Cingulate published Phase 3 results for CTx-1301 in ADHD, showing significant symptom improvement, favorable safety, and support for its once-daily Precision Timed Release platform.
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
Cingulate has published the full Phase 3 results for its investigational attention-deficit/hyperactivity disorder (ADHD) therapy CTx-1301 (dexmethylphenidate HCl) in the Journal of Child and Adolescent Psychopharmacology. The peer-reviewed, open-access publication provides independent scientific validation of the efficacy and safety findings from the pivotal pediatric trial and adds to the evidence supporting the company’s proprietary Precision Timed Release™ (PTR™) drug delivery platform.
The publication comes as Cingulate continues to advance CTx-1301 toward potential regulatory submission under the US Food and Drug Administration’s 505(b)(2) pathway. The once-daily formulation is intended to provide rapid onset of action while maintaining symptom control throughout the day using a trimodal drug-release profile.
Precision Timed Release Platform Targets All-Day Symptom Control
CTx-1301 is a once-daily, multi-core dexmethylphenidate tablet that incorporates Cingulate’s Precision Timed Release technology. The platform delivers three precisely timed releases of active medication over the course of the day to improve treatment consistency while reducing the need for multiple daily doses.
The technology uses a proprietary Erosion Barrier Layer (EBL) formulation, known as Oralogik™, licensed from BDD Pharma. The barrier gradually erodes before releasing each drug-containing core, enabling scheduled drug release without premature exposure.
ADHD affects more than 20 million diagnosed individuals in the United States, including approximately 8 million children and adolescents. Despite the availability of multiple stimulant therapies, maintaining symptom control throughout school, work, and evening activities remains a significant treatment challenge for many patients.
Phase 3 Trial Demonstrated Significant Efficacy Across All Dose Groups
The published Phase 3 study (CTx-1301-005) was a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial evaluating fixed doses of 18.75 mg, 25 mg, and 37.5 mg in children and adolescents aged 6 to 17 years with ADHD.
The primary endpoint assessed change from baseline in ADHD Rating Scale-5 (ADHD-RS-5) scores after five weeks of treatment. All three dose groups achieved statistically significant improvements compared with placebo.
The corresponding p-values were:
- 18.75 mg: p=0.018
- 25 mg: p=0.011
- 37.5 mg: p=0.001
Placebo-adjusted effect sizes reached 0.737, 0.782, and 1.185, respectively, with an overall mean effect size of 0.901, indicating a robust treatment effect across the study population.
Secondary assessments included changes in Clinical Global Impression-Severity (CGI-S) scores, alongside pharmacokinetic and safety evaluations. According to the investigators, CTx-1301 maintained a favorable safety profile throughout the study.
Publication Adds Independent Scientific Validation
Cingulate Chairman and Chief Executive Officer Shane J. Schaffer said publication in a peer-reviewed journal reflects the scientific rigor supporting both CTx-1301 and the company’s Precision Timed Release platform. He noted that independent review of the clinical data provides additional scientific support as the program advances toward commercialization.
Lead investigator Ann Childress, MD, said the trial demonstrated clinically meaningful improvement in ADHD symptoms while maintaining favorable tolerability, providing clinicians with peer-reviewed evidence supporting CTx-1301 as a potential once-daily treatment option.
Chief Science Officer Raul Silva, MD, emphasized that the observed placebo-adjusted effect sizes strengthen confidence in the therapy’s clinical impact. He noted that the consistent separation from placebo across all dose levels supports the ability of the Precision Timed Release platform to deliver sustained symptom improvement with once-daily dosing.
Regulatory Path Remains Focused on Commercialization
Publication of the Phase 3 data represents an important milestone as Cingulate continues preparing CTx-1301 for potential regulatory review. The company is pursuing approval through the FDA’s 505(b)(2) pathway and is expanding applications of its Precision Timed Release platform across ADHD, anxiety disorders, and other therapeutic areas where precisely timed multiple drug releases may improve treatment outcomes.
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About the Writer
Farha Farheen, PharmD (LinkedIn) is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.