MIRA (MIRA) posts positive Phase 1 data and DEA decision on Ketamir-2

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

MIRA Pharmaceuticals reported positive unblinded results from a completed Phase 1 trial of Ketamir-2, its selective oral NMDA receptor modulator. In this randomized, double-blind, placebo-controlled study, 57 healthy volunteers across seven cohorts completed treatment with no withdrawals, no serious adverse events and no dose-limiting toxicities. Most side effects were mild, and adverse events were reported more often in the placebo group than in Ketamir-2 recipients.

Pharmacokinetic data showed rapid oral absorption and dose-proportional Cmax, with Ketamir-2 half-life ranging from about 2.5 to 7 hours and its active metabolite nor-Ketamir-2 from about 7 to 9 hours, suggesting potential for once-daily dosing after further evaluation. The company is preparing a Phase 2a protocol under its active IND to test Ketamir-2 in chemotherapy-induced peripheral neuropathy and noted that the DEA determined Ketamir-2 is not a controlled substance.

Positive

Phase 1 safety and tolerability: 57 healthy volunteers completed the randomized trial of Ketamir-2 with no withdrawals, no serious adverse events, and no dose-limiting toxicities, supporting a favorable early safety profile.
Pharmacokinetics support convenient dosing: Rapid oral absorption, dose-proportional Cmax, and half-lives of about 2.5–7 hours (Ketamir-2) and 7–9 hours (nor-Ketamir-2) suggest potential for once-daily oral administration pending further evaluation.
Regulatory positioning: The DEA determined that Ketamir-2 is not classified as a controlled substance, reducing potential constraints around prescribing, distribution, and study logistics if efficacy is shown in later trials.
Pipeline progression: The company is preparing a Phase 2a protocol under an active IND to evaluate Ketamir-2 in chemotherapy-induced peripheral neuropathy, moving the program into a patient efficacy setting.

Negative

None.

Insights

Early human data for Ketamir-2 look encouraging on safety and PK.

The Phase 1 trial of Ketamir-2 in 57 healthy volunteers showed no serious adverse events or dose-limiting toxicities, and all participants completed the study. Mild side effects were actually more common in the placebo group, which is supportive for tolerability at the tested doses.

Pharmacokinetic results indicated rapid absorption and dose-proportional exposure, with half-lives of roughly 2.5–7 hours for Ketamir-2 and 7–9 hours for its active metabolite. This profile may allow once-daily oral dosing, which is commercially attractive if confirmed in later studies.

The company is moving toward a Phase 2a trial in chemotherapy-induced peripheral neuropathy under an active IND, and preclinical data cited suggest better efficacy than ketamine and drugs like pregabalin and gabapentin in neuropathic pain models. The DEA’s conclusion that Ketamir-2 is not a controlled substance removes a potential regulatory hurdle, though ultimate value still depends on future efficacy and safety outcomes in patients.

8-K Event Classification

Item 7.01 — Regulation FD Disclosure

1 item

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Key Figures

Phase 1 participants: 57 healthy volunteers Cohorts: Seven cohorts Ketamir-2 half-life: Approximately 2.5–7 hours +1 more

4 metrics

Phase 1 participants 57 healthy volunteers Enrolled across seven cohorts in Ketamir-2 Phase 1 study

Cohorts Seven cohorts Randomized, double-blind, placebo-controlled Phase 1 trial design

Ketamir-2 half-life Approximately 2.5–7 hours Half-life range for parent compound in Phase 1 PK analysis

nor-Ketamir-2 half-life Approximately 7–9 hours Half-life range for active metabolite in Phase 1 PK analysis

Key Terms

Phase 1 clinical trial, NMDA receptor modulator, chemotherapy-induced peripheral neuropathy, Investigational New Drug (IND), +2 more

6 terms

Phase 1 clinical trial medical

"positive unblinded results from its completed Phase 1 clinical trial evaluating Ketamir-2"

A phase 1 clinical trial is the first stage of testing a new drug or treatment in people, typically involving a small group to assess safety, how the body handles the treatment, and appropriate dosing. For investors, phase 1 results are an early risk check — like a test drive that can reveal fatal flaws or promising signals — and they often cause big changes in a drug’s perceived value and the company’s prospects.

