NEW YORK, Oct. 05, 2026 (GLOBE NEWSWIRE) — Click Therapeutics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (marketing authorization) for Motivista, a prescription digital therapeutic (PDT) indicated for the treatment of negative symptoms of schizophrenia, as an adjunct to clinician-managed outpatient care, including antipsychotic therapy in patients 18 years of age and older with clinically stable positive symptoms. Motivista is the first FDA-authorized treatment indicated specifically for the treatment of negative symptoms of schizophrenia in the United States.

The authorization marks a significant milestone for millions of people living with schizophrenia. While existing treatments primarily treat positive symptoms including hallucinations, delusions and disorganized thinking, most patients continue to struggle with negative symptoms. These include low motivation, reduced ability to experience and anticipate pleasure, and social withdrawal, which can make it difficult to engage in work, relationships, and daily activities.1 These symptoms affect most people living with schizophrenia and are among the most disabling and difficult-to-treat aspects of the disease. Until now, there have been no FDA-authorized treatments indicated specifically for these symptoms, leaving millions of patients without options.

The FDA’s decision was supported by data from the Phase III CONVOKE study (NCT05838625), which evaluated Motivista in patients 18 years of age and older with schizophrenia experiencing negative symptoms. Results from the study were recently published in JAMA Network Open. Patients using Motivista achieved significantly greater improvements in negative symptom severity than those using a digital control application. Improvement was measured by CAINS-MAP at 16 weeks, where treatment with Motivista resulted in a 6.8-point improvement compared to a 4.2-point improvement in the digital control arm, representing a 62% relative improvement (least square means; Cohen’s D effect size of -0.36; p=0.0003).2 Motivista also demonstrated a favorable safety profile, with no serious treatment-related adverse events reported during the study.

“For decades, patients living with schizophrenia and the clinicians who care for them have had few options for addressing negative symptoms, despite the profound impact these symptoms can have on everyday life,” Founder and CEO of Click Therapeutics David Benshoof Klein said. “This FDA authorization represents an important step forward for a patient population that has long been underserved and demonstrates the potential of new digital treatment approaches to address some of the most persistent challenges associated with schizophrenia.”

Negative symptoms of schizophrenia — including avolition, anhedonia, and asociality — represent one of the most costly and disabling aspects of the disease. Schizophrenia affects an estimated 24 million people worldwide, and approximately 60% of individuals living with the condition experience negative symptoms.1,3 These symptoms often persist even when other aspects of the disease are well controlled and are associated with higher healthcare utilization, increased costs, and poorer long-term outcomes.4

Motivista is delivered through a smartphone and is designed to complement schizophrenia treatment as an adjunct to clinician-managed antipsychotic therapy. Developed in partnership with patients and clinicians, the therapeutic combines key elements of evidence-based psychosocial therapies with unique digital methods to treat negative symptoms. Even though the negative symptoms of schizophrenia make it hard for patients to feel motivated, Motivista’s patient-centric design resulted in strong patient engagement and adherence. Data from the Phase III CONVOKE study showed high sustained app usage through the end of the trial, with 70.4% of Motivista users and 76.5% of digital control users maintaining strong adherence through week 15.2 In total, participants in the Motivista arm spent approximately an hour per week using the treatment, which is comparable to the typical time spent in conventional, in-person psychotherapy. Additionally, Click is building a growing body of long-term evidence, including an open-label extension (OLE, NCT06067984) study, that delivers additional results on engagement and durability of effect.

“These engagement results are encouraging because they suggest a new way to address one of the most challenging aspects of schizophrenia, delivered in a patient friendly format that we expect patients will turn to day-to-day,” said Richard DeNunzio, Chief Commercial Officer at Click Therapeutics. “By helping patients engage more fully in daily life, Motivista has the potential to create meaningful value for patients, providers, and the healthcare system. That’s the kind of value we believe payers and state Medicaid programs should want to cover, to deliver access to this breakthrough treatment to patients at scale.”

Motivista is currently being prepared for broader commercial availability, and Click Therapeutics is actively working with payers, providers, and patient advocacy organizations to expand access to the treatment. Visit motivista.com for more information.

Indication

Motivista is a prescription digital therapeutic indicated for the treatment of negative symptoms of schizophrenia as an adjunct to clinician-managed outpatient care, including antipsychotic therapy, in patients 18 years of age and older with clinically stable positive symptoms.

Safety Information

Motivista is not designed to treat patients who present a serious suicide risk such as patients with active suicidal ideation with method or intent within the last 3 months or patients with suicidal behavior within the last 6 months or presentation with suicide risk (based on opinion of the clinician). Motivista is not designed to treat patients with unmanaged positive symptoms. Motivista is not intended to be used as a standalone therapy. It is meant to be used as an adjunct to clinician-managed pharmacotherapy for schizophrenia. Motivista does not replace or substitute the patient’s medication, including medication for treatment of schizophrenia. Patients should continue their current treatment as directed. Motivista cannot send alerts or warnings to the prescriber. If patients feel that their schizophrenia symptoms are worsening or if they have feelings or thoughts of harming themselves or others, they should stop using the app and contact a healthcare provider, dial 988 (for mental health emergencies) or 911 (for medical emergencies), or go to the nearest emergency room immediately. A possibly-related Treatment Emergent Adverse Event (TEAE) was observed during Motivista’s pivotal clinical study. Two events of “psychotic disorder” were considered possibly related to Motivista in a single participant, though neither led to study discontinuation.

The safety and effectiveness of Motivista have not been evaluated in: patients with positive symptoms that are not well-controlled; patients not taking antipsychotic medication; patients with severe cognitive impairment who are unable to use the app independently; patients who present a serious suicide risk, or; patients less than 18 years of age. Motivista is not intended to be used for acute symptoms of schizophrenia.

There are no contraindications to using Motivista.

About Click Therapeutics

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click’s treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options.

Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn.

References

  1. Correll CU, Schooler NR. Negative symptoms in schizophrenia: a review and clinical guide for recognition, assessment, and treatment. Neuropsychiatr Dis Treat. 2020;16:519–534.
  2. Pratap A, et al. Topline results from CONVOKE: a first-in-class Phase 3 RCT evaluating a digital therapeutic for experiential negative symptoms of schizophrenia in adults. Abstract presented at: European College of Neuropsychopharmacology Congress 2025; October 11-14, 2025, Amsterdam, the Netherlands.
  3. WHO. Schizophrenia. Available from: https://www.who.int/news-room/fact-sheets/detail/schizophrenia.
  4. Kadakia A, Catillon M, Fan Q, et al. The economic burden of schizophrenia in the United States. J Clin Psychiatry. 2022 Oct 10;83(6):22m14458.

Media Contact
Karolina Palac
E-Mail: pr@clicktherapeutics.com
Phone Number: +1 347-988-4576


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