The Food and Drug Administration recently approved a new ADHD medication from Otsuka called centanafadine, marking a significant development in treatment options for attention-deficit/hyperactivity disorder. The approval comes as another investigational drug, Cingulate’s CTx-1301, continues working through the regulatory process after receiving a complete response letter from the agency earlier this year.
CTx-1301 utilizes dexmethylphenidate, an established ADHD medication, paired with a proprietary Precision Timed Release system. The technology releases the active ingredient three times throughout the day from a single dose, potentially eliminating the need for multiple daily administrations and reducing the rebound effects that often accompany traditional stimulant formulations.
Regulators accepted Cingulate’s New Drug Application last October, with a target action date set for May 31. However, the agency sent a complete response letter in early June, requesting additional information about chemistry, manufacturing, and controls. The company has stated it is working to address these concerns.
Clinical testing included a Phase 3 study involving 103 pediatric patients aged 6 to 17. Participants received one of three doses of CTx-1301 or a placebo once daily over five weeks, with at least two weeks at the target dose. The trial met its primary endpoint, showing improvement on the ADHD Rating Scale-5, and researchers reported the safety profile aligned with other stimulant medications used to treat ADHD.
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An adult study enrolled 21 participants aged 18 to 55 in a dose-optimization period lasting five weeks, followed by a week of randomized treatment. While the study did not meet its primary efficacy endpoint, researchers observed a trend toward improvement on performance measures. The medication was well tolerated with no reports of insomnia.
Centanafadine works differently from traditional ADHD medications. As a norepinephrine, dopamine, and serotonin reuptake inhibitor, it represents a novel nonstimulant mechanism that could appeal to patients seeking alternatives to stimulant-based treatments. The extended-release capsule is approved for use in children, adolescents, and adults.
Centanafadine’s entry into the market and the ongoing development of CTx-1301 reflect broader efforts to expand options for the millions of Americans managing ADHD. Stimulant medications remain widely prescribed but carry concerns about abuse potential and side effects, creating demand for alternatives that may offer different risk profiles.
Nonstimulant agents like centanafadine could become valuable options for patients who do not respond well to stimulants or prefer to avoid them.
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Long-term data on effectiveness and safety will be important to monitor as these treatments enter broader use.
If eventually approved, CTx-1301 would introduce a different approach by reformulating an existing stimulant with technology designed to smooth out drug delivery throughout the day.
Whether this addresses meaningful unmet needs compared to currently available extended-release formulations remains to be seen as the company works to satisfy the FDA’s outstanding questions.