Cingulate Completes Pre-NDA Meeting with FDA to Discuss New Drug Application for lead ADHD Asset CTx-1301
Cingulate Inc. (NASDAQ: CING) has completed a Pre-NDA meeting with the FDA regarding its lead ADHD treatment asset CTx-1301 (dexmethylphenidate HCl). The company remains on schedule for a New Drug Application submission in mid-2025.
The company recently released Phase 3 safety data for CTx-1301 and results from a food effect study using a single 50-mg dose in healthy adults. The safety profile has remained consistent across nine clinical trials. CTx-1301 is positioned to be the first true once-daily stimulant medication for ADHD treatment throughout the active day, utilizing Cingulate's proprietary Precision Timed Release™ (PTR™) drug delivery platform.
A final analysis combining both adult and pediatric safety and efficacy data will be included in the upcoming NDA submission.
Cingulate Inc. (NASDAQ: CING) ha completato un incontro Pre-NDA con la FDA riguardo al suo principale asset per il trattamento dell'ADHD, CTx-1301 (dexmetilfenidato HCl). L'azienda rimane in linea con il programma per la presentazione della domanda di Nuovo Farmaco a metà del 2025.
Recentemente, l'azienda ha rilasciato i dati di sicurezza della Fase 3 per CTx-1301 e i risultati di uno studio sull'effetto del cibo utilizzando una singola dose di 50 mg in adulti sani. Il profilo di sicurezza è rimasto coerente attraverso nove studi clinici. CTx-1301 è posizionato per essere il primo vero farmaco stimolante a somministrazione giornaliera unica per il trattamento dell'ADHD durante l'intera giornata attiva, utilizzando la piattaforma di somministrazione dei farmaci proprietaria di Cingulate, Precision Timed Release™ (PTR™).
Un'analisi finale che combina i dati di sicurezza ed efficacia sia per adulti che per bambini sarà inclusa nella prossima presentazione della NDA.
Cingulate Inc. (NASDAQ: CING) ha completado una reunión Pre-NDA con la FDA sobre su principal activo para el tratamiento del TDAH, CTx-1301 (dexmetilfenidato HCl). La compañía se mantiene en el cronograma para la presentación de la Solicitud de Nuevo Medicamento a mediados de 2025.
Recientemente, la compañía lanzó los datos de seguridad de Fase 3 para CTx-1301 y los resultados de un estudio sobre el efecto de los alimentos utilizando una sola dosis de 50 mg en adultos sanos. El perfil de seguridad se ha mantenido consistente a lo largo de nueve ensayos clínicos. CTx-1301 está posicionado para ser el primer verdadero medicamento estimulante de una sola dosis diaria para el tratamiento del TDAH durante todo el día activo, utilizando la plataforma de entrega de medicamentos patentada de Cingulate, Precision Timed Release™ (PTR™).
Un análisis final que combine los datos de seguridad y eficacia tanto para adultos como para pediátricos se incluirá en la próxima presentación de la NDA.
Cingulate Inc. (NASDAQ: CING)는 FDA와의 Pre-NDA 회의를 완료하고 주요 ADHD 치료 자산인 CTx-1301 (덱스메틸페니데이트 HCl)에 대해 논의했습니다. 회사는 2025년 중반에 새로운 약물 신청서를 제출할 계획입니다.
회사는 최근 CTx-1301에 대한 3상 안전성 데이터와 건강한 성인을 대상으로 한 50mg 단일 용량의 음식 효과 연구 결과를 발표했습니다. 안전성 프로파일은 아홉 개의 임상 시험에서 일관성을 유지했습니다. CTx-1301은 Cingulate의 독점 Precision Timed Release™ (PTR™) 약물 전달 플랫폼을 활용하여 활동적인 하루 동안 ADHD 치료를 위한 첫 번째 진정한 하루 한 번 복용하는 자극제 약물이 될 것으로 예상됩니다.
성인과 소아의 안전성과 유효성 데이터를 결합한 최종 분석이 다가오는 NDA 제출에 포함될 것입니다.
