Cingulate Issued First U.S. Patent for Lead ADHD Asset CTx-1301
Rhea-AI Summary
Cingulate (NASDAQ:CING) received its first U.S. patent fully owned for lead ADHD candidate CTx-1301, issued June 16, 2026 as U.S. Patent No. 12,653,791.
The patent covers formulation and method-of-use claims, extending U.S. protection for CTx-1301’s trimodal Precision Timed Release™ tablet technology through December 2042.
AI-generated analysis. Not financial advice.
Positive
- First wholly owned U.S. patent for lead ADHD asset CTx-1301
- U.S. patent protection for CTx-1301 extended through December 2042
- Patent covers composition, formulation, structural and method-of-treatment claims
- Trimodal, three-phase daily release design protected as intellectual property
- Existing patents in 30 European territories plus Australia, Canada and Israel
- Additional patent applications pending in Hong Kong and Republic of Korea
Negative
- None.
News Market Reaction – CING
On the day this news was published, CING declined 3.85%, reflecting a moderate negative market reaction. Argus tracked a peak move of +12.8% during that session. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $3M from the company's valuation, bringing the market cap to $71.39M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Peers on Argus
Pre-news, CING was up 1.02% while peers were mixed: LEXX down 0.82%, CTXR down 1.6%, ASBP up 12.8%, HOTH up 58.12%, GDTC up 4.55%. Momentum scanner shows LEXX up and ASBP down, reinforcing a stock-specific backdrop for CING rather than a uniform biotech move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jun 04 | CRL coverage update | Negative | -6.3% | Stonegate update on FDA CRL for CTx-1301 and CMC-focused resubmission path. |
| Jun 02 | FDA CRL issued | Negative | +11.9% | FDA Complete Response Letter for CTx-1301 NDA outlining CMC information requests. |
| May 14 | Q1 2026 earnings | Neutral | -10.8% | Q1 2026 results with higher cash from $12M private placement and net loss of $9.3M. |
| Apr 06 | Coverage update | Positive | -4.2% | Stonegate 4Q25 update highlighting CTx-1301 launch progress and capital access. |
| Mar 18 | FY 2025 earnings | Neutral | -31.1% | FY 2025 results with CTx-1301 NDA status, patents, $11M cash and $22.4M net loss. |
Recent CTx-1301 and financing-related news often saw negative or volatile reactions, with more divergences than alignments between news tone and price.
Over the past six months, Cingulate’s key updates have centered on CTx‑1301’s regulatory path and funding. A Complete Response Letter in early June 2026 shifted the NDA toward a CMC‑focused resubmission process, with one CRL update producing a -6.35% move and another a +11.94% move. Earlier, Q1 2026 and FY 2025 results highlighted cash balances, PIPE and private placement activity, and commercial readiness, but those announcements triggered drawdowns of -10.77% and -31.05%. Against this backdrop, today’s long-dated U.S. patent strengthens the IP story around CTx‑1301.
Regulatory & Risk Context
Cingulate has an active shelf registration on Form S-3/A dated 2026-03-23. The amendment added an updated auditor consent and the registration is marked effective, with 3 related prospectus supplements (Form 424B3) filed in March and April 2026, indicating the shelf has been utilized.
Market Pulse Summary
This announcement grants CTx‑1301 its first company-owned U.S. patent, protecting key formulation and use aspects through December 2042 and complementing patents across 30 European territories and several other countries. It reinforces Cingulate’s IP around its Precision Timed Release platform as it advances ADHD candidates CTx‑1301 and CTx‑1302 and anxiety candidate CTx‑2103. Investors may watch how this strengthened protection interacts with ongoing FDA CMC work, existing resale and ATM facilities, and future commercialization steps.
Key Terms
attention deficit hyperactivity disorder medical
precision timed release technical
composition-of-matter medical
method-of-treatment medical
anxiolytic medical
AI-generated analysis. Not financial advice.
Exclusivity Extended into December 2042
KANSAS CITY, Kan., June 16, 2026 (GLOBE NEWSWIRE) -- 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
