MIRA Pharmaceuticals, Inc. operates as a biopharmaceutical enterprise currently in the clinical development phase. Its main objective involves the creation and market introduction of a novel synthetic tetrahydrocannabinol (THC) analog. This compound is undergoing investigation for its potential to address anxiety and the cognitive impairments frequently observed in adult patients suffering from early-stage dementia. The firm's lead candidate, MIRA1a, is a synthetic cannabinoid analog engineered to alleviate both anxiety and chronic pain through its interaction with cannabinoid type 1 and type 2 receptors. Originally established in 2020 as MIRA1a Therapeutics, Inc., MIRA Pharmaceuticals, Inc. maintains its headquarters in Baltimore, Maryland.
MIRA Pharmaceuticals Advances Ketamir-2 to Phase 2a in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Following FDA Review
MIRA Pharmaceuticals advanced Ketamir-2 into Phase 2a for chemotherapy-induced peripheral neuropathy, submitting the protocol for Institutional Review Board review at a leading cancer research institution after incorporating FDA feedback; site initiation is targeted for the first quarter of 2027.
The randomized, double-blind, placebo-controlled crossover study will test oral Ketamir-2 at 300 mg and 600 mg against placebo in adults with moderate-to-severe persistent CIPN, marking the drug's first evaluation in patients after a Phase 1 program that showed no serious adverse events or dose-limiting toxicities.
There are currently no FDA-approved therapies specifically indicated for CIPN, and MIRA views positive Phase 2a data as a potential entry point into the broader neuropathic pain market; Ketamir-2 is an oral NMDA receptor modulator that is not classified as a controlled substance by the DEA.
MIRA will present Phase 1 data in an oral session in Tokyo on October 5-6, 2026, and will participate in BioJapan as licensing and strategic partnership discussions around Ketamir-2 continue.