Cingulate completes final FDA-required food effect study for CTx-1301; NDA submission targeted mid-2025

Cingulate Inc.

Completed food effect study for CTx-1301 (dexmethylphenidate) in 26 healthy adults using 50mg dose.
No serious adverse events reported; data readout on bioavailability with/without food expected Q2 2025.
Final FDA-required study before NDA submission, which is planned for mid-2025.
2022 study with 25mg dose already showed CTx-1301 can be taken with or without food.
CTx-1301 designed as once-daily stimulant for ADHD covering entire active day.

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