MIRA designates neuropathic pain as primary indication for Ketamir-2

MIRA Pharmaceuticals has selected neuropathic pain as the initial and primary indication for its novel oral ketamine analog, Ketamir-2. The company has submitted a request for a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration and anticipates the meeting to occur in November 2024. All ongoing regulatory IND-enabling studies are advancing smoothly, and MIRA remains on track to submit its IND to the FDA by the end of this year, with human trials expected to begin in the first quarter of 2025. Selecting neuropathic pain as the primary indication for Ketamir-2 underscores MIRA’s commitment to addressing a significant and growing market. Additional studies that further highlighting its versatility and strategic value are planned. These studies will explore Ketamir-2’s potential in treating various forms of neuropathic pain such as diabetic neuropathy as well as cancer-and cancer-therapy-induced neuropathic pain. “We see a tremendous opportunity to address the unmet needs in the neuropathic pain market, which is poised to grow substantially over the next decade,” said Erez Aminov, Chairman and CEO of MIRA. “Ketamir-2’s novel mechanism of action, non-opioid classification, and promising safety profile position it as a breakthrough solution that could redefine pain management for millions of patients.”