NEW YORK — October 5, 2026
Click Therapeutics, Inc. announced that the U.S. FDA has granted 510(k) clearance for Motivista (CT-155), a prescription digital therapeutic indicated for the treatment of negative symptoms of schizophrenia as an adjunct to clinician-managed outpatient care, including antipsychotic therapy. The authorization applies to adults 18 years and older with clinically stable positive symptoms and makes Motivista the first FDA-authorized treatment specifically indicated for negative symptoms of schizophrenia in the United States. The clearance provides Click with a new digital treatment option for symptoms such as low motivation, reduced ability to experience pleasure and social withdrawal, which can remain difficult to treat even when positive symptoms are controlled.
Motivista Demonstrates Efficacy in Phase 3 CONVOKE Study
The FDA authorization was supported by results from the Phase 3 CONVOKE study, which evaluated Motivista in adults with schizophrenia experiencing negative symptoms. At 16 weeks, patients treated with Motivista achieved a 6.8-point improvement in CAINS-MAP compared with a 4.2-point improvement with a digital control application, representing a 62% relative improvement, with a Cohen’s D effect size of -0.36 and p=0.0003. The study also reported a favorable safety profile, with no serious treatment-related adverse events. Sustained engagement was observed throughout the trial, with 70.4% of Motivista users maintaining strong adherence through week 15, while participants spent approximately one hour per week using the digital therapeutic.
Smartphone-Based Therapy Targets Persistent Schizophrenia Symptoms
Motivista is delivered through a smartphone and combines elements of evidence-based psychosocial therapies with digital therapeutic methods designed to address negative symptoms. The treatment is intended to complement clinician-managed pharmacotherapy rather than replace antipsychotic medication. Negative symptoms including avolition, anhedonia and asociality affect a substantial proportion of people living with schizophrenia and can contribute to impaired work, relationships and daily functioning. Click developed Motivista with input from patients and clinicians and is continuing to evaluate long-term engagement and durability through an open-label extension study. The company is preparing the product for broader commercial availability while working with healthcare providers, payers and patient advocacy organizations to expand access.
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Click Therapeutics Expands FDA-Regulated Digital Therapeutics
The Motivista clearance expands Click Therapeutics’ portfolio of FDA-regulated prescription digital treatments and establishes a new treatment category for negative symptoms of schizophrenia. The company is developing additional digital therapeutics using cognitive, behavioral and neuromodulatory mechanisms across psychiatry, neurology, oncology, immunology and cardiometabolic diseases. Motivista’s authorization is specifically limited to adults with clinically stable positive symptoms and is not intended as a standalone treatment or for acute schizophrenia symptoms. The treatment is also not designed for patients with unmanaged positive symptoms or serious suicide risk. With FDA clearance now secured, Click Therapeutics is moving Motivista toward broader commercial availability while seeking to increase access to a digital treatment addressing one of the most persistent unmet needs in schizophrenia care.
Source:Click Therapeutics, press release
