MIRA Pharmaceuticals Advances Phase 2a CIPN Study After FDA Review

What Happened
MIRA Pharmaceuticals, Inc. announced on September 17, 2026 (8-K Item 7.01) that its Phase 2a clinical program for Ketamir-2 in chemotherapy‑induced peripheral neuropathy (CIPN) has moved toward site initiation following review of the study protocol by the U.S. Food and Drug Administration. The company incorporated FDA feedback into the protocol and has submitted the revised protocol for Institutional Review Board (IRB) review at a leading cancer research institution. The announcement was furnished as a press release.

Key Details

• Date of disclosure: September 17, 2026 (Form 8‑K, Item 7.01).
• Drug/indication: Ketamir-2 for chemotherapy‑induced peripheral neuropathy (CIPN).
• Regulatory step: FDA reviewed the Phase 2a protocol and provided comments that were incorporated.
• Next step: Revised protocol submitted for IRB review; study has advanced toward site initiation.

Why It Matters
This filing documents a regulatory and administrative milestone in MIRA’s clinical development: FDA feedback was received and addressed, and the company is progressing toward starting study sites. For investors, this is a non‑clinical event that reduces some procedural uncertainty around the Phase 2a program but does not yet indicate patient enrollment, trial outcomes, or financial impact. Continued updates (IRB approval, site activation, first patient in, and trial results) will be the more material milestones to monitor going forward.