Cingulate Presents Positive Phase 3 Results for CTx-1301 Demonstrating Statistically Significant Efficacy and Entire Active-Day Symptom Control

Rhea-AI Summary

Cingulate (NASDAQ: CING) reported positive Phase 3 results for CTx-1301 (dexmethylphenidate HCl) in pediatric ADHD on Oct 28, 2025. The trial met its primary endpoint (p < 0.001), showed dose-dependent improvements on ADHD-RS-5 and CGI-S, and delivered rapid onset with sustained symptom relief up to 12 hours post-dose. The 37.5 mg dose produced the largest effect size. Safety and tolerability were consistent with the stimulant class with no unexpected adverse events. The FDA accepted the New Drug Application in October 2025 with a target PDUFA date of May 31, 2026, and Cingulate received a small-business PDUFA fee waiver saving approximately $4.3 million. Cingulate has a variable-cost commercial partnership with Indegene and plans additional scientific and investor disclosures.

Positive

• Primary endpoint met with p < 0.001
• Sustained symptom relief through 12 hours post-dose
• 37.5 mg dose showed largest effect size
• NDA accepted with PDUFA date May 31, 2026
• Small-business waiver saves about $4.3 million

Negative

• Results from forced-dose study, not dose-optimization
• Safety described as class-consistent, not differentiated

Insights

Clinical Development & Commercialization Analyst

Positive pivotal Phase 3 readout, NDA accepted with a May 31, 2026 PDUFA date and a fee waiver saving $4.3 million.

CTx-1301 achieved its primary endpoint (p < 0.001) with dose-dependent improvements on ADHD-RS-5 and CGI-S and showed sustained symptom relief up to 12 hours after dosing. The program reports a safety profile consistent with the stimulant class and no unexpected adverse events, which supports regulatory review and aligns safety expectations for methylphenidate products.

The business case rests on a reported $23 billion global ADHD market and the potential commercial advantage of once-daily dosing versus multi-dose regimens. The accepted NDA and PDUFA date provide a clear regulatory timeline; the small-business PDUFA fee waiver reduces near-term cash burden by $4.3 million. Key dependencies are final FDA review findings, any briefing‑package questions, and the forthcoming detailed Phase 3 data that the company plans to publish.

Watch the FDA review through May 31, 2026 and upcoming scientific disclosures for effect‑size details, subgroup analyses, and any safety signals. If the detailed data remain consistent with the presentation, the program has a straightforward path to regulatory decision within the specified timeframe.

Once-daily formulation of dexmethylphenidate achieved primary endpoint (p < 0.001) with consistent symptom relief up to 12 hours post-dose

KANSAS CITY, Kan., Oct. 28, 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, announced today that the positive Phase 3 results from its pivotal trial of CTx-1301 (dexmethylphenidate HCl) in pediatric ADHD, were recently presented by Ann Childress, M.D., at the AACAP Annual Meeting in Chicago. CTx-1301 met its primary endpoint, demonstrating dose-dependent improvements on the ADHD ratings scale 5 (ADHD-RS-5), and Clinical Global Impression-Severity (CGI-S) scales, and demonstrated the ability to deliver symptom relief with the convenience of once-daily dosing.

In the randomized, double-blind, pediatric and adolescent, placebo-controlled study, CTx-1301 delivered rapid onset of effect and sustained efficacy through the evening hours. Safety and tolerability were consistent with the stimulant class, with no unexpected adverse events reported.

“In summary, CTx1301 demonstrated dose dependent efficacy in improving ADHD symptoms in children and adolescents. The 37.5mg dose demonstrated the largest effect size in symptom reduction and effect sizes were pretty substantial, considering this was a forced dose and not a dose optimization study,” Dr. Childress stated during the presentation. “The safety profile did not show anything that would be of concern, as it looks like other methylphenidates.” 

ADHD represents a $23 billion global market, yet most treatments require two or more daily doses. CTx-1301 offers the potential for simpler once-daily management, which could translate to better adherence for patients and families. Cingulate’s commercial partnership with Indegene, a digital-first, life sciences commercialization company, is designed around a variable-cost structure that aligns commercial execution with growth milestones as the company approaches launch.

The New Drug Application for CTx-1301 was accepted by the FDA in October 2025, with a target PDUFA date of May 31, 2026. Cingulate also received a waiver of the standard PDUFA filing fee. Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the waiver will save Cingulate approximately $4.3 million.

“These results demonstrate that CTx-1301 can deliver reliable symptom control for the entire active-day in a single dose — something families and clinicians have wanted for years. With this Phase 3 data in hand, we believe CTx-1301 is well positioned to become a next-generation treatment for ADHD as we move toward potential approval and launch in 2026,” said Raul Silva, M.D., Chief Science Officer of Cingulate.

The Company plans to share additional details from the Phase 3 study in upcoming scientific publications and investor communications.

Dr. Childress recently appeared on the “Unboxing Biotech” webcast with John Vandermosten, Senior Analyst for Zacks Investment Research, where she discussed the podium presentation and CTx-1301 data during a wide-ranging discussion about ADHD. The segment can be viewed here.

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 Ann Childress, M.D.
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: tdalton@cingulate.com | Phone: (913) 942-2301

FAQ

What did Cingulate announce about CTx-1301 Phase 3 results on October 28, 2025?

Cingulate announced positive Phase 3 results: primary endpoint met (p < 0.001), dose-dependent efficacy, and symptom relief up to 12 hours.

When is the FDA PDUFA date for Cingulate's CTx-1301 (CING)?

The New Drug Application was accepted in October 2025 with a target PDUFA date of May 31, 2026.

How much did Cingulate save from the PDUFA fee waiver for CTx-1301?

Cingulate received a small-business waiver that will save approximately $4.3 million in PDUFA fees.

What dose produced the largest effect size in CTx-1301 Phase 3 results?

The 37.5 mg dose demonstrated the largest effect size in symptom reduction in the trial.

What is the safety profile reported for CTx-1301 in the Phase 3 pediatric study?

Safety and tolerability were reported as consistent with the stimulant class, with no unexpected adverse events.

How could CTx-1301 once-daily dosing affect ADHD treatment adherence?

CTx-1301 offers once-daily symptom control up to 12 hours, which the company says could translate to simpler management and improved adherence versus multi-dose regimens.

What commercial partner will Cingulate use for CTx-1301 launch preparations?

Cingulate has a variable-cost commercialization partnership with Indegene aligned to growth milestones ahead of launch.