Cingulate Advances ADHD Treatment CTx-1301 Toward Potential 2026 Launch Following FDA Acceptance

Cingulate Inc. (NASDAQ: CING) continues advancing CTx-1301 toward becoming a commercial ADHD franchise following third quarter 2025 results that highlight significant regulatory and operational progress. The company achieved several key milestones including FDA acceptance of the CTx-1301 New Drug Application with a May 31, 2026 Prescription Drug User Fee Act target action date. This regulatory advancement represents a critical step toward potential commercialization in the substantial U.S. ADHD market.

The NDA submission includes adult and pediatric Phase 3 data demonstrating rapid onset and entire active-day symptom control, along with required clinical and chemistry, manufacturing, and controls elements. The filing follows the 505(b)(2) regulatory pathway, which typically allows for streamlined development based on existing safety data for approved drugs. Cingulate also received a small-business PDUFA fee waiver, preserving capital as the company prepares for potential approval and launch activities.

CTx-1301 utilizes Cingulate's proprietary Precision Timed Release platform to deliver three timed releases of dexmethylphenidate in a once-daily tablet designed to provide both rapid onset and full active-day coverage. The company's pipeline extends beyond CTx-1301, with CTx-1302 advancing toward development for patients who respond better to amphetamine-based stimulants and CTx-2103 progressing for anxiety disorders. These programs demonstrate the scalability of the PTR platform across large neuropsychiatric indications and support Cingulate's broader strategic objectives.

Financially, Cingulate reported $6.1 million in cash and cash equivalents and approximately $1.6 million in working capital as of third quarter 2025. Research and development expenses increased to $2.8 million from $1.4 million year-over-year, while general and administrative expenses rose to $3.1 million from $1.9 million, driven by Phase 3 activities, NDA support costs, and commercial planning. Net loss widened to $7.3 million compared to $4.1 million in third quarter 2024, with $13.6 million of net cash used in operations over the first nine months of 2025.

Following the quarter's end, Cingulate secured a $6.0 million unsecured promissory note that extends the company's cash runway into second quarter 2026. Management continues evaluating additional equity, debt, and partnership options to fund launch and early commercialization efforts. The company also strengthened its leadership team with the appointment of industry veteran Bryan Downey as Chief Commercial Officer to lead launch preparation and go-to-market strategy. Downey brings more than 25 years of commercial experience and will oversee execution of the Indegene partnership, including market access, omnichannel engagement, and field deployment ahead of potential 2026 approval and launch.

Cingulate's progress includes execution of an exclusive commercial supply agreement with Bend Bio Sciences to secure U.S. manufacturing capacity ahead of potential launch. This strategic partnership ensures production capabilities are in place to support commercialization efforts if CTx-1301 receives FDA approval. The company's focused commercial strategy and PTR platform position CTx-1301 to address unmet needs in the large U.S. ADHD market as preparations continue for a potential 2026 launch, subject to regulatory approval.