MIRA Pharmaceuticals Completes Phase 1 Dosing of Ketamir-2
Rhea-AI Summary
MIRA (NASDAQ:MIRA) completed dosing in its Phase 1 study of Ketamir-2 on March 4, 2026, enrolling 56 healthy volunteers across SAD and MAD cohorts. No serious adverse events or dose-limiting toxicities were reported, and no clinically significant dissociative effects were observed.
Database lock, unblinding, and final audited pharmacokinetic and safety analyses are underway, and Phase 1 data are accepted for AACR presentation. MIRA aims to file a Phase 2a protocol to the FDA under its active IND in H1 2026 targeting chemotherapy-induced peripheral neuropathy.
Positive
- Phase 1 dosing completed with 56 healthy volunteers
- No serious adverse events or dose-limiting toxicities reported
- Phase 1 data accepted for AACR Annual Meeting presentation
- Planned IND/Phase 2a submission to FDA in H1 2026
Negative
- None.
News Market Reaction – MIRA
In the Mar 4 session, MIRA declined 1.61%, reflecting a mild negative market reaction. Argus tracked a trough of -5.8% from its starting point during tracking. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 03 | Phase 1 final cohort | Positive | -1.6% | Final MAD cohort dosing for Ketamir-2 and Phase 2a planning in CIPN. |
| Oct 24 | MAD Phase 1 start | Positive | -3.2% | Initiation of MAD Phase 1 and selection of CIPN as lead Phase 2a indication. |
| Sep 22 | Positive SAD topline | Positive | +6.4% | Favorable Phase 1 SAD data with no serious AEs and supportive PK profile. |
| Aug 19 | SAD completion | Positive | -4.0% | Completion of SAD portion with good safety, advancing to MAD dosing stage. |
| Apr 16 | Preclinical neuropathy data | Positive | +19.3% | Strong diabetic neuropathy animal data supporting ongoing Phase 1 clinical trial. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical-trial headlines for Ketamir-2 have produced mixed reactions, with 3 divergence events where positive development updates coincided with negative price moves and 2 aligned up-moves on favorable data.
Over the past year, MIRA has steadily advanced Ketamir-2 from early Phase 1 work toward patient trials. Updates on SAD completion, MAD initiation, and positive diabetic neuropathy animal data (e.g., Apr 16, 2025 and Aug 19, 2025) highlighted favorable safety and preclinical efficacy. Some of these clinical milestones, including MAD initiation on Oct 24, 2025 and final cohort dosing on Feb 3, 2026, were met with short-term share price declines. Today’s completion of Phase 1 dosing fits this progression toward Phase 2a in neuropathic indications.
Key Terms
nmda receptor medical
chemotherapy-induced peripheral neuropathy medical
columbia-suicide severity rating scale (c-ssrs) medical
visual analogue scale (vas) medical
ketamine side effect tool (kset) medical
p-glycoprotein medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Advancing a selective oral NMDA receptor modulator toward Phase 2a in chemotherapy-induced peripheral neuropathy following favorable Phase 1 safety and tolerability findings
MIAMI, FLORIDA / ACCESS Newswire / March 4, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications, today announced completion of dosing in its Phase 1 clinical trial evaluating Ketamir-2, the Company's proprietary selective oral NMDA receptor modulator.
The randomized, double-blind, placebo-controlled study enrolled 56 healthy adult volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Based on safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported at any dose level tested. In addition, no clinically significant dissociative or psychotomimetic effects typically associated with ketamine were observed.
Database lock, unblinding, and final audited pharmacokinetic and safety analyses are underway.
Phase 1 data have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting.
Phase 1 Clinical Overview
The study was conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel, and was designed to characterize the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2.
Study Design
Randomized, double-blind, placebo-controlled
SAD: Four dose cohorts (50 mg to 600 mg), 32 participants
MAD: Three cohorts (150 mg, 300 mg, 600 mg daily for five days), 24 participants
Study Endpoints: Safety, tolerability, pharmacokinetics
Central nervous system safety was prospectively evaluated using validated clinical instruments, including the Columbia-Suicide Severity Rating Scale (C-SSRS), Bowdle Visual Analogue Scale (VAS), and the Ketamine Side Effect Tool (KSET), to assess dissociative, perceptual, or mood-related effects.
Targeting a High-Unmet-Need Indication: Chemotherapy-Induced Peripheral Neuropathy (CIPN)
MIRA intends to submit the Phase 2a clinical study and supporting documentation to the U.S. Food and Drug Administration under its active IND in the first half of 2026, targeting patients with moderate to severe chemotherapy-induced peripheral neuropathy (CIPN).
CIPN is a debilitating and often dose-limiting complication of cancer treatment. There are currently no FDA-approved therapies specifically indicated for this condition, and management typically relies on off-label agents or intravenous ketamine.
The global chemotherapy-induced peripheral neuropathy market is projected to reach approximately
Ketamir-2: A Differentiated Selective Oral NMDA Receptor Modulator
Ketamir-2 is a proprietary, orally bioavailable new molecular entity designed to selectively modulate the NMDA receptor (PCP binding site) with low binding affinity and minimal off-target receptor activity.
Key attributes include:
Oral administration with predictable pharmacokinetics
Non-scheduled status following scientific review by the U.S. Drug Enforcement Administration
No clinically significant dissociative effects observed in preclinical and Phase 1 assessments to date
Not a P-glycoprotein substrate, supporting good oral bioavailability and central nervous system penetration
An active metabolite (nor-Ketamir-2) with a longer half-life
In validated rodent 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. The drug did not induce hyperlocomotor or psychotomimetic-like behaviors in animal models.
Phase 2a Development Plan
The planned proof-of-concept study is being designed with rigorous methodological standards intended to generate safety and preliminary efficacy data in patients with moderate to severe CIPN.
The Company expects the trial to incorporate clearly defined endpoints, validated neuropathic pain assessment instruments, appropriate statistical powering, and design elements intended to minimize bias and variability. MIRA's objective is to generate a well-controlled dataset suitable for regulatory advancement and potential peer-reviewed scientific publication.
Management Commentary
Erez Aminov, Chairman and CEO of MIRA, stated:
"Completion dosing of Phase 1 marks an important inflection point for MIRA as we advance Ketamir-2 into patient studies. Our objective has been to create a selective oral NMDA modulator with a differentiated safety profile suitable for chronic use. With favorable Phase 1 findings and a clear regulatory path forward, we are now focused on generating clinical efficacy data in a high-unmet-need indication."
Dr. Itzchak Angel, Chief Scientific Advisor of MIRA, added:
"Ketamir-2 was rationally engineered to achieve selective NMDA modulation with a pharmacokinetic and CNS profile distinct from ketamine. The Phase 1 program provides a translational foundation for patient studies. As we move into Phase 2a, our priority is executing a scientifically rigorous trial capable of producing high-quality data that can withstand regulatory and academic scrutiny."
About Ketamir-2
Ketamir-2 is a proprietary, orally bioavailable new molecular entity designed as a next-generation NMDA receptor antagonist. Preclinical and early clinical data support its potential as an oral, non-opioid therapy for neuropathic pain and related conditions. Ketamir-2 is not classified as a controlled substance under the U.S. Controlled Substances Act.
About MIRA Pharmaceuticals, Inc.
MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications with significant unmet medical need.
Cautionary Note Regarding Forward-Looking Statements
This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact:
Krystina Quintana
info@mirapharma.com
(786) 432-9792
SOURCE: MIRA Pharmaceuticals
View the original press release on ACCESS Newswire