Cingulate Publishes Peer-Reviewed Data Demonstrating CTx-1301’s Differentiated Pharmacokinetic Profile
Rhea-AI Summary
Cingulate (NASDAQ: CING) reported publication of a peer-reviewed study, “Comparative Bioavailability of Trimodal CTx-1301 Versus Bimodal Dexmethylphenidate,” in the journal CNS Drugs. The open-access paper presents pharmacokinetic, bioavailability, safety, and tolerability data for CTx-1301, the company’s lead ADHD product candidate based on its Precision Timed Release™ (PTR™) platform.
In a randomized crossover study in adults with ADHD, CTx-1301 delivered rapid early dexmethylphenidate exposure comparable to a marketed bimodal formulation, then maintained statistically higher plasma concentrations later in the dosing interval, with a controlled decline designed to reduce late-day “wear-off.” CTx-1301 also showed fewer treatment-emergent adverse events than the comparator despite greater total dexmethylphenidate exposure. According to Cingulate, this publication, together with an earlier Phase 3 efficacy and safety paper, builds a peer-reviewed scientific foundation for CTx-1301 and further validates the PTR trimodal drug-delivery approach.
Positive
- Peer-reviewed CNS Drugs publication of comparative CTx-1301 pharmacokinetic and safety data
- Statistically higher late-day plasma levels versus bimodal comparator, consistent with active-day coverage profile
- Fewer treatment-emergent adverse events than comparator despite higher total dexmethylphenidate dose
- Phase 3 efficacy and safety data plus PK analysis now published in peer-reviewed journals
- PTR trimodal delivery platform further supported by detailed pharmacokinetic evidence
Negative
- Study evaluated CTx-1301 in adult ADHD subjects only; pediatric pharmacokinetic data were not reported
- Publication focused on pharmacokinetics and tolerability rather than new long-term outcomes or commercial timelines
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 30 | Phase 3 publication | Positive | +5.2% | Peer-reviewed Phase 3 ADHD results showed improvement across all three dose groups. |
| Jul 02 | Index inclusion | Positive | -8.7% | Cingulate was added to the Russell 3000E Index during the June reconstitution. |
| Jun 16 | Patent issuance | Positive | -3.9% | Cingulate received its first fully owned U.S. patent covering CTx-1301 technology. |
| Jun 02 | FDA response letter | Negative | +11.9% | FDA requested additional Chemistry, Manufacturing and Controls information for CTx-1301. |
| May 14 | Quarterly earnings | Negative | -10.8% | Cingulate reported a first-quarter net loss of $9.3 million. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
CING's recent news reactions were mixed, with positive announcements producing both gains and declines.
Key Terms
pharmacokinetic medical
bioavailability medical
505(b)(2) regulatory
treatment-emergent adverse events medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Findings further validate Cingulate’s Precision Timed Release™ (PTR™) platform and its trimodal drug delivery approach
KANSAS CITY, Kan., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company advancing next-generation pharmaceutical products through its proprietary Precision Timed Release™ (PTR™) drug delivery platform, today announced the publication of "Comparative Bioavailability of Trimodal CTx-1301 Versus Bimodal Dexmethylphenidate" in the peer-reviewed journal CNS Drugs. The open-access manuscript provides clinicians and researchers with pharmacokinetic data supporting CTx-1301 (dexmethylphenidate HCl), Cingulate's lead product candidate for the treatment of attention-deficit/hyperactivity disorder (ADHD).
Available through open access, the manuscript expands Cingulate's growing body of peer-reviewed evidence supporting CTx-1301 and follows the recent publication of the Company's Phase 3 efficacy and safety study in the Journal of Child and Adolescent Psychopharmacology.
"As a clinician, I look closely at how a stimulant medication is delivered over the course of a patient’s active day because that helps us understand its pharmacokinetic profile," said Ann Childress, MD, lead investigator for Cingulate's Phase 3 efficacy and safety trial. "This study demonstrates that CTx-1301 was designed as a true once-daily medication, delivering three distinct releases of dexmethylphenidate that create a pharmacokinetic profile different from currently available stimulant formulations. These data help clinicians better understand the science behind the formulation and how it was designed to provide medication exposure throughout the active day."
While the Phase 3 study demonstrated CTx-1301's clinical efficacy and safety, this publication helps explain the proprietary drug delivery profile designed to produce those pharmacokinetic characteristics.
"With the publication of our Phase 3 efficacy study followed now by this pharmacokinetic analysis, we have established a peer-reviewed scientific foundation for CTx-1301," stated Cingulate Chairman and CEO Shane J. Schaffer, PharmD "Together, these publications help explain both the clinical performance observed in the Phase 3 study and the proprietary technology designed to support CTx-1301's delivery profile."
The publication reports that CTx-1301 achieved plasma dexmethylphenidate concentrations comparable to the reference product during the early portion of the dosing interval while maintaining higher plasma concentrations later in the day, consistent with the product's proprietary trimodal release profile. In the study, CTx-1301 also demonstrated fewer treatment-emergent adverse events than the reference bimodal formulation, despite delivering a higher overall dexmethylphenidate dose.
"Think of pharmacokinetics as a medication's timetable. It tells us when medicine is released into the body, how much is available at different times of the day, and how long exposure may be sustained," said Matthew Brams, MD, Chief Medical Officer of Cingulate. "For ADHD treatment, that timing is important because functional demands often extend beyond the school or workday. This study shows how CTx-1301 was designed to provide medication coverage across the entire active day."
The full publication is available through open access at link.springer.com.
About the Study
The publication reports results from a randomized, crossover study evaluating the comparative bioavailability, pharmacokinetics, safety, and tolerability of CTx-1301 versus a commercially available bimodal dexmethylphenidate formulation in adult subjects with ADHD. The study demonstrated:
- Rapid early exposure as compared to the reference product, supporting the potential for fast onset of action.
- Statistically significant higher dexmethylphenidate plasma concentrations during the later hours of the dosing interval, consistent with an active-day treatment exposure profile.
- A controlled decline in plasma drug concentrations designed to reduce late-day "wear-off."
- A favorable tolerability profile with fewer treatment-emergent adverse events than the comparator despite greater total dexmethylphenidate exposure.
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 estimated market size of the US ADHD market is approximately 100 million annual prescriptions. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 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.
About CTx-1301
CTx-1301 (dexmethylphenidate HCl) is a once-daily, multi-core tablet utilizing Cingulate’s proprietary Precision Timed Release™ (PTR™) platform to deliver three precisely timed releases of active medication across the day. This design aims to provide rapid onset of effect and entire active-day duration. CTx-1301 is being evaluated for the treatment of ADHD under the FDA’s 505(b)(2) pathway.
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 Inc.
Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary 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 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. Specifically, these statements include, but are not limited to, the efficacy and safety profile of CTx-1301, the potential of Cingulate’s Precision Timed Release™ (PTR™) platform technology, CTx-1301’s potential as a once-daily treatment option, the potential regulatory approval of CTx-1301, and the potential commercialization of CTx-1301, if approved. 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 March 18, 2026 and our other filings with the SEC. 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 & Media Relations:
Thomas Dalton
Vice President, Corporate and Government Relations, Cingulate
tdalton@cingulate.com
(480) 529-5434
