Cingulate, gunning for pharma majors, seeks $58M to develop extended-release ADHD drugs

Can drug delivery technology equip Cingulate to win market share from Johnson & Johnson, Novartis and Takeda? That is the question facing investors as they weigh up whether to back Cingulate’s pitch to raise up to $58 million to bankroll its attack on the attention deficit hyperactivity disorder (ADHD) market.

Kansas-based Cingulate faces the challenge of muscling in on a market fought over by multiple big companies that have well-established brands. Takeda sells the amphetamine drug product Adderall XR, while J&J and Novartis sell extended-release formulations of methylphenidate under the brand names Concerta and Ritalin LA, respectively. According to Cingulate, the extended-release drugs account for 85% of sales of stimulants in ADHD.

Cingulate is betting it can take a slice of those sales by improving on the delivery of the stimulants. While existing products were approved as once-daily treatments, Cingulate says most patients need a booster dose of a short-acting stimulant in the early afternoon to get through to nighttime. 

The solution, as Cingulate sees it, is to combine three stimulant layers in single film-coated tablets. After an immediate-release section is eroded, barrier layers delay the release of the second and third waves of the stimulant. 

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Cingulate sees a range of benefits to providing up to 16 hours of activity from a single dose. Taking a second dose during the school day can be embarrassing for children and adolescents, according to Cingulate, and raises the risk of noncompliance. Cingulate sees opportunities to lower costs and the potential for abuse by removing the short-acting dose from treatment regimens.

The next few years could set Cingulate up to pitch those perceived benefits to patients, payers and physicians. Lead asset CTx-1301, Cingulate’s twist on methylphenidate, is set to enter phase 3 by the end of the year, putting the company on a path it expects to lead to a filing for FDA approval in the first half of 2023. A phase 3 trial of a second asset, based on amphetamine, is expected to start late next year and deliver data early in 2024.