Cingulate Inc. (NASDAQ: CING) has appointed Nilay Patel, JD, as Chief Legal Officer as the biopharmaceutical company prepares to submit a new drug application to the FDA in the coming weeks for its lead asset CTx-1301 (dexmethylphenidate HCl) for treating Attention Deficit Hyperactivity Disorder (ADHD).
The appointment comes at a critical juncture for the Kansas City-based company, which is advancing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to address unmet needs in ADHD treatment. Patel brings more than two decades of legal and compliance leadership in the pharmaceutical industry, having advised companies across every stage of drug development, launch, and commercialization.
"We are pleased to welcome Nilay Patel to Cingulate at such a pivotal time in our company's progression," said Shane J. Schaffer, Chairman and CEO of Cingulate. "As we file to seek approval for CTx-1301, Nilay brings an extensive knowledge of the ADHD landscape and a rare blend of deep legal expertise, operational insight, and proven leadership in navigating the complexities of pharmaceutical commercialization."
Addressing ADHD Treatment Gaps
ADHD represents a significant unmet medical need, affecting over 20 million diagnosed patients in the United States. Among this population, 12 million are adults and over 8 million are under the age of 17. According to the CDC, only 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood.
Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined, highlighting the expanding therapeutic opportunity for effective treatments.
Novel Drug Delivery Technology
CTx-1301 utilizes Cingulate's proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of dexmethylphenidate, a compound already approved by the FDA for ADHD treatment. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior.
While stimulants are considered the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at predefined time, ratio, and style of release to optimize patient care in one tablet.
The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off. This approach addresses a critical gap in current ADHD management, where patients often experience symptom return as medications wear off during the day.
Precision Timed Release Platform
The PTR technology incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form, designed to erode at a controlled rate until eventually the drug is released from the core tablet.
The EBL formulation, OralogiK™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas beyond ADHD and anxiety disorders.
Leadership Expertise
Patel most recently served as Chief Legal Officer, Chief Compliance Officer and Corporate Secretary at Ironshore Pharmaceuticals. Before joining Ironshore, he held senior legal roles at Grifols, where he served as Assistant General Counsel for the company's U.S. Bioscience division, and at Life Sciences Law PLLC, where he represented both emerging biotech firms and global pharmaceutical clients in licensing, mergers and acquisitions, and intellectual property matters.
"I'm honored to join Cingulate at an exciting and inflectional stage in its growth," Patel stated. "I was drawn to Cingulate because of its seasoned management team and innovative approach to addressing long-standing challenges in ADHD treatment through science-driven, patient-focused solutions, and I look forward to advancing the company's vision and long-term success as we move closer to commercialization."
As part of his appointment, Patel received non-qualified stock options to purchase 30,000 shares of the company's common stock at an exercise price of $4.51 per share, with vesting over four years.
