Cingulate Inc.
CRL Confirmed
CTx-1301
Attention Deficit/Hyperactivity Disorder (ADHD)
Resolved
35days ago
FDA decision Β· Jun 2, 2026
What's at stake An FDA complete response letter on CTx-1301 for Attention Deficit/Hyperactivity Disorder (ADHD) is in focus around Jun 2, 2026.
β€œOn June 2, 2026, the Company announced that the FDA has issued a CRL for its New Drug Application for CTx-1301. The FDA identified specific Chemistry, Manufacturing and Controls information requests in the CRL and did not raise any current ”

Provenance

4 sources on file.

Link copied βœ“