08:07 AM EDT, 09/11/2024 (MT Newswires) -- MIRA Pharmaceuticals ( MIRA ) said Wednesday it has selected neuropathic pain as the initial and primary indication for its new oral ketamine analog, Ketamir-2.
The company said it has submitted a request for a pre-investigational New Drug meeting with the US Food and Drug Administration, which is expected to occur in November.
MIRA said it is on track to file an investigational new drug application by the end of the year, with human trials set to start in Q1 2025.
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