Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301
Cingulate Inc. (NASDAQ: CING) has submitted a New Drug Application (NDA) to the FDA for CTx-1301, its lead ADHD treatment candidate. The drug, utilizing Cingulate's proprietary Precision Timed Release鈩� (PTR鈩�) platform, is designed to provide once-daily dosing with fast onset and entire active-day efficacy.
CTx-1301 is a novel extended-release formulation of dexmethylphenidate HCl that aims to address major limitations of current ADHD therapies. The company expects to receive notification of NDA acceptance within 60 days of its July 31 submission. The drug targets the $23 billion U.S. ADHD market and represents the first regulatory application of Cingulate's PTR鈩� platform technology.
Cingulate Inc. (NASDAQ: CING) ha presentato una Domanda di Nuovo Farmaco (NDA) alla FDA per CTx-1301, il suo principale candidato terapeutico per l'ADHD. Il farmaco, che utilizza la piattaforma proprietaria di Cingulate Precision Timed Release鈩� (PTR鈩�), 猫 progettato per una somministrazione una volta al giorno con un rapido inizio d'azione e un'efficacia per tutta la giornata attiva.
CTx-1301 猫 una nuova formulazione a rilascio prolungato di dexmetilfenidato HCl che mira a superare le principali limitazioni delle terapie attuali per l'ADHD. La societ脿 prevede di ricevere la notifica di accettazione della NDA entro 60 giorni dalla presentazione del 31 luglio. Il farmaco si rivolge al mercato statunitense dell'ADHD da 23 miliardi di dollari e rappresenta la prima domanda regolatoria basata sulla tecnologia della piattaforma PTR鈩� di Cingulate.
Cingulate Inc. (NASDAQ: CING) ha presentado una Solicitud de Nuevo Medicamento (NDA) a la FDA para CTx-1301, su principal candidato para el tratamiento del TDAH. El medicamento, que utiliza la plataforma propietaria Precision Timed Release鈩� (PTR鈩�) de Cingulate, est谩 dise帽ado para una dosificaci贸n diaria 煤nica con un inicio r谩pido y eficacia durante todo el d铆a activo.
CTx-1301 es una formulaci贸n novedosa de liberaci贸n prolongada de dexmetilfenidato HCl que busca superar las principales limitaciones de las terapias actuales para el TDAH. La compa帽铆a espera recibir la notificaci贸n de aceptaci贸n de la NDA dentro de 60 d铆as desde su presentaci贸n el 31 de julio. El medicamento apunta al mercado estadounidense del TDAH de 23 mil millones de d贸lares y representa la primera aplicaci贸n regulatoria de la tecnolog铆a de la plataforma PTR鈩� de Cingulate.
Cingulate Inc. (NASDAQ: CING)電� ADHD 旃橂 頉勲炒氍检鞚� CTx-1301鞐� 雽�頃� FDA鞐� 鞁犾暯 鞁犾箔靹�(NDA)毳� 鞝滌稖頄堨姷雼堧嫟. 鞚� 鞎诫鞚� Cingulate鞚� 霃呾瀽鞝侅澑 Precision Timed Release鈩� (PTR鈩�) 頂岆灚韽检潉 頇滌毄頃橃棳 頃橂（ 頃� 氩� 氤奠毄鞙茧 牍犽ジ 須臣 氚滍槃瓿� 頃橂（ 膦呾澕 歆�靻嶋悩電� 須姤鞚� 鞝滉车頃橂弰搿� 靹り硠霅橃棃鞀惦媹雼�.
CTx-1301鞚� 雿膘姢氅旐嫺韼橂媹雿办澊韸� HCl鞚� 靸堧鞖� 靹滊癌順� 鞝滌牅搿�, 順勳灛 ADHD 旃橂鞝滌潣 欤检殧 頃滉硠毳� 攴闺车頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�. 須岇偓電� 7鞗� 31鞚� 鞝滌稖 頉� 60鞚� 鞚措偞鞐� NDA 鞝戩垬 韱奠毳� 氚涭潉 瓴冹溂搿� 鞓堨儊頃╇媹雼�. 鞚� 鞎诫鞚� 230鞏� 雼煬 攴滊鞚� 氙戈淡 ADHD 鞁滌灔鞚� 氇╉憸搿� 頃橂┌, Cingulate鞚� PTR鈩� 頂岆灚韽� 旮办垹鞚� 鞝侅毄頃� 觳� 氩堨Ц 攴滌牅 鞁犾箔鞛呺媹雼�.
Cingulate Inc. (NASDAQ : CING) a soumis une demande d'autorisation de mise sur le march茅 (NDA) 脿 la FDA pour CTx-1301, son principal candidat pour le traitement du TDAH. Ce m茅dicament, utilisant la plateforme propri茅taire de Cingulate Precision Timed Release鈩� (PTR鈩�), est con莽u pour une administration quotidienne unique avec un d茅but d'action rapide et une efficacit茅 sur toute la journ茅e active.
