USFDANov 10, 2026, 08:16 AM
Cingulate to Resubmit CTx-1301 NDA by January 2027 After FDA CRL
AI Summary
Cingulate Inc. announced an update on its CTx-1301 new drug application (NDA) following a Complete Response Letter (CRL) from the FDA. The company is preparing to resubmit the NDA between December 2026 and January 2027, having substantially completed the requested chemistry, manufacturing, and controls (CMC) information. The CRL did not raise concerns about clinical safety or efficacy. Cingulate anticipates a potential commercial launch in the third quarter of 2027, pending FDA approval and classification of the resubmission.
Key Highlights
- Cingulate Inc. to resubmit New Drug Application (NDA) for CTx-1301 between December 2026 and January 2027.
- FDA issued a Complete Response Letter (CRL) for CTx-1301 NDA on June 1, 2026.
- CRL requested additional chemistry, manufacturing, and controls (CMC) information; no clinical safety or efficacy concerns.
- Manufacturing work to address CMC requests is substantially complete.
- Anticipated commercial launch of CTx-1301 could commence in Q3 2027, subject to FDA approval.
- FDA review goal for resubmission is two months (Class 1) or six months (Class 2).
Price Impact
More from CING