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$Cingulate (CING.US)$ Cingulate Releases European Patent CTx...

$Cingulate (CING.US)$
Cingulate Releases European Patent CTx-1301 for Lead Assets to Treat ADHD
Cingulate Inc.
Thursday, August 15, 2024, 7:45 PM GMT+85 min read

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Cingulate Inc.
KANSAS CITY, KS, August 15, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc., a biopharmaceutical company using its proprietary Precise Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation medicines, today announced a European patent for its primary asset, ctX-1301 (dimethyl phenidate) for the treatment of attention deficit hyperactivity disorder (ADHD).


The patent application was granted on August 14, 2024, and is EP patent number 3261625, which will include up to 30 European territories, including the United Kingdom. In addition to European patents, Cingulate also holds patents in Australia, Canada, and Israel, and pending patents in Hong Kong, the Republic of Korea, and the US.

“The grant of this patent is another significant milestone as Cingulate seeks to expand its reach beyond the US and positively impact the growing ADHD market in Europe and other overseas regions. We look forward to receiving additional patents soon as we continue to demonstrate the clinical success of CTx-1301 and get closer to submitting a new drug application to the FDA,” said Shane J. Schaffer, Chairman and CEO of Cingulate.

attention-deficit/hyperactivity disorder (ADHD)
ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. This condition is characterized by constant inattention and/or hyperactive-impulsive patterns that interfere with function or development. In the US, around 6.4 million children and adolescents under 18 (11%) have been diagnosed with ADHD. In this group, approximately 80% were treated, and 65-90% of them showed clinical ADHD symptoms that continued into adulthood. The prevalence of ADHD in adults is estimated to be around 11 million patients (4.4%), almost double that of children and adolescents combined. However, it is estimated that only 20% of people receive treatment.

About CTx-1301
Cingulate's primary drug candidate, CTx-1301, leverages Cingulate's proprietary PTR drug delivery platform to create a breakthrough multi-nucleated formulation for the active pharmaceutical ingredient methylphenidate, an FDA-approved compound for the treatment of ADHD. Dimethyl phenidate is part of the stimulant class of drugs and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. Although stimulants are the gold standard for ADHD treatment due to their efficacy and safety, the long-standing challenge remains providing patients with the duration of action throughout the active day. CTx-1301 is designed to accurately deliver three drug releases at pre-defined times, ratios, and release styles to optimize patient care in one tablet. The result was rapid onset and full activity day efficacy, with a third dose released as other sustained-release stimulant products began to disappear.

About Precision Timed Release™ (PTR™) platform technology
Cingulate is developing ADHD and anxiety selective products that can achieve true once-a-day administration using Cingulate's innovative PTR drug delivery platform technology. It contains a proprietary Erosion Barrier Layer (EBL) that controls drug release at precise, pre-defined times and does not release the drug until it is scheduled to be released. EBL technology is wrapped around a drug-containing core to provide dosage forms in tablets. It is designed to erode at a controlled rate until the final drug is released from the core tablet. The EBL preparation Oralogik™ is licensed by BDD Pharmaceuticals. Cingulate intends to use its PTR technology to expand and enhance its clinical-stage pipeline by identifying and developing additional product candidates in treatment areas other than anxiety and ADHD, where one or more active pharmaceutical ingredients need to be delivered several times a day at specific pre-defined time intervals and released in a way that provides significant improvements over existing treatments. To view Cingulate's PTR platform, click here.

About Cingulate®
Cingulate Inc. (NASDAQ: CING) is a biopharmaceutical company that uses its proprietary Precise Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products aimed at improving the lives of patients with diseases often diagnosed with burdensome daily dosing regimens and poor treatment outcomes. Cingulate initially focused on treating attention-deficit/hyperactivity disorder (ADHD), is identifying and evaluating other treatment areas where PTR technology can be used to develop future product candidates, including treating anxiety disorders.
Cingulate is headquartered in Kansas City.
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