FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date
Cingulate (NASDAQ: CING) announced the FDA has accepted the New Drug Application for CTx-1301 (dexmethylphenidate) for ADHD with a PDUFA date of May 31, 2026. The NDA was filed under the FDA’s 505(b)(2) pathway after completion of adult and pediatric Phase 3 trials and all FDA-requested studies.
Phase 3 data showed rapid onset and sustained daily efficacy across multiple measures in adults and children (ages 6+); no serious treatment-emergent adverse events were reported. Cingulate reports completed commercial-scale manufacturing transfer with Bend Bio Sciences and early payer receptivity for a once-daily product.
Cingulate (NASDAQ: CING) ha annunciato che la FDA ha accettato la New Drug Application per CTx-1301 (dexmetilfenidato) per l'ADHD con una data PDUFA del 31 maggio 2026. L'NDA è stata presentata secondo il percorso 505(b)(2) della FDA dopo il completamento di studi di fase 3 per adulti e pediatrici e di tutti gli studi richiesti dalla FDA.
I dati di fase 3 hanno mostrato un innesco rapido e un'efficacia giornaliera sostenuta su più misure negli adulti e nei bambini (età 6+); non sono stati riportati eventi avversi gravi legati al trattamento. Cingulate segnala di aver completato il trasferimento della produzione su scala commerciale con Bend Bio Sciences e una precoce accoglienza da parte dei pagatori per un prodotto da prendere una volta al giorno.
Cingulate (NASDAQ: CING) anunció que la FDA ha aceptado la New Drug Application para CTx-1301 (dextrimetilfenidato) para el TDAH con una fecha PDUFA del 31 de mayo de 2026. La NDA se presentó bajo la vía 505(b)(2) de la FDA tras la finalización de ensayos de fase 3 en adultos y pediátricos y todos los estudios solicitados por la FDA.
Los datos de fase 3 mostraron inicio rápido y eficacia diaria sostenida en múltiples medidas en adultos y niños (mayores de 6 años); no se informaron eventos adversos graves relacionados con el tratamiento. Cingulate informa haber completado la transferencia de fabricación a escala comercial con Bend Bio Sciences y una receptividad temprana de los pagadores para un producto de dosis única diaria.
Cingulate (NASDAQ: CING)는 FDA가 ADHD용 CTx-1301 (덱스메틸페니데이트)에 대한 신약신청서를 수용했고 PDUFA 날짜를 2026년 5월 31일로 설정했다고 발표했습니다. NDA는 FDA의 505(b)(2) 경로를 통해 성인 및 소아 3상 시험과 FDA가 요청한 모든 연구를 완료한 뒤 제출되었습니다.
3상 데이터는 성인 및 아동(6세 이상)에서 여러 지표에 걸쳐 빠른 시작과 지속적인 일일 효능을 나타냈으며, 중대한 치료관련 이상반응은 보고되지 않았습니다. Cingulate은 Bend Bio Sciences와의 상업 규모 제조 이전을 완료했고 조기 지불자 수용도 또한 일일 1회 복용 제품에 대해 확인되었다고 보고합니다.
Cingulate (NASDAQ: CING) a annoncé que la FDA a accepté la New Drug Application pour CTx-1301 (dextrométhylphénidate) pour le TDAH avec une date PDUFA du 31 mai 2026. La NDA a été déposée via la voie 505(b)(2) de la FDA après l'achèvement des essais de phase 3 chez l'adulte et l'enfant et toutes les études demandées par la FDA.
Les données de phase 3 ont montré un démarrage rapide et une efficacité quotidienne soutenue sur plusieurs mesures chez les adultes et les enfants (à partir de 6 ans); aucun événement indésirable grave lié au traitement n'a été rapporté. Cingulate indique avoir terminé le transfert de fabrication à l’échelle commerciale avec Bend Bio Sciences et une réceptivité précoce des payeurs pour un produit à prise unique quotidienne.
Cingulate (NASDAQ: CING) hat bekannt gegeben, dass die FDA die New Drug Application für CTx-1301 (Dexmethylphenidat) zur Behandlung von ADHS angenommen hat mit einem PDUFA-Termin vom 31. Mai 2026. Die NDA wurde im Rahmen des FDA-505(b)(2)-Weges eingereicht, nachdem Abschluss von Erwachsenen- und pädiatrischen Phase-3-Studien und alle von der FDA geforderten Untersuchungen.
