Cingulate's Lead ADHD Candidate CTx-1301 Selected for Podium Presentation at AACAP Annual Meeting
KANSAS CITY, Kan., Oct. 23, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, today announced that data from its lead ADHD candidate CTx-1301 (dexmethylphenidate HCl) has been selected for podium presentation at the American Academy of Child and Adolescent Psychiatry (AACAP) Annual Meeting in Chicago. This recognition highlights growing scientific interest in CTx-1301, a once-daily, extended-release formulation designed to simplify treatment for millions living with ADHD.
The Phase 3 data will be presented by Ann Childress, M.D., a leading ADHD specialist and past President of the American Professional Society of ADHD and Related Disorders (APSARD). Her presentation, "Efficacy and Safety of CTx-1301 in Pediatric Subjects With ADHD," is scheduled for Friday, October 24, 2025.
"We look forward to presenting the results of this pivotal trial at AACAP, a premier scientific forum for child and adolescent psychiatry," said Dr. Childress. "The data provide valuable insights into CTx-1301's ability to deliver symptom relief with the convenience of once-daily dosing."
"Selection for an AACAP podium presentation is a meaningful acknowledgment of the scientific rigor behind our Phase 3 program," said Raul Silva, M.D., Chief Science Officer of Cingulate. "CTx-1301 was designed to help address well-documented limitations in current stimulant therapies — such as delayed onset, inconsistent duration, and the need for multiple daily doses — with the goal of improving function for individuals living with ADHD."
The session will be livestreamed and available on demand at aacap.confex.com. Results from the study will be discussed in detail during the presentation and summarized in a follow-up company announcement following the conference.
About Attention-Deficit/Hyperactivity Disorder (ADHD)
ADHD is a chronic neurodevelopmental disorder affecting an estimated 20 million individuals in the U.S., including approximately 8 million children and 12 million adults. The condition is characterized by inattention, hyperactivity, and impulsivity that impair academic, professional, and social functioning. Stimulant medications remain the gold-standard therapy; however, most currently available extended-release formulations require multiple doses per day and often fail to provide consistent coverage across the entire active day.
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 Cingulate Inc.
Cingulate Inc. (NASDAQ:CING) is a biopharmaceutical company utilizing its proprietary Precision Timed Release™ platform technology to build and advance a pipeline of next-generation pharmaceutical products designed to improve patient outcomes in conditions characterized by burdensome daily dosing and suboptimal therapeutic coverage. Cingulate's lead candidate, CTx-1301, is in late-stage development for ADHD, with additional candidates in anxiety and other neuropsychiatric indications. Cingulate is headquartered in Kansas City, Kansas. For more information, visit Cingulate.com.
About Dr. Ann Childress
Ann C. Childress, M.D., a board-certified physician in Psychiatry and Child and Adolescent Psychiatry, has been a practicing psychiatrist for more than 35 years. Dr. Childress has held numerous prominent positions, including chief of mental health at various psychiatric hospitals as well as professorships within prestigious universities. Dr. Childress is past President of the American Professional Society of ADHD and Related Disorders, Education Director for the Nevada Psychiatric Association, a Distinguished Life Fellow of the American Psychiatric Association and a member of the American Academy of Child and Adolescent Psychiatry.
Dr. Childress is the founder and principal investigator of Clinical Research of Southern Nevada and is the founder and president of the Center for Psychiatry and Behavioral Medicine, both entities located in Las Vegas, Nevada. She has conducted more than 200 clinical studies, working on most of the major psychiatric drugs that have been approved for ADHD over the last few decades by various major pharmaceutical companies, including Pfizer, Janssen, Shire, and Novartis.
Dr. Childress has been working with Cingulate since 2018, serving as a key opinion and thought leader, helping design multiple clinical protocols, and currently serving as the lead investigator on Cingulate's Phase 3 Fixed-Dose Study in pediatrics and adolescents.
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, the potential approval and commercialization of CTx-1301 and other statements that are predictive in nature. 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 27, 2025, 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 Contact
Thomas Dalton, Vice President, Corporate Communications
Cingulate Inc.
Email: [email protected] | Phone: (913) 942-2301
