Curated News
By: NewsRamp Editorial Staff
June 17, 2025
Cingulate Inc. Pioneers ADHD Treatment with CTx-1301, Aims for FDA Nod
TLDR
- Cingulate Inc.'s CTx-1301 offers a competitive edge in the $22 billion ADHD market with its once-daily, rapid-onset therapy, potentially outperforming current treatments.
- CTx-1301's Phase 3 results show significant ADHD-RS-5 scale improvements, with a flexible dosing regimen that enhances adherence, supporting its mid-2025 NDA submission to the FDA.
- CTx-1301 could improve daily life for millions with ADHD by providing a more effective and convenient treatment option, marking a step forward in mental health care.
- Discover how Cingulate Inc.'s innovative CTx-1301, with its promising Phase 3 results, could revolutionize ADHD treatment by offering flexibility and efficacy in one daily dose.
Impact - Why it Matters
The advancement of CTx-1301 by Cingulate Inc. represents a significant leap forward in ADHD treatment, offering a potential solution to the limitations of current therapies. For patients, this means the possibility of a more effective, convenient once-daily medication that doesn't require booster doses and can be taken with or without food. For the healthcare industry and investors, it signals a promising shift towards innovative treatments in a lucrative market, highlighting the importance of supporting pharmaceutical advancements that address real patient needs.
Summary
Cingulate Inc. (NASDAQ: CING) has captured attention with its lead ADHD asset, CTx-1301, following coverage initiation by Stonegate Capital Partners. This innovative once-daily stimulant therapy promises rapid onset and sustained efficacy, addressing the $22 billion U.S. ADHD market's need for treatments beyond current limitations. Phase 3 pediatric study results for CTx-1301 showed significant improvements on the ADHD-RS-5 scale within five weeks, with the high-dose food effect study confirming its flexibility in administration. These advancements support the drug's efficacy and safety, aiming for an FDA NDA submission in mid-2025. Despite a reported net loss of $3.8M in Q1 2025, Cingulate is exploring strategic financing to bolster its NDA filing and pre-launch activities. The potential approval of CTx-1301 could revolutionize ADHD treatment and significantly impact Cingulate's financial and the pharmaceutical industry's landscape. This development offers hope to millions seeking more effective ADHD treatments, with the healthcare community and investors closely monitoring progress. The story highlights the transformative potential of CTx-1301 in a market eager for innovation, amplified by NewsRamp in collaboration with Evertise Studios.
Source Statement
This curated news summary relied on content disributed by Evertise Digital. Read the original source here, Cingulate Inc. Pioneers ADHD Treatment with CTx-1301, Aims for FDA Nod
