FDA accepts Cingulate's NDA for CTx-1301 in ADHD; PDUFA date May 31, 2026

Cingulate Inc.

FDA accepted NDA for CTx-1301 (dexmethylphenidate), a once-daily PTR stimulant for ADHD in children and adults, under 505(b)(2) pathway.
PDUFA target action date is May 31, 2026; acceptance confirms submission sufficiently complete for substantive review.
Phase 3 trials showed large effect sizes on PERMP, AISRS, ADHD-RS-5, CGI scales; no serious treatment-emergent adverse events.
Commercial readiness: process transfer and scale-up completed with Bend Bio Sciences; AI-driven omnichannel platform with Indegene launched.
Early payer research indicates strong formulary receptivity for once-daily CTx-1301, aligning with adherence priorities in ADHD care.

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