Drug Enforcement Administration classifies 3 experimental MIRA drugs as non-controlled substances
Key Facts
MIRA Pharmaceuticals said the U.S. Drug Enforcement Administration determined, following a scientific review, that Ketamir-2, MIRA-55 and SKNY-1 are not controlled substances. The company reported the decision in a statement published by Nasdaq, noting that the review covered its three drug candidates. The decision removes uncertainty about how the agency classifies these programs, but does not amount to approval of the drugs or proof of their efficacy in humans. The programs remain at different stages of development, spanning one clinical program and two preclinical programs. The company says its pipeline includes one program in the clinical stage and two in the preclinical stage.
Ketamir-2 is the program closest to a new clinical trial, having completed phase 1 and advancing toward phase 2a for chemotherapy-induced peripheral neuropathy. On September 17, 2026, MIRA said the proposed study protocol had been submitted to an institutional review board following review and comments from the U.S. Food and Drug Administration. The company is targeting site initiation in the first quarter of 2027, according to its statement. The proposed study is designed to be randomized, double-blind and placebo-controlled, with three treatment periods, each lasting 7 days. The plan includes doses of 300 and 600 mg, with a 13-day washout period between treatment periods.
MIRA-55 remains in the preclinical stage, and its safety and efficacy in humans have not been established. The company said a study of inflammatory pain showed pain relief persisted throughout the 3-week study, with no evidence of declining efficacy. It also said the drug reduced inflammation-related swelling, and no adverse clinical signs were observed during repeated daily administration. MIRA is targeting submission of an investigational new drug application to the U.S. Food and Drug Administration in the first quarter of 2027. The timing depends on completing the required studies and regulatory requirements, according to the company’s statement.
For the SKNY-1 program, the company announced on October 29, 2026, results from a pilot study in mice with diet-induced obesity. It said the drug statistically reduced body weight and fat mass compared with the vehicle group, with no statistical decrease in food consumption. In the body-composition assessment on day 14, mice that received SKNY-1 showed no statistically significant loss of lean mass, while the semaglutide group did compared with the vehicle group. After treatment was stopped, the study monitored the mice for 2 weeks; the company said weight gain was slow and limited in the SKNY-1 group, versus a rapid and substantial rebound in the semaglutide group. These are preclinical animal results and do not establish the drug’s efficacy in humans.
MIRA said the next SKNY-1 study will test the hypothesis that it affects energy expenditure and other metabolic markers, while longer preclinical studies and manufacturing work needed to support clinical development continue. The company quoted its officials as saying, "The next study will examine this hypothesis more directly by measuring energy expenditure and other metabolic markers." The program also draws on earlier research published by the company on a zebrafish model, which showed a weight reduction of about 30% while maintaining whole-body density. Those results, like the more recent mouse data, remain preclinical research. Near-term development is therefore split between preparing a phase 2a study of Ketamir-2, completing studies needed for an MIRA-55 application, and expanding SKNY-1 testing.
EL7 data showed MIRA shares closed at $0.5485 on October 30, 2026, after closing at $0.5716 on October 29. The stock had closed at $0.5561 on October 28, $0.55 on October 27 and $0.5328 on October 26. These daily moves come as the company remains in clinical and preclinical development stages. In its quarterly report, MIRA said it had generated no revenue and that available cash was insufficient to fund its operations for at least 12 months. The company said this raises substantial doubt about its ability to continue as a going concern.