Cingulate Achieves Key Manufacturing Milestone in the Development of its ADHD Drug CTx-1301 in Preparation for FDA Marketing Clearance
Cingulate announced a significant achievement in the development of its ADHD drug, CTx-1301, by completing twelve required registration batches. This milestone meets the U.S. Food and Drug Administration (FDA) manufacturing requirements necessary for New Drug Application (NDA) submission. The company is using its Precision Timed Release™ (PTR™) technology to develop CTx-1301, intended to offer a reliable manufacturing process and acceptable shelf life. Cingulate plans to submit the NDA for CTx-1301 in the first half of 2025, marking a important step towards FDA marketing clearance.
- Completion of twelve required registration batches for CTx-1301.
- Alignment with FDA manufacturing requirements for NDA submission.
- Plan to submit the NDA in the first half of 2025.
- None.
The completion of twelve registration batches is a critical milestone in the drug development process. This step ensures that Cingulate has a reliable and reproducible manufacturing process, which is essential for FDA approval. The NDA submission will consider these batches as evidence that Cingulate can produce CTx-1301 consistently and maintain its quality over time.
From a manufacturing perspective, the ability to meet these stringent FDA requirements suggests that Cingulate has a robust production process in place, which is a positive indicator for future scalability. The preparation and completion of these batches also hint at potential readiness for large-scale production post-approval, minimizing risks related to manufacturing delays or issues that could affect commercialization timelines.
The announcement that Cingulate Inc. has achieved a key manufacturing milestone is particularly significant for investors. Completing the twelve registration batches as per FDA guidelines indicates the company is on track with its drug development timeline. This achievement reduces the regulatory risk associated with the approval of CTx-1301, potentially increasing investor confidence.
In financial terms, meeting these milestones suggests that Cingulate is effectively managing its resources and timelines, which is often reflected in the company's stock price. However, it's important to note that while this is a positive step, the actual market approval and subsequent commercialization are what will drive substantial revenue. Investors should keep an eye on subsequent announcements related to the NDA submission and any interim results that might affect the approval process.
For retail investors, understanding the market dynamics for ADHD treatments is crucial. The ADHD drug market is highly competitive with several well-established players. Cingulate's CTx-1301 promises a next-generation solution utilizing their proprietary Precision Timed Release™ technology, which could offer distinct advantages over existing treatments. If successfully brought to market, CTx-1301 could potentially capture a significant share by offering improved efficacy or better patient compliance.
The completion of these registration batches signals that Cingulate is making steady progress towards entering this lucrative market. However, investors should also be aware of potential challenges such as competition from generic drugs and the ability of Cingulate to effectively market and distribute their product post-approval. Monitoring Cingulate’s strategies for market entry and differentiation will be important in assessing long-term growth potential.
Twelve Required Registration Batches Completed
New Drug Application Being Prepped for Submission
KANSAS CITY, Kan., June 25, 2024 (GLOBE NEWSWIRE) -- In alignment with U.S. Food and Drug Administration (FDA) requirements, Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it has completed the manufacturing of its twelve registration batches for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Registration batches are required by the U.S. Food and Drug Administration (FDA) to be manufactured before submitting a new drug application (NDA) using the actual equipment, dosage strengths and procedures that will be used to commercialize the drug product candidate.
“This achievement brings us one step closer to compliance with the FDA’s guidance for submission of an NDA, and is an important chemical, manufacturing and control (CMC) inflection point for CTx-1301, as these pivotal batches are used to demonstrate that we have a reliable manufacturing process and acceptable shelf life for our product,” said Cingulate Chief Operating Officer Laurie Myers.
Cingulate, which recently announced it had received confirmation from and agrees with the FDA on the requirements necessary for filing an NDA for CTx-1301, has begun NDA preparation and expects to submit its application in the first half of 2025.
About Attention Deficit/Hyperactivity Disorder (ADHD)
ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., approximately 6.4 million children and adolescents (11 percent) aged under the age of 18 have been diagnosed with ADHD. Among this group, approximately 80 percent receive treatment, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients (4.4 percent), almost double the size of the child and adolescent segment combined. However, only an estimated 20 percent receive treatment.
About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. 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 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 the 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.
About Precision Timed Release™ (PTR™) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It 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. It is 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 in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here.
About Cingulate®
Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of attention deficit/hyperactivity disorder (ADHD), Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders.
Cingulate is headquartered in Kansas City. For more information visit Cingulate.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on April 1, 2024. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.
Investor Relations
Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
TDalton@cingulate.com
913-942-2301
Matt Kreps
Darrow Associates
mkreps@darrowir.com
214-597-8200
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