Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025
Cingulate (NASDAQ: CING) has announced positive safety results from its final Phase 3 trials for CTx-1301, their lead ADHD treatment asset. The data encompasses two Phase 3 pediatric and adolescent studies (fixed dose and dose optimization) and a food effect study with healthy adults using a 50mg dose.
Key safety findings show no serious treatment emergent adverse events (TEAEs) or deaths, with no clinically relevant trends in TEAEs overall. The food effect study's medical findings align with previous 25mg dose results, indicating CTx-1301 can be taken with or without food.
The company has submitted these results to the FDA ahead of an in-person Pre-NDA meeting scheduled for April 2, 2025. Cingulate plans to file for FDA approval in mid-2025, positioning CTx-1301 as the first true once-daily stimulant medication for treating ADHD throughout the entire active day.
Cingulate (NASDAQ: CING) ha annunciato risultati di sicurezza positivi dai suoi trial finali di Fase 3 per CTx-1301, il loro principale trattamento per l'ADHD. I dati comprendono due studi pediatrici e adolescenti di Fase 3 (dose fissa e ottimizzazione della dose) e uno studio sull'effetto del cibo con adulti sani utilizzando una dose di 50 mg.
I principali risultati di sicurezza mostrano nessun evento avverso emergente da trattamento serio (TEAE) o decessi, senza tendenze clinicamente rilevanti nei TEAE complessivamente. I risultati medici dello studio sull'effetto del cibo si allineano con i risultati precedenti della dose di 25 mg, indicando che CTx-1301 può essere assunto con o senza cibo.
L'azienda ha presentato questi risultati alla FDA in preparazione di un incontro Pre-NDA di persona programmato per il 2 aprile 2025. Cingulate prevede di richiedere l'approvazione della FDA a metà del 2025, posizionando CTx-1301 come il primo vero farmaco stimolante da assumere una volta al giorno per il trattamento dell'ADHD durante l'intera giornata attiva.
Cingulate (NASDAQ: CING) ha anunciado resultados positivos de seguridad de sus ensayos finales de Fase 3 para CTx-1301, su principal activo en el tratamiento del TDAH. Los datos abarcan dos estudios pediátricos y adolescentes de Fase 3 (dosis fija y optimización de dosis) y un estudio del efecto de los alimentos con adultos sanos usando una dosis de 50 mg.
Los hallazgos clave de seguridad muestran ningún evento adverso emergente del tratamiento serio (TEAE) ni muertes, sin tendencias clínicamente relevantes en los TEAE en general. Los hallazgos médicos del estudio sobre el efecto de los alimentos se alinean con los resultados previos de la dosis de 25 mg, indicando que CTx-1301 se puede tomar con o sin alimentos.
La empresa ha presentado estos resultados a la FDA antes de una reunión Pre-NDA en persona programada para el 2 de abril de 2025. Cingulate planea solicitar la aprobación de la FDA a mediados de 2025, posicionando a CTx-1301 como el primer verdadero medicamento estimulante de una sola dosis diaria para tratar el TDAH durante todo el día activo.
싱귤레이트 (NASDAQ: CING)는 CTx-1301의 최종 3상 시험에서 긍정적인 안전성 결과를 발표했습니다. 이는 그들의 주요 ADHD 치료 자산입니다. 데이터는 50mg 용량을 사용한 건강한 성인에 대한 식사 효과 연구와 함께 고정 용량 및 용량 최적화의 두 가지 소아 및 청소년 3상 연구를 포함합니다.
주요 안전성 결과는 심각한 치료 유발 부작용(TEAE)이나 사망자가 없으며, TEAE 전반에 걸쳐 임상적으로 관련된 경향이 없음을 보여줍니다. 식사 효과 연구의 의학적 발견은 이전 25mg 용량 결과와 일치하며, CTx-1301은 음식과 함께 또는 없이 복용할 수 있음을 나타냅니다.
회사는 2025년 4월 2일로 예정된 대면 Pre-NDA 회의에 앞서 이 결과를 FDA에 제출했습니다. 싱귤레이트는 2025년 중반에 FDA 승인을 신청할 계획이며, CTx-1301을 ADHD 치료를 위한 하루에 한 번 복용하는 첫 번째 진정한 자극제 약물로 자리매김할 것입니다.
Cingulate (NASDAQ: CING) a annoncé des résultats de sécurité positifs de ses essais de phase 3 pour CTx-1301, leur principal actif de traitement du TDAH. Les données comprennent deux études pédiatriques et adolescentes de phase 3 (dose fixe et optimisation de la dose) ainsi qu'une étude sur l'effet des aliments avec des adultes en bonne santé utilisant une dose de 50 mg.
