- Cingulate Inc filed for an IPO, penciling in a modest $58 million raise, and expects to list on NASDAQ under CING ticker.
- Cingulate has a Phase 3-ready attention deficit hyperactivity disorder (ADHD) program in addition to a follow-up candidate soon to enter human trials and a third program in preclinical development for anxiety.
- The company says in its S-1 filing that most ADHD meds currently approved are stimulants taken in the morning with quick-acting effects, leaving patients needing additional pills in the afternoon after they experience a "crash."
- Cingulate's lead candidate, CTx-1301, is designed to slowly release its active ingredients in three phases throughout the day.
- The first portion is an immediate release, accounting for about 35% of the total medicine contained in the pill, and is delivered over 30 minutes.
- After three to four hours, the second part comprises 45% of the total and is delivered over 90 minutes.
- These first two release schedules are comparable to some meds on the market, such as Focalin, Cingulate says, but CTx-1301 has a third timed-release built-in as a "booster," making up the remaining 20%.
- This booster releases about seven hours after taking the pill and enters the bloodstream over the following 30 minutes.
- The company plans to initiate Phase 3 trials in Q4 of 2021 and file a marketing application to the FDA in 1H of 2023.
- If approved, both CTx-1301 and CTx-1302 will compete against methylphenidate and amphetamine products to treat ADHD.
- The currently available products include Johnson & Johnson (NYSE:JNJ) owned Janssen's Concerta, Novartis AG's (NYSE:NVS) Focalin XR, and Takeda Pharmaceutical Co Ltd's (NYSE:TAK) Adderall XR and Vyvanse, which will lose exclusivity in 2023.
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