Final Study Completed for Cingulate’s Lead Asset CTx-1301
Cingulate Inc. (NASDAQ: CING) has completed its final FDA-required food effect study for CTx-1301, its lead ADHD treatment drug. The study evaluated a single 50mg dose of CTx-1301 (dexmethylphenidate) to determine if the medication can be taken with or without food, with no serious adverse events reported.
Data readout regarding bioavailability is expected in Q2 2025. A previous study in 2022 with a 25mg dose demonstrated that CTx-1301 could be taken regardless of food intake. The company is developing CTx-1301 to be the first true once-daily stimulant medication for ADHD treatment over an entire active day. Cingulate targets submission of the New Drug Application (NDA) to the FDA by mid 2025.
Cingulate Inc. (NASDAQ: CING) ha completato il suo ultimo studio sugli effetti del cibo richiesto dalla FDA per CTx-1301, il suo principale farmaco per il trattamento dell'ADHD. Lo studio ha valutato una singola dose di 50 mg di CTx-1301 (dexmetilfenidato) per determinare se il farmaco possa essere assunto con o senza cibo, senza riportare eventi avversi gravi.
I dati sulla biodisponibilità sono attesi per il Q2 2025. Un precedente studio del 2022 con una dose di 25 mg ha dimostrato che CTx-1301 può essere assunto indipendentemente dall'assunzione di cibo. L'azienda sta sviluppando CTx-1301 per essere il primo vero farmaco stimolante da assumere una volta al giorno per il trattamento dell'ADHD durante un'intera giornata attiva. Cingulate prevede di presentare la domanda per il nuovo farmaco (NDA) alla FDA entro la metà del 2025.
Cingulate Inc. (NASDAQ: CING) ha completado su estudio final requerido por la FDA sobre el efecto de los alimentos para CTx-1301, su principal medicamento para el tratamiento del TDAH. El estudio evaluó una dosis única de 50 mg de CTx-1301 (dexmetilfenidato) para determinar si el medicamento puede tomarse con o sin alimentos, sin reportar eventos adversos graves.
Se espera que los datos sobre la biodisponibilidad se divulguen en el Q2 2025. Un estudio previo en 2022 con una dosis de 25 mg demostró que CTx-1301 podría tomarse sin importar la ingesta de alimentos. La compañía está desarrollando CTx-1301 para ser el primer verdadero medicamento estimulante de una sola toma diaria para el tratamiento del TDAH durante un día activo completo. Cingulate tiene como objetivo presentar la Solicitud de Nuevo Medicamento (NDA) a la FDA para mediados de 2025.
싱귤레이트 주식회사 (NASDAQ: CING)는 CTx-1301에 대한 FDA 요구 최종 식사 효과 연구를 완료했습니다. 이 연구는 CTx-1301 (덱스메틸페니데이트)의 50mg 단일 용량이 음식과 함께 또는 없이 섭취할 수 있는지를 평가했으며, 심각한 부작용은 보고되지 않았습니다.
생체이용률에 대한 데이터 공개는 2025년 2분기에 예정되어 있습니다. 2022년에 실시된 25mg 용량의 이전 연구에서는 CTx-1301이 음식 섭취와 상관없이 복용할 수 있는 것으로 나타났습니다. 회사는 CTx-1301을 ADHD 치료를 위한 진정한 하루 1회 복용 자극제 약물로 개발하고 있습니다. 싱귤레이트는 2025년 중반까지 FDA에 신규 의약품 신청서(NDA)를 제출할 계획입니다.
Cingulate Inc. (NASDAQ: CING) a terminé sa dernière étude sur l'effet des aliments requise par la FDA pour CTx-1301, son principal médicament contre le TDAH. L'étude a évalué une dose unique de 50 mg de CTx-1301 (dexméthylphénidate) pour déterminer si le médicament peut être pris avec ou sans nourriture, sans signalement d'événements indésirables graves.
Les données concernant la biodisponibilité devraient être divulguées au Q2 2025. Une étude précédente en 2022 avec une dose de 25 mg a montré que CTx-1301 pouvait être pris indépendamment de l'apport alimentaire. L'entreprise développe CTx-1301 pour être le premier véritable médicament stimulant à prendre une fois par jour pour le traitement du TDAH tout au long d'une journée active. Cingulate vise à soumettre la Demande de Nouveau Médicament (NDA) à la FDA d'ici mi-2025.
Cingulate Inc. (NASDAQ: CING) hat seine letzte von der FDA geforderte Lebensmittelwirkungenstudie für CTx-1301, sein führendes ADHS-Medikament, abgeschlossen. Die Studie bewertete eine einmalige Dosis von 50 mg CTx-1301 (Dexmethylphenidat), um festzustellen, ob das Medikament mit oder ohne Nahrung eingenommen werden kann, ohne dass schwerwiegende unerwünschte Ereignisse gemeldet wurden.
