2 June 2026 - Cingulate today announced that the US FDA has issued a complete response letter for its new drug application for CTx-1301 (dexmethylphenidate hydrochloride) for the treatment of attention deficit/hyperactivity disorder.

The response identified specific Chemistry, Manufacturing and Controls information requests and did not raise any current concerns regarding the clinical safety or efficacy of CTx-1301. Cingulate expects a prompt submission to FDA of the requested information addressing issues raised.

Read Cingulate press release