Cingulate Announces Publication of Phase 3 ADHD Trial Results in Journal of Child and Adolescent Psychopharmacology
Rhea-AI Summary
Cingulate (NASDAQ: CING) announced that Phase 3 trial results for its lead ADHD candidate CTx-1301 (dexmethylphenidate HCl) have been published via open access in the Journal of Child and Adolescent Psychopharmacology. The peer-reviewed article describes a randomized, double-blind, placebo-controlled, fixed-dose study in children and adolescents aged 6–17 with ADHD.
According to Cingulate, all three CTx-1301 dose groups (18.75 mg, 25 mg, 37.5 mg) showed improvement versus placebo in the primary endpoint, ADHD Rating Scale-5 score change at Week 5, with p-values of 0.018, 0.011, and 0.001 and placebo-adjusted effect sizes of 0.737, 0.782, and 1.185, respectively. The mean effect size across the study population was 0.901. Investigators reported clinically meaningful symptom improvements with a favorable safety profile, supporting CTx-1301 as a once-daily treatment candidate and reinforcing the potential of Cingulate’s Precision Timed Release™ platform, which delivers three timed medication releases across the day and is also being developed for anxiety and other conditions.
Positive
- Statistically significant efficacy across all doses with p-values 0.018, 0.011, 0.001 in Phase 3 primary endpoint
- Strong placebo-adjusted effect sizes of 0.737, 0.782, 1.185; overall mean effect size 0.901 in pediatric ADHD
- Peer-reviewed Phase 3 publication in Journal of Child and Adolescent Psychopharmacology enhances clinical validation of CTx-1301
- Once-daily PTR™ platform demonstrated expert-reviewed evidence of clinically meaningful symptom improvement and favorable safety profile
Negative
- CTx-1301 remains a development-stage asset, still being evaluated under the FDA’s 505(b)(2) pathway with no approval yet
- Phase 3 results are from a fixed-dose pediatric trial, with no adult data or flexible-dosing outcomes discussed in this announcement
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Oct 28 | Phase 3 results | Positive | -3.2% | Positive Phase 3 efficacy results with statistically significant endpoint and sustained symptom control |
| Oct 14 | FDA NDA acceptance | Positive | +2.5% | FDA accepted the CTx-1301 NDA and assigned a May 31, 2026 PDUFA date |
| Aug 06 | NDA submission | Positive | -16.6% | Company submitted the CTx-1301 New Drug Application to the FDA |
| May 20 | Phase 3 results | Positive | -5.0% | Pediatric Phase 3 study showed statistically significant improvement across all fixed doses |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Cingulate's tagged clinical-trial announcements historically showed negative reactions in three of four events despite positive clinical or regulatory milestones.
Key Terms
placebo-adjusted effect sizes medical
pharmacokinetic medical
505(b)(2) pathway regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Publication helps establish the efficacy and safety profile of of CTx-1301, reinforcing the potential of Cingulate’s Precision Timed Release™ platform technology
KANSAS CITY, Kan., July 30, 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, announced today that Phase 3 clinical trial results for its lead asset, CTx-1301 (dexmethylphenidate HCl), for the treatment of attention-deficit/hyperactivity disorder (ADHD), have been published in the Journal of Child and Adolescent Psychopharmacology and are now available through open access.
The peer-reviewed publication helps establish the efficacy and safety profile of CTx-1301 and reinforces the potential of Cingulate’s Precision Timed Release™ (PTR™) platform technology, as the Company advances its lead asset toward potential regulatory approval and commercialization. The manuscript represents an important addition to the scientific literature supporting next-generation ADHD treatments designed to address ongoing challenges associated with symptom control, dosing convenience, and treatment consistency.
“Publication of these Phase 3 results in a respected peer-reviewed journal represents an important milestone for Cingulate and reflects the rigorous science behind our Precision Timed Release™ (PTR™) platform,” said Cingulate Chairman and CEO Shane J. Schaffer. “The independent review and publication of our clinical data provide additional scientific support for CTx-1301 as we continue advancing this potential new treatment option for individuals living with ADHD and their families. We thank our clinical investigators, research partners, and the patients and families who participated in this study. Their contributions made this work possible.”
Ann Childress, M.D., lead investigator for the Phase 3 trial, stated, “The study demonstrated clinically meaningful improvements in ADHD symptoms while maintaining a favorable safety profile, and the publication of these results provides clinicians with expert-reviewed evidence supporting CTx-1301’s potential as a once-daily treatment option.”
In the Phase 3 study, all three CTx-1301 dose groups demonstrated improvements compared with placebo in the primary efficacy endpoint, measured by change from baseline in ADHD Rating Scale-5 (ADHD-RS-5) scores at Week 5. The p-values for the 18.75 mg, 25 mg, and 37.5 mg dose groups were 0.018, 0.011, and 0.001, respectively. The placebo-adjusted effect sizes were 0.737, 0.782, and 1.185, respectively, with an overall mean effect size of 0.901 across the study population.
“Beyond achieving statistical significance, the magnitude of the treatment effect observed in the Phase 3 study is an important measure of the potential clinical impact of CTx-1301,” said Raul Silva, M.D., Chief Science Officer of Cingulate. “Effect size helps quantify how much improvement was observed compared with placebo, providing context on the strength of the treatment response. The effect sizes observed across all three CTx-1301 dose groups demonstrate a meaningful separation from placebo and provide additional confidence in the potential of the Precision Timed Release™ platform to deliver consistent, clinically relevant symptom improvement with once-daily dosing.”
The full publication, “Efficacy and Safety of Trimodal Dexmethylphenidate (CTx-1301) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Results From a Phase 3, Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial," is available at journals.sagepub.com.
About the Phase 3 Children/Adolescent Fixed Dose Study (CTx-1301-005)
- A double-blind, randomized, placebo-controlled, multi-center, fixed-dose (doses 18.75mg, 25mg and 37.5mg), parallel-group efficacy and safety study in a pediatric population (6-17) with ADHD
- The study was comprised of a screening period, a double-blind randomized phase, and a safety follow-up visit
- The primary endpoint of the trial was mean change in ADHD Rating Scale 5 (ADHD-RS-5) scores from baseline (pre-dose) at Visit 2 to ADHD-RS-5 scores at Visit 8
- The secondary endpoint was mean change in Clinical Global Impression - Severity (CGI-S) scores within the same time frame. Multiple safety and pharmacokinetic analyses were also measured
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.
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 efficacy and safety profile of CTx-1301, the potential of Cingulate’s Precision Timed Release™ (PTR™) platform technology, CTx-1301’s potential as a once-daily treatment option, the potential 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