Die Datenfreigabe zur Bioverfügbarkeit wird im Q2 2025 erwartet. Eine frühere Studie im Jahr 2022 mit einer Dosis von 25 mg zeigte, dass CTx-1301 unabhängig von der Nahrungsaufnahme eingenommen werden konnte. Das Unternehmen entwickelt CTx-1301, um das erste echte einmal täglich einzunehmende Stimulans für die ADHS-Behandlung über einen gesamten aktiven Tag zu sein. Cingulate plant die Einreichung des Antrags auf Zulassung eines neuen Arzneimittels (NDA) bei der FDA bis mitte 2025.
- Successful completion of final FDA-required study with no serious adverse events
- Previous 25mg dose study in 2022 showed positive food intake flexibility
- On track for NDA submission by mid 2025
- None.
Insights
The investigation of food effect is particularly important for ADHD medications, as consistent drug absorption and bioavailability are essential for reliable therapeutic outcomes. Most current ADHD medications require specific timing around meals, which can impact patient compliance and treatment effectiveness.
A successful bioavailability profile regardless of food intake would be a significant differentiator in the
The planned NDA submission timeline for mid-2025 appears achievable given the completion of this final FDA-required study. The comprehensive development program, including the previous positive 25mg study results, positions CTx-1301 well for regulatory review.
Current market leaders like Adderall XR and Vyvanse face challenges with duration of action and food effect limitations. CTx-1301's potential for true once-daily dosing, independent of food intake, could capture significant market share.
The timing is strategically important - with several ADHD medications facing generic competition, there's a market opportunity for novel, differentiated products. For a small-cap company like Cingulate, successful commercialization of CTx-1301 could transform its market position.
Investor focus should now shift to the 2Q 2025 bioavailability data readout and subsequent NDA submission, which could serve as significant catalysts for the stock.
No Serious Adverse Events Reported
Submission of New Drug Application Targeted for Mid 2025
KANSAS CITY, Kan., Jan. 07, 2025 (GLOBE NEWSWIRE) -- 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 its final FDA-required study, which is a food effect study, for CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The subjects in the study were given a single 50mg dose of CTx-1301, Cingulate’s highest dosage, to determine if the medication can be taken in fed and fasted states. No serious adverse events were reported. A data readout regarding bioavailability with or without food is expected in 2Q 2025.
A study conducted in 2022 using a single 25mg dose of CTx-1301 demonstrated that it could be taken with or without food.
“We are developing CTx-1301 to be the first true, once-daily stimulant medication that treats ADHD over an entire active day, and crucial to this is ensuring a pharmacokinetic profile customized for the unique attributes of stimulant medications and ADHD, regardless of food intake and dosage size,” said Cingulate Chairman and CEO Shane J. Schaffer. “The completion of this study marks another important milestone and is one of the final activities required for NDA submission to the FDA, which is targeted for mid 2025.”
About the Food Effect Study
- An open-label, randomized, single-dose, two-sequence, two-period, in-clinic crossover study in 26 healthy adult subjects, 18 to 50 years of age. Subjects were randomized into one of two sequences (a fasted state, and a fed state [after a high-fat test meal]) and dosed with a 50mg dose of CTx-1301
- The primary PK endpoints were maximum concentration (expressed as Cmax) during the first 28 hours after dosing, and the total amount of the active pharmaceutical ingredient (API), dexmethylphenidate, in the blood (expressed as the area the plasma drug concentration-time curve [AUC]) from dosing to the time of the last measured concentration (AUC0-last) and from dosing taken to the limit as the end time becomes arbitrarily large (AUC0-∞)
- Results from the study are expected in Q2 2025 and will confirm how food impacts the absorption and bioavailability of CTx-1301
Pharmacokinetics (PK)
PK refers to the activity of drugs in the body over a period of time, including the extent of Absorption, Distribution, Metabolism and Excretion (ADME). A fundamental understanding of PK parameters is required to design an appropriate drug regimen for a patient, to help plan subsequent studies and to support labeling.
Overall, the effect of food on the PK of orally administered long-acting stimulants is generally minimal: following a high-fat meal, there is potential for the rate and extent of absorption to be either slightly decreased or increased compared to the fasted state. However, a thorough understanding of the unique PK profile and pharmacodynamic response of investigational formulations allows developers to optimize the most effective formulation of their therapy based on the clinical needs and dosing preferences of patients.
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 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. 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 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 & Public 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
FAQ
When will Cingulate (CINGW) release the food effect study data for CTx-1301?
What was the dosage tested in Cingulate's latest CTx-1301 food effect study?
When is Cingulate planning to submit the NDA for CTx-1301?
Were there any serious adverse events in Cingulate's CTx-1301 food effect study?
What makes Cingulate's CTx-1301 ADHD treatment unique?
