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Cingulate Submits ADHD Drug NDA, Eyes 2026 FDA Decision

Cingulate submits NDA for CTx-1301 ADHD treatment with Precision Timed Release technology. FDA decision expected 2026, potential breakthrough in once-daily dosing.

This development matters because ADHD affects millions of children and adults worldwide, many of whom struggle with current treatment options that require multiple daily doses or cause inconsistent symptom control. Cingulate's Precision Timed Release technology promises true once-daily dosing that could significantly improve medication adherence and quality of life for patients. If approved, CTx-1301 would represent the first product from this innovative platform, potentially setting a new standard in ADHD treatment while opening doors for similar approaches in other psychiatric conditions like anxiety disorders. The company's progress also signals ongoing innovation in neuropsychiatric pharmaceuticals, addressing substantial unmet needs in mental healthcare.