ADHD Drug CTx-1301 Receives Complete Response Letter - Takeaways - MDSpire

ADHD Drug CTx-1301 Receives Complete Response Letter

  • By

  • Kathryn Wighton

  • June 2, 2026

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  • 1

    Cingulate's CTx-1301 received a Complete Response Letter from the FDA regarding its New Drug Application for ADHD treatment.

  • 2

    The FDA's feedback focused on Chemistry, Manufacturing and Controls requests, with no current concerns about clinical safety or efficacy.

  • 3

    Cingulate plans to submit the requested information to the FDA, with related CMC work already in progress.

  • 4

    CTx-1301 is designed as a once-daily, multi-core tablet for timed release of dexmethylphenidate throughout the day.

  • 5

    The FDA accepted the NDA for review in October 2025, with a target action date of May 31, 2026, but CTx-1301 remains investigational.

Original Source(s)

ADHD Drug CTx-1301 Receives Complete Response Letter

  • by Kathryn Wighton

  • June 2, 2026

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