FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301
Cingulate Inc. (NASDAQ: CING) has received formal pre-New Drug Application (NDA) meeting minutes from the FDA for CTx-1301, its lead ADHD treatment asset. The company plans to submit the NDA this summer following positive feedback from the April 2, 2025 meeting. CTx-1301, a dexmethylphenidate-based medication, is positioned as the first true once-daily stimulant for full-day ADHD treatment.
Key FDA agreements include: post-NDA approval commitment for additional stability data on 6 intermediate dose strengths, expected 24-month shelf-life at launch, adequacy of nonclinical safety data, ability to rely on Focalin XR's efficacy and safety data, and acceptance of the company's approach to integrated safety and efficacy summaries.
Cingulate Inc. (NASDAQ: CING) ha ricevuto i verbali ufficiali dell'incontro pre-New Drug Application (NDA) dalla FDA riguardanti CTx-1301, il suo principale farmaco per il trattamento dell'ADHD. L'azienda prevede di presentare la NDA questa estate, a seguito del riscontro positivo ottenuto durante l'incontro del 2 aprile 2025. CTx-1301, un medicinale a base di desmetilfenidato, si presenta come il primo vero stimolante a somministrazione giornaliera unica per il trattamento dell'ADHD per l'intera giornata.
I principali accordi con la FDA includono: l'impegno post-approvazione NDA per dati aggiuntivi di stabilità su 6 dosaggi intermedi, una durata di conservazione prevista di 24 mesi al momento del lancio, l'adeguatezza dei dati di sicurezza non clinici, la possibilità di fare affidamento sui dati di efficacia e sicurezza di Focalin XR e l'accettazione dell'approccio aziendale ai riepiloghi integrati di sicurezza ed efficacia.
Cingulate Inc. (NASDAQ: CING) ha recibido las actas formales de la reunión pre-Solicitud de Nuevo Medicamento (NDA) de la FDA para CTx-1301, su principal tratamiento para el TDAH. La compañía planea presentar la NDA este verano tras recibir comentarios positivos en la reunión del 2 de abril de 2025. CTx-1301, un medicamento basado en dexmetilfenidato, se posiciona como el primer estimulante verdadero de dosificación única diaria para el tratamiento del TDAH durante todo el día.
Los acuerdos clave con la FDA incluyen: compromiso post-aprobación NDA para datos adicionales de estabilidad en 6 dosis intermedias, vida útil esperada de 24 meses al lanzamiento, suficiencia de los datos de seguridad no clínicos, la posibilidad de basarse en los datos de eficacia y seguridad de Focalin XR, y la aceptación del enfoque de la compañía para los resúmenes integrados de seguridad y eficacia.
Cingulate Inc. (NASDAQ: CING)는 주요 ADHD 치료제인 CTx-1301에 대한 FDA의 신약 신청서(NDA) 사전 회의 공식 회의록을 받았습니다. 회사는 2025년 4월 2일 회의에서 긍정적인 피드백을 받은 후 이번 여름에 NDA를 제출할 계획입니다. CTx-1301은 덱스메틸페니데이트 기반 약물로, 하루 한 번 복용하는 최초의 진정한 전일 ADHD 치료용 자극제로 자리매김하고 있습니다.
FDA와의 주요 합의 내용은 다음과 같습니다: NDA 승인 후 6가지 중간 용량에 대한 추가 안정성 데이터 제출 약속, 출시 시 예상 유통기한 24개월, 비임상 안전성 데이터의 적절성, Focalin XR의 효능 및 안전성 데이터 활용 가능성, 그리고 회사의 통합 안전성 및 효능 요약 접근법 승인.
Cingulate Inc. (NASDAQ: CING) a reçu les procès-verbaux officiels de la réunion pré-New Drug Application (NDA) de la FDA concernant CTx-1301, son principal traitement contre le TDAH. La société prévoit de soumettre la NDA cet été, suite aux retours positifs de la réunion du 2 avril 2025. CTx-1301, un médicament à base de dexmethylphénidate, est présenté comme le premier stimulant véritablement à prise unique quotidienne pour le traitement complet du TDAH sur la journée.
Les principaux accords avec la FDA incluent : un engagement post-approbation NDA pour des données supplémentaires de stabilité sur 6 dosages intermédiaires, une durée de conservation prévue de 24 mois au lancement, la suffisance des données de sécurité non cliniques, la possibilité de s'appuyer sur les données d'efficacité et de sécurité de Focalin XR, ainsi que l'acceptation de l'approche de la société pour les synthèses intégrées de sécurité et d'efficacité.
