Selective oral NMDA receptor modulator demonstrated favorable safety, tolerability, and pharmacokinetic profile supporting planned Phase 2a development in chemotherapy-induced peripheral neuropathy

MIAMI, FL / ACCESS Newswire / May 14, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), today announced positive unblinded results from its completed Phase 1 clinical trial evaluating Ketamir-2, the Company's proprietary selective oral NMDA receptor modulator.

The randomized, double-blind, placebo-controlled Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2 in healthy volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.

A total of 57 healthy volunteers were enrolled across seven cohorts, including placebo. All participants completed the study with no withdrawals, and all subjects were fit for discharge following final administration.

No serious adverse events or dose-limiting toxicities were reported during the study. Adverse events observed were predominantly mild in severity. The incidence of subjects reporting adverse events was higher in the placebo group than in the Ketamir-2-treated group.

Pharmacokinetic analysis demonstrated rapid oral absorption and favorable systemic exposure, with dose-proportional Cmax observed across the evaluated dose range. No major differences were observed in pharmacokinetic parameters for Ketamir-2 or its active metabolite, nor-Ketamir-2, between Day 1 and Day 5 of administration, supporting pharmacokinetic consistency across repeated dosing.

The half-life (t1/2) of Ketamir-2 ranged from approximately 2.5 to 7 hours, while the active metabolite nor-Ketamir-2 demonstrated a half-life of approximately 7 to 9 hours, supporting sustained pharmacologic exposure. Based on the observed pharmacokinetic profile of the parent compound and active metabolite, Ketamir-2 may support once-daily administration, subject to further clinical evaluation.

Advancing Toward Phase 2a Development in Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Based on the completed Phase 1 data package, MIRA is advancing preparations for submission of its Phase 2a clinical protocol and supporting documentation to the U.S. Food and Drug Administration under its active Investigational New Drug (IND) application.

The planned proof-of-concept Phase 2a study is expected to evaluate Ketamir-2 in patients with moderate to severe chemotherapy-induced peripheral neuropathy (CIPN), a debilitating neurological complication associated with certain chemotherapy regimens for which there are currently no FDA-approved therapies.

CIPN is characterized by neuropathic pain, numbness, tingling, and sensory dysfunction that may persist long after chemotherapy treatment ends. In severe cases, symptoms may lead to chemotherapy dose reductions or discontinuation of treatment, negatively impacting patient quality of life and treatment continuity.

The global chemotherapy-induced peripheral neuropathy market is projected to reach approximately $1.7 billion by 2035, according to Spherical Insights & Consulting (Chemotherapy-Induced Peripheral Neuropathy Market Report, 2024).

Management Commentary

Erez Aminov, Chairman and CEO of MIRA, stated:

"Ketamir-2 was designed to retain the therapeutic potential of NMDA modulation while minimizing the dissociative effects associated with ketamine. We believe the Phase 1 findings observed to date support that objective and represent an important milestone as we advance toward Phase 2a development."

Dr. Itzchak Angel, Chief Scientific Advisor of MIRA, added:

"The observed pharmacokinetic and CNS tolerability findings support the translational profile of Ketamir-2 and its continued evaluation in neuropathic pain indications requiring chronic treatment."

About Ketamir-2

Ketamir-2 is a proprietary, orally bioavailable investigational new molecular entity designed to selectively modulate the NMDA receptor (PCP binding site) with low binding affinity and limited off-target receptor activity.

In validated preclinical models of neuropathic pain, including paclitaxel-induced neuropathy and sciatic nerve ligation, Ketamir-2 demonstrated superior efficacy compared with ketamine and established neuropathic pain agents, including pregabalin and gabapentin.

Following scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Ketamir-2 is not classified as a controlled substance.

Ketamir-2 has not been approved by the U.S. Food and Drug Administration for any indication, and its safety and efficacy have not been established.

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of investigational therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates being evaluated for neuropathic pain(CIPN), inflammatory pain, obesity, addiction-related disorders, anxiety, and cognitive impairment.

For more information, please visit MIRA Pharmaceuticals.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "can," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project," "guidance," "potential," "intend," "seek," "target" and other words of similar meaning, although not all forward-looking statements include these words. Forward-looking statements may include, but are not limited to, statements regarding the therapeutic potential, mechanism of action, development plans, regulatory pathway, safety profile, clinical utility, market opportunity, and future development of SKNY-1 and the Company's other product candidates. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management's beliefs and assumptions, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to preclinical and clinical development, the ability to obtain regulatory approvals, the outcome of future studies, reliance on third parties, intellectual property protection, financing needs, market conditions, and the other risks identified in the Company's under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K and the Company's other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update or revise such statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.

We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at SEC website and in the "Investors" section of our website at MIRA Investors, for a discussion of these and other risks and uncertainties.

Contact:
Krystina Quintana
info@mirapharma.com
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

View the original press release on ACCESS Newswire

MIRA Pharmaceuticals Reports Positive Unblinded Phase 1 Data for Ketamir-2