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
- Oct 28, 2026positive SKNY-1 demonstrated statistically significant reductions in body weight and fat mass in diet-induced obese mice compared with vehicle controls, with favorable lean-mass and weight-regain outcomes versus semaglutide.
Oral SKNY-1 demonstrated statistically significant reductions in body weight and fat mass compared with vehicle-treated controls.
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
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.