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

Core Insights - Cingulate Inc. announced positive Phase 3 results for CTx-1301, a once-daily formulation of dexmethylphenidate for pediatric ADHD, achieving primary endpoints with significant symptom relief [1][3] - The ADHD market is valued at $23 billion, with CTx-1301 offering a potential advantage through its once-daily dosing, which may improve patient adherence [3] Group 1: Clinical Trial Results - CTx-1301 demonstrated dose-dependent improvements on ADHD ratings scale and Clinical Global Impression-Severity scales, providing symptom relief for up to 12 hours post-dose [1] - The randomized, double-blind, placebo-controlled study showed rapid onset of effect and sustained efficacy, with a safety profile consistent with other stimulant medications [2] Group 2: Product and Market Potential - The 37.5mg dose of CTx-1301 showed the largest effect size in symptom reduction, indicating substantial efficacy [3] - Cingulate's partnership with Indegene is structured to align commercial execution with growth milestones as the company approaches product launch [3] Group 3: Regulatory and Financial Aspects - The New Drug Application for CTx-1301 was accepted by the FDA, with a target PDUFA date of May 31, 2026, and a waiver of the standard PDUFA filing fee saving the company approximately $4.3 million [4] - Cingulate plans to share additional details from the Phase 3 study in future scientific publications and investor communications [6] Group 4: Company Overview - Cingulate Inc. utilizes its Precision Timed Release™ platform to develop next-generation pharmaceutical products aimed at improving patient outcomes in conditions requiring complex dosing [9] - CTx-1301 is in late-stage development for ADHD, with additional candidates targeting anxiety and other neuropsychiatric conditions [9]