Cingulate Inc. CING
Cingulate Inc. (Nasdaq: CING) is a CNS/neurology/psychiatry drug developer. Its lead program, CTx-1301 (dexmethylphenidate, PTR platform), is in Phase 3 for ADHD. Its next catalyst on record is CTx-1301: NDA resubmission following completion of requested CMC work (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: CTx-1301 — NDA resubmission following completion of requested CMC work (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| CTx-1301 (dexmethylphenidate) | ADHD | small molecule | Phase 3 |
| CTx-1302 (dextroamphetamine) | ADHD | small molecule | Pre-clinical |
Recent results and decisions
- Jun 2, 2026CRL FDA issued a Complete Response Letter for the CTx-1301 NDA, citing CMC information requests with no current clinical safety or efficacy concerns.
the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).
Filing - Nov 13, 2025met Pivotal Phase 3 of CTx-1301 met its primary endpoint with dose-dependent improvements on ADHD-RS-5 and CGI-S (presented at AACAP; no numbers given).
CTx-1301 met its primary endpoint, demonstrating dose-dependent improvements on the ADHD ratings scale 5 (ADHD-RS-5), and Clinical Global Impression-Severity (CGI-S) scales, and demonstrated the ability to deliver symptom relief with the convenience of once-daily dosing.
Filing - Nov 10, 2025accepted FDA accepted the CTx-1301 NDA for review with a PDUFA target action date of May 31, 2026.
the U.S. Food and Drug Administration’s (FDA) acceptance of Cingulate’s New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl) and assignment of a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
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- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.