Mira Pharmaceuticals, Inc. MIRA
Mira Pharmaceuticals, Inc. (Nasdaq: MIRA) is a pain/anesthesia drug developer. Its lead program, Ketamir-2, is in Phase 1 for chemotherapy-induced peripheral neuropathy (CIPN). Its next catalyst on record is Ketamir-2: Initiation of Phase 2a trial in CIPN (Q1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Ketamir-2 — Initiation of Phase 2a trial in CIPN (Q1 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Ketamir-2 (oral NMDA receptor modulator, ketamine analog) | CIPN (Phase 1 healthy-volunteer SAD/MAD completed; Phase 2a planned under active IND) | small molecule | Phase 1 |
| MIRA-55 (synthetic cannabinoid-derived oral candidate) | chronic inflammatory pain (non-opioid) | small molecule | Pre-clinical |
| SKNY-1 (oral candidate, acquired Sept 2025) | obesity | small molecule | Pre-clinical |
Recent results and decisions
- Jun 17, 2026submitted Phase 2a protocol (randomized, double-blind, placebo-controlled three-period crossover, 300 mg and 600 mg) for Ketamir-2 in CIPN submitted to the FDA.
today announced the submission of a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration (FDA) for Ketamir-2, the Company’s proprietary oral NMDA receptor modulator, in chemotherapy-induced peripheral neuropathy (CIPN).
Filing - Oct 23, 2025positive Single-ascending-dose portion of the Phase 1 Ketamir-2 study completed with no serious or dose-limiting adverse events; multiple-ascending-dose portion (150-600 mg for five days) initiated.
According to data reviewed to date, no serious or dose-limiting adverse events were observed, and no clinically significant safety concerns have been reported.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 1 pain/anesthesia companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.