Full Press Release Details
Pharmaceuticals Secures Worldwide Rights for Ketamir-2, Expanding Global IP Portfolio Across 10 Major Markets Ahead of Phase 2a in CIPN
global intellectual property portfolio enhances strategic flexibility and long-term value potential for Ketamir-2
FL / ACCESS Newswire / May 27, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"),
a clinical-stage pharmaceutical company focused on the development of proprietary therapeutics for neurologic, neuropsychiatric, inflammatory,
and metabolic disorders, today announced the execution of Amendment No. 1 to its exclusive Ketamir-2 license agreement with MIRALOGX
LLC, expanding the Company's licensed territory from the United States, Canada, and Mexico to worldwide rights across all countries
in which patent rights exist.
amended agreement incorporates an expanded international patent portfolio now covering filings in the United States, Europe, China, Japan,
Canada, Australia, India, Israel, Mexico, and South Korea, representing the world's largest pharmaceutical markets.
is MIRA's proprietary oral NMDA receptor modulator currently advancing toward planned Phase 2a development in chemotherapy-induced
peripheral neuropathy ("CIPN"), an indication with significant unmet medical need. The Company recently announced positive
Phase 1 clinical results across 56 healthy volunteers, demonstrating favorable safety, tolerability, and pharmacokinetic findings, with
no serious adverse events or study discontinuations reported.
Aminov, Chairman and CEO of MIRA, stated:
worldwide rights for Ketamir-2 represents an important strategic milestone for MIRA and significantly strengthens the long-term global
commercial potential of the program. As we advance toward planned Phase 2a development in CIPN, this expanded intellectual property position
strengthens our ability to pursue global licensing, co-development, or commercialization discussions with potential strategic partners.
amendment does not materially modify the previously disclosed core economic terms of the original license agreement.
worldwide IP rights secured and a completed Phase 1 data package in hand, MIRA is advancing Phase 2a protocol documentation for submission
to the FDA under its active Investigational New Drug (IND) application.
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.
validated preclinical models of neuropathic pain, including paclitaxel-induced neuropathy and sciatic nerve ligation, Ketamir-2 demonstrated
improved efficacy compared with ketamine and established neuropathic pain agents, including pregabalin and gabapentin.
scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Ketamir-2 is not classified as a controlled substance.
has not been approved by the U.S. Food and Drug Administration for any indication, and its safety and efficacy have not been established.
MIRA Pharmaceuticals, Inc.
Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of investigational
therapeutics for neurologic, neuropsychiatric, inflammatory, 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
more information, please visit MIRA Pharmaceuticals.
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mechanism of action, development plans, regulatory pathway, safety profile, clinical utility, market opportunity, and future development
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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.
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.