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US patent extends Cingulate (NASDAQ: CING) CTx-1301 ADHD exclusivity

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Rhea-AI Filing Summary

Cingulate Inc. announced issuance of a new U.S. patent protecting its lead ADHD treatment candidate CTx-1301 through December 2042. Granted as U.S. Patent No. 12,653,791, it covers key aspects of the drug’s trimodal Precision Timed Release tablet formulation and method of use.

The patent is the first U.S. patent owned wholly by Cingulate for CTx-1301 and further strengthens the company’s intellectual property around its PTR platform as it moves toward potential commercialization. Cingulate also holds related patents across 30 European territories and in Australia, Canada and Israel, with additional applications pending.

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New U.S. patent extends CTx-1301 protection to 2042, reinforcing Cingulate’s ADHD franchise potential.

The USPTO issued U.S. Patent No. 12,653,791 for CTx-1301, Cingulate’s lead ADHD asset, with protection through December 2042. Claims span composition-of-matter, formulation, structure and method of treatment for the trimodal Precision Timed Release tablet, a broad scope for a late-stage asset.

This strengthens Cingulate’s long-term intellectual property position around its PTR platform as CTx-1301 advances under the FDA’s 505(b)(2) pathway. Combined with patents in 30 European territories plus Australia, Canada and Israel, the portfolio supports potential exclusivity across major ADHD markets, though actual commercial impact will depend on future regulatory approvals and market uptake.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Patent number U.S. Patent No. 12,653,791 Issued by USPTO for CTx-1301 on June 16, 2026
Patent term Through December 2042 Protection period for CTx-1301 formulation and use
US ADHD market size 100 million annual prescriptions Estimated size of the U.S. ADHD market
Diagnosed ADHD patients in US Over 20 million patients Includes adults and patients under age 17
Adult ADHD patients 12 million adults Subset of U.S. ADHD-diagnosed population
Child and teen ADHD patients Over 8 million under 17 U.S. ADHD-diagnosed children and teens
Children/teens on medication 53.6 percent Share of U.S. children and teens with ADHD treated with medication in 2022
Persistent ADHD symptoms 65-90 percent Children and teens whose ADHD symptoms persist into adulthood
Precision Timed Release™ (PTR™) technical
"utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology"
composition-of-matter regulatory
"The patent includes composition-of-matter, formulation, structural and method-of-treatment claims"
A composition-of-matter is a legal description of a specific chemical or biological substance or mixture—think of it as the exact recipe and ingredients that make up a drug, material, or chemical product. For investors, ownership of a composition-of-matter patent can act like a locked recipe that keeps competitors out, protecting future sales and profit margins and reducing the risk that a product will be easily copied.
505(b)(2) pathway regulatory
"CTx-1301 is being evaluated for the treatment of ADHD under the FDA’s 505(b)(2) pathway"
A 505(b)(2) pathway is a U.S. regulatory route that lets a drug developer get approval by relying in part on existing clinical data or published studies instead of repeating every test. Think of it as building on someone else’s homework to shorten development time and cost. For investors, it signals potentially faster, lower‑risk market entry and a chance for competitive protection compared with starting brand‑new drug approvals.
Notice of Allowance regulatory
"The Company previously announced the USPTO’s issuance of a Notice of Allowance for the Patent"
A notice of allowance is an official confirmation from a patent office that a patent application has met all necessary requirements and is approved for granting. It signals that the invention is likely to receive legal protection soon, which can be important for investors considering the value and exclusivity of a new product or technology. Think of it as a green light indicating that the invention is on track to become legally protected.
forward-looking statements regulatory
"This press release contains “forward-looking statements” within the meaning of Section 27A"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
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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): June 16, 2026

 

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 June 16, 2026, Cingulate Inc. (the “Company”) issued a press release announcing that the United States Patent and Trademark Office (“USPTO”) issued the Company U.S. Patent No. 12,653,791 (the “Patent”) covering key aspects of CTx-1301’s formulation and method of use through December 2042. The Company previously announced the USPTO’s issuance of a Notice of Allowance for the Patent. A copy of the press release announcing the issuance of the Patent is attached hereto as Exhibit 99.1.

 

The information included in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K is not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall this Item 7.01 and Exhibit 99.1 be incorporated by reference into the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such future filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
     
99.1   Press Release, dated June 16, 2026
     
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: June 16, 2026 By: /s/ Shane J. Schaffer
  Name: Shane J. Schaffer
  Title: Chief Executive Officer

 

 

 

 

 

Exhibit 99.1 

 

Cingulate Issued First U.S. Patent for Lead ADHD Asset CTx-1301

 

Exclusivity Extended into December 2042

 

Kansas City, Kan., June 16, 2026 — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced the issuance of its first company-owned U.S. patent covering its lead asset, CTx-1301 (dexmethylphenidate HCl), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

 

The patent, issued by the United States Patent and Trademark Office (USPTO) on June 16, 2026, as U.S. Patent No. 12,653,791, protects key aspects of CTx-1301’s formulation and method of use through December 2042, further strengthening Cingulate’s intellectual property portfolio surrounding its PTR™ platform.