Phase-3-Daten zeigten einen raschen Beginn und eine nachhaltige tägliche Wirksamkeit über mehrere Messgrößen bei Erwachsenen und Kindern (6 Jahre und älter); schwere behandlungsbedingte unerwünschte Ereignisse wurden nicht berichtet. Cingulate meldet den Abschluss der kommerziellen Maßstabsfertigungstransfer mit Bend Bio Sciences und eine frühe Zuliefererakzeptanz für ein Produkt mit einmal täglicher Einnahme.
Cingulate (NASDAQ: CING) أعلنت أن FDA قبلت طلب الدواء الجديد لـ CTx-1301 (دكسميثيلفينيديت) لعلاج اضطراب فرط الحركة وتشتت الانتباه مع تاريخ PDUFA في 31 مايو 2026. تم تقديم NDA بموجب مسار FDA 505(b)(2) بعد إكمال تجارب المرحلة 3 للبالغين والأطفال وجميع الدراسات التي طلبتها FDA.
أظهرت بيانات المرحلة 3 بداية سريعة وفعالية يومية مستمرة عبر مقاييس متعددة لدى البالغين والأطفال (6 سنوات فأكثر); لم يتم الإبلاغ عن أحداث سلبية خطيرة مرتبطة بالعلاج. كما تفيد Cingulate بأنها أكملت نقل التصنيع على مستوى تجاري مع Bend Bio Sciences وتقبل مبكر من الجهات الدافعة لدواء ذو جرعة واحدة يوميًا.
Cingulate (NASDAQ: CING) 宣布 FDA 已接受用于注意力缺陷多动障碍治疗的 CTx-1301（右旋甲基苯丙胺）的新药申请，PDUFA日期为2026年5月31日。该NDA通过 FDA 的 505(b)(2) 路径提交，提交前已完成成人与儿科III期试验及FDA要求的所有研究。
III期数据在成人及儿童（6岁及以上）中显示了快速起效及每日疗效的持续性，在多项指标上均有表现；未报告与治疗相关的严重不良事件。Cingulate 表示已完成与 Bend Bio Sciences 的商业规模制造转移，并对单日一次给药产品的潜在支付方初步表现出接受度。
- FDA accepted NDA under 505(b)(2)
- PDUFA target date May 31, 2026
- Phase 3 showed rapid onset and sustained efficacy in adults and pediatrics
- No serious treatment-emergent adverse events reported across studies
- Completed commercial process transfer with Bend Bio Sciences
- Regulatory approval not granted; final decision pending by May 31, 2026
Insights
NDA acceptance and a
Cingulate moves into formal FDA review for CTx-1301, a once-daily PTR™ dexmethylphenidate formulation, after completing adult and pediatric Phase 3 trials and FDA-requested studies. NDA acceptance under the 505(b)(2) pathway confirms the submission is complete enough for substantive review and leverages existing dexmethylphenidate data while focusing on the drug-delivery differentiation.
The program’s factual strengths include demonstrated large effect sizes across the day in Phase 3, dose-dependent pediatric efficacy, no reported serious treatment-emergent adverse events, and a positive pre-NDA meeting confirming clinical and CMC adequacy. These facts support a favorable regulatory dossier but do not guarantee approval; the FDA review will assess full risk–benefit and labeling.
Key dependencies and near-term items to watch include the
- Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration
- NDA accepted under the FDA’s 505(b)(2) regulatory pathway
KANSAS CITY, Kan., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CTx-1301 (dexmethylphenidate), the company’s lead candidate for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. NDA acceptance signifies that the Agency has determined the submission is sufficiently complete to permit substantive review.
A Key Regulatory Milestone Under the 505(b)(2) Pathway
This marks a major regulatory inflection point for Cingulate and for the CTx-1301 program. CTx-1301 is being reviewed under the FDA’s 505(b)(2) regulatory pathway, which allows sponsors to reference existing data on previously approved active ingredients while demonstrating novel clinical benefit through a differentiated delivery mechanism. For Cingulate, this pathway offers the opportunity to leverage the extensive safety and efficacy data of dexmethylphenidate—an established and well-characterized stimulant—while enabling CTx-1301 to demonstrate rapid onset of effect and entire active-day duration through its proprietary multi-core PTR™ technology.
The NDA submission follows completion of adult and pediatric Phase 3 trials, completion of all FDA-requested studies, and a positive pre-NDA meeting in April 2025 confirming adequacy of the clinical and Chemistry, Manufacturing, and Controls (CMC) data packages for review. The FDA’s acceptance validates that Cingulate’s application meets the Agency’s standards for completeness and marks the beginning of the formal review period.
