Cingulate is a clinical-stage biopharmaceutical company developing next-generation ADHD medications, with no approved products or revenue. The company's core asset is its proprietary Precision Timed Release (PTR) drug delivery platform, which uses a proprietary Erosion Barrier Layer to release a drug in multiple distinct pulses at pre-defined intervals within a single tablet. Cingulate's lead candidate, CTx-1301 (dexmethylphenidate), delivers three timed pulses — 35% immediately, 45% at three hours, and 20% at seven hours — designed to provide full active-day coverage in a single dose and eliminate the afternoon booster dose that up to 60% of current patients require. Cingulate submitted an NDA to the FDA in July 2025 under the 505(b)(2) pathway, with a PDUFA target action date of May 31, 2026. Beyond CTx-1301, Cingulate has two earlier-stage candidates: CTx-1302, applying the same PTR approach to dextroamphetamine for ADHD, and CTx-2103, a once-daily buspirone formulation for generalized anxiety disorder — both awaiting additional capital to advance. Cingulate operates as a lean, asset-light company with 14 employees, outsourcing manufacturing to Bend Biosciences and planning to commercialize through Indegene and IQVIA rather than building its own sales force. The PTR platform is licensed from BDD Pharma, with milestone payments and low-to-mid single-digit royalties owed on net sales, and is protected by patents extending to 2042-2043.
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