Cingulate Submits NDA for ADHD Treatment, Potential $23 Billion Market Opportunity

Cingulate Inc submitted a New Drug Application to the FDA for CTx-1301, an extended-release tablet for ADHD treatment. This marks a significant milestone for the company, potentially capturing a share of the $23 billion US ADHD market. The company's stock score is neutral due to poor financial performance, but recent developments and progress towards FDA approval provide a positive outlook.

KANSAS CITY, Kan., July 2, 2025 (GLOBE NEWSWIRE) — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CTx-1301, its lead asset for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). This regulatory milestone marks a significant step in the company's development timeline, potentially positioning it to capture a substantial share of the $23 billion U.S. ADHD market.

CTx-1301 is a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver fast onset, entire active-day efficacy, and a smooth pharmacokinetic profile with a single dose. This addresses major limitations of current ADHD therapies, which often require multiple daily doses or have inconsistent drug levels throughout the day [1].

Cingulate's NDA submission for CTx-1301 follows years of clinical and manufacturing development. The drug utilizes the company's proprietary Precision Timed Release™ (PTR™) drug delivery platform, which aims to provide fast onset of action, full-day symptom control, and consistent drug levels throughout the day. The PTR platform technology is designed to overcome key limitations in current ADHD medications [2].

From a regulatory perspective, the FDA typically provides notification of acceptance for review within 60 days of submission. If accepted, the standard review timeline would be approximately 10-12 months, though this could vary based on review designation. The company has not indicated whether they've requested priority review.

The $23 billion U.S. ADHD market represents a substantial commercial opportunity, though Cingulate will face competition from established medications and generics. The company's strategic positioning of CTx-1301 as addressing unmet needs in ADHD treatment could potentially differentiate it in this crowded market.

This NDA submission also validates Cingulate's proprietary PTR™ platform technology, which could have broader applications across multiple therapeutic areas beyond ADHD. This could create potential for pipeline expansion and additional value generation.

Cingulate's stock score is currently neutral due to poor financial performance, but recent developments and progress towards FDA approval provide a positive outlook for the company. Investors should closely monitor the regulatory process and the company's financial reports for further insights.

References:
[1] https://www.stocktitan.net/news/CINGW/cingulate-submits-new-drug-application-to-fda-for-lead-adhd-asset-c-vkvsjwjy8a5n.html
[2] https://www.cingulate.com