Cingulate Inc., (NASDAQ: CING) disclosed that the US FDA issued a Complete Response Letter (CRL) for the New Drug Application for CTx-1301 (dexmethylphenidate HCl), a once-daily formulation under development for the treatment of attention deficit/hyperactivity disorder (ADHD). The CRL did not identify clinical safety or efficacy concerns, narrowing the outstanding issues to Chemistry, Manufacturing and Controls information requests. The company said it plans a prompt resubmission incorporating the requested manufacturing and controls data, with work described as already underway with its manufacturing partner.

CTx-1301 is a small molecule dopamine and norepinephrine reuptake inhibitor. The active ingredient, dexmethylphenidate HCl, is the pharmacologically active d-enantiomer of methylphenidate and is not a novel molecular entity. The clinical differentiation of Cingulate CTx-1301 rests on its delivery architecture rather than its pharmacology. The tablet employs Cingulate’s proprietary Precision Timed Release platform, designed to produce three precisely timed releases of active medication across the day from a single oral dose, aiming to provide rapid onset and full active-day duration without multiple administrations. The NDA was submitted under the FDA’s 505(b)(2) regulatory pathway, which permits reliance on existing safety and efficacy data for the active moiety. ADHD affects more than 20 million diagnosed patients in the United States, with adult prevalence described as the fastest-growing segment of the market.

The molecular compound underlying CTx-1301 is off-patent, requiring no external licensing for the active pharmaceutical ingredient. The proprietary element is the PTR delivery platform, developed internally by Cingulate. The Erosion Barrier Layer formulation, marketed as Oralogik, is licensed from BDD Pharma and forms the functional core of the timed-release mechanism.

The FDA accepted the CTx-1301 NDA for substantive review in October 2025, assigning a Prescription Drug User Fee Act target action date of May 31, 2026. The CRL was issued proximate to that date.

Source: Cingulate Inc. press release via GlobeNewswire, June 2, 2026. This report is based solely on information contained in the referenced company disclosure.