Les principaux résultats de sécurité montrent aucun événement indésirable grave lié au traitement (TEAE) ou décès, sans tendances cliniquement pertinentes dans les TEAE au total. Les résultats médicaux de l'étude sur l'effet des aliments s'alignent avec les résultats précédents de la dose de 25 mg, indiquant que CTx-1301 peut être pris avec ou sans nourriture.
L'entreprise a soumis ces résultats à la FDA avant une réunion Pre-NDA en personne prévue pour le 2 avril 2025. Cingulate prévoit de demander l'approbation de la FDA à la mi-2025, positionnant CTx-1301 comme le premier véritable médicament stimulant à prendre une fois par jour pour traiter le TDAH tout au long de la journée active.
Cingulate (NASDAQ: CING) hat positive Sicherheitsresultate aus seinen finalen Phase-3-Studien für CTx-1301, ihr führendes Medikament zur Behandlung von ADHS, bekannt gegeben. Die Daten umfassen zwei Phase-3-Studien für Kinder und Jugendliche (feste Dosis und Dosisoptimierung) sowie eine Lebensmittelauswirkungsstudie mit gesunden Erwachsenen, die eine Dosis von 50 mg verwendeten.
Die wichtigsten Sicherheitsbefunde zeigen keine schwerwiegenden behandlungsbedingten unerwünschten Ereignisse (TEAEs) oder Todesfälle, ohne klinisch relevante Trends bei den TEAEs insgesamt. Die medizinischen Ergebnisse der Lebensmittelauswirkungsstudie stimmen mit den früheren Ergebnissen der 25 mg Dosis überein und zeigen, dass CTx-1301 mit oder ohne Nahrung eingenommen werden kann.
Das Unternehmen hat diese Ergebnisse der FDA vor einem persönlichen Pre-NDA-Treffen, das für den 2. April 2025 geplant ist, vorgelegt. Cingulate plant, Mitte 2025 einen Antrag auf FDA-Zulassung einzureichen und positioniert CTx-1301 als das erste echte einmal täglich einzunehmende Stimulans zur Behandlung von ADHS für den gesamten aktiven Tag.
- No serious adverse events or safety concerns in Phase 3 trials
- Drug can be taken with or without food
- Consistent safety profile across nine clinical trials
- Pre-NDA meeting with FDA already scheduled
- Final FDA approval still pending
- Complete pharmacokinetics analysis of food effect study still ongoing
Insights
Cingulate's Phase 3 safety data for CTx-1301 represents a significant regulatory milestone on their pathway to NDA submission in mid-2025. The consistency of safety findings across nine clinical trials with no serious adverse events strengthens their regulatory position ahead of their April 2 FDA meeting.
What makes this particularly valuable is the positioning of CTx-1301 as the first true once-daily stimulant for ADHD with full-day coverage. This addresses a clear market gap, as current treatments often require multiple daily doses, creating adherence challenges and opportunities for medication misuse.
The ADHD market is substantial, with stimulant medications representing first-line therapy. A once-daily product with reliable day-long coverage could potentially capture significant market share if approved, especially for pediatric/adolescent patients where medication administration during school hours presents logistical challenges.
The upcoming FDA meeting will be pivotal in determining if there are any unexpected regulatory hurdles before submission. With safety data now compiled from pediatric, adolescent, and adult studies, Cingulate appears well-positioned to complete their NDA package, though efficacy data will ultimately be equally important in determining approval and market potential.
The absence of serious treatment-emergent adverse events across multiple Phase 3 studies is particularly noteworthy for a CNS stimulant. Methylphenidate products typically show predictable adverse effect profiles related to their sympathomimetic properties, but any new formulation still requires robust safety demonstration.
Cingulate's Precision Timed Release (PTR) technology appears to maintain the expected safety profile while potentially addressing the pharmacokinetic limitations of existing formulations. The food effect study is especially important, as variable absorption with or without food can significantly impact real-world efficacy and patient experience.
Dr. Childress's commentary highlights a critical unmet need - the requirement for booster doses creates not only adherence challenges but opportunities for stimulant diversion and misuse. A true once-daily formulation with confirmed bioavailability regardless of food status would represent a meaningful advance.
The regulatory strategy appears sound - completing all required studies before the pre-NDA meeting positions Cingulate to address any FDA concerns proactively. While safety data appears strong, the combined efficacy analysis will be equally important for approval. The submission timeline of mid-2025 suggests potential approval and commercialization in 2026 if the review proceeds without major obstacles.
