MIRA Pharmaceuticals Reports Positive Unblinded Phase 1 Data for Ketamir-2
Rhea-AI Summary
MIRA (NASDAQ:MIRA) reported positive unblinded Phase 1 data for Ketamir-2, an oral selective NMDA receptor modulator. The randomized, double-blind, placebo-controlled SAD/MAD trial enrolled 57 healthy volunteers with no withdrawals or serious adverse events.
Adverse events were mostly mild and occurred more often on placebo. Pharmacokinetics showed rapid absorption, dose-proportional Cmax, and half-lives supporting potential once-daily dosing, subject to further evaluation. MIRA plans a Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy, a condition with no FDA-approved therapies and a market projected at $1.7 billion by 2035.
AI-generated analysis. Not financial advice.
Positive
- Phase 1 SAD/MAD trial in 57 volunteers completed with no serious adverse events
- Adverse events mainly mild, with higher incidence in placebo than Ketamir-2 group
- Pharmacokinetics show rapid absorption and dose-proportional Cmax across dose range
- Half-lives of 2.5–7 hours (Ketamir-2) and 7–9 hours (metabolite) support sustained exposure
- Data support potential once-daily oral dosing, pending further clinical evaluation
- Advancing Phase 2a CIPN proof-of-concept under active IND in a $1.7B market
Negative
- None.
News Market Reaction – MIRA
On the day this news was published, MIRA gained 0.42%, reflecting a mild positive market reaction. This price movement added approximately $171K to the company's valuation, bringing the market cap to $40.80M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
MIRA fell 4.8% with modestly above-average volume, while sector peers were mixed: examples include IXHL up 3.38% and TXMD and GELS down between about 3–5%. Scanner data flags a broader sector move rather than an isolated outlier.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 04 | Phase 1 dosing complete | Positive | -1.6% | Completion of Ketamir-2 Phase 1 dosing with no serious adverse events. |
| Feb 03 | Final cohort initiated | Positive | -1.6% | Initiation of final MAD cohort and guidance toward Phase 2a CIPN study. |
| Oct 24 | MAD study initiated | Positive | -3.2% | Start of MAD Phase 1 for Ketamir-2 and CIPN chosen as lead indication. |
| Sep 22 | SAD topline results | Positive | +6.4% | Positive topline SAD data with favorable safety and pharmacokinetics for Ketamir-2. |
| Aug 19 | SAD stage completed | Positive | -4.0% | Completion of SAD stage and transition to MAD stage for Ketamir-2. |
Clinical-trial updates for Ketamir-2 have often been positive but frequently coincided with modest share price declines, with only one notably positive reaction.
Over the past year, MIRA has steadily advanced Ketamir-2 through Phase 1, from completing the SAD portion in Aug 2025 to initiating and progressing MAD dosing, then completing Phase 1 dosing by Mar 4, 2026. Each step reported favorable safety and pharmacokinetics and moved closer to a Phase 2a trial in chemotherapy-induced peripheral neuropathy. Today’s announcement adds full unblinded Phase 1 data, including 57 volunteers and consistent PK, reinforcing that same development trajectory.
Historical Comparison
MIRA’s five prior Ketamir-2 clinical-trial updates saw an average move of -0.83%. Today’s negative reaction of -4.8% to full Phase 1 data is weaker than those earlier responses.
Clinical updates show a clear path: completion of SAD, initiation and conduct of MAD, then full Phase 1 completion, all building toward a planned Phase 2a trial in chemotherapy-induced peripheral neuropathy.
Market Pulse Summary
This announcement reports completed Phase 1 data for Ketamir-2 in 57 healthy volunteers, with no serious adverse events and pharmacokinetics consistent with once-daily dosing. It advances MIRA toward a Phase 2a trial in chemotherapy-induced peripheral neuropathy, a market projected at $1.7 billion by 2035. Historical clinical updates have produced modest share moves, so investors may focus on execution of the planned Phase 2a protocol and future regulatory milestones.
Key Terms
nmda receptor medical
pharmacokinetic medical
chemotherapy-induced peripheral neuropathy medical
placebo-controlled medical
investigational new drug regulatory
cns medical
AI-generated analysis. Not financial advice.
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
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