ADHD Drug CTx-1301 Receives Complete Response Letter
Company says the agency requested additional Chemistry, Manufacturing and Controls information.
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By
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Kathryn Wighton
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June 2, 2026
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Objective:
To report on the FDA's Complete Response Letter regarding CTx-1301 for ADHD.
Key Findings:
- The FDA's feedback was limited to specific CMC information requests.
- CTx-1301 is designed as a once-daily, multi-core tablet for ADHD.
- The product is under evaluation via the FDA’s 505(b)(2) pathway.
Interpretation:
N/A
Limitations:
- The FDA letter was not released to the public.
- CTx-1301 remains investigational and is not approved for ADHD.
Conclusion:
N/A