CTx-1301 est une nouvelle formulation 脿 lib茅ration prolong茅e de chlorhydrate de dexmethylph茅nidate visant 脿 pallier les principales limites des traitements actuels du TDAH. La soci茅t茅 s'attend 脿 recevoir une notification d'acceptation de la NDA dans un d茅lai de 60 jours 脿 compter de son d茅p么t le 31 juillet. Ce m茅dicament cible le march茅 am茅ricain du TDAH de 23 milliards de dollars et repr茅sente la premi猫re demande r茅glementaire utilisant la technologie de la plateforme PTR鈩� de Cingulate.
Cingulate Inc. (NASDAQ: CING) hat einen Antrag auf Zulassung eines neuen Medikaments (NDA) bei der FDA f眉r CTx-1301, seinen f眉hrenden Kandidaten zur Behandlung von ADHS, eingereicht. Das Medikament nutzt Cingulates propriet盲re Precision Timed Release鈩� (PTR鈩�)-Plattform und ist darauf ausgelegt, eine einmal t盲gliche Dosierung mit schnellem Wirkungseintritt und ganzt盲giger Wirksamkeit zu bieten.
CTx-1301 ist eine neuartige Retardformulierung von Dexmethylphenidat HCl, die darauf abzielt, wesentliche Einschr盲nkungen aktueller ADHS-Therapien zu 眉berwinden. Das Unternehmen erwartet eine Benachrichtigung 眉ber die Annahme des NDA innerhalb von 60 Tagen nach der Einreichung am 31. Juli. Das Medikament richtet sich an den 23 Milliarden US-Dollar schweren US-ADHS-Markt und stellt die erste regulatorische Anmeldung der PTR鈩�-Plattformtechnologie von Cingulate dar.
- First regulatory application of proprietary PTR鈩� drug delivery platform technology
- Targeting substantial $23 billion U.S. ADHD market opportunity
- Novel formulation addressing key limitations of existing ADHD therapies
- Potential transition from development to commercial stage company
- FDA acceptance of NDA still pending
- No revenue generation until potential approval and commercialization
- Will face competition in established ADHD market
Insights
Cingulate's NDA submission for its ADHD drug CTx-1301 marks a critical regulatory milestone toward potential commercialization in a $23B market.
Cingulate's submission of a New Drug Application (NDA) for CTx-1301 represents a significant regulatory milestone in the company's development timeline. The NDA submission follows what appears to be completed clinical trials and manufacturing development for their dexmethylphenidate-based ADHD treatment.
The product utilizes Cingulate's proprietary Precision Timed Release鈩� (PTR鈩�) drug delivery platform, which appears designed to overcome key limitations in current ADHD medications. Specifically, CTx-1301 aims to provide three critical benefits with a single daily dose: fast onset of action, full-day symptom control, and consistent drug levels throughout the day.
From a regulatory perspective, the FDA typically provides notification of acceptance for review within 60 days of submission. If accepted, the standard review timeline would be approximately 10-12 months, though this could vary based on review designation. The company has not indicated whether they've requested priority review.
The
This NDA submission also validates Cingulate's proprietary PTR鈩� platform technology, which could have broader applications across multiple therapeutic areas beyond ADHD, creating potential for pipeline expansion and additional value generation.
Regulatory filing marks significant milestone for medication designed to provide once-daily, entire active-day symptom control in ADHD patients
KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc.听(狈础厂顿础蚕: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release鈩� (PTR鈩�) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced that it has submitted its聽New Drug Application (NDA)聽to the U.S. Food and Drug Administration (FDA) for聽CTx-1301(dexmethylphenidate HCl), the company鈥檚 lead asset for the treatment of聽Attention Deficit/Hyperactivity Disorder (ADHD).
CTx-1301聽is a novel, extended-release tablet formulation of聽dexmethylphenidate聽designed to deliver fast onset, entire active-day efficacy, and a smooth pharmacokinetic profile with a single dose, addressing major limitations of current ADHD therapies. Cingulate may learn if the NDA has been accepted for review by the FDA within 60 days of its July 31 submission.
鈥淭he submission of the NDA for CTx-1301 is the culmination of years of clinical and manufacturing development focused on delivering a true, once-daily ADHD treatment that offers fast onset, entire active-day efficacy, and a consistent therapeutic experience,鈥� said聽Cingulate Chief Medical Officer Matthew Brams, MD.聽鈥淲e believe CTx-1301 addresses key limitations of existing therapies and has the potential to improve outcomes for patients across age groups.鈥�
Shane J. Schaffer, Chairman and CEO of Cingulate, stated, 鈥淲ith a differentiated profile supported by robust clinical data, we believe CTx-1301 has the potential to capture meaningful share in the
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.聽, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65鈥�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鈥檚 lead candidate, CTx-1301, utilizes Cingulate鈥檚 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鈩� (PTR鈩�) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate鈥檚 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鈩�, 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鈥檚 PTR Platform, click聽.
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聽.
Forward-Looking Statements聽
This press release contains 鈥渇orward-looking statements鈥� 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 鈥渕ay,鈥� 鈥渃ould,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥渂elieve,鈥� 鈥渁nticipate,鈥� 鈥渇orecast,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥減lan,鈥� 鈥渃ontinue,鈥� 鈥渙utlook,鈥� 鈥渨ill,鈥� 鈥減otential鈥� 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 鈥淩isk Factors鈥� 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 & Media Relations:
Thomas Dalton
Vice President, Corporate Communications, Cingulate
(913) 942-2301
FAQ
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