Cingulate Announces Positive Top-Line Results from High-Dose (50mg) Fed/Fast Study of Lead Asset CTx-1301 for ADHD
Cingulate has announced positive top-line results from its high-dose study of CTx-1301, a treatment for ADHD. The study focused on the 50mg dose of their lead candidate, examining how food affects its absorption.
The trial enrolled 27 healthy adults aged 18-50 years, testing the drug both with a high-fat breakfast and on an empty stomach. Key findings show that CTx-1301 can be taken with or without food, though patients should maintain consistency in their dosing approach.
The drug utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) technology and is designed as the first true once-daily stimulant medication for entire-day ADHD treatment. It offers eight dose strengths for optimal patient customization. The study measured pharmacokinetic parameters including maximum plasma concentration (Cmax) and total drug absorption (AUC), with results showing favorable tolerability and consistent adverse events with previous findings.
Cingulate ha annunciato risultati positivi preliminari dal suo studio ad alta dose su CTx-1301, un trattamento per il ADHD. Lo studio si è concentrato sulla dose da 50 mg del loro candidato principale, analizzando l'effetto del cibo sull'assorbimento del farmaco.
Alla sperimentazione hanno partecipato 27 adulti sani di età compresa tra 18 e 50 anni, testando il farmaco sia con una colazione ricca di grassi sia a stomaco vuoto. I risultati principali indicano che CTx-1301 può essere assunto con o senza cibo, ma è importante che i pazienti mantengano coerenza nel modo di assumere la dose.
Il farmaco utilizza la tecnologia proprietaria di Cingulate, Precision Timed Release™ (PTR™), ed è progettato come il primo vero stimolante da assumere una sola volta al giorno per il trattamento dell'ADHD per l'intera giornata. Offre otto diverse dosi per una personalizzazione ottimale del trattamento. Lo studio ha misurato parametri farmacocinetici come la concentrazione plasmatica massima (Cmax) e l'assorbimento totale del farmaco (AUC), con risultati che mostrano una buona tollerabilità e eventi avversi coerenti con quelli precedentemente riscontrati.
Cingulate ha anunciado resultados positivos preliminares de su estudio con dosis altas de CTx-1301, un tratamiento para el ADHD. El estudio se centró en la dosis de 50 mg de su candidato principal, evaluando cómo la comida afecta su absorción.
El ensayo incluyó a 27 adultos sanos de entre 18 y 50 años, probando el medicamento tanto con un desayuno alto en grasas como en ayunas. Los hallazgos clave muestran que CTx-1301 puede tomarse con o sin alimentos, aunque los pacientes deben mantener consistencia en su forma de dosificación.
El medicamento utiliza la tecnología propietaria de Cingulate Precision Timed Release™ (PTR™) y está diseñado como el primer estimulante de una sola dosis diaria para el tratamiento del ADHD durante todo el día. Ofrece ocho niveles de dosis para una personalización óptima del paciente. El estudio midió parámetros farmacocinéticos como la concentración plasmática máxima (Cmax) y la absorción total del fármaco (AUC), con resultados que muestran buena tolerabilidad y eventos adversos consistentes con hallazgos previos.
Cingulate는 ADHD 치료제인 CTx-1301의 고용량 연구에서 긍정적인 초기 결과를 발표했습니다. 이 연구는 주력 후보물질인 50mg 용량을 대상으로 음식이 약물 흡수에 미치는 영향을 조사했습니다.
이 임상시험에는 18세에서 50세 사이의 건강한 성인 27명이 참여했으며, 고지방 아침 식사 후와 공복 상태에서 약물을 투여해 비교했습니다. 주요 결과는 CTx-1301이 음식과 함께 또는 없이 복용할 수 있으나, 환자들은 복용 방식을 일관되게 유지하는 것이 중요하다는 점을 보여줍니다.
이 약물은 Cingulate의 독자적인 Precision Timed Release™ (PTR™) 기술을 활용하며, 하루 한 번 복용하는 진정한 자극제 약물로 설계되어 ADHD를 하루 종일 치료할 수 있습니다. 8가지 용량 강도로 환자 맞춤형 조절이 가능합니다. 연구에서는 최대 혈장 농도(Cmax)와 총 약물 흡수량(AUC) 등 약동학적 지표를 측정했으며, 내약성은 우수했고 부작용 발생은 이전 연구와 일관된 것으로 나타났습니다.