Clinical Results Support Differentiated Profile
In Phase 3 clinical trials, CTx-1301 improved ADHD signs and symptoms across multiple metrics in adult and pediatric patients (ages 6 years and older). Effect size measurements were large throughout the day, demonstrating that CTx-1301 provides a rapid onset of effect and sustained efficacy into the afternoon and evening, which may address long-standing gaps in ADHD management.
Key findings include:
- Adult dose-optimization study: Achieved clinically meaningful improvements on the Permanent Product Measure of Performance (PERMP) and Adult ADHD Investigator Symptom Rating Scale (AISRS).
- Pediatric fixed-dose study: Demonstrated dose-dependent improvements on the ADHD rating scale 5 (ADHD-RS-5), Clinical Global Impression–Improvement (CGI-I), and Clinical Global Impression–Severity (CGI-S) scales.
- Safety and tolerability: No serious treatment-emergent adverse events were reported across studies, and the tolerability profile was consistent with that of other long-acting methylphenidate products.
Management Commentary
“FDA acceptance of our NDA marks a defining milestone for Cingulate,” said Cingulate Executive Chairman Jay Roberts. “CTx-1301 was engineered to address the practical shortcomings of today’s stimulant therapies—multiple daily dosing, midday rebound, and adherence challenges—through a single, once-daily tablet. This milestone affirms the robustness of our clinical and regulatory strategy, and positions Cingulate to transition from a development-stage to a commercial-stage company in 2026, pending FDA approval of CTx-1301.”
Matt Brams, MD, Chief Medical Officer, added, “The acceptance of our NDA reflects the FDA’s recognition of the completeness of our submission and the strong body of evidence supporting CTx-1301’s efficacy, safety, and patient-centric design. Our adult and pediatric studies consistently demonstrated rapid symptom relief, sustained performance and the flexibility of dosing with or without food—attributes that we believe will resonate strongly with both physicians and patients.”
Launch Readiness
With the NDA now accepted, the FDA will conduct its full review of CTx-1301’s efficacy, safety, and overall risk–benefit profile. In parallel, Cingulate continues advancing key commercial readiness activities to ensure timely launch preparedness following potential approval. Through its exclusive manufacturing partnership with Bend Bio Sciences, Cingulate has completed process transfer and scale-up production using commercial-grade equipment, providing early validation and ensuring a reliable supply chain in preparation for launch.
On the commercial front, Cingulate’s partnership with Indegene delivers an integrated, AI-driven omnichannel platform that combines advanced analytics with targeted field engagement to optimize prescriber reach, payer access, and patient support. Early payer research indicates strong formulary receptivity for once-daily CTx-1301, underscoring the product’s alignment with key clinical and adherence priorities in ADHD care.
About Attention-Deficit/Hyperactivity Disorder (ADHD)
ADHD is a chronic neurodevelopmental disorder affecting an estimated 20 million individuals in the U.S., including approximately 8 million children and 12 million adults. The condition is characterized by inattention, hyperactivity, and impulsivity that impair academic, professional, and social functioning. Stimulant medications remain the gold-standard therapy; however, most currently available extended-release formulations require multiple doses per day and often fail to provide consistent coverage across the entire active day.
About CTx-1301
CTx-1301 (dexmethylphenidate) is a once-daily, multi-core tablet utilizing Cingulate’s proprietary Precision Timed Release™ (PTR™) platform to deliver three precisely timed releases of active medication across the day. This design aims to provide rapid onset of effect and entire active-day duration. CTx-1301 is being evaluated for the treatment of ADHD under the FDA’s 505(b)(2) pathway.
About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING) is a biopharmaceutical company utilizing its proprietary Precision Timed Release™ platform technology to build and advance a pipeline of next-generation pharmaceutical products designed to improve patient outcomes in conditions characterized by burdensome daily dosing and suboptimal therapeutic coverage. Cingulate’s lead candidate, CTx-1301, is in late-stage development for ADHD, with additional candidates in anxiety and other neuropsychiatric indications. Cingulate is headquartered in Kansas City, Kansas. 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, the potential approval and commercialization of CTx-1301 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 & Media Contact
Thomas Dalton, Vice President, Corporate Communications
Cingulate Inc.
Email: tdalton@cingulate.com | Phone: (913) 942-2301
FAQ
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