Cingulate Releases Phase 3 Trial Results For Its ADHD Treatment CTX-1301 Showing The Drug Met Its Primary Endpoints, Showing Dose-Dependent Improvements On ADHD Symptom And Severity Scales, And Demonstrated Effective Once-Daily Symptom Relief Using The Company's Precision Timed Release Technology

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.