NMDA receptor modulator medical

"Ketamir-2, the Company’s proprietary selective oral NMDA receptor modulator"

chemotherapy-induced peripheral neuropathy medical

"planned evaluation of Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN)"

Nerve damage caused by certain cancer drugs that produces numbness, tingling, pain or weakness in the hands and feet; think of it like electrical wiring in the body becoming frayed and sending poor signals. It matters to investors because this side effect can force dose cuts, treatment delays, or additional care, affecting a drug’s safety profile, clinical trial results, patient demand and overall healthcare costs — all of which influence a company’s revenue and regulatory prospects.

Investigational New Drug (IND) regulatory

"under its active Investigational New Drug (IND) application for the planned evaluation"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

placebo-controlled medical

"The randomized, double-blind, placebo-controlled Phase 1 study evaluated the safety"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

controlled substance regulatory

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

A controlled substance is a drug or chemical whose manufacture, possession, use and distribution are restricted by government law because of potential for abuse, addiction or harm. For investors it matters because these rules shape a company’s ability to sell products, obtain licenses, win approvals and avoid fines or criminal risk — like a speed limit that constrains how fast a business can grow or exposes it to penalties if violated.

Understanding 8-K Material Events →

05/13/2026 - 04:01 PM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report: May 13, 2026

MIRA PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

Florida		001-41765		85-3354547
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

1200 Brickell Avenue, Suite 1950 #1183

Miami, Florida 33131

(Address of Principal Executive Offices)

(786) 432-9792

(Registrant’s telephone

number, including area code)

(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
Common Stock, $0.0001 par value per share		MIRA		The Nasdaq Capital Market

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

MIRA Pharmaceuticals, Inc. (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.

The half-life (t_1/2) 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. 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.

The Company 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 for the planned evaluation of Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN).

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.

The information in this Item 7.01, 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, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

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 PHARMACUTICALS, INC.

Dated: May 13, 2026	By:	/s/ Erez Aminov
	Name:	Erez Aminov
	Title:	Chief Executive Officer

Source: View Original Filing on SEC EDGAR

FAQ

What did MIRA (MIRA) report about its Phase 1 trial of Ketamir-2?

MIRA reported positive unblinded Phase 1 results for Ketamir-2 in 57 healthy volunteers, with no serious adverse events or dose-limiting toxicities. All participants completed the study, and most adverse events were mild, supporting a favorable initial safety and tolerability profile.

How well was Ketamir-2 tolerated in the Phase 1 study reported by MIRA?

Ketamir-2 was well tolerated, with no serious adverse events or dose-limiting toxicities reported. All 57 healthy volunteers completed the trial, and adverse events were mostly mild, occurring more frequently in the placebo group than in those receiving Ketamir-2.

What pharmacokinetic characteristics of Ketamir-2 did MIRA highlight in the 8-K filing?

MIRA highlighted rapid oral absorption and dose-proportional Cmax for Ketamir-2 across the evaluated dose range. The half-life was roughly 2.5–7 hours for Ketamir-2 and about 7–9 hours for its active metabolite, supporting potential once-daily dosing after further evaluation.

What is the next clinical step for MIRA’s Ketamir-2 program after this Phase 1 trial?

MIRA is preparing a Phase 2a clinical protocol under its active IND to study Ketamir-2 in chemotherapy-induced peripheral neuropathy. This will move the drug candidate from healthy-volunteer testing into patient populations to evaluate potential pain relief benefits.

How did the DEA classify MIRA’s Ketamir-2 according to the filing?

Following scientific review, the DEA determined Ketamir-2 is not a controlled substance. This means it is not scheduled under controlled substance regulations, potentially simplifying future clinical development, prescribing, and distribution if the drug ultimately gains approval.

What indication is MIRA targeting for Ketamir-2 in upcoming Phase 2a studies?

MIRA plans to evaluate Ketamir-2 in chemotherapy-induced peripheral neuropathy. The filing notes that in preclinical neuropathic pain models, Ketamir-2 showed superior efficacy versus ketamine and established agents such as pregabalin and gabapentin, supporting this development focus.

Filing Exhibits & Attachments

3 documents