Click Therapeutics cleared Motivista under 510(k) on October 5. The prescription smartphone app treats the negative symptoms of schizophrenia in patients 18 and older, as an adjunct to clinician-managed antipsychotic therapy.
The label limits use to patients whose positive symptoms are clinically stable. Motivista works on motivation deficits and social withdrawal through tailored goal setting, cognitive restructuring and social skills training. It is the first FDA-authorized treatment indicated specifically for negative symptoms in the US.
The product carried the name CT-155 until this year. Boehringer Ingelheim put $50 million into Click's Series D in April 2026 along with commercial funding, then transferred full product responsibility back to Click.
A psychiatric indication with no approved drug behind it is a hard place to find a predicate. Getting there on a 510(k) rather than a De Novo suggests the digital therapeutics predicate ladder reaches further than most founders assume.