ADHD Drug CTx-1301 Receives Complete Response Letter

Company says the agency requested additional Chemistry, Manufacturing and Controls information.

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Cingulate's CTx-1301 received a Complete Response Letter from the FDA regarding its New Drug Application for ADHD treatment.
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The FDA's feedback focused on Chemistry, Manufacturing and Controls requests, with no current concerns about clinical safety or efficacy.
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Cingulate plans to submit the requested information to the FDA, with related CMC work already in progress.
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CTx-1301 is designed as a once-daily, multi-core tablet for timed release of dexmethylphenidate throughout the day.
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The FDA accepted the NDA for review in October 2025, with a target action date of May 31, 2026, but CTx-1301 remains investigational.