Cingulate a annoncé des résultats positifs préliminaires de son étude à dose élevée sur CTx-1301, un traitement pour le TDAH. L'étude s'est concentrée sur la dose de 50 mg de leur principal candidat, en examinant l'effet de l'alimentation sur son absorption.
L'essai a inclus 27 adultes en bonne santé âgés de 18 à 50 ans, testant le médicament à la fois avec un petit-déjeuner riche en graisses et à jeun. Les résultats clés montrent que CTx-1301 peut être pris avec ou sans nourriture, bien que les patients doivent maintenir une cohérence dans leur mode de prise.
Le médicament utilise la technologie propriétaire de Cingulate Precision Timed Release™ (PTR™) et est conçu comme le premier véritable stimulant à prendre une fois par jour pour un traitement du TDAH sur toute la journée. Il offre huit dosages différents pour une personnalisation optimale. L'étude a mesuré des paramètres pharmacocinétiques tels que la concentration plasmatique maximale (Cmax) et l'absorption totale du médicament (AUC), avec des résultats montrant une bonne tolérance et des effets indésirables cohérents avec les observations précédentes.
Cingulate hat positive vorläufige Ergebnisse aus seiner Hochdosisstudie mit CTx-1301, einer Behandlung für ADHS, bekannt gegeben. Die Studie konzentrierte sich auf die 50 mg Dosis ihres führenden Kandidaten und untersuchte, wie Nahrung die Aufnahme beeinflusst.
Die Studie umfasste 27 gesunde Erwachsene im Alter von 18 bis 50 Jahren und testete das Medikament sowohl mit einem fettreichen Frühstück als auch auf nüchternen Magen. Die wichtigsten Erkenntnisse zeigen, dass CTx-1301 mit oder ohne Nahrung eingenommen werden kann, jedoch sollten Patienten eine konsistente Einnahmeweise beibehalten.
Das Medikament nutzt die firmeneigene Precision Timed Release™ (PTR™)-Technologie von Cingulate und ist als erstes echtes einmal täglich einzunehmendes Stimulans für die ganztägige ADHS-Behandlung konzipiert. Es bietet acht Dosierungsstärken für eine optimale Anpassung an den Patienten. Die Studie maß pharmakokinetische Parameter wie maximale Plasmakonzentration (Cmax) und gesamte Arzneimittelaufnahme (AUC) und zeigte eine günstige Verträglichkeit sowie Nebenwirkungen, die mit früheren Ergebnissen übereinstimmen.
- Successful completion of FDA-required high-dose (50mg) fed/fast study for CTx-1301
- CTx-1301 demonstrated favorable tolerability profile with consistent adverse events
- Drug can be taken with or without food, increasing patient convenience and market potential
- Eight different dose strengths available for optimal patient treatment
- Positive pharmacokinetic results support regulatory approval pathway
- None.
Insights
Cingulate's ADHD drug CTx-1301 clears FDA-required food effect study, advancing regulatory pathway with favorable pharmacokinetic profile regardless of food intake.
Cingulate's positive results from their CTx-1301-013 study represent a meaningful clinical development milestone. This FDA-required study demonstrated that the highest dose (50mg) of their lead ADHD candidate can be taken with or without food while maintaining appropriate pharmacokinetic parameters - specifically the maximum plasma concentration (Cmax) and total drug absorption (AUC).
The consistent pharmacokinetic profile regardless of food status is particularly valuable for ADHD patients, as it eliminates dietary restrictions that could complicate medication adherence. The study measured multiple pharmacokinetic parameters over a 28-hour period in 27 healthy adult subjects, providing comprehensive data on the drug's absorption and elimination profile.
CTx-1301's trimodal extended-release tablet formulation utilizes the company's Precision Timed Release platform to deliver dexmethylphenidate, an FDA-approved ADHD compound. The company states this approach is designed to provide consistent coverage throughout an "entire active day" - addressing the inconsistent coverage issue that affects many current ADHD medications.
