Cingulate expects CTx-1301 NDA resubmission in Dec 2026-Jan 2027 after CMC-only CRL

Cingulate Inc.

FDA issued a Complete Response Letter for CTx-1301 on June 1, 2026, after accepting the NDA in October 2025 with a May 31, 2026 PDUFA date.
The CRL sought additional chemistry, manufacturing and controls information and raised no clinical safety or efficacy concerns, Cingulate said.
Cingulate and its contract manufacturer have substantially completed the CMC manufacturing work; NDA resubmission is expected between December 2026 and January 2027.
FDA would classify the resubmission as Class 1 with a 2-month review goal or Class 2 with a 6-month goal; launch could begin in Q3 2027 if approved.
CEO Shane J. Schaffer discussed the timeline in an Innovators with Jane King interview; CCO Bryan Downey presented commercialization plans at the Indegene Digital Summit.

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