MIRA advances Ketamir-2 Phase 2a for CIPN; IRB submission after FDA review, site initiation targeted Q1 2027

MIRA PHARMACEUTICALS, INC.

Phase 2a protocol for Ketamir-2 in CIPN submitted for IRB review after incorporating FDA feedback; site initiation targeted Q1 2027.
Randomized, double-blind, placebo-controlled three-period crossover; Ketamir-2 300 mg and 600 mg vs placebo; 7-day periods with 13-day washouts.
Builds on completed Phase 1 in healthy volunteers with favorable safety/PK profile; no serious adverse events or dose-limiting toxicities.
No FDA-approved therapies specifically indicated for CIPN; Ketamir-2 is not a DEA-controlled substance.
MIRA to present Ketamir-2 data at Tokyo conference Oct 5-6, 2026 and attend BioJapan for licensing discussions.

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