 

The issuance marks the first U.S. patent owned wholly by Cingulate covering CTx-1301 and further strengthens the company’s long-term intellectual property position as it advances toward potential commercialization.

 

Titled “Trimodal, Precision-Timed Pulsatile Release Tablet,” the patent includes composition-of-matter, formulation, structural and method-of-treatment claims covering CTx-1301’s trimodal Precision Timed Release™ tablet technology. The patented design enables medication release in three distinct phases throughout the day from a single daily dose and protects key aspects of the tablet’s architecture, release mechanisms and therapeutic use.

 

“This patent represents another important milestone in protecting the technology that differentiates CTx-1301 and underpins our proprietary Precision Timed Release™ Platform,” said Cingulate CEO Shane J. Schaffer. “As we advance toward potential commercialization, strengthening our intellectual property portfolio enhances the long-term value of CTx-1301 while supporting our goal of delivering consistent symptom control throughout the entire active day from a single daily dose.”

 

In addition to the U.S. patent, Cingulate currently holds patents in 30 European territories, including the United Kingdom, as well as in Australia, Canada and Israel. The company also has patent applications pending in Hong Kong and the Republic of Korea.

 

Cingulate is developing CTx-1301 and CTx-1302 as once-daily treatments for ADHD, with the goal of providing symptom control throughout the full active day. Furthermore, Cingulate is developing CTx-2103, to treat anxiety disorders. CTx-2103 contains one of the most widely prescribed anxiolytic agents which must be taken several times a day. CTx-2103 will be designed as a once-daily, multi-release tablet with clear differentiation and compelling advantages over standard anxiety treatment options.

 

 

 

 

About Attention Deficit/Hyperactivity Disorder (ADHD)

 

ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The estimated market size of the US ADHD market is approximately 100 million annual prescriptions. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined.

 

About CTx-1301

 

CTx-1301 (dexmethylphenidate HCl) is a once-daily, multi-core tablet utilizing Cingulate’s proprietary Precision Timed Release™ (PTR™) platform to deliver three precisely timed releases of active medication across the day. This design aims to provide rapid onset of effect and entire active-day duration. CTx-1301 is being evaluated for the treatment of ADHD under the FDA’s 505(b)(2) pathway.

 

About Precision Timed Release™ (PTR™) Platform Technology

 

Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here.

 

About Cingulate Inc.

 

Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com.

 

 

 

 

Forward-Looking Statements

 

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Specifically, these statements include, but are not limited to, the Company’s long-term intellectual property position and the potential timing and process for regulatory approval of CTx-1301 and the potential commercialization of CTx-1301, if approved. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 18, 2026 and our other filings with the SEC. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

 

Investor & Media Relations:

 

Thomas Dalton

Vice President, Corporate and Government Relations, Cingulate

tdalton@cingulate.com

(480) 529-5434

 

 

 

 

Source: View Original Filing on SEC EDGAR

FAQ

What did Cingulate Inc. (CING) announce regarding CTx-1301?

Cingulate announced a new U.S. patent for CTx-1301, its lead ADHD treatment candidate. U.S. Patent No. 12,653,791 protects key formulation and method-of-use aspects of the trimodal Precision Timed Release tablet, reinforcing intellectual property as the program advances toward potential commercialization.

How long does the new Cingulate CTx-1301 patent protect the drug?

The new CTx-1301 patent protects the product through December 2042. This long-dated protection covers composition-of-matter, formulation, structural and method-of-treatment claims, supporting Cingulate’s strategy to maintain exclusivity for its lead ADHD asset over an extended commercial period if approved.

What technology is covered by Cingulate’s new U.S. patent for CTx-1301?

The patent covers CTx-1301’s trimodal Precision Timed Release tablet technology. It includes the tablet’s architecture, release mechanisms and therapeutic use, enabling three distinct medication release phases from a single daily dose aimed at all-day ADHD symptom control using Cingulate’s PTR platform.

What is CTx-1301 and how is it being developed by Cingulate?

CTx-1301 is a once-daily dexmethylphenidate HCl tablet using Cingulate’s Precision Timed Release platform for ADHD treatment. It delivers three precisely timed medication releases across the day and is being evaluated under the FDA’s 505(b)(2) pathway, aiming for rapid onset and full active-day coverage.

What other pipeline products does Cingulate Inc. have besides CTx-1301?

Cingulate is also developing CTx-1302 for ADHD and CTx-2103 for anxiety disorders. CTx-2103 will use the PTR platform to convert a widely prescribed anxiolytic, traditionally taken several times daily, into a once-daily, multi-release tablet with intended differentiation versus standard anxiety treatments.

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