Cingulate Inc. (NASDAQ: CING) hat offizielle Protokolle des Vorab-Meetings zur New Drug Application (NDA) von der FDA für CTx-1301, ihr führendes ADHD-Behandlungspräparat, erhalten. Das Unternehmen plant, die NDA diesen Sommer einzureichen, nachdem es positives Feedback aus dem Treffen am 2. April 2025 erhalten hat. CTx-1301, ein auf Dexmethylphenidat basierendes Medikament, wird als das erste echte einmal täglich einzunehmende Stimulans für die ganztägige Behandlung von ADHD positioniert.
Wichtige FDA-Vereinbarungen umfassen: Verpflichtung zur Nachreichung zusätzlicher Stabilitätsdaten für 6 Zwischenstärken nach NDA-Zulassung, erwartete Haltbarkeit von 24 Monaten beim Markteintritt, Angemessenheit der nichtklinischen Sicherheitsdaten, Möglichkeit der Nutzung der Wirksamkeits- und Sicherheitsdaten von Focalin XR sowie die Akzeptanz des integrierten Sicherheits- und Wirksamkeitsberichts der Firma.
- FDA alignment on NDA filing requirements streamlines the approval process
- Expected 24-month shelf-life at launch with potential for extension
- Ability to leverage Focalin XR's existing safety and efficacy data reduces regulatory burden
- Nonclinical safety data deemed adequate for filing
- Additional post-approval stability data required for 6 intermediate dose strengths
- Final approval still subject to complete FDA review process
Insights
FDA alignment on CTx-1301 NDA requirements positions Cingulate for summer submission, representing significant regulatory advancement.
Cingulate has reached a critical regulatory milestone with the FDA providing formal feedback on their pre-NDA meeting for CTx-1301, their lead ADHD treatment. The agency's response confirms alignment with Cingulate's submission strategy, essentially providing a regulatory green light for their planned summer NDA filing.
The FDA's feedback includes several favorable regulatory determinations:
- Acceptance of post-approval stability data commitments for six intermediate dosage strengths
- Confirmation that available nonclinical safety data appears adequate for filing
- Acknowledgment that CTx-1301 may utilize the 505(b)(2) pathway by referencing Focalin XR's established efficacy and safety data
- Acceptance of Cingulate's proposed approach to the integrated safety and efficacy summaries
These points collectively address key regulatory requirements that could otherwise delay submission. The expected 24-month shelf-life at launch also provides standard commercial viability. Particularly significant is the FDA's agreement with the scientific bridge to Focalin XR, which allows Cingulate to leverage existing data rather than conducting additional extensive clinical trials – representing substantial time and cost efficiencies.
This regulatory alignment follows seven years of interaction with the FDA, suggesting a thorough development process. The summer 2025 submission timeline provides a concrete near-term catalyst that moves Cingulate closer to potentially commercializing what they describe as "the first, true, once-daily stimulant medication to treat ADHD over the entire active day" – a differentiated product in the competitive ADHD treatment landscape.
Pre-NDA Minutes from April 2, 2025, Meeting Received
NDA Submission Planned this Summer
KANSAS CITY, Kan., May 14, 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 has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) for it’s lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
“We are pleased that the feedback we received from our pre-NDA meeting with the FDA is aligned with our plans to submit a new drug application for CTx-1301 this summer. We thank the agency for its guidance and a constructive dialogue over the past seven years, which has been crucial in helping us generate data to demonstrate the safety, consistency and therapeutic benefit of CTx-1301. Today we are one step closer to bringing 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.
Details of the FDA’s minutes include the following, all of which will be a matter of review during the approval process:
- The agency agreed to a post-NDA approval commitment of additional stability date for the 6 intermediate dose strengths of 12.5-mg, 18.75-mg, 25-mg, 31.25-mg, 37.5-mg, and 43.75-mg.
- Cingulate expects shelf-life for all dosage strengths to be 24 months at launch, the results from the aforementioned batches may allow the shelf-life to be extended.
- Available data for nonclinical safety appears adequate to support a filing.
- With a scientific bridge established upon review, CTx-1301 may rely on the efficacy and safety data of the listed drug, Focalin XR.
- Cingulate’s proposed approach to the integrated safety summary (ISS) and integrated summary of efficacy (ISE) appears reasonable.
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
FAQ
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