Results Have Been Submitted Ahead of In-Person Meeting with FDA Set for April 2
CTx-1301 is the First, True, Once-Daily Stimulant Medication to Treat ADHD Over the Entire Active Day
KANSAS CITY, Kan., March 04, 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 released Phase 3 safety data for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The data readout includes safety data from two Phase 3 pediatric and adolescent studies – a fixed dose study and a dose optimization study – as well as a food effect study with healthy adults, using a single 50mg dose of CTx-1301, Cingulate’s highest dosage.
The safety results of these studies have been analyzed and submitted to the FDA in preparation for an in-person Pre-NDA meeting which is scheduled for April 2, 2025. A final analysis that combines both adult and pediatric safety and efficacy data will be prepared and included in the NDA submission.
“The safety data from these three studies has been reviewed thoroughly, and we are pleased that the safety profile of CTx-1301 has remained remarkably consistent and unprecedented over the course of nine clinical trials. As we look to bring to the market the first, true, once-daily stimulant medication that treats ADHD over the entire active day, we look forward to our in-person meeting with the FDA next month in preparation for the submission of our new drug application this summer,” said Cingulate Chairman and CEO Shane J. Schaffer.
An analysis of the data revealed the following:
- No subjects have experienced a serious treatment emergent adverse event (TEAE), a serious TEAE or a TEAE leading to death
- There were no clinically relevant trends in TEAEs overall
- The pharmacokinetics of the food effect study are being analyzed; however the medical findings are consistent with the previous study performed with the 25mg dose, which showed that CTx-1301 could be taken with or without food
“While we have many approved stimulant medications at our disposal as clinicians, booster doses in the morning and/or afternoon are still needed, and these may lead to issues with adherence, efficacy, side effects such as crash and rebound, as well as the potential for abuse and diversion of these short-acting stimulant medications,” stated ADHD expert Ann C. Childress, MD, practicing psychiatrist and recent president of the American Professional Society of ADHD and Related Disorders (APSARD), who has been the lead or primary investigator for all of Cingulate’s Phase 3 clinical trials studying CTx-1301. “Having first-hand experience with Cingulate’s CTx-1301 product, I am excited for both patients and providers to have this treatment option once approved by the FDA to overcome the longstanding unmet needs facing our patients with ADHD.”
About the Phase 3 Children/Adolescent Dose Optimization Study (CTx-1301-004)
- A dose-optimized (doses 6.26mg, 12.5mg, 18.75mg, 25mg, 31.25mg and 37.5mg), randomized, double-blind, placebo-controlled, parallel efficacy and safety laboratory classroom study in children (6-12) with ADHD using CTx-1301 (dexmethylphenidate)
- Subjects underwent a screening visit prior to entering the 8-week dose-optimization phase, attended weekly visits and were titrated to doses ranging between 6.25mg-37.5mg
- Eligible subjects were randomized to their optimal dose or placebo in a 1:1 ratio at the end of Visit 10 completing the practice laboratory classroom study
- Subjects took their assigned/randomized dose over the following 7-day period. On the 7th days subjects completed the full laboratory classroom study
- The duration of the full laboratory classroom study was approximately 15 hours, and subjects had an in-clinic safety follow-up visit within 7 days after the full classroom day
About the Phase 3 Children/Adolescent Fixed Dose Study (CTx-1301-005)
- A double-blind, randomized, placebo-controlled, multi-center, fixed-dose (doses 18.75mg, 25mg and 37.5mg), parallel-group efficacy and safety study in a pediatric population (6-17) with ADHD
- The study was comprised of a screening period, a double-blind randomized phase, and a safety follow-up visit
- The primary endpoint of the trial was mean change in ADHD Rating Scale 5 (ADHD-RS-5) scores from baseline (pre-dose) at Visit 2 to ADHD-RS-5 scores at Visit 8
- The secondary endpoint was mean change in Clinical Global Impression - Severity (CGI-S) scores within the same time frame. Multiple safety and pharmacokinetic analyses were also measured
About the Food Effect Study (CTx-1301-013)
- 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-∞)
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
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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
FAQ
What are the key safety findings from Cingulate's (CINGW) Phase 3 trials for CTx-1301?
When is Cingulate (CINGW) planning to submit its FDA application for CTx-1301?
How does Cingulate's (CINGW) CTx-1301 differ from existing ADHD medications?
What were the types of Phase 3 trials conducted for Cingulate's (CINGW) CTx-1301?
