Phase 2a CIPN trial protocol for Ketamir-2 accepted, MIRA (NASDAQ: MIRA)
Rhea-AI Filing Summary
MIRA Pharmaceuticals submitted a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration for Ketamir-2, its oral NMDA receptor modulator, to treat chemotherapy-induced peripheral neuropathy (CIPN). The company received an FDA acknowledgment confirming acceptance of the Protocol Mira-002 submission.
The planned study is a randomized, double-blind, placebo-controlled, three-period crossover trial at a leading U.S. cancer center, testing 300 mg and 600 mg oral Ketamir-2 versus placebo in patients with moderate-to-severe persistent CIPN. It will focus on safety, tolerability, and dose-response effects on neuropathic pain, building on a prior Phase 1 study in 56 healthy volunteers where no serious adverse events or dose-limiting toxicities were observed.
Positive
- None.
Negative
- None.
Insights
MIRA moves Ketamir-2 into an FDA-accepted Phase 2a CIPN study, an important but early pipeline step.
The company is advancing Ketamir-2 into a Phase 2a trial for chemotherapy-induced peripheral neuropathy using a randomized, double-blind, placebo-controlled, three-period crossover design. This structure lets each patient receive both dose levels and placebo, improving the ability to detect dose-response with fewer participants.
The program builds on a Phase 1 study in 56 healthy volunteers with no serious adverse events or dose-limiting toxicities reported and pharmacokinetics supporting once-daily dosing. While this is promising for safety and feasibility, efficacy in CIPN remains unproven and will depend on outcomes such as changes in Numeric Rating Scale pain scores and proportions of patients achieving 30% and 50% pain reduction.
CIPN is described as a large unmet need, affecting an estimated 30–40% of patients receiving neurotoxic chemotherapy and roughly 3 million new persistent cases annually worldwide. If Phase 2a demonstrates favorable safety and pain relief, later-stage trials would still be required before any potential approval, so development, regulatory, and funding risks remain substantial.
8-K Event Classification
Key Figures
Key Terms
chemotherapy-induced peripheral neuropathy medical
NMDA receptor modulator medical
randomized, double-blind, placebo-controlled medical
three-period crossover trial medical
Numeric Rating Scale medical
EORTC QLQ-CIPN20 medical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
(Exact Name of Registrant as Specified in its Charter)
| (State or Other Jurisdiction | (Commission | (IRS Employer | ||
| of Incorporation) | File Number) | Identification No.) |
(Address of Principal Executive Offices)
Registrant’s
telephone number, including area code:
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||
| The
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On June 17, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the submission of a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration (FDA) for Ketamir-2, the Company’s proprietary oral NMDA receptor modulator, in chemotherapy-induced peripheral neuropathy (CIPN). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
In connection with the submission, the Company received an acknowledgment of receipt from the FDA confirming acceptance of the Phase 2a clinical trial protocol submission for Protocol Mira-002. A copy of the FDA submission receipt is attached hereto as Exhibit 99.2 and incorporated herein by reference.
The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Other Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release of MIRA Pharmaceuticals, Inc., dated June 17, 2026 | |
| 99.2 | FDA Acknowledgment of Receipt — Phase 2a Clinical Trial Protocol Submission, Protocol Mira-002 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MIRA PHARMACEUTICALS, INC. | ||
| Dated: June 17, 2026 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |
Exhibit 99.1
MIRA Pharmaceuticals Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral Neuropathy
Randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and dose-response efficacy of oral Ketamir-2 at a leading U.S. cancer center
MIAMI, FL / ACCESS Newswire / June 17, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the submission of a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration (FDA) for Ketamir-2, the Company’s proprietary oral NMDA receptor modulator, in chemotherapy-induced peripheral neuropathy (CIPN).
Addressing a Significant Unmet Medical Need
Chemotherapy-induced peripheral neuropathy is one of the most common and debilitating consequences of cancer treatment. It affects an estimated 30 to 40 percent of patients who receive neurotoxic chemotherapy, and approximately 3 million new persistent cases are estimated annually worldwide. For many patients, symptoms including pain, numbness, tingling, and loss of sensation do not resolve when treatment ends. Roughly 30 percent continue to experience them six months or more after completing chemotherapy, often with lasting impact on their ability to function and their overall quality of life.
