MIRA (NASDAQ: MIRA) touts Ketamir-2 Phase 1 win and DEA clearance

Rhea-AI Filing Summary

MIRA Pharmaceuticals reported favorable topline results from the single ascending dose portion of its Phase 1 trial of oral Ketamir-2 in 32 healthy volunteers across four dose levels from 50 mg to 600 mg. The drug was generally safe and well tolerated, with no dose-limiting toxicities, serious adverse events, or clinically significant central nervous system effects reported, and any treatment-emergent side effects were transient.

Pharmacokinetic data showed dose-proportional exposure, a time to maximum concentration of 1–2 hours, and a terminal half-life of 2–5 hours, while the main active metabolite, nor-Ketamir, had a half-life of 6.5 to 8.5 hours. These findings support once-daily dosing and allow the company to start a multiple ascending dose Phase 1 study in healthy volunteers, followed by a planned Phase 2a trial in neuropathic pain. The U.S. Drug Enforcement Administration also concluded Ketamir-2 is not a controlled substance or listed chemical.

Positive

• Favorable Phase 1 SAD topline data for oral Ketamir-2, with no serious adverse events, no dose-limiting toxicities, and a safety profile supporting further development.
• DEA non-controlled status for Ketamir-2, as the agency’s scientific review concluded it is not a controlled substance or listed chemical under the Controlled Substances Act.

Negative

• None.

Insights

Biotech clinical development analyst

Early Phase 1 safety and DEA non-controlled status de-risk Ketamir-2’s path.

The report shows that Ketamir-2 met key safety and pharmacokinetic goals in a 32-subject, single ascending dose Phase 1 trial, with doses from 50 mg to 600 mg. No serious adverse events, dose-limiting toxicities, or clinically significant CNS effects were observed, and adverse events resolved without intervention, which is important for an oral CNS-acting drug.

Pharmacokinetic results—dose-proportional exposure, a 1–2 hour time to peak levels, and a 2–5 hour half-life, with the active metabolite nor-Ketamir showing a 6.5–8.5 hour half-life—support once-daily dosing, which can simplify future trial designs. The company plans to proceed to a multiple ascending dose Phase 1 segment and then a Phase 2a neuropathic pain study, indicating a clear development path.

A notable regulatory detail is that the U.S. Drug Enforcement Administration’s scientific review found Ketamir-2 would not be treated as a controlled substance or listed chemical under the Controlled Substances Act. For a ketamine analog, avoiding controlled-substance status can ease trial operations and, if later approved, could simplify prescribing and distribution compared with scheduled drugs.

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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 (Date of earliest event reported): September 22, 2025

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)

Registrant’s telephone number, including area code: (786) 432-9792

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
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 8.01 Other Events

MIRA Pharmaceuticals Announces Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine Analog

Study demonstrated that Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption and a favorable duration of action supporting once-daily dosing.

On September 22, 2025, MIRA Pharmaceuticals, Inc. (the “Company”) announced topline results from the single ascending dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2 in healthy volunteers.

The randomized, placebo-controlled study enrolled 32 healthy adult participants across four escalating oral dose cohorts (50 mg to 600 mg). The primary endpoints were safety, tolerability, and pharmacokinetic (PK) characterization.

Pharmacokinetic Results

	●	Dose-proportional increases in exposure (Cmax and AUC) were observed across all dose levels tested.
	●	Median time to maximum plasma concentration (Tmax) was reached within 1–2 hours, consistent across cohorts.
	●	Terminal half-life (t½) of Ketamir-2 ranged from 2 to 5 hours.
	●	The primary active metabolite, nor-Ketamir, demonstrated a half-life of 6.5 to 8.5 hours.

Safety and Tolerability Results

	●	Ketamir-2 was generally safe and well tolerated across all four cohorts.
	●	No dose-limiting toxicities or serious adverse events were observed.
	●	Reported treatment-emergent adverse events were transient and resolved without intervention.
	●	Central nervous system (CNS) safety was monitored using validated tools (C-SSRS, Bowdle VAS, KSET). Across all SAD cohorts, no clinically significant adverse effects of Ketamir-2 observed.

Next Steps

Based on the data, the Company is initiating the multiple ascending dose (MAD) portion of the Phase 1 study in healthy volunteers, to be followed by a Phase 2a trial in patients with neuropathic pain.

Additional Information

The U.S. Drug Enforcement Administration’s scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations.

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: September 22, 2025	By:	/s/ Erez Aminov
	Name:	Erez Aminov
	Title:	Chief Executive Officer

FAQ

What did MIRA (MIRA) announce about Ketamir-2 in this 8-K?

MIRA reported favorable topline results from the single ascending dose portion of a Phase 1 trial of oral Ketamir-2 in 32 healthy adults, showing it was generally safe, well tolerated, and supported once-daily dosing.

How many subjects were included in MIRA’s Phase 1 Ketamir-2 SAD study?

The Phase 1 single ascending dose study of Ketamir-2 enrolled 32 healthy adult participants across four escalating oral dose cohorts ranging from 50 mg to 600 mg.

What were the key safety findings for Ketamir-2 reported by MIRA?

Ketamir-2 was generally safe and well tolerated, with no dose-limiting toxicities, no serious adverse events, transient treatment-emergent adverse events that resolved without intervention, and no clinically significant CNS effects across all SAD cohorts.

What pharmacokinetic characteristics did MIRA highlight for Ketamir-2?

MIRA reported dose-proportional increases in exposure, a time to maximum plasma concentration of 1–2 hours, a terminal half-life of 2–5 hours for Ketamir-2, and a 6.5–8.5 hour half-life for the primary active metabolite nor-Ketamir.

What are the next clinical steps for Ketamir-2 according to MIRA?

Based on the Phase 1 SAD data, MIRA is starting the multiple ascending dose portion of the Phase 1 study in healthy volunteers, followed by a planned Phase 2a trial in patients with neuropathic pain.

How did the DEA classify Ketamir-2 in relation to controlled substances?

The U.S. Drug Enforcement Administration’s scientific review concluded that Ketamir-2 is not a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations.