CING’s CTx-1301 NDA accepted by FDA with May 31, 2026 PDUFA

Rhea-AI Filing Summary

Cingulate Inc. announced a regulatory milestone: the FDA has accepted for review the New Drug Application for CTx-1301 (dexmethylphenidate), the company’s lead candidate for treating ADHD in children and adults. The FDA assigned a PDUFA target action date of May 31, 2026, setting the timeline for a decision after the agency’s standard review process. This step moves CTx-1301 into formal evaluation but does not indicate approval.

Insights

Regulatory affairs analyst

FDA accepted the NDA; decision targeted by May 31, 2026.

The filing states that the FDA accepted the NDA for CTx-1301 for ADHD across children and adults, which begins the standard review. Acceptance means the submission was deemed sufficiently complete for review; it does not speak to clinical merit.

The disclosed PDUFA target action date of May 31, 2026 anchors the expected timing for an FDA decision. Actual outcomes depend on the review and any labeling, risk management, or inspection findings the agency may require.

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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): October 14, 2025

CINGULATE INC.

(Exact name of registrant as specified in its charter)

Delaware		001-40874		86-3825535
(State or other jurisdiction		(Commission		(IRS Employer
of incorporation)		File Number)		Identification No.)

1901 W. 47th Place
Kansas City, KS				66205
(Address of principal executive offices)				(Zip Code)

(913) 942-2300

(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 (see General Instruction A.2. below):

☐	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(s)		Name of exchange on which registered
Common Stock, par value $0.0001 per share		CING		The Nasdaq Stock Market LLC (Nasdaq Capital Market)
Warrants, exercisable for common stock		CINGW		The Nasdaq Stock Market LLC (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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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 October 14, 2025, Cingulate Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has accepted for review the New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate), the Company’s lead candidate for the treatment of attention deficit/hyperactivity (“ADHD”) for children and adults. The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of May 31, 2026. A copy of the press release is attached hereto as Exhibit 99.1.

The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the 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, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

Item 8.01. Other Events.

On October 14, 2025, the Company announced that the FDA has accepted for review the NDA for CTx-1301 (dexmethylphenidate), the Company’s lead candidate for the treatment of ADHD for children and adults. The FDA has assigned a PDUFA target action date of May 31, 2026.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press release dated October 14, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

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.

	CINGULATE INC.
Dated: October 14, 2025	By:	/s/ Jennifer L. Callahan
	Name:	Jennifer L. Callahan
	Title:	Interim Chief Executive Officer and Chief Financial Officer

FAQ

What did Cingulate (CING) announce in its 8-K?

The FDA accepted for review the NDA for CTx-1301 (dexmethylphenidate) for ADHD in children and adults.

What is the PDUFA date for CTx-1301 noted by Cingulate (CING)?

The FDA assigned a PDUFA target action date of May 31, 2026.

What condition is CTx-1301 intended to treat?

CTx-1301 targets attention deficit/hyperactivity disorder (ADHD) in children and adults.

Does FDA NDA acceptance mean CTx-1301 is approved?

No. Acceptance means the application will be reviewed; it does not indicate approval.

Where did Cingulate (CING) provide more details?

A press release dated October 14, 2025 was furnished as Exhibit 99.1.