FDA Clears Click Therapeutics' Motivista App for Negative Symptoms of Schizophrenia

Click Therapeutics said on Monday that the US Food and Drug Administration has cleared Motivista, a prescription smartphone app, to treat the negative symptoms of schizophrenia, according to the company's announcement. The New York company described the 510(k) clearance as the first FDA authorization of any treatment for those symptoms.

The FDA's 510(k) database lists Motivista (CT-155) with Click Therapeutics as the applicant, a decision date of July 30, 2026, and a finding of substantial equivalence. The device falls under regulation 882.5801, the classification for computerized behavioral therapy devices for psychiatric disorders. The company made its announcement on October 5.

What the clearance covers

According to Click, Motivista is cleared as an adjunct to clinician-managed outpatient care, including antipsychotic therapy, for patients 18 and older whose positive symptoms are clinically stable. The company said it is not intended as a standalone therapy, and its announcement lists exclusions including serious suicide risk and unmanaged positive symptoms.

The app delivers a 16-week program of cognitive and behavioral exercises, using about an hour a week, Healio reported.

The trial behind it

Click said the clearance was supported by CONVOKE (NCT05838625), a Phase 3 randomized trial that compared Motivista with a digital control app. On the trial's primary measure, the CAINS-MAP scale at 16 weeks, the Motivista group improved by 6.8 points and the control group by 4.2 points, which the company called a 62% relative improvement (p=0.0003).

Healio, citing the company, reported that the trial enrolled 457 adults. It reported serious adverse events in 1.3% of the treatment group and 2.2% of the control group, none of which investigators considered related to treatment. Click's announcement says the trial results were published in JAMA Network Open; the company's publications page lists the paper, by Pratap and colleagues, with a date of September 25, 2026. Earlier results had been presented at the 2025 ECNP Congress, according to the company.

Engagement was similar in both arms: 70.4% of Motivista users and 76.5% of control users kept strong adherence through week 15, the company said.

Next steps

Click said Motivista is being prepared for broader commercial availability and gave no launch date. Healio reported that access will depend on coverage decisions made state by state.

"This FDA authorization represents an important step forward for a patient population that has long been underserved," said David Benshoof Klein, Click's founder and chief executive, in the announcement. Richard DeNunzio, the company's chief commercial officer, said the product offered value that "we believe payers and state Medicaid programs should want to cover."

Motivista was developed under the name CT-155 with Boehringer Ingelheim. In April 2026 the two companies announced a Series D investment and funding to advance its commercialization, according to Click's newsroom. Click's newsroom lists two earlier FDA authorizations: Rejoyn (CT-152), announced with Otsuka in April 2024, and CT-132 for episodic migraine, announced in April 2025.