Cingulate's Final Push for CTx-1301 in ADHD Treatment

Cingulate's Advancements in ADHD Treatment

Cingulate Inc. (NASDAQ: CING), a promising player in the biopharmaceutical field, is making strides with its innovative lead asset, CTx-1301. This treatment focuses on alleviating the symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Recently, Cingulate initiated its final FDA-required study, marking a pivotal moment in its journey towards a potentially impactful treatment.

The Importance of the Latest FDA Study

This final study is crucial as it assesses how food affects the absorption of CTx-1301, specifically at its highest dosage. In detailed research designed as an open-label, randomized trial, healthy adult participants will go through various treatment sequences to determine the bioavailability of the drug. This assessment is expected to provide valuable insights and is set to yield data by the close of 2024.

Funding Boost for Progress

In addition to launching this significant study, Cingulate has successfully raised over $10 million since mid-August, a solid portion of which came through its at-the-market facility. This influx of capital is vital for the company, enabling it to focus on the necessary steps leading to the New Drug Application (NDA) submission for CTx-1301, which is targeted for mid-2025. Shane J. Schaffer, Cingulate's Chairman and CEO, expressed enthusiasm regarding the new funds, identifying the current study initiation as a major milestone that propels them closer to their goal.

Understanding ADHD and Its Treatments

ADHD is a challenging neurobiological disorder impacting a significant number of children and adults alike. In the United States alone, approximately 6.4 million children aged under 18 have been diagnosed with this condition, with many continuing to experience symptoms into adulthood. Despite the availability of treatment, it is reported that only about 20 percent of adults with ADHD actively seek help.

CTx-1301: A Unique Approach

CTx-1301 stands out as Cingulate's flagship candidate, utilizing their proprietary Precision Timed Release™ (PTR™) drug delivery technology. This multi-core formulation is designed to optimize the release of dexmethylphenidate, a proven active ingredient for ADHD treatment. CTx-1301 intends to offer an extended duration of action through its innovative design, ensuring patients receive medication effectively throughout the day. The formulation promises a rapid onset and sustained efficacy, filling a critical gap in current treatment options.

The Precision Timed Release™ (PTR™) Advantage

Cingulate’s PTR platform technology boasts significant advantages over traditional delivery methods. By leveraging a proprietary Erosion Barrier Layer (EBL), this technology controls the timing of drug release with precision, ensuring effective dosing that aligns closely with patient needs. This methodology is instrumental for conditions like ADHD, where optimal treatment often requires timely management of symptoms throughout the day.

As Cingulate continues to innovate and expand its pipeline, the PTR technology not only holds promise for ADHD treatment but also opens doors to explore additional therapeutic areas. This adaptability reflects Cingulate’s commitment to enhancing patient care and treatment outcomes in various medical domains.

Conclusion: Looking Ahead for Cingulate

With the initiation of the final FDA-required study for CTx-1301, Cingulate Inc. is positioned for a promising future in the ADHD treatment landscape. The combined effort of raised capital and innovative technology lays a strong foundation for successful drug development. As the company works diligently towards its NDA submission in 2025, stakeholders can look forward to seeing how this trailblazer in biopharmaceuticals continues to develop critical solutions for ADHD and beyond.

Frequently Asked Questions

What is CTx-1301?

CTx-1301 is Cingulate's lead asset designed for the treatment of ADHD, utilizing a proprietary drug delivery technology to enhance patient outcomes.

When is the expected data readout from the final study?

The data readout from the final FDA-required study is anticipated by the end of 2024.

What is the significance of the latest funding raised by Cingulate?

The recent funding exceeding $10 million will support Cingulate in advancing the final activities needed for the NDA submission for CTx-1301.

How prevalent is ADHD among adults?

ADHD affects approximately 11 million adults in the U.S., but only about 20 percent are estimated to be receiving treatment.

What are the unique features of the PTR™ technology?

The PTR™ technology allows for precise timing of medication release, enabling effective once-daily dosing tailored to patient needs.

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