The tolerability profile appears consistent with previous findings, suggesting no new safety concerns at this highest dose level. The company indicates full results will be submitted for presentation at a forthcoming medical meeting, which will provide more detailed data for comprehensive evaluation of this developmental milestone.
Cingulate advances CTx-1301 with successful food effect study, positioning their ADHD candidate to address key medication adherence and dosing flexibility needs.
Cingulate's successful completion of this FDA-required food effect study for CTx-1301 represents meaningful progress in their clinical development program. The demonstration that their highest dose (50mg) maintains consistent pharmacokinetics regardless of food intake addresses a practical challenge in ADHD medication management - dietary restrictions that can complicate treatment adherence, especially for patients who struggle with routine.
The company's strategy to develop eight different dose strengths of CTx-1301 targets a key clinical need for more precise, individualized ADHD management. Current ADHD treatment often requires physicians to balance efficacy against side effects, and having multiple dose options could provide greater flexibility for optimizing individual patient response.
The "trimodal" extended-release approach aims to overcome limitations of existing stimulant medications that may not provide consistent symptom control throughout a patient's day. Stimulant medications with inconsistent coverage can create problematic fluctuations in symptom management for ADHD patients.
While this study represents just one step in the development pathway, it removes a potential regulatory obstacle by addressing the food effect question that the FDA specifically required. This keeps the development program on track as the company continues to build its clinical data package. The company will present complete results at an upcoming medical meeting, which should provide more detailed insights into the drug's performance profile.
Primary Endpoints Demonstrate CTx-1301 Can be Taken With or Without Food
CTx-1301 is Designed as a True, Entire Active-Day Treatment for ADHD
KANSAS CITY, Kan., April 29, 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, today announced positive top-line results from the CTx-1301-013 study, an FDA required study, assessing the effect of food on absorption of the highest dose (50mg) of its lead candidate CTx-1301. CTx-1301 is a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
The trial demonstrated that 50mg CTx-1301 can be taken with or without food. Multiple pharmacokinetic (PK) measurements were taken, and adverse events were consistent with previous findings and indicate a favorable tolerability profile.
“We are developing CTx-1301 to be the first true, once-daily stimulant medication that treats ADHD over an entire active day, and that offers eight dose strengths so that medical professionals can effectively optimize a patient’s medication. Crucial to this is ensuring a pharmacokinetic profile customized for the unique attributes of stimulant medications and ADHD, regardless of food intake,” said Shane J. Schaffer, PharmD, Chairman and CEO, Cingulate. “The results of this study confirm that we have identified the optimal formulation of 50mg CTx-1301.”
CTx-1301 Pharmacokinetics in Both Fed and Fasted States
The CTx-1301-013 study enrolled 27 healthy adult subjects, male and female, (age range: 18 to 50 years) who were randomized into one of two sequences to receive a single 50 mg dose of CTx-1301 on two occasions (once with a standard high fat breakfast and once on an empty stomach). Both doses were administered with 8 oz of water and frequent blood samples were obtained for a period of 28 hours after each dose in order to define the absorption and elimination profile of dexmethylphenidate (i.e. the pharmacokinetics or PK).
The primary PK endpoints of this study were the maximum plasma concentration achieved after each dose (Cmax) as well as the extent of dexmethylphenidate absorbed into the blood expressed as the area the plasma drug concentration vs. time curve (AUC). Knowledge of these two PK parameters which define maximum and total extent of exposure are essential for a drug’s regulatory approval.
“Similar to the 25mg fasted versus fed study conducted with CTx-1301 (NCT04449250), the 50mg dose of CTx-1301 demonstrated that it may also be taken with or without food, however patients should be advised to take the medication consistently as such," said Raul Silva, MD, Chief Science Officer, Cingulate. “Most importantly is that the unique formulation of CTx-1301 is bioavailable irrespective of the presence of food intake and this study provides important clinical knowledge for providers in the treatment of ADHD patients.”
Full results, including data on secondary endpoints measuring half-life and time to onset, will be submitted for presentation at a forthcoming medical meeting.
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., 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. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined.
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.
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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
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