US biopharmaceutical company Cingulate has announced the receipt of a $3m grant from a private foundation to expedite the development of a once-daily formulation of buspirone, CTx-2103, to treat anxiety.
The multi-release tablet utilises the company’s precision timed release (PTR) drug delivery platform.
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The grant will be distributed in three $1m tranches, with the first payment scheduled for 1 May 2025 and the others contingent on achieving specific product development milestones.
In return, the foundation will obtain future royalties from the tablet’s commercialisation, starting six months post the initial commercial sale. These royalties are set at $500,000 per quarter, with a $3.5m maximum cumulative royalty.
The tablet is currently under study for the treatment of anxiety and related disorders.
Buspirone, the active ingredient in CTx-2103, is an azapirone derivative and a 5-hydroxytryptamine receptor 1A (5-HT1A) partial agonist.
It was introduced as the first non-benzodiazepine anxiolytic for generalised anxiety disorder.
Buspirone’s advantage over other anxiolytic treatments is a potentially decreased side-effect profile, particularly the absence of risks related to physical dependence or withdrawal.
Cingulate CEO and chairman Shane Schaffer stated: “We thank the foundation for this funding for the development of CTx-2103, which advances Cingulate’s pipeline and illustrates the applicability of our PTR platform.
“Today, we are one step closer to providing the first once-daily medicine for the millions of patients worldwide who suffer from anxiety-related disorders, the most common mental health issue in America and around the world.”
Cingulate’s PTR technology incorporates an erosion barrier layer (EBL), which controls the release of the drug at pre-defined times.
The company is developing other product candidates for anxiety disorders and attention deficit hyperactivity disorder (ADHD) using its PTR platform.
In 2023, Cingulate entered a joint commercialisation deal with Indegene, a life sciences commercialisation company, for ADHD therapy CTx-1301 (dexmethylphenidate).