Cingulate Inc. (NASDAQ: CING) a terminé une réunion pré-NDA avec la FDA concernant son principal actif de traitement du TDAH, CTx-1301 (dexméthylphénidate HCl). L'entreprise reste dans les délais pour une soumission de demande de nouveau médicament à mi-2025.
Récemment, l'entreprise a publié des données de sécurité de la phase 3 pour CTx-1301 ainsi que les résultats d'une étude sur l'effet des aliments utilisant une dose unique de 50 mg chez des adultes en bonne santé. Le profil de sécurité est resté cohérent au cours de neuf essais cliniques. CTx-1301 est positionné pour être le premier véritable médicament stimulant à prise unique quotidienne pour le traitement du TDAH tout au long de la journée active, en utilisant la plateforme de délivrance de médicaments propriétaire de Cingulate, Precision Timed Release™ (PTR™).
Une analyse finale combinant les données de sécurité et d'efficacité pour les adultes et les enfants sera incluse dans la prochaine soumission de la NDA.
Cingulate Inc. (NASDAQ: CING) hat ein Pre-NDA-Meeting mit der FDA bezüglich seines führenden ADHD-Behandlungsprodukts CTx-1301 (Dexmethylphenidat HCl) abgeschlossen. Das Unternehmen liegt im Zeitplan für die Einreichung eines Antrags auf Zulassung eines neuen Arzneimittels im Mitte 2025.
Das Unternehmen hat kürzlich Phase 3 Sicherheitsdaten für CTx-1301 und Ergebnisse einer Nahrungsmittelwirkungstudie mit einer einzelnen Dosis von 50 mg bei gesunden Erwachsenen veröffentlicht. Das Sicherheitsprofil blieb über neun klinische Studien hinweg konsistent. CTx-1301 ist darauf ausgelegt, das erste echte einmal täglich einzunehmende Stimulans zur Behandlung von ADHD während des aktiven Tages zu sein, indem die proprietäre Precision Timed Release™ (PTR™) Arzneimittelabgabetechnologie von Cingulate genutzt wird.
Eine abschließende Analyse, die sowohl Sicherheits- als auch Wirksamkeitsdaten für Erwachsene und Kinder kombiniert, wird in der kommenden NDA-Einreichung enthalten sein.
- Pre-NDA meeting with FDA completed successfully
- Phase 3 safety data shows consistent safety profile across nine clinical trials
- On track for NDA submission timeline in mid-2025
- Potential to be first once-daily ADHD stimulant medication for full-day treatment
- Final analysis of combined adult and pediatric data still pending
- NDA approval not guaranteed despite completed Pre-NDA meeting
NDA Submission On-Target for Mid-2025
KANSAS CITY, Kan., April 03, 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 that it held a Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) yesterday to discuss the submission of a new drug application (NDA) for its lead Phase 3 asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
“Our meeting with the FDA yesterday was very productive, and we remain on track for an NDA filing of CTx-1301 in mid-2025. We truly appreciate the FDA personnel who have been involved with the regulatory review of CTx-1301 to date. These interactions have been essential in helping us generate data to demonstrate the consistency and therapeutic benefit of our product. This important milestone is validation of our mission to bring to market the first, true, once-daily stimulant medication to treat ADHD over the entire active day,” said Cingulate Chairman and CEO Shane J Schaffer.
Last month Cingulate released Phase 3 safety data for CTx-1301, as well as the results from a food effect study with healthy adults, using a single 50-mg dose of CTx-1301, Cingulate’s highest dosage. A review of the results found that the safety profile of CTx-1301 has remained consistent over the course of nine clinical trials. A final analysis that combines both adult and pediatric safety and efficacy data will be prepared and included in the NDA submission.
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.
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 March 27, 2025, 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) submit the NDA for CTx-1301 ADHD treatment?
How many clinical trials has CTx-1301 completed for ADHD treatment?
What makes Cingulate's CTx-1301 different from other ADHD medications?
What recent clinical data has been released for CTx-1301?
