other material
confidence high
sentiment neutral
materiality 0.65
MIRA Pharma receives Israeli MoH approval to start Phase 1 trial for Ketamir-2 in neuropathic pain
MIRA PHARMACEUTICALS, INC.
- Approval from Israeli Ministry of Health and IRB to initiate Phase 1 trial for Ketamir-2, an oral ketamine analog.
- Randomized, double-blind, placebo-controlled study evaluating safety, tolerability, and PK in healthy volunteers at Hadassah Medical Center.
- Subject recruitment begins Q1 2025; Phase 1 expected to conclude Q4 2025, followed by Phase 2a in neuropathic pain patients by year-end.
- Awaiting neurotoxicity study results from FDA, expected Q2 2025, to enable IND and U.S. patient dosing.