Despite how common and disabling the condition is, there are currently no FDA-approved therapies specifically for CIPN. Oncologists rely on medications such as gabapentin, pregabalin, duloxetine, and tricyclic antidepressants, none of which were developed for this purpose, and many of which provide incomplete relief. In severe cases, CIPN forces dose reductions or the discontinuation of chemotherapy entirely, potentially compromising cancer outcomes. The absence of an approved treatment has remained one of the more glaring gaps in oncology supportive care.
About the Phase 2a Study (Protocol Mira-002)
The planned Phase 2a study is a randomized, double-blind, placebo-controlled, three-period crossover trial that will evaluate the safety, tolerability, and dose-response relationship of oral Ketamir-2 in patients with moderate-to-severe persistent CIPN. The study will be conducted at a leading U.S. cancer center.
Patients will be enrolled and randomized to receive Ketamir-2 at one of two dose levels, 300 mg or 600 mg, or a matching placebo, across three sequential seven-day treatment periods, each separated by a two-week washout. Because each patient moves through all three treatment sequences, the crossover design allows each participant to serve as their own control, producing a more reliable signal with a smaller study population.
The primary objectives are to characterize the safety and tolerability of Ketamir-2 at both dose levels and to evaluate its dose-response relationship on neuropathic pain intensity, measured by change from baseline in the weekly mean 11-point Numeric Rating Scale pain score. Secondary objectives include the proportion of patients achieving meaningful pain reductions of 30 percent or more and 50 percent or more, changes in CIPN-related symptoms and functional status measured by the EORTC QLQ-CIPN20, and assessment of central nervous system pharmacodynamic effects. Each participant will be in the study for up to 82 days.
To be eligible, patients must have experienced persistent CIPN for at least three months following chemotherapy, report a baseline pain score of 4 or higher on the NRS scale, and have underlying cancer that is clinically stable with no active disease requiring systemic treatment at study entry.
The submission builds on results from the successfully completed MIRA-001 Phase 1 study, which enrolled 56 healthy volunteers across single and multiple ascending dose cohorts. No serious adverse events or dose-limiting toxicities were observed at any dose tested, and the pharmacokinetic profile supported the dose levels and once-daily administration schedule selected for Phase 2a.
Management Commentary
“CIPN has been overlooked for too long,” said Erez Aminov, Chairman and Chief Executive Officer of MIRA Pharmaceuticals. “Millions of cancer survivors are managing real, ongoing pain with medications that were never approved for this condition and that often do not work well enough. Ketamir-2 came out of Phase 1 with a clean safety record, and this Phase 2a study is the next step toward building the evidence base the program needs.”
Dr. Itzchak Angel, Chief Scientific Advisor of MIRA Pharmaceuticals, commented: “The crossover design we selected for this study is scientifically well-suited to this patient population. Having each participant experience all three treatment periods gives us a more precise read on dose-response while keeping the study size manageable. The Phase 1 data gave us clear guidance on dosing, and Phase 2a is designed to answer the questions that matter most going forward — how Ketamir-2 performs on safety and pain relief in patients who need it.”
About Ketamir-2
Ketamir-2 is an oral NMDA receptor modulator in development for chronic neuropathic pain. The NMDA receptor pathway is well established in neuropathic pain biology, and ketamine has long demonstrated activity there, but its use for chronic conditions has been constrained by the need for intravenous administration, significant dissociative side effects, Schedule III controlled substance status, and the clinical infrastructure required to administer and monitor it. Ketamir-2 was built to capture the mechanism without those limitations, delivered orally, dosed once daily, and confirmed by the DEA as non-scheduled. MIRA holds exclusive worldwide rights to Ketamir-2 with intellectual property secured across 10 major markets, including the United States, European Union, China, Japan, Canada, Australia, India, Israel, Mexico, and South Korea.
| 1 |
Ketamir-2 has not been approved by the U.S. Food and Drug Administration for any indication. 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, inflammatory pain, obesity, addiction-related disorders, anxiety, and cognitive impairment. For more information, please visit www.mirapharmaceuticals.com.
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 development of Ketamir-2; the planned Phase 2a clinical trial, including its design, objectives, enrollment, timing, initiation and potential outcomes; the potential efficacy, safety, tolerability and therapeutic benefits of Ketamir-2; the potential advantages of Ketamir-2 compared to existing treatment options; the potential market opportunity for Ketamir-2; future regulatory interactions; intellectual property protection; strategic partnership opportunities; and the future development and commercialization of Ketamir-2. 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 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 the 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
Exhibit 99.2
