Cingulate’s CTx-1301 is being developed for the treatment of attention-deficit/hyperactivity disorder. Credit: https://www.scientificanimations.com / Wikimedia.

Biopharmaceutical firm Cingulate and life sciences commercialisation firm Indegene have entered into a joint commercialisation deal for the former’s attention-deficit/hyperactivity disorder (ADHD) therapy CTx-1301 (dexmethylphenidate).

The agreement is intended for providing commercial support for CTx-1301, after receiving the US Food and Drug Administration (FDA) approval.

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It covers cross-functional services through an omnichannel marketing approach designed for the management of the pre-commercial support during the Phase III clinical trials as well as the nationwide commercialisation of CTx-1301.

The new investigational treatment CTx-1301 is being developed as a once-daily stimulant medication for the treatment of ADHD.

Recently, Cingulate commenced its first Phase III trial which has been designed for evaluating CTx-1301’s safety and efficacy.

The company expects to receive data from the trial in the third quarter of this year.

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Additionally, it intends to start a fixed-dose, placebo-controlled, pivotal Phase III trial in ADHD paediatric and adolescent patients in the middle of this year.

Cingulate chairman and CEO Shane Schaffer said: “This agreement provides a clear path to commercialise CTx-1301, upon FDA approval, designed specifically to tackle the unmet needs of this $20bn market by providing the first true, entire-active-day treatment for ADHD.

“But the clinical success of a potential treatment can only be realized with commercial excellence, making this partnership between Cingulate and Indegene a critical step for our company.

“We believe Indegene provides a comprehensive solution combining sales professionals and field medical personnel, and its AI-driven omnichannel marketing suite is unparalleled in the industry, making them the right partner at the right time to help Cingulate redefine the ADHD treatment paradigm.”

The company stated that the deal covers most facets of the commercialisation process, including medical communications, marketing, medical affairs, sales, commercial operations support, regulatory, pricing, reimbursement, market access (PRMA), and pharmacovigilance.