po…
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Frequently Asked Questions

What is the focus of MIRA's Phase 1 study?

The Phase 1 study focuses on oral Ketamir-2 for chemotherapy-induced neuropathic pain.

What condition is Ketamir-2 targeting?

Ketamir-2 targets chemotherapy-induced neuropathic pain, which currently has no approved treatments.

What is the significance of FDA Fast Track designation?

FDA Fast Track designation can expedite the development and review process for drugs addressing unmet medical needs.

What type of study has MIRA initiated?

MIRA has initiated a multiple ascending dose (MAD) Phase 1 study.

Last updated: Oct 24, 2025